Trial Outcomes & Findings for Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-2) (NCT NCT02422797)
NCT ID: NCT02422797
Last Updated: 2024-09-03
Results Overview
Percentage of participants with plasma HIV 1 RNA \< 50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior antiviral activity of switching to DTG+RPV once daily compared to continuation of CAR over 48 weeks in HIV-1 infected antiretroviral therapy (ART)-experienced participants. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
518 participants
Primary outcome timeframe
Week 48
Results posted on
2024-09-03
Participant Flow
The study was conducted at 60 centers in 11 countries.
518 participants were randomized and 2 participants withdrew before being exposed to study drug. The study included an Early Switch Phase, a Late Switch Phase, and a Continuation Phase.
Participant milestones
| Measure |
DTG + RPV
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Early Switch Phase (Up to Week 52)
STARTED
|
261
|
255
|
|
Early Switch Phase (Up to Week 52)
COMPLETED
|
245
|
239
|
|
Early Switch Phase (Up to Week 52)
NOT COMPLETED
|
16
|
16
|
|
Late Switch Phase (Week 52 to Week 148)
STARTED
|
245
|
239
|
|
Late Switch Phase (Week 52 to Week 148)
COMPLETED
|
222
|
221
|
|
Late Switch Phase (Week 52 to Week 148)
NOT COMPLETED
|
23
|
18
|
|
Continuation Phase(Week 148 to Week 410)
STARTED
|
208
|
204
|
|
Continuation Phase(Week 148 to Week 410)
COMPLETED
|
201
|
194
|
|
Continuation Phase(Week 148 to Week 410)
NOT COMPLETED
|
7
|
10
|
Reasons for withdrawal
| Measure |
DTG + RPV
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Early Switch Phase (Up to Week 52)
Adverse Event
|
11
|
1
|
|
Early Switch Phase (Up to Week 52)
Physician Decision
|
0
|
1
|
|
Early Switch Phase (Up to Week 52)
Lack of Efficacy
|
1
|
2
|
|
Early Switch Phase (Up to Week 52)
Lost to Follow-up
|
1
|
1
|
|
Early Switch Phase (Up to Week 52)
Protocol Violation
|
0
|
3
|
|
Early Switch Phase (Up to Week 52)
Reached stopping criteria
|
1
|
1
|
|
Early Switch Phase (Up to Week 52)
Withdrawal by Subject
|
2
|
7
|
|
Late Switch Phase (Week 52 to Week 148)
Physician Decision
|
0
|
1
|
|
Late Switch Phase (Week 52 to Week 148)
Adverse Event
|
10
|
6
|
|
Late Switch Phase (Week 52 to Week 148)
Lack of Efficacy
|
5
|
3
|
|
Late Switch Phase (Week 52 to Week 148)
Lost to Follow-up
|
2
|
2
|
|
Late Switch Phase (Week 52 to Week 148)
Withdrawal by Subject
|
2
|
6
|
|
Late Switch Phase (Week 52 to Week 148)
Reached stopping criteria
|
1
|
0
|
|
Late Switch Phase (Week 52 to Week 148)
Protocol Violation
|
3
|
0
|
|
Continuation Phase(Week 148 to Week 410)
Investigator discretion
|
1
|
2
|
|
Continuation Phase(Week 148 to Week 410)
Lost to Follow-up
|
0
|
3
|
|
Continuation Phase(Week 148 to Week 410)
Subject reached protocol-defined stopping criteria
|
1
|
0
|
|
Continuation Phase(Week 148 to Week 410)
Withdrawal by Subject
|
4
|
1
|
|
Continuation Phase(Week 148 to Week 410)
Protocol Violation
|
0
|
1
|
|
Continuation Phase(Week 148 to Week 410)
Lack of Efficacy
|
1
|
1
|
|
Continuation Phase(Week 148 to Week 410)
Adverse Event
|
0
|
2
|
Baseline Characteristics
Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-2)
Baseline characteristics by cohort
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
Total
n=516 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.3 Years
STANDARD_DEVIATION 11.34 • n=99 Participants
|
43.2 Years
STANDARD_DEVIATION 9.64 • n=107 Participants
|
43.3 Years
STANDARD_DEVIATION 10.52 • n=206 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
199 Participants
n=99 Participants
|
198 Participants
n=107 Participants
|
397 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Central/South Asian Heritage
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Japanese/East Asian (EA) Heritage (H.)/South EA H.
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
13 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
223 Participants
n=99 Participants
|
212 Participants
n=107 Participants
|
435 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American/ African H. and White
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: The Analysis was performed on the Intent-to-Treat Exposed (ITT-E) population which consisted of all randomly assigned participants who received at least one dose of study drug.
Percentage of participants with plasma HIV 1 RNA \< 50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior antiviral activity of switching to DTG+RPV once daily compared to continuation of CAR over 48 weeks in HIV-1 infected antiretroviral therapy (ART)-experienced participants. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm
|
94 Percentage of participants
|
94 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 24 and 48Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunological activity of DTG + RPV once daily compared to continuation of CAR. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48
Week 24
|
42.0 Cells per millimeter cube (mm^3)
Standard Deviation 172.29
|
42.4 Cells per millimeter cube (mm^3)
Standard Deviation 164.85
|
|
Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48
Week 48
|
28.0 Cells per millimeter cube (mm^3)
Standard Deviation 169.35
|
18.4 Cells per millimeter cube (mm^3)
Standard Deviation 159.34
|
SECONDARY outcome
Timeframe: Week 24Population: ITT-E Population
Percentage of participants with plasma HIV 1 RNA \<50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity of DTG +RPV once daily compared to continuation of CAR. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm
|
97 Percentage of participants
|
98 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 410 or study discontinuationPopulation: Safety Population included all randomized participants who received at least one dose of study drug.
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. AEs were graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. Common AEs were those with \>5% incidence for either treatment.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=239 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
Common non-serious AE
|
166 Participants
|
132 Participants
|
|
Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
Any SAE
|
50 Participants
|
32 Participants
|
|
Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
Maximum toxicity Grade 1 AE
|
78 Participants
|
85 Participants
|
|
Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
Maximum toxicity Grade 2 AE
|
104 Participants
|
95 Participants
|
|
Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
Maximum toxicity Grade 3 AE
|
33 Participants
|
29 Participants
|
|
Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
Maximum toxicity Grade 4 AE
|
13 Participants
|
11 Participants
|
|
Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)
AELD
|
23 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Safety Population
Blood samples were collected to evaluate alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, blood urea nitrogen (BUN), total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in clinical chemistry over 48 weeks was summarized. Clinical chemistry toxicities were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a chemistry toxicity.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks
Grade 1
|
92 Participants
|
80 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks
Grade 2
|
72 Participants
|
79 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks
Grade 3
|
11 Participants
|
16 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks
Grade 4
|
1 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Safety Population
Blood samples were collected to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, mean corpuscular volume (MCV), red blood cell (RBC) count, white blood cell (WBC) count and platelet count. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in hematology over 48 weeks was summarized. Hematology toxicities were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a hematology toxicity.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks
Grade 1
|
11 Participants
|
11 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks
Grade 2
|
2 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks
Grade 3
|
3 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks
Grade 4
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess hs-CRP. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=246 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=239 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 48
|
0.10 mg/Liter (L)
Standard Deviation 5.383
|
0.80 mg/Liter (L)
Standard Deviation 8.527
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess cystatin C. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=246 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=237 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Cystatin C at Week 48
|
-0.02 mg/L
Standard Deviation 0.110
|
-0.01 mg/L
Standard Deviation 0.108
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess D-Dimer. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=239 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=228 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in D-Dimer at Week 48
|
0.01 Nanomole/L fibrinogen equivalent units
Standard Deviation 1.629
|
-0.13 Nanomole/L fibrinogen equivalent units
Standard Deviation 2.932
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess FABP and soluble CD14. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48
FABP
|
-1.50 Nanogram/milliliter
Standard Deviation 1.278
|
-0.99 Nanogram/milliliter
Standard Deviation 1.441
|
|
Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48
Soluble CD14
|
456.69 Nanogram/milliliter
Standard Deviation 731.833
|
802.26 Nanogram/milliliter
Standard Deviation 878.304
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess soluble CD163 and oxidized LDL. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48
Soluble CD163
|
65.38 Microgram(µg)/Liter
Standard Deviation 180.869
|
53.94 Microgram(µg)/Liter
Standard Deviation 215.621
|
|
Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48
Oxidized LDL
|
60.87 Microgram(µg)/Liter
Standard Deviation 504.345
|
13.92 Microgram(µg)/Liter
Standard Deviation 575.305
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess RBP, serum creatinine and glucose. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48
RBP
|
-0.13 mg/deciliter (dL)
Standard Deviation 0.825
|
0.00 mg/deciliter (dL)
Standard Deviation 0.872
|
|
Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48
Serum creatinine
|
0.100 mg/deciliter (dL)
Standard Deviation 0.1053
|
-0.003 mg/deciliter (dL)
Standard Deviation 0.0847
|
|
Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48
Glucose
|
0.187 mg/deciliter (dL)
Standard Deviation 19.5808
|
3.220 mg/deciliter (dL)
Standard Deviation 10.0987
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine biomarker samples were collected to at Baseline (Day 1) and Week 48 to assess urine phosphate. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=235 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=229 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Urine Phosphate at Week 48
|
1.335 Millimoles (mmol)/L
Standard Deviation 16.7211
|
-0.798 Millimoles (mmol)/L
Standard Deviation 15.3771
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess B2M and 25 hydroxy-vitamin D. Urine biomarker samples were collected to assess B2M and RBP. Change from Baseline was calculated as value at indicated time point minus Baseline value. For 25 hydroxy-vitamin D, analysis of changes from Baseline was performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48
B2M, blood
|
-16.8800 Nanomoles (nmol)/L
Standard Deviation 34.89330
|
-4.7501 Nanomoles (nmol)/L
Standard Deviation 43.04355
|
|
Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48
25 hydroxy-vitamin D, blood
|
-13.9 Nanomoles (nmol)/L
Standard Deviation 25.30
|
-9.2 Nanomoles (nmol)/L
Standard Deviation 19.55
|
|
Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48
Urine B2M
|
-173.2820 Nanomoles (nmol)/L
Standard Deviation 1311.24142
|
62.3209 Nanomoles (nmol)/L
Standard Deviation 391.32049
|
|
Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48
Urine RBP
|
-6.8123 Nanomoles (nmol)/L
Standard Deviation 24.09650
|
-0.0631 Nanomoles (nmol)/L
Standard Deviation 11.99886
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Urine biomarker samples were collected at Baseline (Day 1) and Week 48 to assess urine albumin/creatinine ratio and urine protein/creatinine ratio. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48
Urine albumin/creatinine ratio
|
-0.78 Grams (g)/mol
Standard Deviation 5.116
|
-0.64 Grams (g)/mol
Standard Deviation 9.538
|
|
Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48
Urine protein/creatinine ratio
|
-2.73 Grams (g)/mol
Standard Deviation 12.683
|
1.23 Grams (g)/mol
Standard Deviation 5.088
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess bone-specific alkaline phosphatase, procollagen 1 N-terminal propeptide, osteocalcin, Type 1 Collagen C-telopeptides and sVCAM. Change from Baseline was calculated as value at indicated time point minus Baseline value. For bone-specific alkaline phosphatase, procollagen 1-N-propeptide, osteocalcin and type 1 collagen C-telopeptide, analyses of changes from Baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48
Bone-specific alkaline phosphatase
|
-3.18 Microgram (ug)/L
Standard Deviation 5.678
|
0.92 Microgram (ug)/L
Standard Deviation 4.634
|
|
Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48
Procollagen type 1 N-propeptide
|
-5.8 Microgram (ug)/L
Standard Deviation 20.00
|
0.3 Microgram (ug)/L
Standard Deviation 19.28
|
|
Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48
Osteocalcin
|
-5.11 Microgram (ug)/L
Standard Deviation 7.334
|
-1.14 Microgram (ug)/L
Standard Deviation 6.017
|
|
Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48
Type I Collagen C-Telopeptides
|
-0.15 Microgram (ug)/L
Standard Deviation 0.313
|
-0.09 Microgram (ug)/L
Standard Deviation 0.344
|
|
Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48
sVCAM
|
-2.63 Microgram (ug)/L
Standard Deviation 571.182
|
37.42 Microgram (ug)/L
Standard Deviation 617.486
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess IL-6. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=245 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=237 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48
|
-0.08 Nanograms (ng)/L
Standard Deviation 2.373
|
-0.07 Nanograms (ng)/L
Standard Deviation 2.761
|
SECONDARY outcome
Timeframe: At Week 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess insulin resistance. Change from Baseline was calculated as value at indicated time point minus Baseline value. The homeostatic model assessment (HOMA) of insulin resistance (HOMA-IR ) index , the product of basal glucose and insulin levels divided by 22.5, is regarded as a simple, inexpensive, and reliable surrogate measure of insulin resistance.
Outcome measures
| Measure |
DTG + RPV
n=237 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=224 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48
|
0.50 HOMA-IR Score
Standard Deviation 4.780
|
0.80 HOMA-IR Score
Standard Deviation 3.938
|
SECONDARY outcome
Timeframe: At Weeks 24 and 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
Total cholesterol, Week 24
|
-0.015 Millimoles (mmol)/L
Standard Deviation 0.7539
|
0.020 Millimoles (mmol)/L
Standard Deviation 0.5777
|
|
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
Total cholesterol, Week 48
|
-0.079 Millimoles (mmol)/L
Standard Deviation 0.7926
|
-0.038 Millimoles (mmol)/L
Standard Deviation 0.6148
|
|
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
LDL cholesterol calculation, Week 24
|
0.085 Millimoles (mmol)/L
Standard Deviation 0.5940
|
0.055 Millimoles (mmol)/L
Standard Deviation 0.5232
|
|
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
LDL cholesterol calculation, Week 48
|
-0.049 Millimoles (mmol)/L
Standard Deviation 0.6276
|
-0.076 Millimoles (mmol)/L
Standard Deviation 0.5280
|
|
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
HDL cholesterol direct, Week 24
|
-0.024 Millimoles (mmol)/L
Standard Deviation 0.2365
|
-0.051 Millimoles (mmol)/L
Standard Deviation 0.2258
|
|
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
HDL cholesterol direct, Week 48
|
0.051 Millimoles (mmol)/L
Standard Deviation 0.2386
|
0.049 Millimoles (mmol)/L
Standard Deviation 0.2489
|
|
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
Triglycerides, Week 24
|
-0.184 Millimoles (mmol)/L
Standard Deviation 1.0102
|
0.040 Millimoles (mmol)/L
Standard Deviation 0.9164
|
|
Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48
Triglycerides, Week 48
|
-0.169 Millimoles (mmol)/L
Standard Deviation 1.0062
|
-0.021 Millimoles (mmol)/L
Standard Deviation 1.0156
|
SECONDARY outcome
Timeframe: Up to Week 48Population: The analysis was performed on the CVW resistance Population which was comprised of all participants in the ITT-E Population who met CVW through the end of visit window (Week 48, Week 100 or Week 148) and have available on-treatment genotypic resistance data at the time CVW criterion is met.
Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (Rilpivirine \[RPV\], Dolutegravir \[DTG\]) in participants Meeting Confirmed Virologic Withdrawal (CVW) criteria has been presented.
Outcome measures
| Measure |
DTG + RPV
n=1 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Genotypic Resistance-Early Switch Phase
INSTI, DTG, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-Early Switch Phase
INSTI, DTG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-Early Switch Phase
INSTI, DTG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-Early Switch Phase
INSTI, DTG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-Early Switch Phase
INSTI, DTG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-Early Switch Phase
NNRTI, RPV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-Early Switch Phase
NNRTI, RPV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-Early Switch Phase
NNRTI, RPV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-Early Switch Phase
NNRTI, RPV, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-Early Switch Phase
NNRTI, RPV, High-level resistance
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 148Population: CVW resistance Population
Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, Elvitegravir \[EVG\], Raltegravir \[RAL\], Delavirdine \[DLV\], Efavirenz \[EFV\], Etravirine \[ETR\], Nevirapine \[NVP\], RPV, Lamivudine \[3TC\], Abacavir \[ABC\], FTC, TDF, Zidovudine \[ZDV\], Stavudine \[d4T\], Didanosine \[ddI\], Atazanavir/r \[ATV/r\], DRV/r, Fosamprenavir/r \[FPV/r\], Indinavir/r \[IDV/r\], Lopinavir/r \[LPV/r\], Nelfinavir \[NFV\], Ritonavir \[RTV\], Saquinavir/r \[SQV/r\], Tipranavir/r \[TPV/r\]) in participants Meeting Confirmed Virologic Withdrawal Criteria has been presented.
Outcome measures
| Measure |
DTG + RPV
n=2 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
INI, DTG, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
INI, DTG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
INI, DTG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
INI, DTG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
INI, DTG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
INI, EVG, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
INI, EVG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
INI, EVG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
INI, EVG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
INI, EVG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
INI, RAL, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
INI, RAL, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
INI, RAL, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
INI, RAL, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
INI, RAL, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, DLV, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, DLV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, DLV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, DLV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, DLV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, EFV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, EFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, EFV, Low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, EFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, EFV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, ETR, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, ETR, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, ETR, Low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, ETR, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, ETR, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, NVP, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, NVP, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, NVP, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, NVP, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, NVP, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, RPV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, RPV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, RPV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, RPV, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NNRTI, RPV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, 3TC, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, 3TC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, 3TC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, 3TC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, 3TC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, ABC, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, ABC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, ABC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, ABC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, ABC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, FTC, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, FTC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, FTC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, FTC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, FTC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, TDF, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, TDF, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, TDF, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, TDF, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, TDF, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, ZDV, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, ZDV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, ZDV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, ZDV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, ZDV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, d4T, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, d4T, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, d4T, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, d4T, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, d4T, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, ddI, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, ddI, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, ddI, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, ddI, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
NRTI, ddI, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, ATV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, ATV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, ATV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, ATV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, ATV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, DRV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, DRV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, DRV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, DRV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, DRV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, FPV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, FPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, FPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, FPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, FPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, IDV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, IDV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, IDV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, IDV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, IDV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, LPV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, LPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, LPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, LPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, LPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, NFV, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, NFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, NFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, NFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, NFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, RTV, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, RTV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, RTV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, RTV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, RTV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, SQV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, SQV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, SQV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, SQV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, SQV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, TPV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, TPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, TPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, TPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Arm Through Early and Late Switch Phase
PI, TPV/r, High-level resistance
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Post-Late switch (LS) Baseline (Week 52) up to Week 148Population: The analysis was performed on the Late Switch (LS) CVW resistance Population which was comprised of all participants in the LS ITT-E Population who met CVW through the end of visit window (Week 48, Week 100 or Week 148) and had available on-treatment genotypic resistance data at the time CVW criterion is met. Only those participants with data available at the specified time point were analyzed.
Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented.
Outcome measures
| Measure |
DTG + RPV
n=1 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
INI, DTG, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
INI, DTG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
INI, DTG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
INI, DTG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
INI, DTG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
INI, EVG, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
INI, EVG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
INI, EVG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
INI, EVG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
INI, EVG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
INI, RAL, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
INI, RAL, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
INI, RAL, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
INI, RAL, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
INI, RAL, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, DLV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, DLV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, DLV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, DLV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, DLV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, EFV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, EFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, EFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, EFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, EFV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, ETR, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, ETR, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, ETR, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, ETR, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, ETR, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, NVP, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, NVP, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, NVP, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, NVP, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, NVP, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, RPV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, RPV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, RPV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, RPV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NNRTI, RPV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, 3TC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, 3TC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, 3TC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, 3TC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, 3TC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, ABC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, ABC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, ABC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, ABC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, ABC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, FTC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, FTC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, FTC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, FTC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, FTC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, TDF, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, TDF, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, TDF, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, TDF, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, TDF, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, ZDV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, ZDV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, ZDV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, ZDV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, ZDV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, d4T, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, d4T, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, d4T, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, d4T, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, d4T, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, ddI, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, ddI, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, ddI, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, ddI, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
NRTI, ddI, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, ATV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, ATV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, ATV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, ATV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, ATV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, DRV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, DRV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, DRV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, DRV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, DRV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, FPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, FPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, FPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, FPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, FPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, IDV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, IDV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, IDV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, IDV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, IDV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, LPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, LPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, LPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, LPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, LPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, NFV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, NFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, NFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, NFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, NFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, RTV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, RTV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, RTV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, RTV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, RTV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, SQV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, SQV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, SQV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, SQV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, SQV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, TPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, TPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, TPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, TPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Arm Through Late Switch Phase
PI, TPV/r, High-level resistance
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 52Population: The analysis was performed on the CVW resistance Population which was comprised of all participants in the ITT-E Population who met CVW through the end of visit window (Week 48, Week 100 or Week 148) and have available on-treatment genotypic resistance data at the time CVW criterion is met. Only participants from the DTG + RPV were analyzed as the CAR participants did not receive study treatment until Week 52.
Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, RAL, EVG, RPV, ETR, 3TC, ABC, FTC, TDF, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented.
Outcome measures
| Measure |
DTG + RPV
n=1 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, RPV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, RPV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, ETR, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, ETR, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, ETR, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, DLV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, DLV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, EFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, EFV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, NVP, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NNRTI, NVP, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, 3TC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, 3TC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, ABC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, ABC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, ABC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, TDF, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, TDF, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, TDF, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, d4T, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, d4T, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, ddI, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, ddI, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, ddI, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, FTC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, FTC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, ZDV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
NRTI, ZDV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, ATV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, ATV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, DRV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, DRV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, DRV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, FPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, FPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, FPV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, IDV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, IDV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, LPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, LPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, LPV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, SQV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, SQV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, SQV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, TPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, TPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, TPV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, NFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, NFV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, RTV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-Early Switch Phase
PI, RTV, Sensitive
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 148Population: CVW resistance Population. Only those participants with data available at the specified time points were analyzed.
Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented.
Outcome measures
| Measure |
DTG + RPV
n=2 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, DTG, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, DTG, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, DTG, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, EVG, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, EVG, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, EVG, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, RAL, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, RAL, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
INI, RAL, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, DLV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, DLV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, DLV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, EFV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, EFV, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, EFV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, ETR, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, ETR, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, ETR, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, NVP, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, NVP, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, NVP, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, RPV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, RPV, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NNRTI, RPV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, 3TC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, 3TC, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, 3TC, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ABC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ABC, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ABC, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, FTC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, FTC, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, FTC, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, TDF, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, TDF, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, TDF, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ZDV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ZDV, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ZDV, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, d4T, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, d4T, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, d4T, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ddI, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ddI, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
NRTI, ddI, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, ATV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, ATV/r, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, ATV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, DRV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, DRV/r, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, DRV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, FPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, FPV/r, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, FPV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, IDV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, IDV/r, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, IDV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, LPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, LPV/r, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, LPV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, NFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, NFV, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, NFV, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, RTV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, RTV, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, RTV, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, SQV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, SQV/r, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, SQV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, TPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, TPV/r, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase
PI, TPV/r, Sensitive
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Post-LS Baseline (Week 52) up to Week 148Population: LS CVW resistance Population
Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented.
Outcome measures
| Measure |
DTG + RPV
n=1 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, DLV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, DLV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, DLV, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, EFV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, EFV, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, EFV, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, ETR, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, ETR, Partially sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, ETR, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, NVP, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, NVP, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, NVP, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, RPV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, RPV, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NNRTI, RPV, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, 3TC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, 3TC, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, 3TC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ABC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ABC, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ABC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, FTC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, FTC, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, FTC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, TDF, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, TDF, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, TDF, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ZDV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ZDV, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ZDV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, d4T, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, d4T, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, d4T, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ddI, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ddI, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
NRTI, ddI, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, ATV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, ATV/r, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, ATV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, DRV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, DRV/r, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, DRV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, FPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, FPV/r, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, FPV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, IDV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, IDV/r, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, IDV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, LPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, LPV/r, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, LPV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, NFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, NFV, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, NFV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, RTV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, RTV, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, RTV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, SQV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, SQV/r, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, SQV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, TPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, TPV/r, Partially sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase
PI, TPV/r, Sensitive
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Pre-dose at Week 4, 24, 48, 56, 76 and 100Population: The analysis was performed on the Pharmacokinetic (PK) Parameter Population which consisted of all participants who received DTG +RPV and provided at least one evaluable estimate of predose concentration (C0). Only those participants with data available at the specified time points were analyzed.
Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 4, 24, 48, 56, 76 and 100. Pre-dose concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the early+late switch phase.
Outcome measures
| Measure |
DTG + RPV
n=254 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=254 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase
Week 4
|
1578.88 ug/ L
Standard Deviation 1170.967
|
79.50 ug/ L
Standard Deviation 38.230
|
|
Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase
Week 24
|
1447.23 ug/ L
Standard Deviation 917.677
|
90.21 ug/ L
Standard Deviation 46.302
|
|
Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase
Week 48
|
1384.36 ug/ L
Standard Deviation 889.829
|
91.41 ug/ L
Standard Deviation 47.073
|
|
Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase
Week 56
|
1637.74 ug/ L
Standard Deviation 1063.391
|
90.55 ug/ L
Standard Deviation 45.686
|
|
Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase
Week 76
|
1507.81 ug/ L
Standard Deviation 913.263
|
92.51 ug/ L
Standard Deviation 46.223
|
|
Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - DTG+RPV Group Through Early and Late Switch Phase
Week 100
|
1532.10 ug/ L
Standard Deviation 916.975
|
91.98 ug/ L
Standard Deviation 44.683
|
SECONDARY outcome
Timeframe: Pre-dose at Weeks 56, 76 and 100Population: The analysis was performed on the Pharmacokinetic (PK) Parameter Population which consisted of all participants who received DTG +RPV and provided at least one evaluable estimate of predose concentration (C0). Only those participants with data available at the specified time points were analyzed.
Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 56, 76 and 100. Pre-dose concentrations of DTG and RPV at Weeks 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the late switch phase.
Outcome measures
| Measure |
DTG + RPV
n=226 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=226 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - CAR Group Through Late Switch Phase
Week 56
|
1544.75 ug/ L
Standard Deviation 1049.595
|
77.27 ug/ L
Standard Deviation 38.931
|
|
Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - CAR Group Through Late Switch Phase
Week 76
|
1806.77 ug/ L
Standard Deviation 1019.300
|
91.46 ug/ L
Standard Deviation 48.568
|
|
Pre-dose Concentrations of DTG and RPV in Participants Switching to DTG + RPV - CAR Group Through Late Switch Phase
Week 100
|
1881.97 ug/ L
Standard Deviation 1160.587
|
90.89 ug/ L
Standard Deviation 47.762
|
SECONDARY outcome
Timeframe: Pre-dose at Weeks 2, 4 and 8Population: PK Parameter NNRTI Subset extra sampling Population. Only those participants with data available at the specified time points were analyzed.
Two blood samples were collected pre-dose for DTG and RPV at Weeks 2 and 8 only for the first 20 participants who switch from EFV or NVP to DTG+RPV, in addition to the pre-dose blood sample collected at Week 4 for all participants. One blood sample was collected pre-dose for EFV or NVP at Week 2 for the first 20 participants who switch from EFV or NVP to DTG + RPV. PK Parameter NNRTI Subset Extra Sampling Population consisted of the first approximately 20 participants in the PK Parameter NNRTI Subset population who have extra PK samples at weeks 2 and 8.
Outcome measures
| Measure |
DTG + RPV
n=28 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=28 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Pre-dose Concentrations of DTG and RPV in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV
Week 2
|
834.58 ug/ L
Standard Deviation 639.622
|
57.342 ug/ L
Standard Deviation 29.5436
|
|
Pre-dose Concentrations of DTG and RPV in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV
Week 4
|
1218.23 ug/ L
Standard Deviation 842.703
|
78.338 ug/ L
Standard Deviation 31.4825
|
|
Pre-dose Concentrations of DTG and RPV in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV
Week 8
|
1472.50 ug/ L
Standard Deviation 818.774
|
79.652 ug/ L
Standard Deviation 40.7546
|
SECONDARY outcome
Timeframe: At Week 48Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
Percentage of participants with plasma HIV 1 RNA \< 50 c/mL at Week 48 using the FDA snapshot algorithm was assessed by Baseline third agent class to assess the impact of Baseline third agent class (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Plasma samples were collected for HIV-1 RNA at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48. The analysis was done using Cochran-Mantel Haenszel test stratified by current antiretroviral third-agent class.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class
NNRTI
|
97 Percentage of participants
|
93 Percentage of participants
|
|
Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class
INSTI
|
92 Percentage of participants
|
94 Percentage of participants
|
|
Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class
PI
|
91 Percentage of participants
|
97 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 48Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out at Baseline (Day 1) and Week 48 to assess the impact of Baseline third agent class (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class
PI
|
10.5 Cells per mm^3
Standard Deviation 163.67
|
12.2 Cells per mm^3
Standard Deviation 163.32
|
|
Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class
NNRTI
|
49.7 Cells per mm^3
Standard Deviation 166.40
|
24.3 Cells per mm^3
Standard Deviation 160.32
|
|
Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class
INSTI
|
-11.2 Cells per mm^3
Standard Deviation 176.56
|
10.3 Cells per mm^3
Standard Deviation 155.53
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any AE, AELD or AE with maximum grade toxicity experienced by any one participant over 48 weeks by Baseline third agent class (INSTI, NNRTI, or PI) is summarized. AEs were graded using the Division of AIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
Any AE, NNRTI
|
106 Participants
|
96 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
Any AE, INSTI
|
47 Participants
|
36 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
Any AE, PI
|
42 Participants
|
42 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI, Maximum toxicity Grade 1 AE
|
68 Participants
|
76 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI, Maximum toxicity Grade 2 AE
|
30 Participants
|
19 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI, Maximum toxicity Grade 3 AE
|
8 Participants
|
0 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI, Maximum toxicity Grade 4 AE
|
0 Participants
|
1 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
INSTI, Maximum toxicity Grade 1 AE
|
27 Participants
|
20 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
INSTI, Maximum toxicity Grade 2 AE
|
15 Participants
|
15 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
INSTI, Maximum toxicity Grade 3 AE
|
5 Participants
|
1 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
INSTI, Maximum toxicity Grade 4 AE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
PI, Maximum toxicity Grade 1 AE
|
24 Participants
|
26 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
PI, Maximum toxicity Grade 2 AE
|
14 Participants
|
13 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
PI, Maximum toxicity Grade 3 AE
|
3 Participants
|
3 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
PI, Maximum toxicity Grade 4 AE
|
1 Participants
|
0 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
AELD, NNRTI
|
5 Participants
|
1 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
AELD, INSTI
|
4 Participants
|
0 Participants
|
|
Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class
AELD, PI
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline (Day 1) and at Weeks 4, 8, 12, 24, 36 and 48 to evaluate ALT, albumin, ALP, AST, total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, BUN, total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Number of participants who experienced maximum toxicity grade post-baseline in chemistry parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) is summarized. Clinical chemistry toxicities were graded using the DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI, Grade 1
|
51 Participants
|
52 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI, Grade 2
|
31 Participants
|
40 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI, Grade 3
|
7 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI, Grade 4
|
1 Participants
|
5 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
INSTI, Grade 1
|
19 Participants
|
11 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
INSTI, Grade 2
|
23 Participants
|
18 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
INSTI, Grade 3
|
3 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
INSTI, Grade 4
|
0 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
PI, Grade 1
|
22 Participants
|
17 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
PI, Grade 2
|
18 Participants
|
21 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
PI, Grade 3
|
1 Participants
|
9 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
PI, Grade 4
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline (Day 1) and at Weeks 4, 8, 12, 24, 36 and 48 to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCV, RBC count, WBC count and platelet count. Number of participants who experienced maximum toxicity grade post-baseline in hematology parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) was summarized. Hematology toxicities were graded using the DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI; Grade 1
|
7 Participants
|
6 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI; Grade 2
|
1 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI; Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
NNRTI; Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
INI; Grade 1
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
INI; Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
INI; Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
INI; Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
PI; Grade 1
|
3 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
PI; Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
PI; Grade 3
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class
PI; Grade 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 48Population: CVW resistance Population. This outcome has not been analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.
For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were to be analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were to be collected at Day 1. Number of participants with genotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 48Population: CVW resistance Population. This outcome was not analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.
For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were to be analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were to be collected at Day 1. Number of participants with phenotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Weeks 24 and 48Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at Baseline (Day 1), Weeks 24 and 48 to assess fasting lipids which included total cholesterol (CHO), LDL cholesterol, HDL cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
CHO, Week 24, overall
|
1.015 mmol/L
Standard Deviation 15.7472
|
1.300 mmol/L
Standard Deviation 12.2269
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
CHO, Week 48, overall
|
-0.165 mmol/L
Standard Deviation 15.9301
|
0.194 mmol/L
Standard Deviation 13.1071
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
CHO, Week 24, NNRTI
|
—
|
1.238 mmol/L
Standard Deviation 12.4889
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
CHO, Week 48, NNRTI
|
—
|
0.281 mmol/L
Standard Deviation 12.2469
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
CHO, Week 24, INSTI
|
—
|
1.973 mmol/L
Standard Deviation 12.1365
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
CHO, Week 48, INSTI
|
—
|
2.798 mmol/L
Standard Deviation 16.1468
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
CHO, Week 24, PI
|
—
|
0.936 mmol/L
Standard Deviation 11.8530
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
CHO, Week 48, PI
|
—
|
-1.971 mmol/L
Standard Deviation 12.2195
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
HDL CHO direct, Overall, Week 24
|
0.557 mmol/L
Standard Deviation 19.4929
|
-2.533 mmol/L
Standard Deviation 16.3641
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
HDL CHO direct, Overall, Week 48
|
6.384 mmol/L
Standard Deviation 20.9244
|
4.723 mmol/L
Standard Deviation 18.3253
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
HDL CHO direct, NNRTI, Week 24
|
—
|
-2.562 mmol/L
Standard Deviation 15.3521
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
HDL CHO direct, NNRTI, Week 48
|
—
|
4.307 mmol/L
Standard Deviation 17.8013
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
HDL CHO direct, INSTI, Week 24
|
—
|
-3.097 mmol/L
Standard Deviation 20.0002
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
HDL CHO direct, INSTI, Week 48
|
—
|
5.386 mmol/L
Standard Deviation 20.6791
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
HDL CHO direct, PI, Week 24
|
—
|
-2.031 mmol/L
Standard Deviation 15.9582
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
HDL CHO direct, PI, Week 48
|
—
|
5.140 mmol/L
Standard Deviation 17.8779
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
LDL CHO calculation, Overall, Week 24
|
5.838 mmol/L
Standard Deviation 22.9614
|
4.395 mmol/L
Standard Deviation 21.6685
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
LDL CHO calculation, Overall, Week 48
|
1.137 mmol/L
Standard Deviation 23.3849
|
-0.598 mmol/L
Standard Deviation 20.6931
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
LDL CHO calculation, NNRTI, Week 24
|
—
|
5.959 mmol/L
Standard Deviation 21.5692
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
LDL CHO calculation, NNRTI, Week 48
|
—
|
0.747 mmol/L
Standard Deviation 19.2299
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
LDL CHO calculation, INSTI, Week 24
|
—
|
3.787 mmol/L
Standard Deviation 17.6755
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
LDL CHO calculation, INSTI, Week 48
|
—
|
2.647 mmol/L
Standard Deviation 24.0430
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
LDL CHO calculation, PI, Week 24
|
—
|
0.983 mmol/L
Standard Deviation 24.5052
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
LDL CHO calculation, PI, Week 48
|
—
|
-6.212 mmol/L
Standard Deviation 20.4774
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Triglycerides, Overall, Week 24
|
-0.825 mmol/L
Standard Deviation 42.5565
|
9.379 mmol/L
Standard Deviation 45.5529
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Triglycerides, Overall, Week 48
|
1.169 mmol/L
Standard Deviation 51.9844
|
7.183 mmol/L
Standard Deviation 44.7044
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Triglycerides, NNRTI, Week 24
|
—
|
4.962 mmol/L
Standard Deviation 40.6201
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Triglycerides, NNRTI, Week 48
|
—
|
5.248 mmol/L
Standard Deviation 41.7728
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Triglycerides, INSTI, Week 24
|
—
|
18.204 mmol/L
Standard Deviation 47.2348
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Triglycerides, INSTI, Week 48
|
—
|
14.627 mmol/L
Standard Deviation 56.2824
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Triglycerides, PI, Week 24
|
—
|
13.241 mmol/L
Standard Deviation 54.2327
|
|
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
Triglycerides, PI, Week 48
|
—
|
5.806 mmol/L
Standard Deviation 41.2106
|
SECONDARY outcome
Timeframe: At Weeks 4, 24 and 48Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant and is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). Last observation carried forward (LOCF) was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase
Symptom count, Week 4
|
-1.1 Scores on a scale
Standard Deviation 4.11
|
-0.8 Scores on a scale
Standard Deviation 4.02
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase
Symptom count, Week 24
|
-0.7 Scores on a scale
Standard Deviation 4.31
|
-0.8 Scores on a scale
Standard Deviation 4.64
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase
Symptom count, Week 48
|
-0.5 Scores on a scale
Standard Deviation 4.33
|
-0.4 Scores on a scale
Standard Deviation 4.82
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase
Symptom Bother Score, Week 4
|
-2.8 Scores on a scale
Standard Deviation 7.44
|
-1.8 Scores on a scale
Standard Deviation 7.24
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase
Symptom Bother Score, Week 24
|
-1.8 Scores on a scale
Standard Deviation 8.40
|
-1.7 Scores on a scale
Standard Deviation 8.72
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase
Symptom Bother Score, Week 48
|
-1.5 Scores on a scale
Standard Deviation 7.97
|
-0.7 Scores on a scale
Standard Deviation 9.30
|
SECONDARY outcome
Timeframe: At Weeks 56, 76, 100 and 148Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant and is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=228 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Symptom count, Week 56
|
-0.8 Scores on a scale
Standard Deviation 4.80
|
—
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Symptom count, Week 76
|
-0.6 Scores on a scale
Standard Deviation 4.66
|
—
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Symptom count, Week 100
|
-0.5 Scores on a scale
Standard Deviation 5.03
|
—
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Symptom count, Week 148
|
-0.7 Scores on a scale
Standard Deviation 4.87
|
—
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Symptom Bother Score, Week 56
|
-1.8 Scores on a scale
Standard Deviation 9.23
|
—
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Symptom Bother Score, Week 76
|
-1.6 Scores on a scale
Standard Deviation 8.70
|
—
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Symptom Bother Score, Week 100
|
-1.4 Scores on a scale
Standard Deviation 9.40
|
—
|
|
Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Symptom Bother Score, Week 148
|
-1.7 Scores on a scale
Standard Deviation 9.54
|
—
|
SECONDARY outcome
Timeframe: At Weeks 56, 76, 100 and 148Population: LS ITT-E Population comprised of all participants randomized to CAR who received at least one dose of study treatment at or after the Week 52 Switch visit. Only those participants with data available at the specified time points were analyzed.
The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant and is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=239 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Symptom count, Week 56
|
-0.9 Scores on a scale
Standard Deviation 4.74
|
—
|
|
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Symptom count, Week 76
|
-0.7 Scores on a scale
Standard Deviation 4.29
|
—
|
|
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Symptom count, Week 100
|
-0.4 Scores on a scale
Standard Deviation 5.04
|
—
|
|
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Symptom count, Week 148
|
-0.6 Scores on a scale
Standard Deviation 4.81
|
—
|
|
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Symptom Bother Score, Week 56
|
-2.1 Scores on a scale
Standard Deviation 7.56
|
—
|
|
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Symptom Bother Score, Week 76
|
-1.0 Scores on a scale
Standard Deviation 7.61
|
—
|
|
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Symptom Bother Score, Week 100
|
-0.8 Scores on a scale
Standard Deviation 8.43
|
—
|
|
Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Symptom Bother Score, Week 148
|
-1.0 Scores on a scale
Standard Deviation 8.54
|
—
|
SECONDARY outcome
Timeframe: At Weeks 4, 24 and 48Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 to 6 where a higher score indicates the greater improvement in the past few weeks. These items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscales: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/clinical sub-score (CS) have been summarized. LOCF was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
n=255 Participants
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
Total score, Week 4
|
0.0 Score on a scale
Interval -21.0 to 23.0
|
0.0 Score on a scale
Interval -22.0 to 22.0
|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
Total score, Week 24
|
0.0 Score on a scale
Interval -27.0 to 23.0
|
0.0 Score on a scale
Interval -24.0 to 24.0
|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
Total score, Week 48
|
0.0 Score on a scale
Interval -27.0 to 25.0
|
0.0 Score on a scale
Interval -50.0 to 23.0
|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
lifestyle/ease Sub-score, Week 4
|
0.0 Score on a scale
Interval -11.0 to 15.0
|
0.0 Score on a scale
Interval -11.0 to 7.0
|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
lifestyle/ease Sub-score, Week 24
|
0.0 Score on a scale
Interval -18.0 to 14.0
|
0.0 Score on a scale
Interval -17.0 to 10.0
|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
lifestyle/ease Sub-score, Week 48
|
0.0 Score on a scale
Interval -18.0 to 12.0
|
0.0 Score on a scale
Interval -21.0 to 11.0
|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
General Satisfaction/CS, Week 4
|
0.0 Score on a scale
Interval -13.0 to 14.0
|
0.0 Score on a scale
Interval -17.0 to 15.0
|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
General Satisfaction/CS, Week 24
|
0.0 Score on a scale
Interval -12.0 to 12.0
|
0.0 Score on a scale
Interval -15.0 to 15.0
|
|
Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase
General Satisfaction/CS, Week 48
|
0.0 Score on a scale
Interval -13.0 to 14.0
|
0.0 Score on a scale
Interval -29.0 to 14.0
|
SECONDARY outcome
Timeframe: At Weeks 56, 76, 100 and 148Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Change from Baseline is calculated as the value at specified time point minus Baseline value. Total score, lifestyle/ease score and General satisfaction/clinical sub-score (CS) have been summarized. LOCF was used as primary method of analysis.
Outcome measures
| Measure |
DTG + RPV
n=257 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Total score, Week 56
|
0.0 Score on a scale
Interval -37.0 to 26.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Total score, Week 76
|
1.0 Score on a scale
Interval -35.0 to 26.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Total score, Week 100
|
0.0 Score on a scale
Interval -27.0 to 26.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Total score, Week 148
|
1.0 Score on a scale
Interval -38.0 to 26.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
lifestyle/ease Sub-score, Week 56
|
0.0 Score on a scale
Interval -21.0 to 12.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
lifestyle/ease Sub-score, Week 76
|
0.0 Score on a scale
Interval -21.0 to 12.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
lifestyle/ease Sub-score, Week 100
|
0.0 Score on a scale
Interval -18.0 to 12.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
lifestyle/ease Sub-score, Week 148
|
0.0 Score on a scale
Interval -18.0 to 12.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
General Satisfaction/CS, Week 56
|
0.0 Score on a scale
Interval -16.0 to 14.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
General Satisfaction/CS, Week 76
|
0.0 Score on a scale
Interval -15.0 to 14.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
General Satisfaction/CS, Week 100
|
0.0 Score on a scale
Interval -15.0 to 14.0
|
—
|
|
Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
General Satisfaction/CS, Week 148
|
0.0 Score on a scale
Interval -26.0 to 14.0
|
—
|
SECONDARY outcome
Timeframe: At Weeks 56, 76, 100 and 148Population: LS ITT-E Population. Only those participants with data available at the specified time points were analyzed.
The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Change from LS Baseline is calculated as the value at specified time point minus LS Baseline value. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis.
Outcome measures
| Measure |
DTG + RPV
n=239 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Total score, Week 56
|
0.0 Score on a scale
Interval -17.0 to 52.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Total score, Week 76
|
0.0 Score on a scale
Interval -26.0 to 52.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Total score, Week 100
|
0.0 Score on a scale
Interval -17.0 to 51.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
Total score, Week 148
|
0.0 Score on a scale
Interval -17.0 to 51.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
lifestyle/ease Sub-score, Week 56
|
0.0 Score on a scale
Interval -10.0 to 22.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
lifestyle/ease Sub-score, Week 76
|
0.0 Score on a scale
Interval -12.0 to 22.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
lifestyle/ease Sub-score, Week 100
|
0.0 Score on a scale
Interval -9.0 to 22.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
lifestyle/ease Sub-score, Week 148
|
0.0 Score on a scale
Interval -10.0 to 22.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
General Satisfaction/CS, Week 56
|
0.0 Score on a scale
Interval -12.0 to 30.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
General Satisfaction/CS, Week 76
|
0.0 Score on a scale
Interval -15.0 to 30.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
General Satisfaction/CS, Week 100
|
0.0 Score on a scale
Interval -9.0 to 29.0
|
—
|
|
Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase
General Satisfaction/CS, Week 148
|
0.0 Score on a scale
Interval -9.0 to 29.0
|
—
|
SECONDARY outcome
Timeframe: Up to Week 410Population: The analysis was performed on the CVW Resistance population.
For all participants who met virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were collected at Day 1. Number of participants with genotypic resistance to DTG or RPV for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI) were summarized.
Outcome measures
| Measure |
DTG + RPV
n=2 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, FPV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, FPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, FPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, FPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, FPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, IDV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, IDV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, IDV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, IDV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, IDV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, LPV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, LPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, LPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, LPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, LPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, NFV, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, NFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, NFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, NFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, NFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, RTV, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, RTV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, RTV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, RTV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, RTV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, SQV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, SQV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, SQV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, SQV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, SQV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, TPV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, TPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, TPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, TPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, TPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, DTG, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, DTG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, DTG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, DTG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, DTG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, EVG, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, EVG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, EVG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, EVG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, EVG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, RAL, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, RAL, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, RAL, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, RAL, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, RAL, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, DLV, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, DLV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, DLV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, DLV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, DLV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, EFV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, EFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, EFV, Low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, EFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, EFV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, ETR, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, ETR, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, ETR, Low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, ETR, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, ETR, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, NVF, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, NVF, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, NVF, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, NVF, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, NVF, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, RPV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, RPV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, RPV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, RPV, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, RPV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, 3TC, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, 3TC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, 3TC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, 3TC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, 3TC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ABC, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ABC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ABC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ABC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ABC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, FTC, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, FTC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, FTC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, FTC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, FTC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, TDF, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, TDF, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, TDF, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, TDF, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, TDF, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ZDF, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ZDF, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ZDF, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ZDF, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ZDF, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, d4T, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, d4T, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, d4T, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, d4T, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, d4T, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, ATV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, ATV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, ATV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, ATV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, ATV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, DRV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, DRV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, DRV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, DRV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, DRV/r, High-level resistance
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 410Population: The analysis was performed on the CVW Resistance population.
For all participants who met virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were collected at Day 1. Number of participants with phenotypic resistance to DTG or RPV for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI) were summarized.
Outcome measures
| Measure |
DTG + RPV
n=2 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, DTG, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, DTG, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, DTG, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, EVG, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, EVG, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, EVG, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, RAL, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, RAL, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, INI, RAL, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, DLV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, DLV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, DLV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, EFV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, EFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, EFV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, ETR, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, ETR, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, ETR, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, NVP, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, NVP, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, NVP, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, RPV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, RPV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NNRTI, RPV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, 3TC, Reistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, 3TC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, 3TC, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ABC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ABC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ABC, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, FTC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, FTC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, FTC, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, TDF, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, TDF, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, TDF, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ZDF, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ZDF, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ZDF, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, d4T, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, d4T, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, d4T, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ddI, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ddI, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, NRTI, ddI, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, ATV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, ATV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, ATV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, DRV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, DRV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, DRV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, FPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, FPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, FPV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, IDV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, IDV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, IDV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, LPV/r, yResistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, LPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, LPV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, NFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, NFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, NFV, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, RTV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, RTV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, RTV, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, SQV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, SQV/r, Partiallly Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, SQV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, TPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, TPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase
NNRTI, PI, TPV/r, Sensitive
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 52 to Week 410Population: The analysis was performed on the Late Switch CVW Resistance population.
For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain genotype data on as many samples as possible. Number of participants with genotypic resistance to CAR for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI) were summarized.
Outcome measures
| Measure |
DTG + RPV
n=1 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, INI, DTG, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, INI, DTG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, INI, DTG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, INI, DTG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, INI, DTG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, INI, EVG, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, INI, EVG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, INI, EVG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, INI, EVG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, INI, EVG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, INI, RAL, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, INI, RAL, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, INI, RAL, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, INI, RAL, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, INI, RAL, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, DLV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, DLV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, DLV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, DLV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, DLV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, EFV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, EFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, EFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, EFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, EFV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, ETR, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, ETR, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, ETR, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, ETR, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, ETR, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, RPV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, RPV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, RPV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, RPV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, RPV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, 3TC, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, 3TC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, 3TC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, 3TC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, 3TC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, ABC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, ABC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, ABC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, ABC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, ABC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, FTC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, FTC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, FTC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, FTC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, FTC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, TDF, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, TDF, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, TDF, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, TDF, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, TDF, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, ZDF, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, ZDF, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, ZDF, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, ZDF, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, ZDF, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, d4T, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, d4T, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, d4T, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, d4T, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, d4T, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, ATV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, ATV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, ATV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, ATV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, ATV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, DRV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, DRV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, DRV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, DRV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, DRV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, FPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, FPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, FPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, FPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, FPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, IDV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, IDV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, IDV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, IDV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, IDV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, LPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, LPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, LPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, LPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, LPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, NFV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, NFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, NFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, NFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, NFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, RTV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, RTV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, RTV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, RTV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, RTV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, SQV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, SQV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, SQV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, SQV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, SQV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, TPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, TPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, TPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, TPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, PI, TPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, NVP, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, NCP, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, NVP, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, NVP, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NNRTI, NVP, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, ddI, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, ddI, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, ddI, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, ddI, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class CAR Group Through Continuation Phase
NNRTI, NRTI, ddI, High-level resistance
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 52 to Week 410Population: The analysis was performed on the Late Switch CVW resistance population.
For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level \>=200 c/mL were analyzed in an attempt to obtain phenotype data on as many samples as possible. Number of participants with phenotypic resistance to CAR for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI) were summarized.
Outcome measures
| Measure |
DTG + RPV
n=1 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NNRTI, DLV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NNRTI, DLV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NNRTI, DLV, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NNRTI, EFV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NNRTI, EFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NNRTI, EFV, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NNRTI, ETR, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NNRTI, ETR, Partially Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NNRTI, ETR, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NNRTI, NVP, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NNRTI, NVP, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NNRTI, NVP, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NNRTI, RPV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NNRTI, RPV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NNRTI, RPV, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, 3TC, Reistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, 3TC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, 3TC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, ABC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, ABC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, ABC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, FTC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, FTC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, FTC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, TDF, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, TDF, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, TDF, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, ZDF, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, ZDF, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, ZDF, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, d4T, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, d4T, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, d4T, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, ddI, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, ddI, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, NRTI, ddI, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, ATV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, ATV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, ATV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, DRV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, DRV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, DRV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, FPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, FPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, FPV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, IDV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, IDV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, IDV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, LPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, LPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, LPV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, NFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, NFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, NFV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, RTV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, RTV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, RTV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, SQV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, SQV/r, Partiallly Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, SQV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, TPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, TPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase
NNRTI, PI, TPV/r, Sensitive
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 410Population: The analysis was performed on the CVW Resistance population which included all participants from the Intent-to-Treat Exposed (ITT-E) population who met CVW through the end of the visit window and had available on-treatment genotypic resistance data at the time the CVW criterion was met.
Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential genotypic evolution of resistance. Genotypic Resistance data for the following drugs was presented: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r.
Outcome measures
| Measure |
DTG + RPV
n=2 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, DTG, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, DTG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, DTG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, DTG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, DTG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, EVG, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, EVG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, EVG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, EVG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, EVG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, RAL, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, RAL, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, RAL, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, RAL, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, RAL, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, DLV, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, DLV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, DLV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, DLV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, DLV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, EFV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, EFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, EFV, Low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, EFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, EFV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, ETR, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, ETR, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, ETR, Low-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, ETR, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, ETR, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, NVP, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, NVP, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, NVP, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, NVP, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, NVP, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, RPV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, RPV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, RPV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, RPV, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, RPV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, 3TC, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, 3TC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, 3TC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, 3TC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, 3TC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ABC, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ABC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ABC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ABC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ABC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, FTC, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, FTC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, FTC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, FTC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, FTC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, TDF, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, TDF, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, TDF, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, TDF, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, TDF, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ZDV, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ZDV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ZDV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ZDV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ZDV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, d4T, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, d4T, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, d4T, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, d4T, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, d4T, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ddI, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ddI, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ddI, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ddI, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ddI, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, ATV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, ATV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, ATV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, ATV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, ATV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, DRV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, DRV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, DRV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, DRV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, DRV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, FPV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, FPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, FPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, FPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, FPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, IDV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, IDV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, IDV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, IDV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, IDV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, LPV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, LPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, LPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, LPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, LPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, NFV, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, NFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, NFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, NFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, NFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, RTV, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, RTV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, RTV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, RTV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, RTV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, SQV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, SQV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, SQV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, SQV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, SQV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, TPV/r, Susceptible
|
2 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, TPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, TPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, TPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, TPV/r, High-level resistance
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 410Population: The analysis was performed on the CVW Resistance population which included all participants from the ITT-E population who met CVW through the end of the visit window and had available on-treatment phenotypic resistance data at the time the CVW criterion was met.
Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential phenotypic evolution of resistance. Phenotypic Resistance data for the following drugs was presented: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r.
Outcome measures
| Measure |
DTG + RPV
n=2 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, DTG, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, DTG, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, DTG, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, EVG, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, EVG, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, EVG, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, RAL, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, RAL, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
INI, RAL, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, DLV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, DLV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, DLV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, EFV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, EFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, EFV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, ETR, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, ETR, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, ETR, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, NVP, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, NVP, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, NVP, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, RPV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, RPV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NNRTI, RPV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, 3TC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, 3TC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, 3TC, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ABC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ABC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ABC, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, FTC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, FTC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, FTC, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, TDF, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, TDF, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, TDF, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ZDV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ZDV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ZDV, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, d4T, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, d4T, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, d4T, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ddI, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ddI, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
NRTI, ddI, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, ATV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, ATV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, ATV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, DRV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, DRV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, DRV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, FPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, FPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, FPV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, IDV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, IDV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, IDV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, LPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, LPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, LPV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, NFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, NFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, NFV, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, RTV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, RTV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, RTV, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, SQV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, SQV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, SQV/r, Sensitive
|
2 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, TPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, TPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase
PI, TPV/r, Sensitive
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 52 to Week 410Population: The analysis was performed on the Late Switch CVW resistance population which included all participants from the Late Switch ITT-E population who met CVW through the end of visit window and had available on-treatment genotypic resistance data at the time the CVW criterion was met.
Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential phenotypic evolution of resistance. Phenotypic Resistance data for the following drugs was presented: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r.
Outcome measures
| Measure |
DTG + RPV
n=1 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, DRV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, TDF, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, DTG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, EVG, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, EVG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, EVG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, EVG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, EVG, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, RAL, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, RAL, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, RAL, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, RAL, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, RAL, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, DLV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, DLV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, DLV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, DLV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, DLV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, EFV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, EFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, EFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, EFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, EFV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, ETR, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, ETR, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, ETR, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, ETR, Intermediate resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, ETR, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, NVP, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, NVP, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, NVP, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, NVP, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, NVP, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, RPV, Susceptible
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, RPV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, RPV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, RPV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NNRTI, RPV, High-level resistance
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, 3TC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, 3TC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, 3TC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, 3TC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, 3TC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ABC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ABC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ABC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ABC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ABC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, FTC, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, FTC, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, FTC, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, FTC, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, FTC, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, TDF, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, TDF, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, TDF, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, TDF, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ZDV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ZDV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ZDV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ZDV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ZDV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, d4T, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, d4T, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, d4T, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, d4T, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, d4T, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ddI, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ddI, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ddI, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ddI, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
NRTI, ddI, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, ATV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, ATV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, ATV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, ATV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, ATV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, DRV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, DRV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, DRV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, DRV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, FPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, FPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, FPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, FPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, FPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, IDV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, IDV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, IDV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, IDV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, IDV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, LPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, LPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, LPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, LPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, LPV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, DTG, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, DTG, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, DTG, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
INI, DTG, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, NFV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, NFV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, NFV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, NFV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, NFV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, RTV, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, RTV, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, RTV, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, RTV, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, RTV, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, SQV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, SQV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, SQV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, SQV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, SQV/r, High-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, TPV/r, Susceptible
|
1 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, TPV/r, Potential low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, TPV/r, Low-level resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, TPV/r, Intermediate resistance
|
0 Participants
|
—
|
|
Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase
PI, TPV/r, High-level resistance
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 52 to Week 410Population: The analysis was performed on the Late Switch CVW Resistance population which included all participants from the Late Switch ITT-E population who met CVW through the end of visit window and had available on-treatment phenotypic resistance data at the time the CVW criterion was met.
Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA \>=50 c/mL and current plasma HIV-1 RNA \>= 200 c/mL) to evaluate any potential phenotypic evolution of resistance. Phenotypic resistance data for the following drugs was presented: DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r.
Outcome measures
| Measure |
DTG + RPV
n=1 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, DLV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, DLV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, DLV, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, EFV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, EFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, EFV, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, ETR, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, ETR, Partially Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, ETR, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, NVP, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, NVP, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, NVP, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, RPV, Resistant
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, RPV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NNRTI, RPV, Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, 3TC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, 3TC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, 3TC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ABC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ABC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ABC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, FTC, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, FTC, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, FTC, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, TDF, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, TDF, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, TDF, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ZDV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ZDV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ZDV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, d4T, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, d4T, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, d4T, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ddI, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ddI, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
NRTI, ddI, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, ATV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, ATV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, ATV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, DRV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, DRV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, DRV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, FPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, FPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, FPV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, IDV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, IDV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, IDV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, LPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, LPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, LPV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, NFV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, NFV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, NFV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, RTV, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, RTV, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, RTV, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, SQV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, SQV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, SQV/r, Sensitive
|
1 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, TPV/r, Resistant
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, TPV/r, Partially Sensitive
|
0 Participants
|
—
|
|
Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase
PI, TPV/r, Sensitive
|
1 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 100 and 148Population: ITT-E Population
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA \< 50 c/mL using the FDA snapshot algorithm was assessed. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-DTG+RPV Group Through Early and Late Switch Phase
Week 100
|
89 Percentage of participants
|
—
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-DTG+RPV Group Through Early and Late Switch Phase
Week 148
|
84 Percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Weeks 100 and 148Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=261 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Week 100
|
55.9 Cells/mm^3
Standard Deviation 202.56
|
—
|
|
Change From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Group Through Early and Late Switch Phase
Week 148
|
51.5 Cells/mm^3
Standard Deviation 205.98
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 100 and 148Population: LS ITT-E Population
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA \< 50 c/mL using the FDA snapshot algorithm was assessed. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest.
Outcome measures
| Measure |
DTG + RPV
n=239 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-CAR Group Through Late Switch Phase
Week 100
|
97 Percentage of participants
|
—
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-CAR Group Through Late Switch Phase
Week 148
|
93 Percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: LS Baseline (Week 48), Weeks 100 and 148Population: LS ITT-E Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.
Outcome measures
| Measure |
DTG + RPV
n=239 Participants
Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
Current Antiretroviral Regimen (CAR)
Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|
|
Change From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Group Through Late Switch Phase
Week 100
|
20.9 Cells/mm^3
Standard Deviation 173.39
|
—
|
|
Change From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Group Through Late Switch Phase
Week 148
|
6.5 Cells/mm^3
Standard Deviation 167.44
|
—
|
Adverse Events
DTG + RPV (Early Switch)
Serious events: 19 serious events
Other events: 121 other events
Deaths: 1 deaths
CAR (Early Switch)
Serious events: 9 serious events
Other events: 106 other events
Deaths: 0 deaths
DTG + RPV (Early + Late Switch)
Serious events: 38 serious events
Other events: 170 other events
Deaths: 2 deaths
CAR (Late Switch)
Serious events: 22 serious events
Other events: 132 other events
Deaths: 0 deaths
DTG + RPV (Continuation Phase)
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
CAR (Continuation Phase)
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DTG + RPV (Early Switch)
n=261 participants at risk
Participants received DTG 50 mg + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
|
CAR (Early Switch)
n=255 participants at risk
Participants continued to receive their current antiretroviral regimen (two NRTIs + a third agent). A third agent included either an: INSTI, a NNRTI or a PI. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
|
DTG + RPV (Early + Late Switch)
n=261 participants at risk
Participants received DTG 50 mg + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
|
CAR (Late Switch)
n=239 participants at risk
Participants continued to receive their current antiretroviral regimen (two NRTIs + a third agent). A third agent included either an: INSTI, a NNRTI or a PI. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
At Week 52, participants who received CAR during the early switch phase, with HIV-1 RNA \<50 c/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
|
DTG + RPV (Continuation Phase)
n=208 participants at risk
Participants received DTG 50 mg + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
CAR (Continuation Phase)
n=204 participants at risk
Participants continued to receive their current antiretroviral regimen (NRTIs + a third agent). A third agent included either an: INSTI, a NNRTI or a PI. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52,participants with HIV-1 RNA \<50 copies per milliliter (c/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Pneumonia
|
0.77%
2/261 • Number of events 2 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.77%
2/261 • Number of events 3 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.98%
2/204 • Number of events 2 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Psychiatric disorders
Suicide attempt
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/255 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.49%
1/204 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
General disorders
Chest pain
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
1.3%
3/239 • Number of events 3 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Orchitis
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.77%
2/261 • Number of events 2 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Periorbital cellulitis
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.77%
2/261 • Number of events 2 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Abscess limb
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Acute hepatitis C
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.77%
2/261 • Number of events 2 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.48%
1/208 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia acute
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Nervous system disorders
Headache
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Lymphogranuloma venereum
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.84%
2/239 • Number of events 2 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Pulmonary sepsis
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Renal and urinary disorders
Renal colic
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Rotavirus infection
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Psychiatric disorders
Suicidal ideation
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.48%
1/208 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Abscess
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.49%
1/204 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Carbuncle
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.49%
1/204 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Psychiatric disorders
Depression
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/255 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.48%
1/208 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 2 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/255 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.48%
1/208 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/255 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.49%
1/204 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Groin abscess
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/28 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Immune system disorders
Jarisch-Herxheimer reaction
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/255 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/255 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Eye disorders
Keratitis
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/255 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer stage 0
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/28 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Proctitis infectious
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/255 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.49%
1/204 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Eye disorders
Retinal detachment
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/255 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/28 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.39%
1/255 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.42%
1/239 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.38%
1/261 • Number of events 2 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
COVID-19
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
1.9%
4/208 • Number of events 4 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.98%
2/204 • Number of events 2 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Acute hepatitis B
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.48%
1/208 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.49%
1/204 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.49%
1/204 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.48%
1/208 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Complicated appendicitis
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.49%
1/204 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Meningitis
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.49%
1/204 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.48%
1/208 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.49%
1/204 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.48%
1/208 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.49%
1/204 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.49%
1/204 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
General disorders
Pyrexia
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.48%
1/208 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/261 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/239 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.48%
1/208 • Number of events 1 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
Other adverse events
| Measure |
DTG + RPV (Early Switch)
n=261 participants at risk
Participants received DTG 50 mg + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.
|
CAR (Early Switch)
n=255 participants at risk
Participants continued to receive their current antiretroviral regimen (two NRTIs + a third agent). A third agent included either an: INSTI, a NNRTI or a PI. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
|
DTG + RPV (Early + Late Switch)
n=261 participants at risk
Participants received DTG 50 mg + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
|
CAR (Late Switch)
n=239 participants at risk
Participants continued to receive their current antiretroviral regimen (two NRTIs + a third agent). A third agent included either an: INSTI, a NNRTI or a PI. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.
At Week 52, participants who received CAR during the early switch phase, with HIV-1 RNA \<50 c/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.
|
DTG + RPV (Continuation Phase)
n=208 participants at risk
Participants received DTG 50 mg + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.
Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
|
CAR (Continuation Phase)
n=204 participants at risk
Participants continued to receive their current antiretroviral regimen (NRTIs + a third agent). A third agent included either an: INSTI, a NNRTI or a PI. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52,participants with HIV-1 RNA \<50 copies per milliliter (c/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.0%
21/261 • Number of events 26 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
9.0%
23/255 • Number of events 25 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
18.4%
48/261 • Number of events 86 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
15.5%
37/239 • Number of events 54 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
19/261 • Number of events 21 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
10.6%
27/255 • Number of events 41 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
14.2%
37/261 • Number of events 53 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
12.6%
30/239 • Number of events 37 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Bronchitis
|
6.5%
17/261 • Number of events 20 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
4.3%
11/255 • Number of events 13 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
10.7%
28/261 • Number of events 39 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
7.9%
19/239 • Number of events 25 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
17/261 • Number of events 19 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
2.7%
7/255 • Number of events 7 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
9.6%
25/261 • Number of events 32 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
9.2%
22/239 • Number of events 26 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Nervous system disorders
Headache
|
6.5%
17/261 • Number of events 36 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
2.4%
6/255 • Number of events 6 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
10.3%
27/261 • Number of events 57 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
5.9%
14/239 • Number of events 16 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
6/261 • Number of events 6 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
5.5%
14/255 • Number of events 16 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
6.5%
17/261 • Number of events 23 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
9.2%
22/239 • Number of events 26 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
10/261 • Number of events 13 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
4.3%
11/255 • Number of events 11 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
6.5%
17/261 • Number of events 23 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
4.2%
10/239 • Number of events 12 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Pharyngitis
|
2.3%
6/261 • Number of events 8 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
2.7%
7/255 • Number of events 7 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
5.7%
15/261 • Number of events 17 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
8.4%
20/239 • Number of events 24 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
General disorders
Asthenia
|
3.1%
8/261 • Number of events 8 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
3.9%
10/255 • Number of events 11 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
5.4%
14/261 • Number of events 14 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
4.2%
10/239 • Number of events 12 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Influenza
|
3.8%
10/261 • Number of events 10 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
1.6%
4/255 • Number of events 5 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
7.3%
19/261 • Number of events 19 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
3.3%
8/239 • Number of events 8 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Gastroenteritis
|
3.4%
9/261 • Number of events 10 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
2.4%
6/255 • Number of events 6 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
6.1%
16/261 • Number of events 23 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
3.8%
9/239 • Number of events 9 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Syphilis
|
1.5%
4/261 • Number of events 4 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
3.5%
9/255 • Number of events 9 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
5.0%
13/261 • Number of events 13 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
5.0%
12/239 • Number of events 13 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
9/261 • Number of events 10 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
1.2%
3/255 • Number of events 4 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
6.9%
18/261 • Number of events 21 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
2.5%
6/239 • Number of events 7 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Sinusitis
|
3.4%
9/261 • Number of events 10 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
1.2%
3/255 • Number of events 3 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
5.7%
15/261 • Number of events 17 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
3.3%
8/239 • Number of events 10 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Nervous system disorders
Dizziness
|
3.8%
10/261 • Number of events 10 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/255 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
5.4%
14/261 • Number of events 16 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
3.3%
8/239 • Number of events 8 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Psychiatric disorders
Insomnia
|
2.7%
7/261 • Number of events 8 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
1.6%
4/255 • Number of events 4 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
5.4%
14/261 • Number of events 17 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
2.9%
7/239 • Number of events 7 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
|
Infections and infestations
Respiratory tract infection
|
2.3%
6/261 • Number of events 8 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
1.2%
3/255 • Number of events 5 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
5.4%
14/261 • Number of events 16 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
1.7%
4/239 • Number of events 5 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/208 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
0.00%
0/204 • Non-serious AEs were collected from study start until Week 148, thereafter SAEs and only AEs leading to withdrawal were collected from study start until Week 410.
On treatment SAEs and non-serious AEs were reported for the Safety Population for DTG+RPV (Early Switch), CAR (Early Switch) and DTG+RPV (Early+Late Switch). LS Safety Population was used for CAR (Late Switch arm). CP Safety Population was used for DTG+RPV (Continuation Phase) and CAR (Continuation Phase).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER