Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants

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: NCT01815736
Recruitment Status : Active, not recruiting
First Posted : March 21, 2013
Results First Posted : April 14, 2016
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV
HIV Infections
Interventions Drug: E/C/F/TAF
Drug: E/C/F/TDF
Drug: EFV/FTC/TDF
Drug: RTV
Drug: ATV
Drug: FTC/TDF
Drug: COBI
Enrollment 1443
Recruitment Details Participants were enrolled at study sites in North America, South America, Europe, Australia, and Thailand . The first participant was screened on 27 March 2013. The last Week 48 study visit occurred on 16 March 2015.
Pre-assignment Details 1559 participants were screened.
Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase. Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF (Stribild®); efavirenz (EFV)/FTC/TDF (Atripla®); ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
Period Title: Overall Study
Started 963 480
Completed 2 2
Not Completed 961 478
Reason Not Completed
Randomized but Not Treated             4             3
Adverse Event             7             4
Death             4             0
Investigator's Discretion             4             0
Withdrew Consent             7             15
Lost to Follow-up             6             7
Still on Study             929             449
Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR) Total
Hide Arm/Group Description E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase. Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase. Total of all reporting groups
Overall Number of Baseline Participants 959 477 1436
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 959 participants 477 participants 1436 participants
41  (10.1) 41  (10.1) 41  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 959 participants 477 participants 1436 participants
Female
103
  10.7%
50
  10.5%
153
  10.7%
Male
856
  89.3%
427
  89.5%
1283
  89.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 959 participants 477 participants 1436 participants
American Indian or Alaska Native 5 2 7
Asian 59 35 94
Black 169 102 271
Native Hawaiian or Pacific Islander 6 1 7
White 651 314 965
Not Permitted 2 1 3
Other 67 22 89
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 959 participants 477 participants 1436 participants
Hispanic or Latino 248 82 330
Not Hispanic or Latino 709 392 1101
Not Permitted 2 3 5
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 959 participants 477 participants 1436 participants
United States 648 316 964
United Kingdom 14 8 22
Thailand 35 21 56
Portugal 8 2 10
Switzerland 5 4 9
Spain 5 3 8
Canada 51 27 78
Austria 16 8 24
Netherlands 2 3 5
Sweden 1 0 1
Belgium 14 8 22
Brazil 14 5 19
Denmark 1 2 3
Dominican Republic 29 13 42
Italy 13 6 19
Mexico 19 6 25
Australia 38 22 60
France 12 12 24
Germany 34 11 45
HIV-1 RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 959 participants 477 participants 1436 participants
< 50 copies/mL 943 466 1409
≥ 50 copies/mL 16 11 27
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.

New Drug Application (NDA Data Cut) = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.

Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
Overall Number of Participants Analyzed 959 477
Measure Type: Number
Unit of Measure: percentage of participants
NDA Data Cut (E/C/F/TAF: n=799; SBR: n=397) 95.6 92.9
All Participants (E/C/F/TAF: n=959; SBR: n=477) 97.2 93.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments NDA Data Cut
Type of Statistical Test Non-Inferiority or Equivalence
Comments Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.
Statistical Test of Hypothesis P-Value 0.051
Comments The p-value for the superiority test used a 2-sided Cochran-Mantel-Haenszel (CMH) test, stratified by prior treatment regimen.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 2.7
Confidence Interval (2-Sided) 95.01%
-0.3 to 5.6
Estimation Comments The difference in percentages and its 95.01% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportion adjusted by the prior treatment regimen.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments All Participants
Type of Statistical Test Non-Inferiority or Equivalence
Comments Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value for the superiority test used a 2-sided Cochran-Mantel-Haenszel (CMH) test, stratified by prior treatment regimen.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 4.1
Confidence Interval (2-Sided) 95%
1.6 to 6.7
Estimation Comments The difference in percentages and its 95% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportion adjusted by the prior treatment regimen.
2.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. BMD is calculated as grams per square centimeter (g/cm^2); the mean (SD) percentage change is presented.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Participants in the Hip DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline hip BMD) with available data were analyzed.

NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.

Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
Overall Number of Participants Analyzed 902 452
Mean (Standard Deviation)
Unit of Measure: percentage change
NDA Data Cut (E/C/F/TAF: n=733; SBR: n=350) 1.949  (2.9956) -0.136  (2.9890)
All Participants (E/C/F/TAF: n=869; SBR: n=428) 1.468  (2.7136) -0.340  (2.8280)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments NDA Data Cut
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value 2.078
Confidence Interval (2-Sided) 95%
1.697 to 2.459
Estimation Comments Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments All Participants
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value 1.807
Confidence Interval (2-Sided) 95%
1.488 to 2.126
Estimation Comments Difference in least squares means and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.
3.Secondary Outcome
Title Percent Change From Baseline in Spine BMD at Week 48
Hide Description Spine BMD was assessed by DXA scan. BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Participants in the Spine DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline spine BMD) with available data were analyzed.

NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.

Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
Overall Number of Participants Analyzed 912 457
Mean (Standard Deviation)
Unit of Measure: percentage change
NDA Data Cut (E/C/F/TAF: n=742; SBR: n=356) 1.861  (3.0889) -0.110  (3.7415)
All Participants (E/C/F/TAF: n=881; SBR: n=436) 1.557  (3.8441) -0.443  (4.1387)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments NDA Data Cut
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value 1.970
Confidence Interval (2-Sided) 95%
1.551 to 2.390
Estimation Comments Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments All Participants
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value 2.000
Confidence Interval (2-Sided) 95%
1.549 to 2.452
Estimation Comments Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.
4.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

Participants in the Safety Analysis Set (randomized participants who received ≥ 1 dose of study drug) excluding participants with prior treatment of EFV/FTC/TDF.

NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut

Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
Overall Number of Participants Analyzed 708 352
Mean (Standard Deviation)
Unit of Measure: mg/dL
NDA Data Cut (E/C/F/TAF: n=545; SBR: n=266) -0.01  (0.117) 0.04  (0.123)
All Participants (E/C/F/TAF: n=696; SBR: n=330) 0.00  (0.115) 0.03  (0.105)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments NDA Data Cut
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was from analysis of covariance (ANCOVA) model including study treatment and prior treatment as fixed effects and baseline serum creatinine as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.07 to -0.03
Estimation Comments Difference in least squares means (LSM) and its 95% CI were from the analysis of covariance (ANCOVA) model including study treatment and prior treatment regimen as fixed effects and baseline serum creatinine as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments All Participants
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was from analysis of covariance (ANCOVA) model including study treatment and prior treatment as fixed effects and baseline serum creatinine as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.05 to -0.02
Estimation Comments Difference in least squares means (LSM) and its 95% CI were from the analysis of covariance (ANCOVA) model including study treatment and prior treatment regimen as fixed effects and baseline serum creatinine as a covariate.
5.Secondary Outcome
Title Change From Baseline in Overall EFV-related Symptom Assessment Score at Week 48
Hide Description

The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream).

EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit.

Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Participants in EFV-Related Symptom Analysis Set with available data were analyzed.

NDA Data Cut = participants through data cut for E/C/F/TAF NDA; All Participants = participants through Week 48 Data Cut

Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
Overall Number of Participants Analyzed 239 116
Mean (Standard Deviation)
Unit of Measure: units on a scale
NDA Data Cut (E/C/F/TAF: n=210; SBR: n=96) -1.6  (3.06) -0.1  (2.43)
All Participants (E/C/F/TAF: n=224; SBR: n=101) -1.5  (3.06) -0.1  (2.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments NDA Data Cut
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The P-value comparing the 2 treatment groups was from the 2-sided Wilcoxon rank sum test.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, Stay on Baseline Treatment Regimen (SBR)
Comments All Participants
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The P-value comparing the 2 treatment groups was from the 2-sided Wilcoxon rank sum test.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Baseline through Week 48 Data Cut (average: E/C/F/TAF = 76.9 weeks; SBR = 75.1 weeks)
Adverse Event Reporting Description Safety Analysis Set: participants who were randomized and received at least one dose of study drug
 
Arm/Group Title E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Hide Arm/Group Description E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase. Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
All-Cause Mortality
E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
E/C/F/TAF Stay on Baseline Treatment Regimen (SBR)
Affected / at Risk (%) Affected / at Risk (%)
Total   65/959 (6.78%)   35/477 (7.34%) 
Blood and lymphatic system disorders     
Anaemia  1  1/959 (0.10%)  0/477 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  1/959 (0.10%)  0/477 (0.00%) 
Acute myocardial infarction  1  1/959 (0.10%)  1/477 (0.21%) 
Cardiac arrest  1  0/959 (0.00%)  1/477 (0.21%) 
Cardiac failure congestive  1  0/959 (0.00%)  1/477 (0.21%) 
Cardiovascular insufficiency  1  1/959 (0.10%)  0/477 (0.00%) 
Coronary artery disease  1  2/959 (0.21%)  0/477 (0.00%) 
Myocardial infarction  1  0/959 (0.00%)  2/477 (0.42%) 
Myocarditis  1  1/959 (0.10%)  0/477 (0.00%) 
Eye disorders     
Retinal detachment  1  1/959 (0.10%)  0/477 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  2/959 (0.21%)  0/477 (0.00%) 
Colitis  1  1/959 (0.10%)  0/477 (0.00%) 
Colitis ulcerative  1  1/959 (0.10%)  0/477 (0.00%) 
Diarrhoea  1  1/959 (0.10%)  2/477 (0.42%) 
Diverticular perforation  1  0/959 (0.00%)  1/477 (0.21%) 
Enteritis  1  1/959 (0.10%)  0/477 (0.00%) 
Erosive oesophagitis  1  0/959 (0.00%)  1/477 (0.21%) 
Gastritis  1  0/959 (0.00%)  1/477 (0.21%) 
Intestinal perforation  1  1/959 (0.10%)  0/477 (0.00%) 
Small intestinal obstruction  1  1/959 (0.10%)  0/477 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/959 (0.10%)  0/477 (0.00%) 
Vomiting  1  1/959 (0.10%)  0/477 (0.00%) 
General disorders     
Chest pain  1  1/959 (0.10%)  0/477 (0.00%) 
General physical health deterioration  1  1/959 (0.10%)  0/477 (0.00%) 
Non-cardiac chest pain  1  2/959 (0.21%)  1/477 (0.21%) 
Sudden death  1  1/959 (0.10%)  0/477 (0.00%) 
Systemic inflammatory response syndrome  1  1/959 (0.10%)  0/477 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  0/959 (0.00%)  1/477 (0.21%) 
Cholecystitis acute  1  0/959 (0.00%)  1/477 (0.21%) 
Infections and infestations     
Abscess limb  1  0/959 (0.00%)  1/477 (0.21%) 
Acute hepatitis C  1  1/959 (0.10%)  0/477 (0.00%) 
Anal abscess  1  1/959 (0.10%)  0/477 (0.00%) 
Appendiceal abscess  1  0/959 (0.00%)  1/477 (0.21%) 
Appendicitis  1  3/959 (0.31%)  0/477 (0.00%) 
Bronchitis  1  1/959 (0.10%)  1/477 (0.21%) 
Cellulitis  1  0/959 (0.00%)  2/477 (0.42%) 
Conjunctivitis bacterial  1  1/959 (0.10%)  0/477 (0.00%) 
Diverticulitis  1  0/959 (0.00%)  1/477 (0.21%) 
Enteritis infectious  1  1/959 (0.10%)  0/477 (0.00%) 
Erysipelas  1  0/959 (0.00%)  1/477 (0.21%) 
Gastroenteritis  1  1/959 (0.10%)  0/477 (0.00%) 
Gonorrhoea  1  1/959 (0.10%)  0/477 (0.00%) 
H1N1 influenza  1  0/959 (0.00%)  1/477 (0.21%) 
Hepatitis A  1  1/959 (0.10%)  0/477 (0.00%) 
Hepatitis syphilitic  1  0/959 (0.00%)  1/477 (0.21%) 
Infectious colitis  1  1/959 (0.10%)  0/477 (0.00%) 
Influenza  1  0/959 (0.00%)  1/477 (0.21%) 
Meningitis aseptic  1  3/959 (0.31%)  0/477 (0.00%) 
Neurosyphilis  1  1/959 (0.10%)  0/477 (0.00%) 
Osteomyelitis  1  1/959 (0.10%)  2/477 (0.42%) 
Parasitic gastroenteritis  1  1/959 (0.10%)  0/477 (0.00%) 
Perineal infection  1  0/959 (0.00%)  1/477 (0.21%) 
Perirectal abscess  1  0/959 (0.00%)  1/477 (0.21%) 
Pneumonia  1  4/959 (0.42%)  0/477 (0.00%) 
Reiter's syndrome  1  1/959 (0.10%)  0/477 (0.00%) 
Scrotal infection  1  0/959 (0.00%)  1/477 (0.21%) 
Sepsis  1  4/959 (0.42%)  1/477 (0.21%) 
Septic shock  1  1/959 (0.10%)  0/477 (0.00%) 
Sinusitis  1  2/959 (0.21%)  0/477 (0.00%) 
Urinary tract infection  1  1/959 (0.10%)  0/477 (0.00%) 
Viral infection  1  1/959 (0.10%)  0/477 (0.00%) 
Injury, poisoning and procedural complications     
Craniocerebral injury  1  1/959 (0.10%)  0/477 (0.00%) 
Hip fracture  1  1/959 (0.10%)  0/477 (0.00%) 
Overdose  1  0/959 (0.00%)  1/477 (0.21%) 
Radius fracture  1  1/959 (0.10%)  0/477 (0.00%) 
Rib fracture  1  0/959 (0.00%)  1/477 (0.21%) 
Road traffic accident  1  1/959 (0.10%)  0/477 (0.00%) 
Skull fracture  1  1/959 (0.10%)  0/477 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/959 (0.10%)  0/477 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis reactive  1  0/959 (0.00%)  1/477 (0.21%) 
Intervertebral disc protrusion  1  1/959 (0.10%)  0/477 (0.00%) 
Osteonecrosis  1  1/959 (0.10%)  0/477 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hodgkin's disease  1  1/959 (0.10%)  1/477 (0.21%) 
Lung adenocarcinoma stage IV  1  1/959 (0.10%)  0/477 (0.00%) 
Prostate cancer  1  1/959 (0.10%)  0/477 (0.00%) 
Nervous system disorders     
Ataxia  1  1/959 (0.10%)  0/477 (0.00%) 
Cauda equina syndrome  1  1/959 (0.10%)  0/477 (0.00%) 
Cerebral haemorrhage  1  1/959 (0.10%)  0/477 (0.00%) 
Convulsion  1  2/959 (0.21%)  0/477 (0.00%) 
Embolic stroke  1  0/959 (0.00%)  1/477 (0.21%) 
Febrile convulsion  1  1/959 (0.10%)  0/477 (0.00%) 
Guillain-Barre syndrome  1  1/959 (0.10%)  0/477 (0.00%) 
Haemorrhagic stroke  1  1/959 (0.10%)  0/477 (0.00%) 
Headache  1  1/959 (0.10%)  1/477 (0.21%) 
Memory impairment  1  1/959 (0.10%)  0/477 (0.00%) 
Migraine  1  1/959 (0.10%)  0/477 (0.00%) 
Transient ischaemic attack  1  0/959 (0.00%)  1/477 (0.21%) 
Psychiatric disorders     
Acute psychosis  1  1/959 (0.10%)  0/477 (0.00%) 
Depression  1  0/959 (0.00%)  2/477 (0.42%) 
Drug abuse  1  0/959 (0.00%)  1/477 (0.21%) 
Hallucination  1  1/959 (0.10%)  0/477 (0.00%) 
Major depression  1  1/959 (0.10%)  0/477 (0.00%) 
Mental status changes  1  1/959 (0.10%)  0/477 (0.00%) 
Substance abuse  1  0/959 (0.00%)  1/477 (0.21%) 
Substance-induced psychotic disorder  1  1/959 (0.10%)  0/477 (0.00%) 
Suicidal ideation  1  1/959 (0.10%)  0/477 (0.00%) 
Suicide attempt  1  4/959 (0.42%)  0/477 (0.00%) 
Renal and urinary disorders     
Bladder disorder  1  1/959 (0.10%)  0/477 (0.00%) 
Fanconi syndrome acquired  1  0/959 (0.00%)  1/477 (0.21%) 
Renal failure acute  1  1/959 (0.10%)  1/477 (0.21%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/959 (0.00%)  1/477 (0.21%) 
Chronic obstructive pulmonary disease  1  1/959 (0.10%)  0/477 (0.00%) 
Non-cardiogenic pulmonary oedema  1  1/959 (0.10%)  0/477 (0.00%) 
Pleuritic pain  1  0/959 (0.00%)  1/477 (0.21%) 
Pneumothorax  1  1/959 (0.10%)  0/477 (0.00%) 
Respiratory failure  1  1/959 (0.10%)  0/477 (0.00%) 
Skin and subcutaneous tissue disorders     
Subcutaneous emphysema  1  0/959 (0.00%)  1/477 (0.21%) 
Social circumstances     
Substance use  1  0/959 (0.00%)  1/477 (0.21%) 
Vascular disorders     
Hypertension  1  0/959 (0.00%)  1/477 (0.21%) 
Hypotension  1  0/959 (0.00%)  1/477 (0.21%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
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 Stay on Baseline Treatment Regimen (SBR)
Affected / at Risk (%) Affected / at Risk (%)
Total   539/959 (56.20%)   243/477 (50.94%) 
Gastrointestinal disorders     
Diarrhoea  1  95/959 (9.91%)  41/477 (8.60%) 
Nausea  1  50/959 (5.21%)  16/477 (3.35%) 
Infections and infestations     
Bronchitis  1  57/959 (5.94%)  25/477 (5.24%) 
Nasopharyngitis  1  88/959 (9.18%)  39/477 (8.18%) 
Sinusitis  1  47/959 (4.90%)  25/477 (5.24%) 
Syphilis  1  46/959 (4.80%)  30/477 (6.29%) 
Upper respiratory tract infection  1  151/959 (15.75%)  54/477 (11.32%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  59/959 (6.15%)  24/477 (5.03%) 
Back pain  1  52/959 (5.42%)  25/477 (5.24%) 
Osteopenia  1  56/959 (5.84%)  22/477 (4.61%) 
Nervous system disorders     
Headache  1  68/959 (7.09%)  20/477 (4.19%) 
Psychiatric disorders     
Depression  1  42/959 (4.38%)  28/477 (5.87%) 
Insomnia  1  50/959 (5.21%)  30/477 (6.29%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  64/959 (6.67%)  25/477 (5.24%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
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: NCT01815736     History of Changes
Other Study ID Numbers: GS-US-292-0109
2012-005114-20 ( EudraCT Number )
First Submitted: March 19, 2013
First Posted: March 21, 2013
Results First Submitted: March 15, 2016
Results First Posted: April 14, 2016
Last Update Posted: March 1, 2019