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

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ClinicalTrials.gov Identifier: NCT01780506
Recruitment Status : Completed
First Posted : January 31, 2013
Results First Posted : January 8, 2016
Last Update Posted : November 19, 2018
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, Europe, and Asia. The first participant was screened on 26 December 2012. The last study visit occurred on 06 September 2017.
Pre-assignment Details 1105 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 at least 144 weeks.

Open-Label Extension Phase: After study unblinding, participants who completed 144 weeks of the study were given the option to receive open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available, or until Gilead Sciences 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 at least 144 weeks.

Open-Label Extension Phase: After study unblinding, participants who completed 144 weeks of the study were given the option to receive open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available, or until Gilead Sciences terminated the study in that country.
Period Title: Double-Blind Phase
Started 438 434
Completed 368 356
Not Completed 70 78
Reason Not Completed
Randomized but not Treated             3             2
Adverse Event             4             14
Death             1             2
Pregnancy             2             1
Lack of Efficacy             1             1
Investigator's Discretion             5             2
Non-Compliance with Study Drug             4             3
Protocol Violation             4             3
Withdrew Consent             23             24
Lost to Follow-up             23             26
Period Title: Open-Label Extension Phase
Started 90 [1] 95 [2]
Completed 90 94
Not Completed 0 1
Reason Not Completed
Enrolled but not Treated             0             1
[1]
278 participants completed the Double-Blind Phase but did not enter the Open-Label Extension Phase
[2]
261 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 435 432 867
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 435 participants 432 participants 867 participants
35  (10.0) 36  (10.5) 35  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 435 participants 432 participants 867 participants
Female
71
  16.3%
56
  13.0%
127
  14.6%
Male
364
  83.7%
376
  87.0%
740
  85.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 435 participants 432 participants 867 participants
Hispanic or Latino
60
  13.8%
70
  16.2%
130
  15.0%
Not Hispanic or Latino
375
  86.2%
362
  83.8%
737
  85.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 435 participants 432 participants 867 participants
American Indian or Alaska Native
4
   0.9%
5
   1.2%
9
   1.0%
Asian
76
  17.5%
77
  17.8%
153
  17.6%
Black
94
  21.6%
81
  18.8%
175
  20.2%
Native Hawaiian or Pacific Islander
1
   0.2%
3
   0.7%
4
   0.5%
White
250
  57.5%
255
  59.0%
505
  58.2%
Other
10
   2.3%
11
   2.5%
21
   2.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 435 participants 432 participants 867 participants
United States
252
  57.9%
250
  57.9%
502
  57.9%
Japan
4
   0.9%
6
   1.4%
10
   1.2%
United Kingdom
1
   0.2%
5
   1.2%
6
   0.7%
Thailand
63
  14.5%
58
  13.4%
121
  14.0%
Switzerland
6
   1.4%
12
   2.8%
18
   2.1%
Spain
42
   9.7%
42
   9.7%
84
   9.7%
Canada
23
   5.3%
23
   5.3%
46
   5.3%
Austria
15
   3.4%
8
   1.9%
23
   2.7%
Belgium
7
   1.6%
7
   1.6%
14
   1.6%
Italy
3
   0.7%
6
   1.4%
9
   1.0%
Australia
19
   4.4%
15
   3.5%
34
   3.9%
HIV-1 RNA (log10 copies/mL)  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 435 participants 432 participants 867 participants
4.55  (0.682) 4.55  (0.674) 4.55  (0.678)
HIV-1 RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 435 participants 432 participants 867 participants
≤ 100,000 copies/mL
331
  76.1%
336
  77.8%
667
  76.9%
> 100,000 to ≤ 400,000 copies/mL
79
  18.2%
72
  16.7%
151
  17.4%
> 400,000 copies/mL
25
   5.7%
24
   5.6%
49
   5.7%
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 435 participants 432 participants 867 participants
437  (223.7) 426  (212.3) 432  (218.0)
CD4 Cell Count Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 435 participants 432 participants 867 participants
< 50 cells/µL
10
   2.3%
12
   2.8%
22
   2.5%
≥ 50 to < 200 cells/µL
48
  11.0%
41
   9.5%
89
  10.3%
≥ 200 to < 350 cells/µL
103
  23.7%
111
  25.7%
214
  24.7%
≥ 350 to < 500 cells/µL
122
  28.0%
135
  31.3%
257
  29.6%
≥ 500 cells/µL
152
  34.9%
133
  30.8%
285
  32.9%
HIV Disease Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 435 participants 432 participants 867 participants
Asymptomatic
402
  92.4%
406
  94.0%
808
  93.2%
Symptomatic HIV Infection
23
   5.3%
15
   3.5%
38
   4.4%
AIDS
9
   2.1%
10
   2.3%
19
   2.2%
Unknown
1
   0.2%
1
   0.2%
2
   0.2%
1.Primary Outcome
Title Percentage of Participants With 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
Full Analysis Set: 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 435 432
Measure Type: Number
Unit of Measure: percentage of participants
93.1 92.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, E/C/F/TDF
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
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.
Statistical Test of Hypothesis P-Value 0.78
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 0.5
Confidence Interval (2-Sided) 95.002%
-3.0 to 4.0
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 Weeks 96 and 144
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Weeks 96 and 144 were 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 96 and 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
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 435 432
Measure Type: Number
Unit of Measure: percentage of participants
Week 96 89.2 88.2
Week 144 86.9 83.1
3.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144
Hide Description The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48, 96, and 144 were 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, 96. and 144
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
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 435 432
Measure Type: Number
Unit of Measure: percentage of participants
Week 48 86.4 87.3
Week 96 84.4 83.6
Week 144 84.6 80.1
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 on-treatment 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 413 404
Mean (Standard Deviation)
Unit of Measure: cells/µL
235  (183.1) 221  (178.9)
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 on-treatment 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 395 384
Mean (Standard Deviation)
Unit of Measure: cells/µL
285  (203.0) 271  (208.1)
6.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 144
Hide Description [Not Specified]
Time Frame Baseline; Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with on-treatment 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 379 360
Mean (Standard Deviation)
Unit of Measure: cells/µL
323  (213.1) 310  (207.2)
7.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
Hip DXA Analysis Set: participants who were randomized and received at least 1 dose of study drugs and had nonmissing baseline hip BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, 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 404 394
Mean (Standard Deviation)
Unit of Measure: percent change
-0.865  (3.2532) -3.200  (3.1759)
8.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
Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, 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 375 365
Mean (Standard Deviation)
Unit of Measure: percent change
-0.951  (3.8633) -3.515  (3.9451)
9.Secondary Outcome
Title Percent Change From Baseline in Hip BMD at Week 144
Hide Description Hip BMD was assessed by DXA scan.
Time Frame Baseline; Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, 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 362 354
Mean (Standard Deviation)
Unit of Measure: percent change
-0.826  (4.6786) -3.475  (4.1551)
10.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
Spine DXA Analysis Set: participants who were randomized and received at least 1 dose of study drugs and had nonmissing baseline spine BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, 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 402 396
Mean (Standard Deviation)
Unit of Measure: percent change
-1.337  (3.0715) -2.956  (3.3524)
11.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
Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, 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 376 367
Mean (Standard Deviation)
Unit of Measure: percent change
-0.907  (4.0039) -3.053  (3.9539)
12.Secondary Outcome
Title Percent Change From Baseline in Spine BMD at Week 144
Hide Description Spine BMD was assessed by DXA scan.
Time Frame Baseline; Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, 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 369 352
Mean (Standard Deviation)
Unit of Measure: percent change
-0.809  (4.5041) -3.023  (4.3122)
13.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
Safety Analysis Set. The missing-equals-excluded approach was used, 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 415 406
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.08  (0.110) 0.11  (0.116)
14.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
Safety Analysis Set. The missing-equals-excluded approach was used, 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 398 386
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.05  (0.109) 0.07  (0.132)
15.Secondary Outcome
Title Change From Baseline in Serum Creatinine at Week 144
Hide Description [Not Specified]
Time Frame Baseline; Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. The missing-equals-excluded approach was used, 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 384 362
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.04  (0.115) 0.08  (0.133)
16.Secondary Outcome
Title Percentage of Participants Experiencing 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 Up to 48 weeks
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 434 431
Measure Type: Number
Unit of Measure: percentage of participants
Grade 1 25.8 32.3
Grade 2 4.6 4.9
Grade 3 0 0.2
17.Secondary Outcome
Title Percentage of Participants Experiencing 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 Up to 96 weeks
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 434 431
Measure Type: Number
Unit of Measure: percentage of participants
Grade 1 28.8 33.9
Grade 2 5.1 5.8
Grade 3 0.2 0.2
18.Secondary Outcome
Title Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144
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 Up to 144 weeks
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 434 431
Measure Type: Number
Unit of Measure: percentage of participants
Grade 1 31.3 37.1
Grade 2 6.0 7.0
Grade 3 0.2 0.2
19.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 411 403
Median (Inter-Quartile Range)
Unit of Measure: percent change
6.9
(-23.3 to 42.1)
51.2
(3.3 to 127.1)
20.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 393 382
Median (Inter-Quartile Range)
Unit of Measure: percent change
11.3
(-20.3 to 61.5)
75.0
(9.9 to 182.6)
21.Secondary Outcome
Title Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 144
Hide Description Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Time Frame Baseline; Week 144
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 381 355
Median (Inter-Quartile Range)
Unit of Measure: percent change
37.4
(-6.0 to 87.3)
106.9
(38.0 to 254.9)
22.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 407 397
Median (Inter-Quartile Range)
Unit of Measure: percent change
-32.8
(-58.7 to 1.3)
18.0
(-28.8 to 171.6)
23.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 390 378
Median (Inter-Quartile Range)
Unit of Measure: percent change
-33.5
(-60.0 to 2.0)
32.5
(-27.8 to 205.6)
24.Secondary Outcome
Title Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 144
Hide Description Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
Time Frame Baseline; Week 144
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 379 351
Median (Inter-Quartile Range)
Unit of Measure: percent change
-24.6
(-57.5 to 13.3)
60.4
(-10.4 to 318.8)
Time Frame Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
 
Arm/Group Title Double-Blind: E/C/F/TAF Double-Blind: E/C/F/TDF Open-Label: E/C/F/TAF to E/C/F/TAF Open-Label: E/C/F/TDF to E/C/F/TAF
Hide Arm/Group Description Adverse events reported in this group occurred during the Double-Blind Phase in participants 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 in this group occurred during the Double-Blind Phase in participants 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 in this group occurred during the Open-Label Extension Phase in participants who switched from the Double-Blind E/C/F/TAF group to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available or until Gilead Sciences terminated the study in that country. Adverse events reported in this group occurred during the Open-Label Extension Phase in participants who switched from the Double-Blind E/C/F/TAF group to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available or until Gilead Sciences terminated the study in that country.
All-Cause Mortality
Double-Blind: E/C/F/TAF Double-Blind: E/C/F/TDF Open-Label: E/C/F/TAF to E/C/F/TAF Open-Label: E/C/F/TDF to E/C/F/TAF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Double-Blind: E/C/F/TAF Double-Blind: E/C/F/TDF Open-Label: E/C/F/TAF to E/C/F/TAF Open-Label: E/C/F/TDF to E/C/F/TAF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   73/435 (16.78%)   65/432 (15.05%)   0/90 (0.00%)   1/94 (1.06%) 
Blood and lymphatic system disorders         
Anaemia † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Iron deficiency anaemia † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Leukocytosis † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Cardiac disorders         
Acute myocardial infarction † 1  2/435 (0.46%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Cardiac arrest † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Cardiac failure congestive † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Tachycardia † 1  1/435 (0.23%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Congenital, familial and genetic disorders         
Dermoid cyst † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Eye disorders         
Retinal detachment † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Gastrointestinal disorders         
Abdominal pain † 1  2/435 (0.46%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Alcoholic pancreatitis † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Anal fissure † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Colitis † 1  1/435 (0.23%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Diarrhoea † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Food poisoning † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Haemorrhoids † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Intestinal obstruction † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Proctitis † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Rectal haemorrhage † 1  0/435 (0.00%)  2/432 (0.46%)  0/90 (0.00%)  0/94 (0.00%) 
Upper gastrointestinal haemorrhage † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
General disorders         
Chest pain † 1  1/435 (0.23%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Death † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Incarcerated hernia † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Pyrexia † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Hepatobiliary disorders         
Cholelithiasis † 1  1/435 (0.23%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Immune system disorders         
Immune reconstitution inflammatory syndrome † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Infections and infestations         
Abdominal wall abscess † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Abscess limb † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Acute hepatitis C † 1  2/435 (0.46%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Appendicitis † 1  8/435 (1.84%)  3/432 (0.69%)  0/90 (0.00%)  0/94 (0.00%) 
Appendicitis perforated † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Atypical mycobacterial lower respiratory tract infection † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Bacterial sepsis † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Bronchitis † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Campylobacter infection † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Cellulitis † 1  0/435 (0.00%)  3/432 (0.69%)  0/90 (0.00%)  0/94 (0.00%) 
Cellulitis of male external genital organ † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Dengue fever † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Epididymitis † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Eye infection syphilitic † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Hepatitis C † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Hepatitis syphilitic † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Herpes zoster disseminated † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Infected skin ulcer † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Influenza † 1  0/435 (0.00%)  3/432 (0.69%)  0/90 (0.00%)  1/94 (1.06%) 
Meningitis viral † 1  3/435 (0.69%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Mycobacterium avium complex infection † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Neurosyphilis † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Penile abscess † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Perirectal abscess † 1  1/435 (0.23%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Pneumonia † 1  1/435 (0.23%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Pneumonia bacterial † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Psoas abscess † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Pyelonephritis † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Pyelonephritis acute † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Respiratory tract infection † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Secondary syphilis † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Septic shock † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Shigella infection † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Soft tissue infection † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Staphylococcal skin infection † 1  2/435 (0.46%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Streptococcal bacteraemia † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Tonsillitis † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Tooth abscess † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Upper respiratory tract infection † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Viral infection † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Injury, poisoning and procedural complications         
Accidental overdose † 1  2/435 (0.46%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Alcohol poisoning † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Ankle fracture † 1  1/435 (0.23%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Cartilage injury † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Facial bones fracture † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Fall † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Foot fracture † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Head injury † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Humerus fracture † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Injury † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Kidney contusion † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Laceration † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Ligament rupture † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Liver contusion † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Lower limb fracture † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Meniscus injury † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Radius fracture † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Rib fracture † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Scrotal haematoma † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Stab wound † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Thoracic vertebral fracture † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Toxicity to various agents † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Traumatic arthritis † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Ulna fracture † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Uterine perforation † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Musculoskeletal and connective tissue disorders         
Osteoarthritis † 1  2/435 (0.46%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Prognathism † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Retrognathia † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Rotator cuff syndrome † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Tenosynovitis † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Anal squamous cell carcinoma † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Anogenital warts † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Bladder transitional cell carcinoma † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Burkitt's lymphoma † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Castleman's disease † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Cervix carcinoma † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Diffuse large B-cell lymphoma † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Hodgkin's disease † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Laryngeal squamous cell carcinoma † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Non-small cell lung cancer † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Papillary thyroid cancer † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Pleomorphic adenoma † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Uterine leiomyoma † 1  2/435 (0.46%)  3/432 (0.69%)  0/90 (0.00%)  0/94 (0.00%) 
Nervous system disorders         
Brain injury † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Cerebral infarction † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Haemorrhage intracranial † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Haemorrhagic transformation stroke † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Headache † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Migraine † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Paraesthesia † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Syncope † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Vascular headache † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Psychiatric disorders         
Alcohol abuse † 1  1/435 (0.23%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Alcohol withdrawal syndrome † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Bipolar disorder † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Completed suicide † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Confusional state † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Depression † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Drug use disorder † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Homicidal ideation † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Major depression † 1  1/435 (0.23%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Schizoaffective disorder † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Substance use disorder † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Substance-induced mood disorder † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Suicidal ideation † 1  4/435 (0.92%)  2/432 (0.46%)  0/90 (0.00%)  0/94 (0.00%) 
Suicide attempt † 1  1/435 (0.23%)  2/432 (0.46%)  0/90 (0.00%)  0/94 (0.00%) 
Renal and urinary disorders         
Acute kidney injury † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Nephrotic syndrome † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Post infection glomerulonephritis † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Reproductive system and breast disorders         
Prostatitis † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Scrotal pain † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Bronchospasm † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Dyspnoea † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Pulmonary embolism † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Sleep apnoea syndrome † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash erythematous † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Surgical and medical procedures         
Alcohol detoxification † 1  0/435 (0.00%)  1/432 (0.23%)  0/90 (0.00%)  0/94 (0.00%) 
Vascular disorders         
Deep vein thrombosis † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
Hypovolaemic shock † 1  1/435 (0.23%)  0/432 (0.00%)  0/90 (0.00%)  0/94 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 20.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Double-Blind: E/C/F/TAF Double-Blind: E/C/F/TDF Open-Label: E/C/F/TAF to E/C/F/TAF Open-Label: E/C/F/TDF to E/C/F/TAF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   380/435 (87.36%)   375/432 (86.81%)   16/90 (17.78%)   14/94 (14.89%) 
Gastrointestinal disorders         
Abdominal pain † 1  30/435 (6.90%)  24/432 (5.56%)  0/90 (0.00%)  0/94 (0.00%) 
Constipation † 1  15/435 (3.45%)  23/432 (5.32%)  0/90 (0.00%)  0/94 (0.00%) 
Diarrhoea † 1  112/435 (25.75%)  105/432 (24.31%)  1/90 (1.11%)  1/94 (1.06%) 
Flatulence † 1  18/435 (4.14%)  29/432 (6.71%)  0/90 (0.00%)  0/94 (0.00%) 
Gastrooesophageal reflux disease † 1  23/435 (5.29%)  20/432 (4.63%)  0/90 (0.00%)  0/94 (0.00%) 
Haemorrhoids † 1  20/435 (4.60%)  23/432 (5.32%)  0/90 (0.00%)  1/94 (1.06%) 
Nausea † 1  73/435 (16.78%)  84/432 (19.44%)  2/90 (2.22%)  0/94 (0.00%) 
Vomiting † 1  39/435 (8.97%)  26/432 (6.02%)  0/90 (0.00%)  0/94 (0.00%) 
General disorders         
Fatigue † 1  49/435 (11.26%)  47/432 (10.88%)  0/90 (0.00%)  0/94 (0.00%) 
Pyrexia † 1  29/435 (6.67%)  31/432 (7.18%)  0/90 (0.00%)  1/94 (1.06%) 
Infections and infestations         
Bronchitis † 1  41/435 (9.43%)  29/432 (6.71%)  0/90 (0.00%)  1/94 (1.06%) 
Chlamydial infection † 1  19/435 (4.37%)  22/432 (5.09%)  0/90 (0.00%)  0/94 (0.00%) 
Folliculitis † 1  26/435 (5.98%)  14/432 (3.24%)  0/90 (0.00%)  0/94 (0.00%) 
Gastroenteritis † 1  28/435 (6.44%)  25/432 (5.79%)  0/90 (0.00%)  1/94 (1.06%) 
Gonorrhoea † 1  22/435 (5.06%)  20/432 (4.63%)  0/90 (0.00%)  2/94 (2.13%) 
Influenza † 1  28/435 (6.44%)  32/432 (7.41%)  0/90 (0.00%)  0/94 (0.00%) 
Pharyngitis † 1  26/435 (5.98%)  23/432 (5.32%)  1/90 (1.11%)  1/94 (1.06%) 
Sinusitis † 1  43/435 (9.89%)  25/432 (5.79%)  0/90 (0.00%)  0/94 (0.00%) 
Syphilis † 1  55/435 (12.64%)  56/432 (12.96%)  4/90 (4.44%)  2/94 (2.13%) 
Upper respiratory tract infection † 1  92/435 (21.15%)  95/432 (21.99%)  3/90 (3.33%)  2/94 (2.13%) 
Viral upper respiratory tract infection † 1  69/435 (15.86%)  64/432 (14.81%)  2/90 (2.22%)  1/94 (1.06%) 
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  46/435 (10.57%)  36/432 (8.33%)  0/90 (0.00%)  0/94 (0.00%) 
Back pain † 1  50/435 (11.49%)  61/432 (14.12%)  0/90 (0.00%)  0/94 (0.00%) 
Osteopenia † 1  41/435 (9.43%)  57/432 (13.19%)  0/90 (0.00%)  0/94 (0.00%) 
Pain in extremity † 1  34/435 (7.82%)  26/432 (6.02%)  0/90 (0.00%)  0/94 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Anogenital warts † 1  29/435 (6.67%)  29/432 (6.71%)  0/90 (0.00%)  0/94 (0.00%) 
Nervous system disorders         
Dizziness † 1  30/435 (6.90%)  25/432 (5.79%)  0/90 (0.00%)  0/94 (0.00%) 
Headache † 1  69/435 (15.86%)  63/432 (14.58%)  0/90 (0.00%)  0/94 (0.00%) 
Psychiatric disorders         
Anxiety † 1  32/435 (7.36%)  25/432 (5.79%)  0/90 (0.00%)  0/94 (0.00%) 
Depression † 1  37/435 (8.51%)  35/432 (8.10%)  0/90 (0.00%)  0/94 (0.00%) 
Insomnia † 1  45/435 (10.34%)  35/432 (8.10%)  0/90 (0.00%)  0/94 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough † 1  58/435 (13.33%)  56/432 (12.96%)  4/90 (4.44%)  1/94 (1.06%) 
Oropharyngeal pain † 1  34/435 (7.82%)  25/432 (5.79%)  0/90 (0.00%)  1/94 (1.06%) 
Skin and subcutaneous tissue disorders         
Acne † 1  24/435 (5.52%)  9/432 (2.08%)  1/90 (1.11%)  0/94 (0.00%) 
Rash † 1  37/435 (8.51%)  27/432 (6.25%)  1/90 (1.11%)  0/94 (0.00%) 
Vascular disorders         
Hypertension † 1  23/435 (5.29%)  23/432 (5.32%)  0/90 (0.00%)  1/94 (1.06%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 20.0
[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.
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: NCT01780506    
Other Study ID Numbers: GS-US-292-0104
2012-004458-27 ( EudraCT Number )
First Submitted: January 16, 2013
First Posted: January 31, 2013
Results First Submitted: December 4, 2015
Results First Posted: January 8, 2016
Last Update Posted: November 19, 2018