Trial Outcomes & Findings for A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF (NCT NCT05911360)
NCT ID: NCT05911360
Last Updated: 2026-05-14
Results Overview
Participants with HIV-1 RNA \>= 50 c/mL were evaluated. Virologic outcome was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the Week 48 Window. The analysis was done using the modified Snapshot algorithm.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
203 participants
Primary outcome timeframe
At Week 48
Results posted on
2026-05-14
Participant Flow
Analysis presented includes data up to Primary Completion (Week 48 of the study). Additional results will be provided within one year of study completion.
Participant milestones
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) Antiretroviral Therapy (ART).
|
|---|---|
|
Overall Study
STARTED
|
205
|
|
Overall Study
COMPLETED
|
175
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) Antiretroviral Therapy (ART).
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Death
|
1
|
|
Overall Study
Participant reached protocol defined stopping criteria
|
15
|
Baseline Characteristics
A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF
Baseline characteristics by cohort
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=205 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) Antiretroviral Therapy (ART).
|
|---|---|
|
Age, Continuous
|
62.2 Years
STANDARD_DEVIATION 7.46 • n=1512 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=1512 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=1512 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=1512 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=1512 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
68 Participants
n=1512 Participants
|
|
Race/Ethnicity, Customized
White
|
125 Participants
n=1512 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=1512 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
1 Participants
n=1512 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=1512 Participants
|
PRIMARY outcome
Timeframe: At Week 48Population: The analysis was performed on the Full Analysis Set (FAS) which included all assigned participants who received at least one dose of study treatment. Only participants with data available at the mentioned timepoints were included in this analysis.
Participants with HIV-1 RNA \>= 50 c/mL were evaluated. Virologic outcome was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the Week 48 Window. The analysis was done using the modified Snapshot algorithm.
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=205 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
|
|---|---|
|
Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=)50 Copies/Millilitre (c/mL) at Week 48
|
2 Participants
|
SECONDARY outcome
Timeframe: At Week 24Population: The analysis was performed on the FAS. Only participants with data available at the mentioned timepoints were included in this analysis.
The number of participants with plasma HIV-1 RNA \>/=50 c/mL at Week 24 was analyzed using the Snapshot Algorithm.
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=205 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
|
|---|---|
|
Number of Participants With Plasma HIV-1 RNA >= 50 c/mL at Week 24
|
14 Participants
|
SECONDARY outcome
Timeframe: At Week 96Data not available at the time of posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Week 24Population: The analysis was performed on the FAS.
The number of participants with plasma HIV-1 RNA \<50 c/mL at Week 24 was analyzed using the Snapshot Algorithm.
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=205 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
|
|---|---|
|
Number of Participants With Plasma HIV-1 RNA Less Than (<) 50 c/mL at Week 24
Participants with Plasma HIV-1 RNA < 50 c/mL
|
183 Participants
|
|
Number of Participants With Plasma HIV-1 RNA Less Than (<) 50 c/mL at Week 24
Participants with no virologic data
|
8 Participants
|
SECONDARY outcome
Timeframe: At Week 48Population: The analysis was performed on the FAS.
The number of participants with plasma HIV-1 RNA \< 50 c/mL at Week 48 was analyzed using the modified Snapshot Algorithm.
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=205 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
|
|---|---|
|
Number of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 48
Participants with Plasma HIV-1 RNA < 50 c/mL
|
177 Participants
|
|
Number of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 48
Participants with no virologic data
|
26 Participants
|
SECONDARY outcome
Timeframe: At Week 96Data not available at the time of posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Week 24Population: The analysis was performed on the FAS. Only participants with data available at the mentioned timepoints were included in this analysis.
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=187 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
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|---|---|
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Absolute Values for Cluster of Differentiation 4 (CD4+) Cells Count at Week 24
|
724.8 cells per cubic millimeter (cells/mm^3)
Standard Deviation 322.69
|
SECONDARY outcome
Timeframe: At Week 48Population: The analysis was performed on the FAS. Only participants with data available at the mentioned timepoints were included in this analysis.
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=178 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
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|---|---|
|
Absolute Values for CD4+ Cells Count at Week 48
|
723.6 cells/mm^3
Standard Deviation 334.76
|
SECONDARY outcome
Timeframe: At Week 96Data not available at the time of posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Week 24Population: The analysis was performed on the FAS. Only participants with data available at the mentioned timepoints were included in this analysis.
The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=187 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
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|---|---|
|
Absolute Values for CD4: Cluster of Differentiation 8 (CD8) Ratio at Week 24
|
1.127 Ratio
Standard Deviation 0.5861
|
SECONDARY outcome
Timeframe: At Week 48Population: The analysis was performed on the FAS. Only participants with data available at the mentioned timepoints were included in this analysis.
The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=178 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
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|---|---|
|
Absolute Values for CD4:CD8 Ratio at Week 48
|
1.210 Ratio
Standard Deviation 0.6203
|
SECONDARY outcome
Timeframe: At Week 96Data not available at the time of posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Week 24 compared to BaselinePopulation: The analysis was performed on the FAS. Only participants with data available at the mentioned timepoints were included in this analysis.
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=201 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
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|---|---|
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Change From Baseline in CD4+ Cells Count at Week 24
Baseline
|
733.6 cells/mm^3
Standard Deviation 313.32
|
|
Change From Baseline in CD4+ Cells Count at Week 24
Week 24
|
-8.9 cells/mm^3
Standard Deviation 162.16
|
SECONDARY outcome
Timeframe: At Week 48 compared to BaselinePopulation: The analysis was performed on the FAS. Only participants with data available at the mentioned timepoints were included in this analysis.
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=201 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
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|---|---|
|
Change From Baseline in CD4+ Cells Count at Week 48
Baseline
|
733.6 cells/mm^3
Standard Deviation 313.32
|
|
Change From Baseline in CD4+ Cells Count at Week 48
Week 48
|
-16.8 cells/mm^3
Standard Deviation 190.56
|
SECONDARY outcome
Timeframe: At Week 96 compared to baselineData not available at the time of posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Week 24 compared to BaselinePopulation: The analysis was performed on the FAS. Only participants with data available at the mentioned timepoints were included in this analysis.
The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=201 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
|
|---|---|
|
Change From Baseline in CD4:CD8 Ratio at Week 24
Baseline
|
1.167 Ratio
Standard Deviation 0.6125
|
|
Change From Baseline in CD4:CD8 Ratio at Week 24
Week 24
|
-0.027 Ratio
Standard Deviation 0.2325
|
SECONDARY outcome
Timeframe: At Week 48 compared to BaselinePopulation: The analysis was performed on the FAS. Only participants with data available at the mentioned timepoints were included in this analysis.
The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=201 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
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|---|---|
|
Change From Baseline in CD4:CD8 Ratio at Week 48
Baseline
|
1.167 Ratio
Standard Deviation 0.6125
|
|
Change From Baseline in CD4:CD8 Ratio at Week 48
Week 48
|
0.030 Ratio
Standard Deviation 0.2065
|
SECONDARY outcome
Timeframe: At Week 96 compared to baselineData not available at the time of posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 24Population: The analysis was performed on the FAS. Only participants with data available at the mentioned timepoints were included in this analysis.
Occurrence of disease progression was evaluated through HIV-associated conditions and incidence of disease progression to United States Centers for Disease Control and Prevention (CDC) stage 3 or death.
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=205 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
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|---|---|
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Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 24
|
4 Participants
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SECONDARY outcome
Timeframe: Up to Week 48Population: The analysis was performed on the FAS. Only participants with data available at the mentioned timepoints were included in this analysis.
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=205 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
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|---|---|
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Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 48
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 96Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 48Population: The analysis was performed on the CVW Set which included all participants in the FAS who met CVW criteria defined as: two consecutive assessments with HIV-1 RNA\>=200 c/mL after Day 1.
Confirmed virologic withdrawal criteria is defined as two consecutive assessments with HIV-1 RNA greater than or equal to (\>=)200 c/mL after Day 1 visit.
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=3 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
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|---|---|
|
Number of Participants With Viral Resistance After Meeting Confirmed Virologic Withdrawal (CVW) Criterion
|
0 Participants
|
SECONDARY outcome
Timeframe: From Week 48 to Week 96Data not available at the time of posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 48Population: The analysis was performed on the FAS.
A treatment related non-serious AE is defined as any untoward medical occurrence in a clinical study participant considered related to the study treatment. Any = occurrence of the event regardless of intensity grade
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=205 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
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|---|---|
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Number of Participants With Treatment Related Non-serious Adverse Events (AEs)
|
17 Participants
|
SECONDARY outcome
Timeframe: From Week 48 to Week 96Data not available at the time of posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 48Population: The analysis was performed on the FAS. Only participants with data available at the mentioned timepoints were included in this analysis.
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=205 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
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|---|---|
|
Number of Participants With Any Serious Adverse Events (SAEs)
|
26 Participants
|
SECONDARY outcome
Timeframe: From Week 48 to Week 96Data not available at the time of posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 48Population: The analysis was performed on the FAS. Only participants with data available at the mentioned timepoints were included in this analysis.
Outcome measures
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=205 Participants
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
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|---|---|
|
Number of Participants With AEs Leading to Treatment Discontinuation
|
9 Participants
|
SECONDARY outcome
Timeframe: From Week 48 to Week 96Data not available at the time of posting, will be updated at the final results disclosure stage.
Outcome measures
Outcome data not reported
Adverse Events
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Serious events: 26 serious events
Other events: 69 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=205 participants at risk
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
|
|---|---|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Injury, poisoning and procedural complications
Medication error
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Infections and infestations
Complicated appendicitis
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Infections and infestations
Diverticulitis
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Infections and infestations
Erysipelas
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Infections and infestations
Laryngitis
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Infections and infestations
Pneumonia
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Cardiac disorders
Angina unstable
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Gastrointestinal disorders
Gastritis
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma metastatic
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.98%
2/205 • Number of events 2 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Nervous system disorders
Lacunar stroke
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Nervous system disorders
Syncope
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Surgical and medical procedures
Internal fixation of fracture
|
0.49%
1/205 • Number of events 1 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
Other adverse events
| Measure |
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
n=205 participants at risk
Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) ART.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.8%
18/205 • Number of events 20 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
6/205 • Number of events 6 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Nervous system disorders
Headache
|
7.3%
15/205 • Number of events 16 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Nervous system disorders
Dizziness
|
2.9%
6/205 • Number of events 6 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
10/205 • Number of events 11 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Gastrointestinal disorders
Nausea
|
4.4%
9/205 • Number of events 9 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
5/205 • Number of events 5 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
General disorders
Fatigue
|
4.4%
9/205 • Number of events 9 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Infections and infestations
COVID-19
|
4.4%
9/205 • Number of events 9 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.9%
8/205 • Number of events 8 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Infections and infestations
Bronchitis
|
2.4%
5/205 • Number of events 5 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
7/205 • Number of events 7 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Psychiatric disorders
Anxiety
|
2.9%
6/205 • Number of events 6 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
|
Psychiatric disorders
Insomnia
|
2.4%
5/205 • Number of events 5 • Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.
There was 1 Death that occurred during the treatment phase and 1 participant died after withdrawing from the study, hence, 2 Deaths are reported in All-cause Mortality. These events were not related to study treatment. Data presented was collected up to Week 48 (time of Primary Posting). Data will be updated at the time of final analysis.
|
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