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Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC

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ClinicalTrials.gov Identifier: NCT02469246
Recruitment Status : Completed
First Posted : June 11, 2015
Results First Posted : June 11, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition HIV-1 Infection
Interventions Drug: F/TAF
Drug: ABC/3TC
Drug: ABC/3TC Placebo
Drug: F/TAF Placebo
Drug: Third ARV agent
Enrollment 567
Recruitment Details Participants were enrolled across 80 study sites in North America and Europe. The first participant was screened on 29 June 2015. The last study visit for primary outcome measure occurred on 07 April 2017.
Pre-assignment Details 626 participants were screened. Data submitted represent analysis performed on data collected by the Primary Completion Date, 07 April 2017. Complete data will be submitted in November 2019.
Arm/Group Title F/TAF ABC/3TC
Hide Arm/Group Description Emtricitabine/tenofovir alafenamide (Descovy®; F/TAF) (200/10 mg) fixed-dose combination (FDC) tablet (with boosted third antiretroviral (ARV) agents) or F/TAF (200/25 mg) FDC tablet (with unboosted third ARV agents) orally once daily + placebo to match abacavir/lamivudine (ABC/3TC) for 96 weeks. [An allowed third ARV agent of the participant's pre-existing regimen may include one of the following boosted ARV agents, with F/TAF (200/10 mg) FDC tablet: ritonavir boosted lopinavir (LPV/r), atazanavir (ATV) + ritonavir (RTV), ATV + cobicistat (COBI) or ATV/COBI FDC, darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC; or, one of the following unboosted agents, with F/TAF (200/25 mg) FDC tablet: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP)] ABC/3TC (600/300 mg) FDC tablet orally once daily + placebo to match F/TAF + allowed third ARV agent for 96 weeks. (An allowed third ARV agent of the participant's pre-existing regimen may include one of the following boosted ARV agents: LPV/r, ATV + RTV, ATV + COBI or ATV/COBI FDC, DRV + RTV, DRV+COBI or DRV/COBI FDC; or, one of the following unboosted agents: EFV, RPV, RAL, DTG, MVC, or NVP)
Period Title: Overall Study
Started 285 282
Completed 0 0
Not Completed 285 282
Reason Not Completed
Randomized and Never Treated             5             6
Still in Study up to the Data Cut Date             258             264
Adverse Event             6             5
Death             1             0
Lack of Efficacy             1             0
Investigator's Discretion             1             0
Non-Compliance with Study Drug             1             0
Protocol Violation             0             1
Withdrew Consent             9             6
Lost to Follow-up             3             0
Arm/Group Title F/TAF ABC/3TC Total
Hide Arm/Group Description F/TAF (200/10) mg FDC tablet (with boosted third ARV agents) or F/TAF (200/25 mg) FDC tablet (with unboosted third ARV agents), orally once daily + placebo to match ABC/3TC for 96 weeks ABC/3TC (600/300) mg FDC tablet orally once daily + placebo to match F/TAF + allowed third ARV agent for 96 weeks Total of all reporting groups
Overall Number of Baseline Participants 280 276 556
Hide Baseline Analysis Population Description
Safety Analysis Set: all randomized participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 280 participants 276 participants 556 participants
51  (9.4) 51  (9.3) 51  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 276 participants 556 participants
Female
40
  14.3%
61
  22.1%
101
  18.2%
Male
240
  85.7%
215
  77.9%
455
  81.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 276 participants 556 participants
American Indian or Alaska Native
1
   0.4%
0
   0.0%
1
   0.2%
Asian
5
   1.8%
5
   1.8%
10
   1.8%
Black
64
  22.9%
66
  23.9%
130
  23.4%
Native Hawaiian or Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
White
205
  73.2%
199
  72.1%
404
  72.7%
Not Permitted
0
   0.0%
0
   0.0%
0
   0.0%
Other
5
   1.8%
6
   2.2%
11
   2.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 276 participants 556 participants
Hispanic or Latino
16
   5.7%
19
   6.9%
35
   6.3%
Not Hispanic or Latino
264
  94.3%
257
  93.1%
521
  93.7%
Not Permitted
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Belgium Number Analyzed 280 participants 276 participants 556 participants
4
   1.4%
6
   2.2%
10
   1.8%
Canada Number Analyzed 280 participants 276 participants 556 participants
9
   3.2%
8
   2.9%
17
   3.1%
Denmark Number Analyzed 280 participants 276 participants 556 participants
4
   1.4%
3
   1.1%
7
   1.3%
France Number Analyzed 280 participants 276 participants 556 participants
18
   6.4%
17
   6.2%
35
   6.3%
Germany Number Analyzed 280 participants 276 participants 556 participants
20
   7.1%
19
   6.9%
39
   7.0%
Ireland Number Analyzed 280 participants 276 participants 556 participants
9
   3.2%
8
   2.9%
17
   3.1%
Italy Number Analyzed 280 participants 276 participants 556 participants
26
   9.3%
17
   6.2%
43
   7.7%
Spain Number Analyzed 280 participants 276 participants 556 participants
32
  11.4%
34
  12.3%
66
  11.9%
Sweden Number Analyzed 280 participants 276 participants 556 participants
3
   1.1%
4
   1.4%
7
   1.3%
United Kingdom Number Analyzed 280 participants 276 participants 556 participants
50
  17.9%
59
  21.4%
109
  19.6%
United States Number Analyzed 280 participants 276 participants 556 participants
105
  37.5%
101
  36.6%
206
  37.1%
HIV-1 RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 276 participants 556 participants
< 50 copies/mL
278
  99.3%
273
  98.9%
551
  99.1%
≥ 50 copies/mL
2
   0.7%
3
   1.1%
5
   0.9%
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 280 participants 276 participants 556 participants
703  (298.7) 727  (275.2) 715  (287.3)
CD4 Cell Count Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 276 participants 556 participants
< 50 cells/µL
0
   0.0%
1
   0.4%
1
   0.2%
≥ 50 to < 200 cells/µL
0
   0.0%
0
   0.0%
0
   0.0%
≥ 200 to < 350 cells/µL
20
   7.1%
16
   5.8%
36
   6.5%
≥ 350 to < 500 cells/µL
56
  20.0%
38
  13.8%
94
  16.9%
≥ 500 cells/µL
204
  72.9%
221
  80.1%
425
  76.4%
HIV Disease Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 276 participants 556 participants
Asymptomatic
201
  71.8%
201
  72.8%
402
  72.3%
Symptomatic HIV Infection
31
  11.1%
24
   8.7%
55
   9.9%
AIDS
47
  16.8%
50
  18.1%
97
  17.4%
Unknown
1
   0.4%
1
   0.4%
2
   0.4%
Hip Bone Mineral Density (BMD)   [1] 
Mean (Standard Deviation)
Unit of measure:  G/cm^2
Number Analyzed 253 participants 248 participants 501 participants
1.006  (0.1555) 1.000  (0.1459) NA [2]   (NA)
[1]
Measure Analysis Population Description: Only participants with nonmissing baseline hip BMD values were included.
[2]
Total was not calculated for baseline hip BMD.
Spine BMD   [1] 
Mean (Standard Deviation)
Unit of measure:  G/cm^2
Number Analyzed 256 participants 251 participants 507 participants
1.130  (0.1885) 1.121  (0.1838) NA [2]   (NA)
[1]
Measure Analysis Population Description: Only participants with nonmissing baseline spine BMD values were included.
[2]
Total was not calculated for baseline spine BMD.
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
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 participant'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: all randomized participants who received at least one dose of study drug on or before 23 May 2016.
Arm/Group Title F/TAF ABC/3TC
Hide Arm/Group Description:
F/TAF (200/10) mg FDC tablet (with boosted third ARV agents) or F/TAF (200/25 mg) FDC tablet (with unboosted third ARV agents), orally once daily + placebo to match ABC/3TC for 96 weeks
ABC/3TC (600/300 mg) FDC tablet orally once daily + placebo to match F/TAF + allowed third ARV agent for 96 weeks
Overall Number of Participants Analyzed 253 248
Measure Type: Number
Unit of Measure: percentage of participants
89.7 92.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection F/TAF, ABC/3TC
Comments The analysis purpose of the primary efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority was assessed using a 2-sided exact 95% confidence interval (CI) approach, with a non-inferiority margin of 10%.
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -3.0
Confidence Interval (2-Sided) 95.002%
-8.2 to 2.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
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 participant'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
Arm/Group Title F/TAF ABC/3TC
Hide Arm/Group Description:
F/TAF (200/10) mg FDC tablet (with boosted third ARV agents) or F/TAF (200/25 mg) FDC tablet (with unboosted third ARV agents), orally once daily + placebo to match ABC/3TC for 96 weeks
ABC/3TC (600/300) mg FDC tablet orally once daily + placebo to match F/TAF + allowed third ARV agent for 96 weeks
Overall Number of Participants Analyzed 253 248
Measure Type: Number
Unit of Measure: percentage of participants
1.6 0.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection F/TAF, ABC/3TC
Comments The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority was assessed using a 2-sided exact 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages]
Estimated Value 0.8
Confidence Interval (2-Sided) 95.002%
-1.5 to 3.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
Hide Description The percentage of participants achieving HIV-1 RNA < 20 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the 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
Arm/Group Title F/TAF ABC/3TC
Hide Arm/Group Description:
F/TAF (200/10) mg FDC tablet (with boosted third ARV agents) or F/TAF (200/25 mg) FDC tablet (with unboosted third ARV agents), orally once daily + placebo to match ABC/3TC for 96 weeks
ABC/3TC (600/300) mg FDC tablet orally once daily + placebo to match F/TAF + allowed third ARV agent for 96 weeks
Overall Number of Participants Analyzed 253 248
Measure Type: Number
Unit of Measure: percentage of participants
87.0 87.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection F/TAF, ABC/3TC
Comments The analysis purpose of this efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority was assessed using a 2-sided exact 95% confidence interval (CI) approach, with a non-inferiority margin of 10%.
Statistical Test of Hypothesis P-Value 0.89
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-6.5 to 5.5
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 48
Hide Description [Not Specified]
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title F/TAF ABC/3TC
Hide Arm/Group Description:
F/TAF (200/10) mg FDC tablet (with boosted third ARV agents) or F/TAF (200/25 mg) FDC tablet (with unboosted third ARV agents), orally once daily + placebo to match ABC/3TC for 96 weeks
ABC/3TC (600/300) mg FDC tablet orally once daily + placebo to match F/TAF + allowed third ARV agent for 96 weeks
Overall Number of Participants Analyzed 226 229
Mean (Standard Deviation)
Unit of Measure: cells/µL
-29  (153.5) 1  (177.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection F/TAF, ABC/3TC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments For postbaseline visits, p-value, difference in least squares means (LSM), and its 95% CI were from ANOVA model with treatment and the third agent stratum (boosted protease inhibitors vs. others) as fixed effects in the model.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Means
Estimated Value -29
Confidence Interval (2-Sided) 95%
-59 to 2
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percent Change From Baseline in Hip BMD at Week 48
Hide Description [Not Specified]
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set: all participants who are randomized and have received at least one dose of study drug, and have nonmissing baseline hip BMD values. Participants in the Hip DXA Analysis Set with available data were analyzed.
Arm/Group Title F/TAF ABC/3TC
Hide Arm/Group Description:
F/TAF (200/10) mg FDC tablet (with boosted third ARV agents) or F/TAF (200/25 mg) FDC tablet (with unboosted third ARV agents), orally once daily + placebo to match ABC/3TC for 96 weeks
ABC/3TC (600/300) mg FDC tablet orally once daily + placebo to match F/TAF + allowed third ARV agent for 96 weeks
Overall Number of Participants Analyzed 212 212
Mean (Standard Deviation)
Unit of Measure: percent
0.271  (2.3434) 0.159  (2.3858)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection F/TAF, ABC/3TC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments For postbaseline visits, p-value, difference in least squares means (LSM), and its 95% CI were from ANOVA model with treatment and the third agent stratum (boosted protease inhibitors vs. others) as fixed effects in the model.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Means
Estimated Value 0.136
Confidence Interval (2-Sided) 95%
-0.315 to 0.587
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percent Change From Baseline in Spine BMD at Week 48
Hide Description [Not Specified]
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Spine DXA Analysis Set: all participants who are randomized and have received at least one dose of study drug, and have nonmissing baseline spine BMD values. Participants in the spine DXA Analysis Set with available data were analyzed.
Arm/Group Title F/TAF ABC/3TC
Hide Arm/Group Description:
F/TAF (200/10) mg FDC tablet (with boosted third ARV agents) or F/TAF (200/25 mg) FDC tablet (with unboosted third ARV agents), orally once daily + placebo to match ABC/3TC for 96 weeks
ABC/3TC (600/300) mg FDC tablet orally once daily + placebo to match F/TAF + allowed third ARV agent for 96 weeks
Overall Number of Participants Analyzed 213 217
Mean (Standard Deviation)
Unit of Measure: percent
0.099  (3.0405) 0.026  (3.8523)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection F/TAF, ABC/3TC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments For postbaseline visits, p-value, difference in least squares means (LSM), and its 95% CI were from ANOVA model with treatment and the third agent stratum (boosted protease inhibitors vs. others) as fixed effects in the model.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Means
Estimated Value 0.096
Confidence Interval (2-Sided) 95%
-0.563 to 0.755
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 96 will be analyzed using the snapshot algorithm, which defines a participant'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
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm
Hide Description The percentage of participants achieving HIV-1 RNA ≥ 50 copies/mL at week 96 will be analyzed using the snapshot algorithm, which defines a participant'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
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm
Hide Description The percentage of participants achieving HIV-1 RNA < 20 copies/mL at week 96 will be analyzed using the snapshot algorithm, which defines a participant'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
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 96
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 96
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 96
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Outcome Measure Data Not Reported
Time Frame Up to 96 Weeks Plus 30 days
Adverse Event Reporting Description

Safety Analysis Set: all participants who were randomized and received at least 1 dose of study drug.

Data submitted represent adverse events (AEs) collected by the Primary Completion Date, 07 April 2017. Complete AE data will be submitted in November 2019.

 
Arm/Group Title F/TAF ABC/3TC
Hide Arm/Group Description F/TAF (200/10) mg FDC tablet (with boosted third ARV agents) or F/TAF (200/25 mg) FDC tablet (with unboosted third ARV agents), orally once daily + placebo to match ABC/3TC ABC/3TC (600/300 mg) FDC tablet orally once daily + placebo to match F/TAF + allowed third ARV agent
All-Cause Mortality
F/TAF ABC/3TC
Affected / at Risk (%) Affected / at Risk (%)
Total   2/280 (0.71%)   0/276 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
F/TAF ABC/3TC
Affected / at Risk (%) Affected / at Risk (%)
Total   26/280 (9.29%)   17/276 (6.16%) 
Blood and lymphatic system disorders     
Iron deficiency anaemia  1  1/280 (0.36%)  0/276 (0.00%) 
Leukocytosis  1  0/280 (0.00%)  1/276 (0.36%) 
Neutropenia  1  1/280 (0.36%)  0/276 (0.00%) 
Cardiac disorders     
Cardiac failure congestive  1  1/280 (0.36%)  0/276 (0.00%) 
Coronary artery disease  1  1/280 (0.36%)  1/276 (0.36%) 
Coronary artery stenosis  1  1/280 (0.36%)  0/276 (0.00%) 
Myocardial infarction  1  1/280 (0.36%)  1/276 (0.36%) 
Pericarditis  1  0/280 (0.00%)  1/276 (0.36%) 
Gastrointestinal disorders     
Abdominal pain  1  1/280 (0.36%)  1/276 (0.36%) 
Diarrhoea  1  1/280 (0.36%)  0/276 (0.00%) 
Faecaloma  1  0/280 (0.00%)  1/276 (0.36%) 
Oesophageal ulcer  1  1/280 (0.36%)  0/276 (0.00%) 
Pancreatitis acute  1  1/280 (0.36%)  0/276 (0.00%) 
Rectal haemorrhage  1  1/280 (0.36%)  0/276 (0.00%) 
General disorders     
Hernia  1  0/280 (0.00%)  1/276 (0.36%) 
Sudden cardiac death  1  1/280 (0.36%)  0/276 (0.00%) 
Infections and infestations     
Acute hepatitis C  1  0/280 (0.00%)  1/276 (0.36%) 
Appendicitis  1  1/280 (0.36%)  0/276 (0.00%) 
Diarrhoea infectious  1  1/280 (0.36%)  0/276 (0.00%) 
Diverticulitis  1  1/280 (0.36%)  0/276 (0.00%) 
Escherichia pyelonephritis  1  1/280 (0.36%)  0/276 (0.00%) 
Gastroenteritis  1  0/280 (0.00%)  2/276 (0.72%) 
Herpes zoster oticus  1  1/280 (0.36%)  0/276 (0.00%) 
Pneumonia  1  1/280 (0.36%)  0/276 (0.00%) 
Respiratory tract infection  1  1/280 (0.36%)  0/276 (0.00%) 
Urosepsis  1  1/280 (0.36%)  2/276 (0.72%) 
Viral myocarditis  1  0/280 (0.00%)  1/276 (0.36%) 
Injury, poisoning and procedural complications     
Femur fracture  1  0/280 (0.00%)  1/276 (0.36%) 
Poisoning  1  1/280 (0.36%)  0/276 (0.00%) 
Uterine perforation  1  0/280 (0.00%)  1/276 (0.36%) 
Investigations     
Haemoglobin decreased  1  1/280 (0.36%)  0/276 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  0/280 (0.00%)  1/276 (0.36%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  0/280 (0.00%)  1/276 (0.36%) 
Osteonecrosis  1  1/280 (0.36%)  0/276 (0.00%) 
Rotator cuff syndrome  1  0/280 (0.00%)  1/276 (0.36%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  1/280 (0.36%)  0/276 (0.00%) 
Anal cancer  1  1/280 (0.36%)  0/276 (0.00%) 
Choroid melanoma  1  1/280 (0.36%)  0/276 (0.00%) 
Colon cancer  1  1/280 (0.36%)  0/276 (0.00%) 
Ganglioneuroma  1  1/280 (0.36%)  0/276 (0.00%) 
Nervous system disorders     
Epilepsy  1  1/280 (0.36%)  0/276 (0.00%) 
Hydrocephalus  1  1/280 (0.36%)  0/276 (0.00%) 
Seizure  1  1/280 (0.36%)  0/276 (0.00%) 
Psychiatric disorders     
Bipolar disorder  1  1/280 (0.36%)  0/276 (0.00%) 
Depression  1  0/280 (0.00%)  1/276 (0.36%) 
Intentional self-injury  1  0/280 (0.00%)  1/276 (0.36%) 
Substance abuse  1  1/280 (0.36%)  0/276 (0.00%) 
Suicide attempt  1  1/280 (0.36%)  1/276 (0.36%) 
Renal and urinary disorders     
Acute kidney injury  1  1/280 (0.36%)  0/276 (0.00%) 
Renal colic  1  1/280 (0.36%)  0/276 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  0/280 (0.00%)  1/276 (0.36%) 
Vascular disorders     
Deep vein thrombosis  1  0/280 (0.00%)  2/276 (0.72%) 
Hypertension  1  1/280 (0.36%)  0/276 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
F/TAF ABC/3TC
Affected / at Risk (%) Affected / at Risk (%)
Total   107/280 (38.21%)   129/276 (46.74%) 
Gastrointestinal disorders     
Diarrhoea  1  23/280 (8.21%)  25/276 (9.06%) 
General disorders     
Fatigue  1  15/280 (5.36%)  10/276 (3.62%) 
Infections and infestations     
Nasopharyngitis  1  36/280 (12.86%)  31/276 (11.23%) 
Upper respiratory tract infection  1  25/280 (8.93%)  34/276 (12.32%) 
Urinary tract infection  1  6/280 (2.14%)  14/276 (5.07%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  18/280 (6.43%)  20/276 (7.25%) 
Back pain  1  13/280 (4.64%)  17/276 (6.16%) 
Nervous system disorders     
Headache  1  20/280 (7.14%)  14/276 (5.07%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  18/280 (6.43%)  15/276 (5.43%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
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
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02469246     History of Changes
Other Study ID Numbers: GS-US-311-1717
2015-000871-28 ( EudraCT Number )
First Submitted: June 9, 2015
First Posted: June 11, 2015
Results First Submitted: March 29, 2018
Results First Posted: June 11, 2018
Last Update Posted: April 16, 2019