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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: NCT01797445
Recruitment Status : Completed
First Posted : February 22, 2013
Results First Posted : January 8, 2016
Last Update Posted : December 4, 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 and Europe. The first participant was screened on 12 March 2013. The last Week 96 study visit occurred on 03 August 2015.
Pre-assignment Details 1070 participants were screened.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; 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
Period Title: Overall Study
Started 435 437
Completed 0 0
Not Completed 435 437
Reason Not Completed
Randomized but Not Treated             4             2
Adverse Event             3             0
Death             1             2
Lack of Efficacy             1             2
Investigator's Discretion             8             12
Noncompliance with Study Drug             3             1
Protocol Violation             0             1
Withdrew Consent             12             19
Lost to Follow-up             22             15
Still on Study             381             383
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
Safety Analysis Set: participants were randomized and received at least one 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
  14.4%
71
  16.3%
133
  15.4%
Male
369
  85.6%
364
  83.7%
733
  84.6%
Race/Ethnicity, Customized  
Measure Type: Number
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: Number
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: Number
Unit of measure:  Participants
Number Analyzed 431 participants 435 participants 866 participants
United States 280 282 562
United Kingdom 25 31 56
Portugal 21 16 37
Canada 19 22 41
Netherlands 6 8 14
Sweden 8 3 11
Dominican Republic 30 35 65
Italy 10 8 18
Mexico 16 12 28
France 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: Number
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  
Mean (Standard Deviation)
Unit of measure:  /µL
Number Analyzed 431 participants 435 participants 866 participants
414  (206.8) 431  (226.8) 423  (217.1)
CD4 Cell Count Category  
Measure Type: Number
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: Number
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants were randomized and received at least one 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
Show Statistical Analysis 1 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
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
Show Outcome Measure DataHide 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 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
Show Outcome Measure DataHide 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 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
Show Outcome Measure DataHide 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
Show Outcome Measure DataHide 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
Show Outcome Measure DataHide 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 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: percentage change in hip BMD (g/cm^2)
-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
Show Outcome Measure DataHide 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 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: percentage change in hip BMD (g/cm^2)
-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
Show Outcome Measure DataHide 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 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: percentage change in spine BMD (g/cm^2)
-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
Show Outcome Measure DataHide 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 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: percentage change in spine BMD (g/cm^2)
-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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. 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 Up to 48 weeks
Show Outcome Measure DataHide 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 431 435
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 Up to 96 weeks
Show Outcome Measure DataHide 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
Show Outcome Measure DataHide 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 in ratio (µg/g)
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
Show Outcome Measure DataHide 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 in ratio (µg/g)
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
Show Outcome Measure DataHide 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 in ratio (µg/g)
-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
Show Outcome Measure DataHide 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 in ratio (µg/g)
-31.0
(-62.7 to 6.1)
35.2
(-27.5 to 248.8)
Time Frame Up to 96 weeks
Adverse Event Reporting Description Safety Analysis Set: participants were randomized and received at least one 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
All-Cause Mortality
E/C/F/TAF E/C/F/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
E/C/F/TAF E/C/F/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   43/431 (9.98%)   40/435 (9.20%) 
Blood and lymphatic system disorders     
Leukocytosis  1  1/431 (0.23%)  0/435 (0.00%) 
Neutropenia  1  1/431 (0.23%)  0/435 (0.00%) 
Sickle cell anaemia with crisis  1  1/431 (0.23%)  0/435 (0.00%) 
Cardiac disorders     
Acute myocardial infarction  1  0/431 (0.00%)  1/435 (0.23%) 
Coronary artery disease  1  0/431 (0.00%)  1/435 (0.23%) 
Ischaemic cardiomyopathy  1  0/431 (0.00%)  1/435 (0.23%) 
Myocardial infarction  1  1/431 (0.23%)  0/435 (0.00%) 
Endocrine disorders     
Goitre  1  1/431 (0.23%)  0/435 (0.00%) 
Eye disorders     
Iridocyclitis  1  0/431 (0.00%)  1/435 (0.23%) 
Retinal detachment  1  0/431 (0.00%)  1/435 (0.23%) 
Gastrointestinal disorders     
Abdominal pain  1  1/431 (0.23%)  1/435 (0.23%) 
Constipation  1  0/431 (0.00%)  1/435 (0.23%) 
Impaired gastric emptying  1  0/431 (0.00%)  1/435 (0.23%) 
Inguinal hernia  1  0/431 (0.00%)  1/435 (0.23%) 
Mouth ulceration  1  0/431 (0.00%)  1/435 (0.23%) 
Palatal dysplasia  1  0/431 (0.00%)  1/435 (0.23%) 
Pancreatitis  1  0/431 (0.00%)  1/435 (0.23%) 
Pancreatitis acute  1  0/431 (0.00%)  2/435 (0.46%) 
Rectal haemorrhage  1  1/431 (0.23%)  0/435 (0.00%) 
Vomiting  1  2/431 (0.46%)  0/435 (0.00%) 
General disorders     
Pyrexia  1  1/431 (0.23%)  0/435 (0.00%) 
Systemic inflammatory response syndrome  1  1/431 (0.23%)  0/435 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis  1  1/431 (0.23%)  1/435 (0.23%) 
Immune system disorders     
Immune reconstitution inflammatory syndrome  1  0/431 (0.00%)  1/435 (0.23%) 
Infections and infestations     
Appendicitis  1  1/431 (0.23%)  3/435 (0.69%) 
Cellulitis  1  1/431 (0.23%)  1/435 (0.23%) 
Chorioretinitis  1  1/431 (0.23%)  0/435 (0.00%) 
Dengue fever  1  0/431 (0.00%)  1/435 (0.23%) 
Diarrhoea infectious  1  1/431 (0.23%)  0/435 (0.00%) 
Encephalitis  1  1/431 (0.23%)  0/435 (0.00%) 
Epididymitis  1  0/431 (0.00%)  1/435 (0.23%) 
Erysipelas  1  1/431 (0.23%)  0/435 (0.00%) 
Gastroenteritis  1  2/431 (0.46%)  0/435 (0.00%) 
Infectious colitis  1  0/431 (0.00%)  1/435 (0.23%) 
Mastoiditis  1  1/431 (0.23%)  0/435 (0.00%) 
Meningitis  1  1/431 (0.23%)  0/435 (0.00%) 
Meningitis meningococcal  1  0/431 (0.00%)  1/435 (0.23%) 
Osteomyelitis  1  0/431 (0.00%)  1/435 (0.23%) 
Otitis externa  1  1/431 (0.23%)  0/435 (0.00%) 
Otitis media  1  1/431 (0.23%)  0/435 (0.00%) 
Penile abscess  1  1/431 (0.23%)  0/435 (0.00%) 
Periorbital cellulitis  1  1/431 (0.23%)  0/435 (0.00%) 
Perirectal abscess  1  1/431 (0.23%)  0/435 (0.00%) 
Pharyngitis streptococcal  1  1/431 (0.23%)  0/435 (0.00%) 
Pyelonephritis  1  2/431 (0.46%)  0/435 (0.00%) 
Secondary syphilis  1  1/431 (0.23%)  0/435 (0.00%) 
Sepsis  1  0/431 (0.00%)  1/435 (0.23%) 
Shigella infection  1  1/431 (0.23%)  0/435 (0.00%) 
Staphylococcal infection  1  1/431 (0.23%)  0/435 (0.00%) 
Streptococcal bacteraemia  1  1/431 (0.23%)  0/435 (0.00%) 
Urinary tract infection  1  0/431 (0.00%)  2/435 (0.46%) 
West Nile viral infection  1  0/431 (0.00%)  1/435 (0.23%) 
Wound infection  1  1/431 (0.23%)  0/435 (0.00%) 
Injury, poisoning and procedural complications     
Alcohol poisoning  1  1/431 (0.23%)  0/435 (0.00%) 
Ankle fracture  1  1/431 (0.23%)  0/435 (0.00%) 
Cervical vertebral fracture  1  0/431 (0.00%)  1/435 (0.23%) 
Gun shot wound  1  0/431 (0.00%)  1/435 (0.23%) 
Muscle strain  1  0/431 (0.00%)  1/435 (0.23%) 
Overdose  1  0/431 (0.00%)  3/435 (0.69%) 
Postoperative respiratory failure  1  1/431 (0.23%)  0/435 (0.00%) 
Renal haematoma  1  0/431 (0.00%)  1/435 (0.23%) 
Road traffic accident  1  0/431 (0.00%)  1/435 (0.23%) 
Stab wound  1  1/431 (0.23%)  0/435 (0.00%) 
Thoracic vertebral fracture  1  0/431 (0.00%)  1/435 (0.23%) 
Toxicity to various agents  1  0/431 (0.00%)  1/435 (0.23%) 
Traumatic liver injury  1  0/431 (0.00%)  1/435 (0.23%) 
Wound  1  0/431 (0.00%)  1/435 (0.23%) 
Investigations     
Alanine aminotransferase abnormal  1  1/431 (0.23%)  0/435 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  0/431 (0.00%)  1/435 (0.23%) 
Diabetic complication  1  1/431 (0.23%)  0/435 (0.00%) 
Hyperglycaemia  1  0/431 (0.00%)  1/435 (0.23%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  1/431 (0.23%)  0/435 (0.00%) 
Muscular weakness  1  0/431 (0.00%)  1/435 (0.23%) 
Rhabdomyolysis  1  1/431 (0.23%)  1/435 (0.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anal squamous cell carcinoma  1  0/431 (0.00%)  1/435 (0.23%) 
Cervix carcinoma  1  0/431 (0.00%)  1/435 (0.23%) 
Meningioma  1  0/431 (0.00%)  1/435 (0.23%) 
Nervous system disorders     
Cerebrovascular accident  1  1/431 (0.23%)  1/435 (0.23%) 
Dysaesthesia  1  0/431 (0.00%)  1/435 (0.23%) 
Headache  1  1/431 (0.23%)  0/435 (0.00%) 
Migraine  1  1/431 (0.23%)  0/435 (0.00%) 
Paraesthesia  1  0/431 (0.00%)  1/435 (0.23%) 
Sciatica  1  0/431 (0.00%)  1/435 (0.23%) 
Seizure  1  0/431 (0.00%)  1/435 (0.23%) 
Subarachnoid haemorrhage  1  0/431 (0.00%)  1/435 (0.23%) 
Syncope  1  1/431 (0.23%)  0/435 (0.00%) 
Transient ischaemic attack  1  1/431 (0.23%)  0/435 (0.00%) 
Unresponsive to stimuli  1  0/431 (0.00%)  1/435 (0.23%) 
VIIth nerve paralysis  1  1/431 (0.23%)  0/435 (0.00%) 
Psychiatric disorders     
Acute psychosis  1  1/431 (0.23%)  0/435 (0.00%) 
Affective disorder  1  0/431 (0.00%)  1/435 (0.23%) 
Anxiety  1  0/431 (0.00%)  1/435 (0.23%) 
Bipolar II disorder  1  1/431 (0.23%)  0/435 (0.00%) 
Depression  1  1/431 (0.23%)  1/435 (0.23%) 
Depression suicidal  1  0/431 (0.00%)  2/435 (0.46%) 
Homicidal ideation  1  1/431 (0.23%)  0/435 (0.00%) 
Major depression  1  1/431 (0.23%)  0/435 (0.00%) 
Mental status changes  1  0/431 (0.00%)  1/435 (0.23%) 
Psychotic disorder  1  2/431 (0.46%)  0/435 (0.00%) 
Suicidal ideation  1  0/431 (0.00%)  1/435 (0.23%) 
Suicide attempt  1  2/431 (0.46%)  2/435 (0.46%) 
Renal and urinary disorders     
Calculus ureteric  1  1/431 (0.23%)  0/435 (0.00%) 
Reproductive system and breast disorders     
Vaginal dysplasia  1  0/431 (0.00%)  1/435 (0.23%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  0/431 (0.00%)  1/435 (0.23%) 
Asthma  1  2/431 (0.46%)  1/435 (0.23%) 
Bronchospasm  1  1/431 (0.23%)  0/435 (0.00%) 
Dyspnoea  1  1/431 (0.23%)  0/435 (0.00%) 
Pneumonia aspiration  1  0/431 (0.00%)  1/435 (0.23%) 
Pulmonary oedema  1  0/431 (0.00%)  1/435 (0.23%) 
Respiratory failure  1  0/431 (0.00%)  1/435 (0.23%) 
Skin and subcutaneous tissue disorders     
Hidradenitis  1  1/431 (0.23%)  0/435 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
E/C/F/TAF E/C/F/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   344/431 (79.81%)   340/435 (78.16%) 
Blood and lymphatic system disorders     
Lymphadenopathy  1  26/431 (6.03%)  24/435 (5.52%) 
Gastrointestinal disorders     
Abdominal pain  1  19/431 (4.41%)  27/435 (6.21%) 
Constipation  1  15/431 (3.48%)  26/435 (5.98%) 
Diarrhoea  1  78/431 (18.10%)  103/435 (23.68%) 
Haemorrhoids  1  21/431 (4.87%)  22/435 (5.06%) 
Nausea  1  73/431 (16.94%)  81/435 (18.62%) 
Vomiting  1  40/431 (9.28%)  43/435 (9.89%) 
General disorders     
Fatigue  1  48/431 (11.14%)  42/435 (9.66%) 
Pyrexia  1  31/431 (7.19%)  27/435 (6.21%) 
Infections and infestations     
Bronchitis  1  27/431 (6.26%)  22/435 (5.06%) 
Nasopharyngitis  1  57/431 (13.23%)  64/435 (14.71%) 
Sinusitis  1  18/431 (4.18%)  23/435 (5.29%) 
Syphilis  1  32/431 (7.42%)  27/435 (6.21%) 
Upper respiratory tract infection  1  68/431 (15.78%)  71/435 (16.32%) 
Urinary tract infection  1  14/431 (3.25%)  26/435 (5.98%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  44/431 (10.21%)  34/435 (7.82%) 
Back pain  1  48/431 (11.14%)  42/435 (9.66%) 
Osteopenia  1  29/431 (6.73%)  28/435 (6.44%) 
Pain in extremity  1  24/431 (5.57%)  18/435 (4.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anogenital warts  1  22/431 (5.10%)  20/435 (4.60%) 
Nervous system disorders     
Dizziness  1  26/431 (6.03%)  23/435 (5.29%) 
Headache  1  88/431 (20.42%)  69/435 (15.86%) 
Psychiatric disorders     
Anxiety  1  29/431 (6.73%)  32/435 (7.36%) 
Depression  1  26/431 (6.03%)  19/435 (4.37%) 
Insomnia  1  38/431 (8.82%)  31/435 (7.13%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  46/431 (10.67%)  40/435 (9.20%) 
Oropharyngeal pain  1  22/431 (5.10%)  34/435 (7.82%) 
Skin and subcutaneous tissue disorders     
Rash  1  40/431 (9.28%)  36/435 (8.28%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
There were no limitations affecting the analysis or results.
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
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01797445     History of Changes
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: December 4, 2018