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Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01797445
Recruitment Status : Completed
First Posted : February 22, 2013
Results First Posted : January 8, 2016
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions HIV
HIV Infections
Interventions Drug: E/C/F/TAF
Drug: E/C/F/TDF
Drug: E/C/F/TDF Placebo
Drug: E/C/F/TAF Placebo
Enrollment 872
Recruitment Details Participants were enrolled at study sites in North America and Europe. The first participant was screened on 12 March 2013. The last study visit occurred on 03 October 2018.
Pre-assignment Details 1070 participants were screened.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description

Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) placebo tablet administered orally once daily for 144 weeks.

Open-Label Extension Phase: After the unblinding visit, in countries where E/C/F/TAF FDC was not commercially available, participants (except in UK) were given the option to receive the open-label E/C/F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country.

Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks.

Open-Label Extension Phase: After the unblinding visit, in countries where E/C/F/TAF FDC was not commercially available, participants (except in UK) were given the option to receive the open-label E/C/F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country.
Period Title: Double-Blind Phase
Started 435 437
Completed 348 348
Not Completed 87 89
Reason Not Completed
Randomized but Not Treated             4             2
Adverse Event             3             0
Death             5             4
Pregnancy             0             1
Lack of Efficacy             1             2
Investigator's Discretion             15             17
Noncompliance with Study Drug             5             1
Protocol Violation             0             1
Withdrew Consent             20             35
Lost to Follow-up             34             26
Period Title: Open-Label Extension Phase
Started 141 [1] 119 [2]
Completed 140 119
Not Completed 1 0
Reason Not Completed
Investigator's Discretion             1             0
[1]
207 participants completed the Double-Blind Phase, but did not enter the Open-Label Extension Phase.
[2]
229 participants completed the Double-Blind Phase, but did not enter the Open-Label Extension Phase.
Arm/Group Title E/C/F/TAF E/C/F/TDF Total
Hide Arm/Group Description E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks Total of all reporting groups
Overall Number of Baseline Participants 431 435 866
Hide Baseline Analysis Population Description
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 431 participants 435 participants 866 participants
35  (10.8) 36  (10.9) 36  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 431 participants 435 participants 866 participants
Female 62 71 133
Male 369 364 733
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 431 participants 435 participants 866 participants
American Indian or Alaska Native 1 3 4
Asian 15 12 27
Black 129 132 261
Native Hawaiian or Pacific Islander 4 1 5
White 235 243 478
Other 47 44 91
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 431 participants 435 participants 866 participants
Hispanic or Latino 107 97 204
Not Hispanic or Latino 323 336 659
Not Permitted 1 1 2
Missing 0 1 1
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 431 participants 435 participants 866 participants
280 282 562
United Kingdom Number Analyzed 431 participants 435 participants 866 participants
25 31 56
Portugal Number Analyzed 431 participants 435 participants 866 participants
21 16 37
Canada Number Analyzed 431 participants 435 participants 866 participants
19 22 41
Netherlands Number Analyzed 431 participants 435 participants 866 participants
6 8 14
Sweden Number Analyzed 431 participants 435 participants 866 participants
8 3 11
Dominican Republic Number Analyzed 431 participants 435 participants 866 participants
30 35 65
Italy Number Analyzed 431 participants 435 participants 866 participants
10 8 18
Mexico Number Analyzed 431 participants 435 participants 866 participants
16 12 28
France Number Analyzed 431 participants 435 participants 866 participants
16 18 34
HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 431 participants 435 participants 866 participants
4.53  (0.647) 4.50  (0.690) 4.52  (0.669)
HIV-1 RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 431 participants 435 participants 866 participants
≤ 100,000 copies/mL 339 336 675
> 100,000 to ≤ 400,000 copies/mL 68 82 150
> 400,000 copies/mL 24 17 41
CD4 Cell Count   [1] 
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 430 participants 435 participants 865 participants
414  (206.8) 431  (226.8) 423  (217.1)
[1]
Measure Analysis Population Description: Participants in the Safety Analysis Set with available data were analyzed (E/C/F/TAF: N = 430; E/C/F/TDF: N = 435)
CD4 Cell Count Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 431 participants 435 participants 866 participants
< 50 cells/μL 14 15 29
≥ 50 to < 200 cells/μL 40 49 89
≥ 200 to < 350 cells/μL 115 89 204
≥ 350 to < 500 cells/μL 134 149 283
≥ 500 cells/μL 127 133 260
Missing 1 0 1
HIV Disease Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 431 participants 435 participants 866 participants
Asymptomatic 377 394 771
Symptomatic HIV Infection 30 19 49
AIDS 22 19 41
Unknown 2 3 5
1.Primary Outcome
Title Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Overall Number of Participants Analyzed 431 435
Measure Type: Number
Unit of Measure: percentage of participants
91.6 88.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, E/C/F/TDF
Comments Null hypothesis: the E/C/F/TAF group was ≥ 12% worse than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48; alternative hypothesis: the E/C/F/TAF group was < 12% worse than the E/C/F/TDF group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA (≤ 100,000 or > 100,000 copies/mL) and region (US vs ex-US).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 3.1
Confidence Interval (2-Sided) 95.002%
-1.0 to 7.1
Estimation Comments The difference in percentages and its 95.002% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA and region stratum.
2.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Overall Number of Participants Analyzed 431 435
Measure Type: Number
Unit of Measure: percentage of participants
84.0 82.3
3.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96
Hide Description The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48 and 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Weeks 48 and 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Overall Number of Participants Analyzed 431 435
Measure Type: Number
Unit of Measure: percentage of participants
Week 48 82.4 80.7
Week 96 78.7 76.8
4.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Overall Number of Participants Analyzed 404 400
Mean (Standard Deviation)
Unit of Measure: cells/µL
225  (171.2) 200  (162.5)
5.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 96
Hide Description [Not Specified]
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Overall Number of Participants Analyzed 369 369
Mean (Standard Deviation)
Unit of Measure: cells/µL
274  (184.0) 260  (179.6)
6.Secondary Outcome
Title Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Hide Description Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Hip DXA Analysis Set included all participants who were randomized and received at least 1 dose of study drug, and have nonmissing baseline hip BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Overall Number of Participants Analyzed 380 381
Mean (Standard Deviation)
Unit of Measure: percent change
-0.420  (3.2268) -2.603  (3.1482)
7.Secondary Outcome
Title Percent Change From Baseline in Hip BMD at Week 96
Hide Description Hip BMD was assessed by DXA scan.
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Hip DXA Analysis Set were analyzed. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Overall Number of Participants Analyzed 341 346
Mean (Standard Deviation)
Unit of Measure: percent change
-0.364  (3.8990) -3.023  (3.9796)
8.Secondary Outcome
Title Percent Change From Baseline in Spine BMD at Week 48
Hide Description Spine BMD was assessed by DXA scan.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Spine DXA Analysis Set included all participants who were randomized and received at least 1 dose of study drug, and have nonmissing baseline spine BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Overall Number of Participants Analyzed 386 385
Mean (Standard Deviation)
Unit of Measure: percent change
-1.278  (3.0098) -2.759  (3.0024)
9.Secondary Outcome
Title Percent Change From Baseline in Spine BMD at Week 96
Hide Description Spine BMD was assessed by DXA scan.
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Spine DXA Analysis Set were analyzed. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Overall Number of Participants Analyzed 346 347
Mean (Standard Deviation)
Unit of Measure: percent change
-1.017  (3.3957) -2.516  (3.8612)
10.Secondary Outcome
Title Change From Baseline in Serum Creatinine at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Overall Number of Participants Analyzed 405 402
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.08  (0.136) 0.12  (0.283)
11.Secondary Outcome
Title Change From Baseline in Serum Creatinine at Week 96
Hide Description [Not Specified]
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Overall Number of Participants Analyzed 373 370
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.04  (0.119) 0.07  (0.122)
12.Secondary Outcome
Title Percentage of Participants With Treatment-emergent Proteinuria Through Week 48
Hide Description Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Overall Number of Participants Analyzed 428 434
Measure Type: Number
Unit of Measure: percentage of participants
Grade 1 27.3 31.6
Grade 2 4.7 4.6
Grade 3 0 0
13.Secondary Outcome
Title Percentage of Participants With Treatment-emergent Proteinuria Through Week 96
Hide Description Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.
Time Frame Baseline to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Overall Number of Participants Analyzed 428 434
Measure Type: Number
Unit of Measure: percentage of participants
Grade 1 31.8 36.9
Grade 2 5.4 5.1
Grade 3 0 0
14.Secondary Outcome
Title Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48
Hide Description Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Overall Number of Participants Analyzed 400 397
Median (Inter-Quartile Range)
Unit of Measure: percent change
13.3
(-22.6 to 52.4)
51.7
(2.6 to 138.6)
15.Secondary Outcome
Title Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96
Hide Description Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Overall Number of Participants Analyzed 379 363
Median (Inter-Quartile Range)
Unit of Measure: percent change
16.9
(-18.6 to 72.4)
73.7
(10.4 to 196.3)
16.Secondary Outcome
Title Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48
Hide Description Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Overall Number of Participants Analyzed 395 392
Median (Inter-Quartile Range)
Unit of Measure: percent change
-29.3
(-55.1 to 6.1)
32.3
(-36.4 to 159.9)
17.Secondary Outcome
Title Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96
Hide Description Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
Overall Number of Participants Analyzed 375 360
Median (Inter-Quartile Range)
Unit of Measure: percent change
-31.0
(-62.7 to 6.1)
35.2
(-27.5 to 248.8)
Time Frame First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
Adverse Event Reporting Description The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
 
Arm/Group Title E/C/F/TAF (Double-Blind Phase) E/C/F/TDF (Double-Blind Phase) Open-Label E/C/F/TAF From E/C/F/TAF Open-Label E/C/F/TAF From E/C/F/TDF
Hide Arm/Group Description Adverse events reported occurred during the Double-Blind Phase in participants from the E/C/F/TAF group, who received E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks. Adverse events reported occurred during the Double-Blind Phase in participants from the E/C/F/TDF group, who received E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks. Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the E/C/F/TAF group and received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily. Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the E/C/F/TDF group and received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily.
All-Cause Mortality
E/C/F/TAF (Double-Blind Phase) E/C/F/TDF (Double-Blind Phase) Open-Label E/C/F/TAF From E/C/F/TAF Open-Label E/C/F/TAF From E/C/F/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/431 (1.16%)   4/435 (0.92%)   0/141 (0.00%)   0/119 (0.00%) 
Hide Serious Adverse Events
E/C/F/TAF (Double-Blind Phase) E/C/F/TDF (Double-Blind Phase) Open-Label E/C/F/TAF From E/C/F/TAF Open-Label E/C/F/TAF From E/C/F/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   54/431 (12.53%)   68/435 (15.63%)   4/141 (2.84%)   2/119 (1.68%) 
Blood and lymphatic system disorders         
Febrile neutropenia † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Leukocytosis † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Neutropenia † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Sickle cell anaemia with crisis † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Cardiac disorders         
Acute myocardial infarction † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Cardiac arrest † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Coronary artery disease † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Ischaemic cardiomyopathy † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Myocardial infarction † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Endocrine disorders         
Goitre † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Eye disorders         
Iridocyclitis † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Retinal detachment † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Gastrointestinal disorders         
Abdominal pain † 1  1/431 (0.23%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Abdominal pain upper † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Constipation † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Hiatus hernia † 1  0/431 (0.00%)  0/435 (0.00%)  1/141 (0.71%)  0/119 (0.00%) 
Ileus † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Impaired gastric emptying † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Inguinal hernia † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Mouth ulceration † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Palatal dysplasia † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Pancreatitis † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Pancreatitis acute † 1  0/431 (0.00%)  3/435 (0.69%)  0/141 (0.00%)  0/119 (0.00%) 
Rectal haemorrhage † 1  1/431 (0.23%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Vomiting † 1  2/431 (0.46%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
General disorders         
Chest pain † 1  0/431 (0.00%)  3/435 (0.69%)  0/141 (0.00%)  0/119 (0.00%) 
Death † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Pyrexia † 1  1/431 (0.23%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Systemic inflammatory response syndrome † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Hepatobiliary disorders         
Cholelithiasis † 1  2/431 (0.46%)  2/435 (0.46%)  1/141 (0.71%)  0/119 (0.00%) 
Hepatitis acute † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Immune system disorders         
Immune reconstitution inflammatory syndrome † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Infections and infestations         
Abscess limb † 1  0/431 (0.00%)  2/435 (0.46%)  0/141 (0.00%)  0/119 (0.00%) 
Anal abscess † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  1/119 (0.84%) 
Appendicitis † 1  1/431 (0.23%)  4/435 (0.92%)  1/141 (0.71%)  0/119 (0.00%) 
Appendicitis perforated † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Bacteraemia † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Cellulitis † 1  2/431 (0.46%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Chorioretinitis † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Dengue fever † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Diarrhoea infectious † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Encephalitis † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Erysipelas † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Gastroenteritis † 1  4/431 (0.93%)  0/435 (0.00%)  1/141 (0.71%)  0/119 (0.00%) 
Hepatitis A † 1  0/431 (0.00%)  0/435 (0.00%)  1/141 (0.71%)  0/119 (0.00%) 
Herpes simplex † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Infectious colitis † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Lung abscess † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Mastoiditis † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Meningitis † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Meningitis meningococcal † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Orchitis † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Osteomyelitis † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Otitis externa † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Otitis media † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Penile abscess † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Periorbital cellulitis † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Perirectal abscess † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Pharyngitis streptococcal † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Pneumonia † 1  2/431 (0.46%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Pneumonia necrotising † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Pyelonephritis † 1  2/431 (0.46%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Rectal abscess † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Scrotal abscess † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Secondary syphilis † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Sepsis † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Shigella infection † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Staphylococcal infection † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Streptococcal bacteraemia † 1  2/431 (0.46%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Subcutaneous abscess † 1  1/431 (0.23%)  1/435 (0.23%)  0/141 (0.00%)  1/119 (0.84%) 
Tonsillitis † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Urinary tract infection † 1  0/431 (0.00%)  2/435 (0.46%)  0/141 (0.00%)  0/119 (0.00%) 
Vulval abscess † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
West Nile viral infection † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Wound infection † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Injury, poisoning and procedural complications         
Alcohol poisoning † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Ankle fracture † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Cervical vertebral fracture † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Femur fracture † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Gun shot wound † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Labelled drug-drug interaction medication error † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Muscle strain † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Overdose † 1  0/431 (0.00%)  3/435 (0.69%)  0/141 (0.00%)  0/119 (0.00%) 
Postoperative respiratory failure † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Rib fracture † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Road traffic accident † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Spinal fracture † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Stab wound † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Subarachnoid haemorrhage † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Thoracic vertebral fracture † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Toxicity to various agents † 1  0/431 (0.00%)  2/435 (0.46%)  0/141 (0.00%)  0/119 (0.00%) 
Traumatic liver injury † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Wound † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Investigations         
Alanine aminotransferase abnormal † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Metabolism and nutrition disorders         
Dehydration † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Diabetic complication † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Hyperglycaemia † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Muscular weakness † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Osteonecrosis † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Rhabdomyolysis † 1  2/431 (0.46%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenocarcinoma of colon † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Anal squamous cell carcinoma † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Cervix carcinoma † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Hodgkin's disease † 1  2/431 (0.46%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Lymphoma † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Lymphoproliferative disorder † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Meningioma † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Metastases to liver † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Prostate cancer † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Uterine leiomyoma † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Nervous system disorders         
Cerebrovascular accident † 1  1/431 (0.23%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Dysaesthesia † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Facial paralysis † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Headache † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Intracranial pressure increased † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Migraine † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Nerve compression † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Paraesthesia † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Sciatica † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Seizure † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Syncope † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Transient ischaemic attack † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Unresponsive to stimuli † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Psychiatric disorders         
Acute psychosis † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Affective disorder † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Bipolar II disorder † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Completed suicide † 1  2/431 (0.46%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Depression † 1  1/431 (0.23%)  3/435 (0.69%)  0/141 (0.00%)  0/119 (0.00%) 
Depression suicidal † 1  0/431 (0.00%)  2/435 (0.46%)  0/141 (0.00%)  0/119 (0.00%) 
Homicidal ideation † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Major depression † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Mental status changes † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Psychotic disorder † 1  2/431 (0.46%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Suicidal ideation † 1  0/431 (0.00%)  2/435 (0.46%)  0/141 (0.00%)  0/119 (0.00%) 
Suicide attempt † 1  2/431 (0.46%)  2/435 (0.46%)  0/141 (0.00%)  0/119 (0.00%) 
Renal and urinary disorders         
Renal haematoma † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Ureterolithiasis † 1  1/431 (0.23%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Reproductive system and breast disorders         
Vaginal dysplasia † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Asthma † 1  3/431 (0.70%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Bronchospasm † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Dyspnoea † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
Pneumomediastinum † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Pneumonia aspiration † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Pulmonary oedema † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Respiratory failure † 1  0/431 (0.00%)  1/435 (0.23%)  0/141 (0.00%)  0/119 (0.00%) 
Skin and subcutaneous tissue disorders         
Hidradenitis † 1  1/431 (0.23%)  0/435 (0.00%)  0/141 (0.00%)  0/119 (0.00%) 
1
Term from vocabulary, MedDRA (21.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
E/C/F/TAF (Double-Blind Phase) E/C/F/TDF (Double-Blind Phase) Open-Label E/C/F/TAF From E/C/F/TAF Open-Label E/C/F/TAF From E/C/F/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   374/431 (86.77%)   366/435 (84.14%)   32/141 (22.70%)   27/119 (22.69%) 
Blood and lymphatic system disorders         
Lymphadenopathy † 1  29/431 (6.73%)  24/435 (5.52%)  2/141 (1.42%)  2/119 (1.68%) 
Gastrointestinal disorders         
Abdominal pain † 1  33/431 (7.66%)  34/435 (7.82%)  0/141 (0.00%)  2/119 (1.68%) 
Constipation † 1  24/431 (5.57%)  33/435 (7.59%)  0/141 (0.00%)  0/119 (0.00%) 
Diarrhoea † 1  99/431 (22.97%)  114/435 (26.21%)  0/141 (0.00%)  2/119 (1.68%) 
Dyspepsia † 1  23/431 (5.34%)  15/435 (3.45%)  1/141 (0.71%)  0/119 (0.00%) 
Haemorrhoids † 1  26/431 (6.03%)  27/435 (6.21%)  1/141 (0.71%)  1/119 (0.84%) 
Nausea † 1  78/431 (18.10%)  86/435 (19.77%)  1/141 (0.71%)  2/119 (1.68%) 
Toothache † 1  26/431 (6.03%)  19/435 (4.37%)  1/141 (0.71%)  1/119 (0.84%) 
Vomiting † 1  44/431 (10.21%)  46/435 (10.57%)  0/141 (0.00%)  2/119 (1.68%) 
General disorders         
Fatigue † 1  53/431 (12.30%)  52/435 (11.95%)  1/141 (0.71%)  0/119 (0.00%) 
Pyrexia † 1  37/431 (8.58%)  32/435 (7.36%)  0/141 (0.00%)  0/119 (0.00%) 
Infections and infestations         
Bronchitis † 1  38/431 (8.82%)  26/435 (5.98%)  2/141 (1.42%)  1/119 (0.84%) 
Chlamydial infection † 1  24/431 (5.57%)  20/435 (4.60%)  1/141 (0.71%)  0/119 (0.00%) 
Folliculitis † 1  19/431 (4.41%)  26/435 (5.98%)  2/141 (1.42%)  0/119 (0.00%) 
Gastroenteritis † 1  23/431 (5.34%)  21/435 (4.83%)  0/141 (0.00%)  2/119 (1.68%) 
Gonorrhoea † 1  26/431 (6.03%)  20/435 (4.60%)  1/141 (0.71%)  0/119 (0.00%) 
Influenza † 1  25/431 (5.80%)  18/435 (4.14%)  1/141 (0.71%)  2/119 (1.68%) 
Nasopharyngitis † 1  68/431 (15.78%)  75/435 (17.24%)  5/141 (3.55%)  5/119 (4.20%) 
Pharyngitis † 1  22/431 (5.10%)  25/435 (5.75%)  0/141 (0.00%)  0/119 (0.00%) 
Sinusitis † 1  25/431 (5.80%)  28/435 (6.44%)  2/141 (1.42%)  1/119 (0.84%) 
Syphilis † 1  42/431 (9.74%)  44/435 (10.11%)  2/141 (1.42%)  3/119 (2.52%) 
Upper respiratory tract infection † 1  87/431 (20.19%)  82/435 (18.85%)  2/141 (1.42%)  2/119 (1.68%) 
Urinary tract infection † 1  17/431 (3.94%)  31/435 (7.13%)  1/141 (0.71%)  2/119 (1.68%) 
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  61/431 (14.15%)  49/435 (11.26%)  2/141 (1.42%)  0/119 (0.00%) 
Back pain † 1  63/431 (14.62%)  53/435 (12.18%)  0/141 (0.00%)  0/119 (0.00%) 
Osteopenia † 1  34/431 (7.89%)  38/435 (8.74%)  2/141 (1.42%)  1/119 (0.84%) 
Pain in extremity † 1  31/431 (7.19%)  26/435 (5.98%)  2/141 (1.42%)  0/119 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Anogenital warts † 1  29/431 (6.73%)  25/435 (5.75%)  0/141 (0.00%)  1/119 (0.84%) 
Nervous system disorders         
Dizziness † 1  27/431 (6.26%)  28/435 (6.44%)  1/141 (0.71%)  0/119 (0.00%) 
Headache † 1  98/431 (22.74%)  80/435 (18.39%)  4/141 (2.84%)  2/119 (1.68%) 
Psychiatric disorders         
Anxiety † 1  34/431 (7.89%)  43/435 (9.89%)  0/141 (0.00%)  0/119 (0.00%) 
Depression † 1  34/431 (7.89%)  26/435 (5.98%)  0/141 (0.00%)  1/119 (0.84%) 
Insomnia † 1  51/431 (11.83%)  37/435 (8.51%)  1/141 (0.71%)  0/119 (0.00%) 
Renal and urinary disorders         
Proteinuria † 1  11/431 (2.55%)  22/435 (5.06%)  0/141 (0.00%)  0/119 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough † 1  62/431 (14.39%)  49/435 (11.26%)  1/141 (0.71%)  3/119 (2.52%) 
Nasal congestion † 1  16/431 (3.71%)  22/435 (5.06%)  0/141 (0.00%)  0/119 (0.00%) 
Oropharyngeal pain † 1  25/431 (5.80%)  39/435 (8.97%)  0/141 (0.00%)  0/119 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash † 1  47/431 (10.90%)  42/435 (9.66%)  1/141 (0.71%)  0/119 (0.00%) 
Vascular disorders         
Hypertension † 1  26/431 (6.03%)  11/435 (2.53%)  0/141 (0.00%)  0/119 (0.00%) 
1
Term from vocabulary, MedDRA (21.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
EMail: GileadClinicalTrials@gilead.com
Publications of Results:
Sax PE, Wohl D, Yin MT, Post F, DeJesus E, Saag M, Pozniak A, Thompson M, Podzamczer D, Molina JM, Oka S, Koenig E, Trottier B, Andrade-Villanueva J, Crofoot G, Custodio JM, Plummer A, Zhong L, Cao H, Martin H, Callebaut C, Cheng AK, Fordyce MW, McCallister S; GS-US-292-0104/0111 Study Team. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet. 2015 Jun 27;385(9987):2606-15. doi: 10.1016/S0140-6736(15)60616-X. Epub 2015 Apr 15. Erratum in: Lancet. 2016 Apr 30;387(10030):1816.
Margot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naïve patients receiving elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide for 144 weeks. J Clin Virol. 2018 Jun;103:37-42. doi: 10.1016/j.jcv.2018.03.012. Epub 2018 Apr 2.
Arribas JR, Thompson M, Sax PE, Haas B, McDonald C, Wohl DA, DeJesus E, Clarke AE, Guo S, Wang H, Callebaut C, Plummer A, Cheng A, Das M, McCallister S. Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results. J Acquir Immune Defic Syndr. 2017 Jun 1;75(2):211-218. doi: 10.1097/QAI.0000000000001350.
Margot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Infrequent development of drug resistance in HIV-1-infected treatment-naive subjects after 96 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate. Antivir Ther. 2017;22(5):443-446. doi: 10.3851/IMP3125. Epub 2017 Jan 11.
Margot NA, Kitrinos KM, Fordyce M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naïve patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. HIV Clin Trials. 2016 Mar;17(2):78-87. doi: 10.1080/15284336.2016.1142731.
Funderburg NT, McComsey GA, Kulkarni M, Bannerman T, Mantini J, Thornton B, Liu HC, Zhang Y, Song Q, Fang L, Dinoso J, Cheng A, McCallister S, Fordyce MW, Das M. Equivalent Decline in Inflammation Markers with Tenofovir Disoproxil Fumarate vs. Tenofovir Alafenamide. EBioMedicine. 2016 Nov;13:321-327. doi: 10.1016/j.ebiom.2016.10.009. Epub 2016 Oct 11.
Wohl D, Oka S, Clumeck N, Clarke A, Brinson C, Stephens J, Tashima K, Arribas JR, Rashbaum B, Cheret A, Brunetta J, Mussini C, Tebas P, Sax PE, Cheng A, Zhong L, Callebaut C, Das M, Fordyce M; GS-US-2,92-01040111 and Study Team. Brief Report: A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results. J Acquir Immune Defic Syndr. 2016 May 1;72(1):58-64. doi: 10.1097/QAI.0000000000000940.
Custodio JM, Garner W, Callebaut C, Fordyce M, Plummer A, Zhong L, et al. The Pharmacokinetics of Tenofovir and Tenofovir Diphosphate Following Administration of Tenofovir Alafenamide vs Tenofovir Disoproxil Fumarate [Oral Abstract #6]. The 16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy. Washington DC, USA, May 26-28, 2015.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01797445    
Other Study ID Numbers: GS-US-292-0111
2013-000102-37 ( EudraCT Number )
First Submitted: February 20, 2013
First Posted: February 22, 2013
Results First Submitted: December 4, 2015
Results First Posted: January 8, 2016
Last Update Posted: March 2, 2020