Trial Outcomes & Findings for D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults (NCT NCT01565850)
NCT ID: NCT01565850
Last Updated: 2016-04-11
Results Overview
The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
153 participants
Primary outcome timeframe
Week 24
Results posted on
2016-04-11
Participant Flow
Participants were enrolled at study sites in the United States (including Puerto Rico). The first participant was screened on 16 April 2012. The last study visit occurred on 19 February 2014.
232 participants were screened.
Participant milestones
| Measure |
D/C/F/TAF
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) (800/150/200/10 mg) fixed-dose combination (FDC) tablet plus darunavir (DRV) placebo plus cobicistat (COBI) placebo plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo once daily
|
DRV+COBI+FTC/TDF
DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
50
|
|
Overall Study
COMPLETED
|
83
|
42
|
|
Overall Study
NOT COMPLETED
|
20
|
8
|
Reasons for withdrawal
| Measure |
D/C/F/TAF
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) (800/150/200/10 mg) fixed-dose combination (FDC) tablet plus darunavir (DRV) placebo plus cobicistat (COBI) placebo plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo once daily
|
DRV+COBI+FTC/TDF
DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
12
|
4
|
|
Overall Study
Investigator's Discretion
|
2
|
1
|
|
Overall Study
Participant noncompliance
|
2
|
0
|
|
Overall Study
Withdrew Consent
|
4
|
2
|
Baseline Characteristics
D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults
Baseline characteristics by cohort
| Measure |
D/C/F/TAF
n=103 Participants
D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
|
DRV+COBI+FTC/TDF
n=50 Participants
DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 11.3 • n=99 Participants
|
37 years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
35 years
STANDARD_DEVIATION 11.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
62 participants
n=99 Participants
|
30 participants
n=107 Participants
|
92 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
36 participants
n=99 Participants
|
17 participants
n=107 Participants
|
53 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=99 Participants
|
50 participants
n=107 Participants
|
153 participants
n=206 Participants
|
|
HIV-1 RNA
|
4.70 log10 copies/mL
STANDARD_DEVIATION 0.516 • n=99 Participants
|
4.65 log10 copies/mL
STANDARD_DEVIATION 0.514 • n=107 Participants
|
4.68 log10 copies/mL
STANDARD_DEVIATION 0.515 • n=206 Participants
|
|
HIV-1 RNA Category
≤ 100,000 copies/mL
|
80 participants
n=99 Participants
|
43 participants
n=107 Participants
|
123 participants
n=206 Participants
|
|
HIV-1 RNA Category
> 100,000 to ≤ 400,000 copies/mL
|
17 participants
n=99 Participants
|
5 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
HIV-1 RNA Category
> 400,000 copies/mL
|
6 participants
n=99 Participants
|
2 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
CD4 Cell Count
|
395 cells/µL
STANDARD_DEVIATION 169.3 • n=99 Participants
|
464 cells/µL
STANDARD_DEVIATION 261.6 • n=107 Participants
|
417 cells/µL
STANDARD_DEVIATION 205.7 • n=206 Participants
|
|
CD4 Cell Count Category
< 50 cells/μL
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
CD4 Cell Count Category
50 to ≤ 199 cells/µL
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
CD4 Cell Count Category
200 to ≤ 349 cells/µL
|
37 participants
n=99 Participants
|
8 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
CD4 Cell Count Category
351 to ≤ 499 cells/µL
|
27 participants
n=99 Participants
|
12 participants
n=107 Participants
|
39 participants
n=206 Participants
|
|
CD4 Cell Count Category
≥ 500 cells/μL
|
28 participants
n=99 Participants
|
20 participants
n=107 Participants
|
48 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Full Analysis Set: participant who were randomized;enrolled and received at least one dose of study drug
The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
D/C/F/TAF
n=103 Participants
D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
|
DRV+COBI+FTC/TDF
n=50 Participants
DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
|
74.8 percentage of participants
|
74.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Full Analysis Set
The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
D/C/F/TAF
n=103 Participants
D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
|
DRV+COBI+FTC/TDF
n=50 Participants
DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
|
76.7 percentage of participants
|
84.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set with Week 24 data were analyzed.
Outcome measures
| Measure |
D/C/F/TAF
n=92 Participants
D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
|
DRV+COBI+FTC/TDF
n=48 Participants
DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
|
|---|---|---|
|
Change From Baseline in HIV-1 RNA at Week 24
|
-3.20 log10 copies/mL
Standard Deviation 0.653
|
-3.18 log10 copies/mL
Standard Deviation 0.416
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Full Analysis Set with Week 48 data were analyzed.
Outcome measures
| Measure |
D/C/F/TAF
n=89 Participants
D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
|
DRV+COBI+FTC/TDF
n=47 Participants
DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
|
|---|---|---|
|
Change From Baseline in HIV-1 RNA at Week 48
|
-3.27 log10 copies/mL
Standard Deviation 0.668
|
-3.26 log10 copies/mL
Standard Deviation 0.521
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set with Week 24 data were analyzed.
Outcome measures
| Measure |
D/C/F/TAF
n=91 Participants
D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
|
DRV+COBI+FTC/TDF
n=48 Participants
DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 24
|
186 cells/µL
Standard Deviation 137.9
|
139 cells/µL
Standard Deviation 185.8
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Full Analysis Set with Week 48 data were analyzed.
Outcome measures
| Measure |
D/C/F/TAF
n=85 Participants
D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
|
DRV+COBI+FTC/TDF
n=46 Participants
DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 48
|
231 cells/µL
Standard Deviation 141.9
|
212 cells/µL
Standard Deviation 151.5
|
Adverse Events
D/C/F/TAF
Serious events: 5 serious events
Other events: 77 other events
Deaths: 0 deaths
DRV+COBI+FTC/TDF
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
D/C/F/TAF
n=103 participants at risk
D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
|
DRV+COBI+FTC/TDF
n=50 participants at risk
DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.97%
1/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Immune system disorders
Hypersensitivity
|
0.97%
1/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Bronchitis
|
0.00%
0/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
2.0%
1/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
2.0%
1/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Cellulitis
|
0.97%
1/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Pneumonia
|
0.00%
0/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
2.0%
1/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Psychotic disorder
|
0.97%
1/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Substance abuse
|
0.97%
1/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Renal tubular disorder
|
0.00%
0/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
2.0%
1/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
Other adverse events
| Measure |
D/C/F/TAF
n=103 participants at risk
D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
|
DRV+COBI+FTC/TDF
n=50 participants at risk
DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
6/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.0%
3/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
22/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
26.0%
13/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Flatulence
|
4.9%
5/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
12.0%
6/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.9%
3/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
8.0%
4/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
12.6%
13/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
10.0%
5/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
4/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
10.0%
5/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Fatigue
|
13.6%
14/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
18.0%
9/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Pyrexia
|
6.8%
7/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
4.0%
2/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Bronchitis
|
8.7%
9/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
4.0%
2/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Folliculitis
|
2.9%
3/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
8.0%
4/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Influenza
|
1.9%
2/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.0%
3/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
5/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.0%
3/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Pharyngitis
|
0.97%
1/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.0%
3/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Sinusitis
|
6.8%
7/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
8.0%
4/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.0%
3/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
15.5%
16/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
14.0%
7/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.9%
4/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.0%
3/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.9%
2/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
10.0%
5/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
9/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.97%
1/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.0%
3/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.8%
8/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
10.0%
5/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
2.9%
3/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.0%
3/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Headache
|
6.8%
7/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
8.0%
4/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Insomnia
|
5.8%
6/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
4.0%
2/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.8%
7/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.0%
3/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.9%
5/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
8.0%
4/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.8%
6/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.0%
3/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.7%
12/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
8.0%
4/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Hypertension
|
1.9%
2/103 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.0%
3/50 • Baseline through end of study drug treatment (average exposure: D/C/F/TAF group = 61.7 weeks; DRV+COBI+FTC/TDF group = 66.1 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER