Trial Outcomes & Findings for Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults (NCT NCT01108510)
NCT ID: NCT01108510
Last Updated: 2016-05-23
Results Overview
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
698 participants
Primary outcome timeframe
Week 48
Results posted on
2016-05-23
Participant Flow
Participants were enrolled in a total of 144 study sites in Asia, Australia, Europe, and South and North America. The last study visit occurred on 17 April 2015.
867 participants were screened.
Participant milestones
| Measure |
ATV+COBI+FTC/TDF
Cobicistat (COBI) 150 mg + ritonavir (RTV) placebo + atazanavir (ATV) 300 mg + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) once daily
|
ATV+RTV+FTC/TDF
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
|---|---|---|
|
Overall Study
STARTED
|
349
|
349
|
|
Overall Study
COMPLETED
|
70
|
81
|
|
Overall Study
NOT COMPLETED
|
279
|
268
|
Reasons for withdrawal
| Measure |
ATV+COBI+FTC/TDF
Cobicistat (COBI) 150 mg + ritonavir (RTV) placebo + atazanavir (ATV) 300 mg + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) once daily
|
ATV+RTV+FTC/TDF
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
|---|---|---|
|
Overall Study
Randomized but Not Treated
|
5
|
1
|
|
Overall Study
Joined Another Gilead-sponsored Study
|
186
|
195
|
|
Overall Study
Adverse Event
|
26
|
19
|
|
Overall Study
Lost to Follow-up
|
20
|
17
|
|
Overall Study
Withdrew Consent
|
21
|
15
|
|
Overall Study
Investigator's Discretion
|
12
|
10
|
|
Overall Study
Participant Noncompliance
|
5
|
7
|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
|
Overall Study
Pregnancy
|
0
|
3
|
|
Overall Study
Death
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Baseline characteristics by cohort
| Measure |
ATV+COBI+FTC/TDF
n=344 Participants
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
ATV+RTV+FTC/TDF
n=348 Participants
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
Total
n=692 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
38 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
37 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
287 Participants
n=5 Participants
|
287 Participants
n=7 Participants
|
574 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
97 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
245 Participants
n=5 Participants
|
253 Participants
n=7 Participants
|
498 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
44 participants
n=5 Participants
|
37 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African Heritage
|
65 participants
n=5 Participants
|
63 participants
n=7 Participants
|
128 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
198 participants
n=5 Participants
|
215 participants
n=7 Participants
|
413 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
33 participants
n=5 Participants
|
27 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
13 participants
n=5 Participants
|
5 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
26 participants
n=5 Participants
|
18 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Dominican Republic
|
27 participants
n=5 Participants
|
31 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Region of Enrollment
France
|
12 participants
n=5 Participants
|
19 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
17 participants
n=5 Participants
|
21 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
6 participants
n=5 Participants
|
15 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
3 participants
n=5 Participants
|
12 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
35 participants
n=5 Participants
|
31 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
14 participants
n=5 Participants
|
18 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
134 participants
n=5 Participants
|
114 participants
n=7 Participants
|
248 participants
n=5 Participants
|
|
HIV-1 RNA
|
4.81 log10 copies/mL
STANDARD_DEVIATION 0.585 • n=5 Participants
|
4.84 log10 copies/mL
STANDARD_DEVIATION 0.594 • n=7 Participants
|
4.83 log10 copies/mL
STANDARD_DEVIATION 0.589 • n=5 Participants
|
|
HIV-1 RNA Category
≤ 100,000 copies/mL
|
212 participants
n=5 Participants
|
205 participants
n=7 Participants
|
417 participants
n=5 Participants
|
|
HIV-1 RNA Category
> 100,000 copies/mL
|
132 participants
n=5 Participants
|
143 participants
n=7 Participants
|
275 participants
n=5 Participants
|
|
Cluster of differentiation (CD4) Cell Count
|
353 cells/µL
STANDARD_DEVIATION 170.5 • n=5 Participants
|
351 cells/µL
STANDARD_DEVIATION 175.5 • n=7 Participants
|
352 cells/µL
STANDARD_DEVIATION 172.9 • n=5 Participants
|
|
CD4 Cell Count Category
≤ 50 cells/μL
|
11 participants
3.2 • n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
CD4 Cell Count Category
51 to ≤ 200 cells/μL
|
49 participants
n=5 Participants
|
45 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
CD4 Cell Count Category
201 to ≤ 350 cells/μL
|
114 participants
n=5 Participants
|
126 participants
n=7 Participants
|
240 participants
n=5 Participants
|
|
CD4 Cell Count Category
351 to ≤ 500 cells/μL
|
123 participants
n=5 Participants
|
117 participants
n=7 Participants
|
240 participants
n=5 Participants
|
|
CD4 Cell Count Category
> 500 cells/μL
|
47 participants
n=5 Participants
|
48 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
HIV Disease Status
Asymptomatic
|
285 participants
n=5 Participants
|
292 participants
n=7 Participants
|
577 participants
n=5 Participants
|
|
HIV Disease Status
Symptomatic HIV Infections
|
31 participants
n=5 Participants
|
32 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
HIV Disease Status
AIDS
|
28 participants
n=5 Participants
|
24 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Hepatitis B Surface Antigen Status
Positive
|
16 participants
n=5 Participants
|
9 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Hepatitis B Surface Antigen Status
Negative
|
328 participants
n=5 Participants
|
339 participants
n=7 Participants
|
667 participants
n=5 Participants
|
|
Hepatitis C Antibody Status
Positive
|
21 participants
n=5 Participants
|
16 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Hepatitis C Antibody Status
Negative
|
323 participants
n=5 Participants
|
331 participants
n=7 Participants
|
654 participants
n=5 Participants
|
|
Hepatitis C Antibody Status
Indeterminate
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Intent-to-Treat (ITT) Analysis Set: participants who were randomized and received at least one dose of study drug
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
ATV+COBI+FTC/TDF
n=344 Participants
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
ATV+RTV+FTC/TDF
n=348 Participants
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
|
85.2 percentage of participants
|
87.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 96Population: ITT Analysis Set
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm.
Outcome measures
| Measure |
ATV+COBI+FTC/TDF
n=344 Participants
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
ATV+RTV+FTC/TDF
n=348 Participants
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
|
77.9 percentage of participants
|
79.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 144Population: ITT Analysis Set
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 144 was analyzed using the snapshot algorithm.
Outcome measures
| Measure |
ATV+COBI+FTC/TDF
n=344 Participants
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
ATV+RTV+FTC/TDF
n=348 Participants
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144
|
72.1 percentage of participants
|
74.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 192Population: Week 192 Modified ITT Analysis Set: includes participants in the ITT analysis set excluding those who either (1) transferred to other Gilead-sponsored studies after completing their Week 144 visit and before the lower limit of the Week 192 analysis window, or (2) prematurely discontinued study drug prior to the Week 144 visit.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 192 was analyzed using the snapshot algorithm.
Outcome measures
| Measure |
ATV+COBI+FTC/TDF
n=74 Participants
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
ATV+RTV+FTC/TDF
n=69 Participants
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192
|
71.6 percentage of participants
|
79.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the ITT Analysis Set with available change data at Week 48 were analyzed.
Outcome measures
| Measure |
ATV+COBI+FTC/TDF
n=313 Participants
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
ATV+RTV+FTC/TDF
n=324 Participants
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
|---|---|---|
|
Change From Baseline in CD4 Cell Count at Week 48
|
213 cells/μL
Standard Deviation 151.0
|
219 cells/μL
Standard Deviation 150.4
|
SECONDARY outcome
Timeframe: Baseline to Week 96Population: Participants in the ITT Analysis Set with available change data at Week 96 were analyzed.
Outcome measures
| Measure |
ATV+COBI+FTC/TDF
n=300 Participants
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
ATV+RTV+FTC/TDF
n=311 Participants
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
|---|---|---|
|
Change From Baseline in CD4 Cell Count at Week 96
|
277 cells/μL
Standard Deviation 176.8
|
287 cells/μL
Standard Deviation 181.5
|
SECONDARY outcome
Timeframe: Baseline to Week 144Population: Participants in the ITT Analysis Set with available change data at Week 144 were analyzed.
Outcome measures
| Measure |
ATV+COBI+FTC/TDF
n=275 Participants
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
ATV+RTV+FTC/TDF
n=288 Participants
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
|---|---|---|
|
Change From Baseline in CD4 Cell Count at Week 144
|
310 cells/μL
Standard Deviation 188.0
|
332 cells/μL
Standard Deviation 199.8
|
SECONDARY outcome
Timeframe: Baseline to Week 192Population: Participants in the ITT Analysis Set with available change data at Week 192 were analyzed.
Outcome measures
| Measure |
ATV+COBI+FTC/TDF
n=73 Participants
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
ATV+RTV+FTC/TDF
n=83 Participants
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
|---|---|---|
|
Change From Baseline in CD4 Cell Count at Week 192
|
350 cells/μL
Standard Deviation 191.3
|
343 cells/μL
Standard Deviation 190.7
|
Adverse Events
ATV+COBI+FTC/TDF
Serious events: 64 serious events
Other events: 311 other events
Deaths: 0 deaths
ATV+RTV+FTC/TDF
Serious events: 50 serious events
Other events: 312 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ATV+COBI+FTC/TDF
n=344 participants at risk
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
ATV+RTV+FTC/TDF
n=348 participants at risk
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
|---|---|---|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Anaemia
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Atrial tachycardia
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Cardiac disorders
Palpitations
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal mass
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Colitis
|
0.58%
2/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Crohn's disease
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Enteritis
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Food poisoning
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Haematemesis
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Haematochezia
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Chest pain
|
0.87%
3/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.86%
3/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
General physical health deterioration
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Oedema peripheral
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Pyrexia
|
0.87%
3/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.86%
3/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Immune system disorders
Immune reconstitution inflammatory syndrome
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Abdominal wall abscess
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Abscess limb
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.57%
2/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Abscess neck
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Anal abscess
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Appendicitis
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Appendicitis perforated
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Bacteraemia
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Cellulitis
|
0.58%
2/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.57%
2/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Chancroid
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Dengue fever
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Enterobacter sepsis
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.86%
3/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Gastroenteritis shigella
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Genital abscess
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Gonorrhoea
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Groin abscess
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Herpes zoster
|
0.87%
3/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Influenza
|
0.58%
2/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Meningitis toxoplasmal
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Meningitis viral
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Oesophageal candidiasis
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Orchitis
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Otitis media chronic
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Perineal abscess
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Peritonitis
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Pneumonia
|
0.58%
2/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.57%
2/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Post procedural infection
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Pyelonephritis
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Scrotal abscess
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Sepsis
|
0.58%
2/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.57%
2/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Skin infection
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Subcutaneous abscess
|
1.2%
4/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Renal haematoma
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Investigations
Blood creatine phosphokinase increased
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Investigations
Coma scale abnormal
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Investigations
Hepatic enzyme increased
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Investigations
White blood cell count increased
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Dehydration
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.58%
2/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
Intervertebral disc protrusion
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
Muscular weakness
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
Rhabdomyolysis
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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)
Burkitt's lymphoma
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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)
Hodgkin's disease
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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)
Uterine leiomyoma
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Ataxia
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Headache
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Migraine
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Syncope
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.58%
2/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.57%
2/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Depression
|
0.87%
3/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Drug dependence
|
0.58%
2/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Schizophrenia
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Suicidal ideation
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Calculus ureteric
|
0.58%
2/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.57%
2/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Fanconi syndrome acquired
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Renal and urinary disorders
Nephropathy
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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 colic
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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 failure
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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 failure acute
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
1.1%
4/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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 acidosis
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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 necrosis
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.58%
2/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Reproductive system and breast disorders
Colpocele
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.57%
2/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
Asthma
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
Chronic obstructive pulmonary disease
|
0.58%
2/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
Pneumonia aspiration
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
Angioedema
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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 papular
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
Skin abrasion
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
Vasculitic rash
|
0.29%
1/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.00%
0/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
0.29%
1/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
Other adverse events
| Measure |
ATV+COBI+FTC/TDF
n=344 participants at risk
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
ATV+RTV+FTC/TDF
n=348 participants at risk
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.2%
18/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
7.5%
26/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Eye disorders
Ocular icterus
|
20.1%
69/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
22.7%
79/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal distension
|
4.7%
16/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
5.5%
19/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
6.4%
22/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
7.5%
26/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.5%
19/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.6%
23/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
22.1%
76/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
27.6%
96/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
4.4%
15/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.0%
21/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Flatulence
|
8.1%
28/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
2.9%
10/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.7%
23/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.0%
21/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
19.2%
66/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
19.0%
66/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
9.9%
34/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
7.2%
25/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Fatigue
|
11.0%
38/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
9.8%
34/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
General disorders
Pyrexia
|
10.5%
36/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
8.6%
30/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
12.2%
42/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
11.2%
39/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Hepatobiliary disorders
Jaundice
|
22.1%
76/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
17.5%
61/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Bronchitis
|
9.6%
33/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
9.5%
33/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Folliculitis
|
5.2%
18/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
2.0%
7/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
3.5%
12/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
5.7%
20/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Influenza
|
7.3%
25/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
5.5%
19/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Nasopharyngitis
|
17.2%
59/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
22.7%
79/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Oral candidiasis
|
6.1%
21/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
5.5%
19/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Pharyngitis
|
4.9%
17/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
7.8%
27/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Sinusitis
|
8.1%
28/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
8.0%
28/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Syphilis
|
6.7%
23/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
7.5%
26/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Tinea pedis
|
5.2%
18/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
3.2%
11/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
|
19.5%
67/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
18.7%
65/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Urinary tract infection
|
7.3%
25/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
7.2%
25/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
|
5.5%
19/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
5.5%
19/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
|
9.9%
34/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
12.1%
42/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
Myalgia
|
5.2%
18/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
5.7%
20/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
|
5.2%
18/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
4.3%
15/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
|
7.0%
24/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
4.6%
16/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Dizziness
|
9.3%
32/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
8.0%
28/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Headache
|
16.6%
57/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
21.0%
73/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Anxiety
|
5.5%
19/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
4.6%
16/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Depression
|
7.3%
25/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
8.0%
28/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Psychiatric disorders
Insomnia
|
7.6%
26/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
8.3%
29/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
|
10.5%
36/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
8.3%
29/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
Nasal congestion
|
4.4%
15/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
8.3%
29/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
|
5.8%
20/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.9%
24/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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
|
7.6%
26/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
8.9%
31/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Hypertension
|
5.2%
18/344 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
|
6.6%
23/348 • Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 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