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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 : October 25, 2019
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
Condition HIV-1 Infection
Interventions Drug: F/TAF
Drug: ABC/3TC
Drug: ABC/3TC Placebo
Drug: F/TAF Placebo
Drug: 3rd ARV agent
Enrollment 567
Recruitment Details Participants were enrolled at study sites in North America and Europe. The first participant was screened on 29 June 2015. The last study visit occurred on 13 March 2019.
Pre-assignment Details 626 participants were screened.
Arm/Group Title F/TAF ABC/3TC
Hide Arm/Group Description

Double-Blind Phase: Emtricitabine/tenofovir alafenamide (F/TAF) (200/10 mg) fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral (ARV) agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + abacavir/lamivudine (ABC/3TC) placebo tablet once daily for 96 weeks, and continued blinded treatment until unblinding. [Allowed boosted 3rd ARV agents: 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; Allowed unboosted 3rd ARV agents: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP)].

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

Double-Blind Phase: ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks, and continued blinded treatment until unblinding. (Allowed boosted 3rd ARV agents: LPV/r, ATV + RTV, ATV + COBI or ATV/COBI FDC, DRV + RTV, DRV+COBI or DRV/COBI FDC; Allowed unboosted 3rd ARV agents: EFV, RPV, RAL, DTG, MVC, or NVP)

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

Period Title: Double-Blind Phase
Started 285 282
Completed 218 226
Not Completed 67 56
Reason Not Completed
Randomized and Never Treated             5             6
Adverse Event             12             9
Death             2             0
Lack of Efficacy             2             1
Investigator's Discretion             8             8
Non-Compliance with Study Drug             3             1
Protocol Violation             1             1
Withdrew Consent             25             25
Lost to Follow-up             9             5
Period Title: Open-Label Extension (OLE)
Started 6 [1] 5 [1]
Completed 6 5
Not Completed 0 0
[1]
Only participants in countries where F/TAF was not commercially available were eligible for the OLE.
Arm/Group Title F/TAF ABC/3TC Total
Hide Arm/Group Description F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks Total of all reporting groups
Overall Number of Baseline Participants 280 276 556
Hide Baseline Analysis Population Description
The Safety Analysis Set included all randomized participants who received at least one dose of study drug. Participants were grouped according to the treatment they actually received.
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 61 101
Male 240 215 455
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 276 participants 556 participants
Hispanic or Latino 16 19 35
Not Hispanic or Latino 264 257 521
Unknown or Not Reported 0 0 0
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 1
Asian 5 5 10
Black 64 66 130
White 205 199 404
Other 5 6 11
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 276 participants 556 participants
Belgium 4 6 10
Canada 9 8 17
Denmark 4 3 7
France 18 17 35
Germany 20 19 39
Ireland 9 8 17
Italy 26 17 43
Spain 32 34 66
Sweden 3 4 7
United Kingdom 50 59 109
United States 105 101 206
HIV-1 RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 276 participants 556 participants
< 50 copies/mL 278 273 551
≥ 50 copies/mL 2 3 5
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 1 1
≥ 50 to < 200 cells/µL 0 0 0
≥ 200 to < 350 cells/µL 20 16 36
≥ 350 to < 500 cells/µL 56 38 94
≥ 500 cells/µL 204 221 425
HIV Disease Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 276 participants 556 participants
Asymptomatic 201 201 402
Symptomatic HIV Infection 31 24 55
AIDS 47 50 97
Unknown 1 1 2
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
The Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. Participants were grouped according to the treatment to which they were randomized.
Arm/Group Title F/TAF ABC/3TC
Hide Arm/Group Description:
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed 280 276
Measure Type: Number
Unit of Measure: percentage of participants
88.6 92.4
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 0.15
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -3.8
Confidence Interval (2-Sided) 95.002%
-8.9 to 1.1
Estimation Comments The difference in percentages and its 95.002% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.
2.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 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 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title F/TAF ABC/3TC
Hide Arm/Group Description:
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed 280 276
Measure Type: Number
Unit of Measure: percentage of participants
82.1 88.4
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% CI approach, with a non-inferiority margin of 4%.
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -6.3
Confidence Interval (2-Sided) 95%
-12.3 to -0.3
Estimation Comments The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.
3.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 with 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
Participants in the Full Analysis Set were analyzed.
Arm/Group Title F/TAF ABC/3TC
Hide Arm/Group Description:
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed 280 276
Measure Type: Number
Unit of Measure: percentage of participants
1.8 0.7
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% CI approach, with a non-inferiority margin of 4%.
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 1.1
Confidence Interval (2-Sided) 95.002%
-1.0 to 3.5
Estimation Comments The difference in percentages and its 95.002% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.
4.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 with HIV-1 RNA ≥ 50 copies/mL at Week 96 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 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title F/TAF ABC/3TC
Hide Arm/Group Description:
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed 280 276
Measure Type: Number
Unit of Measure: percentage of participants
2.5 1.1
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% CI approach, with a non-inferiority margin of 4%.
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-1.0 to 4.2
Estimation Comments The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.
5.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
Participants in the Full Analysis Set were analyzed.
Arm/Group Title F/TAF ABC/3TC
Hide Arm/Group Description:
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed 280 276
Measure Type: Number
Unit of Measure: percentage of participants
85.7 87.3
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% CI approach, with a non-inferiority margin of 10%.
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-7.4 to 4.2
Estimation Comments The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.
6.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 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 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title F/TAF ABC/3TC
Hide Arm/Group Description:
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed 280 276
Measure Type: Number
Unit of Measure: percentage of participants
80.4 86.2
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% CI approach, with a non-inferiority margin of 10%.
Statistical Test of Hypothesis P-Value 0.069
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -5.9
Confidence Interval (2-Sided) 95%
-12.2 to 0.4
Estimation Comments The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.
7.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title F/TAF ABC/3TC
Hide Arm/Group Description:
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed 249 254
Mean (Standard Deviation)
Unit of Measure: cells/µL
-30  (152.3) 2  (171.2)
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 0.026
Comments P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -32
Confidence Interval (2-Sided) 95%
-61 to -4
Estimation Comments Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).
8.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 96
Hide Description [Not Specified]
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title F/TAF ABC/3TC
Hide Arm/Group Description:
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed 229 238
Mean (Standard Deviation)
Unit of Measure: cells/μL
-29  (160.7) 10  (178.2)
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 0.013
Comments P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -39
Confidence Interval (2-Sided) 95%
-70 to -8
Estimation Comments Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).
9.Secondary Outcome
Title Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the 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) 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 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed 231 236
Mean (Standard Deviation)
Unit of Measure: percent change
0.246  (2.2914) 0.086  (2.3315)
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 0.40
Comments P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.179
Confidence Interval (2-Sided) 95%
-0.240 to 0.598
Estimation Comments Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).
10.Secondary Outcome
Title Percent Change From Baseline in Hip BMD at Week 96
Hide Description [Not Specified]
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
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 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed 213 221
Mean (Standard Deviation)
Unit of Measure: percent change
0.169  (2.7277) 0.021  (2.7212)
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 0.53
Comments P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.165
Confidence Interval (2-Sided) 95%
-0.348 to 0.678
Estimation Comments Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).
11.Secondary Outcome
Title Percent Change From Baseline in Spine BMD at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the 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) 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 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed 232 240
Mean (Standard Deviation)
Unit of Measure: percent change
0.081  (3.0051) -0.052  (3.7550)
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 0.63
Comments P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.151
Confidence Interval (2-Sided) 95%
-0.465 to 0.767
Estimation Comments Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).
12.Secondary Outcome
Title Percent Change From Baseline in Spine BMD at Week 96
Hide Description [Not Specified]
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
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 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
Overall Number of Participants Analyzed 217 225
Mean (Standard Deviation)
Unit of Measure: percent change
0.178  (3.8881) 0.235  (4.3066)
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 0.89
Comments P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.056
Confidence Interval (2-Sided) 95%
-0.825 to 0.713
Estimation Comments Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).
Time Frame First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
Adverse Event Reporting Description The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
 
Arm/Group Title F/TAF (Double-Blind Phase) ABC/3TC (Double-Blind Phase) Open-Label F/TAF From F/TAF Open-Label F/TAF From ABC/3TC
Hide Arm/Group Description Adverse events reported occurred during the Double-Blind Phase in participants from the F/TAF group, who received F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily. Adverse events reported occurred during the Double-Blind Phase in participants from the ABC/3TC group, who received ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent. Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the F/TAF group and received F/TAF (200/10 mg or 200/25 mg) FDC tablet once daily. Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the ABC/3TC group and received F/TAF (200/10 mg or 200/25 mg) FDC tablet once daily.
All-Cause Mortality
F/TAF (Double-Blind Phase) ABC/3TC (Double-Blind Phase) Open-Label F/TAF From F/TAF Open-Label F/TAF From ABC/3TC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/280 (1.79%)   0/276 (0.00%)   0/6 (0.00%)   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
F/TAF (Double-Blind Phase) ABC/3TC (Double-Blind Phase) Open-Label F/TAF From F/TAF Open-Label F/TAF From ABC/3TC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   55/280 (19.64%)   32/276 (11.59%)   0/6 (0.00%)   0/5 (0.00%) 
Blood and lymphatic system disorders         
Iron deficiency anaemia  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Leukocytosis  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Neutropenia  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Cardiac disorders         
Atrial fibrillation  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Cardiac failure congestive  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Cardio-respiratory arrest  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Coronary artery disease  1  1/280 (0.36%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Coronary artery stenosis  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Myocardial infarction  1  1/280 (0.36%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Pericarditis  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  1/280 (0.36%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Diarrhoea  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Faecaloma  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Gastrointestinal haemorrhage  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Haematemesis  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Ileus paralytic  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Intestinal ischaemia  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Large intestine perforation  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Oesophageal ulcer  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Pancreatitis  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Pancreatitis acute  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Rectal haemorrhage  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Small intestinal obstruction  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Umbilical hernia  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
General disorders         
Asthenia  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Chest pain  1  2/280 (0.71%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Death  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Sudden cardiac death  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Infections and infestations         
Abdominal wall abscess  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Abscess neck  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Acute hepatitis C  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Appendicitis  1  1/280 (0.36%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Clostridium difficile infection  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Dengue fever  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Diarrhoea infectious  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Diverticulitis  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Erysipelas  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Escherichia pyelonephritis  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Gastroenteritis  1  0/280 (0.00%)  2/276 (0.72%)  0/6 (0.00%)  0/5 (0.00%) 
Groin abscess  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Herpes zoster oticus  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Oesophageal candidiasis  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Peritonitis  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Pneumonia  1  5/280 (1.79%)  2/276 (0.72%)  0/6 (0.00%)  0/5 (0.00%) 
Pneumonia legionella  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Postoperative wound infection  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Pyelonephritis  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Respiratory tract infection  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Staphylococcal abscess  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Staphylococcal infection  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Urosepsis  1  1/280 (0.36%)  2/276 (0.72%)  0/6 (0.00%)  0/5 (0.00%) 
Viral myocarditis  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Injury, poisoning and procedural complications         
Fall  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Femoral neck fracture  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Femur fracture  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Fibula fracture  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Meniscus injury  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Poisoning  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Road traffic accident  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Seroma  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Uterine perforation  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Investigations         
Blood creatine phosphokinase increased  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Transaminases increased  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Viral load increased  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Diabetic ketoacidosis  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Hyponatraemia  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Type 2 diabetes mellitus  1  2/280 (0.71%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion  1  1/280 (0.36%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Osteonecrosis  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Pathological fracture  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Rhabdomyolysis  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Rotator cuff syndrome  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Acute myeloid leukaemia  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Anal cancer  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Anogenital warts  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Bladder transitional cell carcinoma  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Choroid melanoma  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Colon cancer  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Ganglioneuroma  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Hodgkin's disease  1  2/280 (0.71%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Lung cancer metastatic  1  1/280 (0.36%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Ovarian cancer metastatic  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Prostate cancer  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Rectal cancer  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Nervous system disorders         
Cerebral haemorrhage  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Cerebral infarction  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Epilepsy  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Hydrocephalus  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Loss of consciousness  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Metabolic encephalopathy  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Presyncope  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Seizure  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Transient ischaemic attack  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Psychiatric disorders         
Alcohol abuse  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Bipolar disorder  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Depression  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Drug abuse  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Intentional self-injury  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Psychotic disorder  1  1/280 (0.36%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Schizophrenia  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Substance abuse  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Suicide attempt  1  2/280 (0.71%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Renal and urinary disorders         
Acute kidney injury  1  3/280 (1.07%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Nephrolithiasis  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Renal colic  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Reproductive system and breast disorders         
Benign prostatic hyperplasia  1  0/280 (0.00%)  1/276 (0.36%)  0/6 (0.00%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pneumonia aspiration  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Pulmonary embolism  1  0/280 (0.00%)  3/276 (1.09%)  0/6 (0.00%)  0/5 (0.00%) 
Social circumstances         
Substance use  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
Vascular disorders         
Deep vein thrombosis  1  2/280 (0.71%)  3/276 (1.09%)  0/6 (0.00%)  0/5 (0.00%) 
Hypertension  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  0/5 (0.00%) 
1
Term from vocabulary, MedDRA 21.1
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 (Double-Blind Phase) ABC/3TC (Double-Blind Phase) Open-Label F/TAF From F/TAF Open-Label F/TAF From ABC/3TC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   190/280 (67.86%)   199/276 (72.10%)   1/6 (16.67%)   2/5 (40.00%) 
Gastrointestinal disorders         
Diarrhoea  1  30/280 (10.71%)  37/276 (13.41%)  0/6 (0.00%)  0/5 (0.00%) 
Nausea  1  14/280 (5.00%)  11/276 (3.99%)  0/6 (0.00%)  0/5 (0.00%) 
Vomiting  1  14/280 (5.00%)  10/276 (3.62%)  0/6 (0.00%)  0/5 (0.00%) 
General disorders         
Fatigue  1  21/280 (7.50%)  15/276 (5.43%)  0/6 (0.00%)  0/5 (0.00%) 
Infections and infestations         
Bronchitis  1  19/280 (6.79%)  14/276 (5.07%)  0/6 (0.00%)  0/5 (0.00%) 
Gastroenteritis  1  11/280 (3.93%)  15/276 (5.43%)  0/6 (0.00%)  0/5 (0.00%) 
Influenza  1  12/280 (4.29%)  15/276 (5.43%)  0/6 (0.00%)  0/5 (0.00%) 
Nasopharyngitis  1  57/280 (20.36%)  49/276 (17.75%)  0/6 (0.00%)  1/5 (20.00%) 
Rhinitis  1  7/280 (2.50%)  6/276 (2.17%)  0/6 (0.00%)  1/5 (20.00%) 
Syphilis  1  15/280 (5.36%)  5/276 (1.81%)  0/6 (0.00%)  0/5 (0.00%) 
Upper respiratory tract infection  1  36/280 (12.86%)  46/276 (16.67%)  0/6 (0.00%)  0/5 (0.00%) 
Urinary tract infection  1  13/280 (4.64%)  18/276 (6.52%)  0/6 (0.00%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  28/280 (10.00%)  29/276 (10.51%)  0/6 (0.00%)  0/5 (0.00%) 
Back pain  1  24/280 (8.57%)  31/276 (11.23%)  0/6 (0.00%)  0/5 (0.00%) 
Musculoskeletal pain  1  11/280 (3.93%)  14/276 (5.07%)  0/6 (0.00%)  0/5 (0.00%) 
Pain in extremity  1  22/280 (7.86%)  15/276 (5.43%)  0/6 (0.00%)  0/5 (0.00%) 
Spinal pain  1  0/280 (0.00%)  1/276 (0.36%)  1/6 (16.67%)  0/5 (0.00%) 
Nervous system disorders         
Headache  1  31/280 (11.07%)  25/276 (9.06%)  0/6 (0.00%)  0/5 (0.00%) 
Renal and urinary disorders         
Renal colic  1  1/280 (0.36%)  0/276 (0.00%)  0/6 (0.00%)  1/5 (20.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  34/280 (12.14%)  30/276 (10.87%)  0/6 (0.00%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash  1  14/280 (5.00%)  17/276 (6.16%)  0/6 (0.00%)  0/5 (0.00%) 
Vascular disorders         
Hypertension  1  15/280 (5.36%)  15/276 (5.43%)  0/6 (0.00%)  0/5 (0.00%) 
1
Term from vocabulary, MedDRA 21.1
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: October 25, 2019