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Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

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: NCT02607956
Recruitment Status : Active, not recruiting
First Posted : November 18, 2015
Results First Posted : June 6, 2018
Last Update Posted : April 29, 2020
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: DTG
Drug: F/TAF
Drug: B/F/TAF
Drug: DTG Placebo
Drug: F/TAF Placebo
Drug: B/F/TAF Placebo
Enrollment 657
Recruitment Details Participants were enrolled at centers in Australia, Europe, North America, and the Dominican Republic. The first participant was screened on 11 November 2015. The last Week 144 study visit occurred on 17 May 2019.
Pre-assignment Details 742 participants were screened.
Arm/Group Title B/F/TAF DTG + F/TAF
Hide Arm/Group Description

Blinded Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food

Extension Phase: After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.

Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks without regard to food

Extension Phase: After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.

Period Title: Overall Study
Started 327 330
Completed 0 0
Not Completed 327 330
Reason Not Completed
Randomized and Never Treated             7             5
Still on Study             268             281
Adverse Event             4             3
Death             4             4
Investigator's Discretion             7             2
Non-Compliance with Study Drug             0             3
Protocol Violation             3             1
Withdrew Consent             16             16
Lost to Follow-up             18             15
Arm/Group Title B/F/TAF DTG + F/TAF Total
Hide Arm/Group Description

Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food

Extension Phase: After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.

Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food

Extension Phase: After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.

Total of all reporting groups
Overall Number of Baseline Participants 320 325 645
Hide Baseline Analysis Population Description
Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of the study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 320 participants 325 participants 645 participants
37  (12.3) 37  (11.6) 37  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants 325 participants 645 participants
Female 40 37 77
Male 280 288 568
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants 325 participants 645 participants
American Indian or Alaska Native 1 1 2
Asian 7 10 17
Black 97 100 197
Native Hawaiian or Pacific Islander 1 0 1
White 183 195 378
Other 31 19 50
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants 325 participants 645 participants
Hispanic or Latino 83 81 164
Not Hispanic or Latino 237 244 481
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants 325 participants 645 participants
Canada 12 9 21
Belgium 4 4 8
United States 193 193 386
Dominican Republic 27 18 45
Italy 15 18 33
United Kingdom 21 23 44
Australia 4 10 14
France 7 5 12
Germany 20 28 48
Spain 17 17 34
HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 320 participants 325 participants 645 participants
4.39  (0.730) 4.42  (0.669) 4.41  (0.700)
HIV-1 RNA Categories  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants 325 participants 645 participants
≤ 100,000 copies/mL 254 271 525
> 100,000 ≤ 400,000 copies/mL 54 41 95
> 400,000 copies/mL 12 13 25
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  Cells/µL
Number Analyzed 320 participants 325 participants 645 participants
457  (255.3) 454  (231.5) 456  (243.4)
CD4 Cell Count Categories  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants 325 participants 645 participants
< 50 cells/μL 15 13 28
≥ 50 to < 200 cells/μL 29 21 50
≥ 200 to < 350 cells/μL 67 77 144
≥ 350 to < 500 cells/μL 91 94 185
≥ 500 cells/μL 118 120 238
1.Primary Outcome
Title Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US 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 included all participants who were randomized into the study and received at least 1 dose of study drug.
Arm/Group Title B/F/TAF DTG + F/TAF
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 320 325
Measure Type: Number
Unit of Measure: percentage of participants
89.4 92.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments A sample of approximately 600 participants randomized 1:1 achieves at least 95% power using a non-inferiority margin of 12% assuming a response rate in both groups of 91% (Reference Genvoya studies) and a one-sided alpha level of 0.025.
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -3.5
Confidence Interval (2-Sided) 95.002%
-7.9 to 1.0
Estimation Comments Differences in percentages of participants between groups and their 95.002% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
2.Secondary Outcome
Title Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US 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 B/F/TAF DTG + F/TAF
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 320 325
Measure Type: Number
Unit of Measure: percentage of participants
84.1 86.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-7.9 to 3.2
Estimation Comments Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
3.Secondary Outcome
Title Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 144 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 144
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title B/F/TAF DTG + F/TAF
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 320 325
Measure Type: Number
Unit of Measure: percentage of participants
81.9 84.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-7.8 to 3.9
Estimation Comments Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
4.Secondary Outcome
Title Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US 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 B/F/TAF DTG + F/TAF
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 320 325
Measure Type: Number
Unit of Measure: percentage of participants
82.2 87.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-9.4 to 1.5
Estimation Comments The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
5.Secondary Outcome
Title Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US 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 B/F/TAF DTG + F/TAF
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 320 325
Measure Type: Number
Unit of Measure: percentage of participants
77.5 80.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-8.8 to 3.8
Estimation Comments The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
6.Secondary Outcome
Title Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
Hide Description The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 144 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 144
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title B/F/TAF DTG + F/TAF
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 320 325
Measure Type: Number
Unit of Measure: percentage of participants
77.5 79.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-7.4 to 5.3
Estimation Comments The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
7.Secondary Outcome
Title Change From Baseline in log10 HIV-1 RNA 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 B/F/TAF DTG + F/TAF
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 294 308
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-3.07  (0.719) -3.12  (0.672)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.081
Comments [Not Specified]
Method ANOVA
Comments p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.01 to 0.17
Estimation Comments Difference in least-squares mean (LSM), and its 95% confidence interval (CI) were adjusted by baseline HIV-1 RNA stratum and region stratum.
8.Secondary Outcome
Title Change From Baseline in log10 HIV-1 RNA 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 B/F/TAF DTG + F/TAF
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 276 291
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-3.08  (0.703) -3.10  (0.713)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method ANOVA
Comments p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.03 to 0.15
Estimation Comments Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.
9.Secondary Outcome
Title Change From Baseline in log10 HIV-1 RNA at Week 144
Hide Description [Not Specified]
Time Frame Baseline; Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title B/F/TAF DTG + F/TAF
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 270 280
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-3.06  (0.731) -3.11  (0.672)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments [Not Specified]
Method ANOVA
Comments p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
0.00 to 0.18
Estimation Comments Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.
10.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 B/F/TAF DTG + F/TAF
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 290 304
Mean (Standard Deviation)
Unit of Measure: cells/μL
180  (166.2) 201  (165.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.096
Comments [Not Specified]
Method ANOVA
Comments P-value was adjusted by the baseline HIV-1 RNA and region stratum.
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -23
Confidence Interval (2-Sided) 95%
-49 to 4
Estimation Comments Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.
11.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 B/F/TAF DTG + F/TAF
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 269 285
Mean (Standard Deviation)
Unit of Measure: cells/μL
237  (204.2) 281  (209.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method ANOVA
Comments P-value was adjusted by the baseline HIV-1 RNA and region stratum.
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -47
Confidence Interval (2-Sided) 95%
-81 to -12
Estimation Comments Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.
12.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 144
Hide Description [Not Specified]
Time Frame Baseline; Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title B/F/TAF DTG + F/TAF
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 262 277
Mean (Standard Deviation)
Unit of Measure: cells/μL
278  (236.6) 289  (218.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method ANOVA
Comments p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -14
Confidence Interval (2-Sided) 95%
-52 to 25
Estimation Comments Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.
13.Secondary Outcome
Title Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded and Missing = Failure Algorithm
Hide Description [Not Specified]
Time Frame Baseline; open-label Week 48
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded and Missing = Failure Algorithm
Hide Description [Not Specified]
Time Frame Baseline; open-label Week 96
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 48 Open-Label
Hide Description [Not Specified]
Time Frame Baseline; open-label Week 48
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 96 Open-Label
Hide Description [Not Specified]
Time Frame Baseline; open-label Week 96
Outcome Measure Data Not Reported
Time Frame First dose date up to the Week 144 Data Cut
Adverse Event Reporting Description Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.
 
Arm/Group Title B/F/TAF DTG + F/TAF
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Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food

Extension Phase: After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.

Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food

Extension Phase: After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.

All-Cause Mortality
B/F/TAF DTG + F/TAF
Affected / at Risk (%) Affected / at Risk (%)
Total   4/320 (1.25%)   4/325 (1.23%) 
Hide Serious Adverse Events
B/F/TAF DTG + F/TAF
Affected / at Risk (%) Affected / at Risk (%)
Total   63/320 (19.69%)   40/325 (12.31%) 
Blood and lymphatic system disorders     
Anaemia  1  2/320 (0.63%)  0/325 (0.00%) 
Disseminated intravascular coagulation  1  1/320 (0.31%)  0/325 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  1/320 (0.31%)  0/325 (0.00%) 
Atrial flutter  1  1/320 (0.31%)  0/325 (0.00%) 
Cardiac arrest  1  2/320 (0.63%)  0/325 (0.00%) 
Cardiac failure congestive  1  2/320 (0.63%)  0/325 (0.00%) 
Hypertensive heart disease  1  1/320 (0.31%)  0/325 (0.00%) 
Myocardial infarction  1  1/320 (0.31%)  0/325 (0.00%) 
Supraventricular tachycardia  1  0/320 (0.00%)  1/325 (0.31%) 
Eye disorders     
Iridocyclitis  1  0/320 (0.00%)  1/325 (0.31%) 
Gastrointestinal disorders     
Abdominal pain  1  1/320 (0.31%)  1/325 (0.31%) 
Abdominal pain upper  1  1/320 (0.31%)  1/325 (0.31%) 
Anal fissure  1  1/320 (0.31%)  0/325 (0.00%) 
Anal fistula  1  1/320 (0.31%)  0/325 (0.00%) 
Anal ulcer  1  1/320 (0.31%)  0/325 (0.00%) 
Colitis  1  1/320 (0.31%)  1/325 (0.31%) 
Constipation  1  0/320 (0.00%)  1/325 (0.31%) 
Diarrhoea  1  1/320 (0.31%)  1/325 (0.31%) 
Gastrointestinal haemorrhage  1  1/320 (0.31%)  0/325 (0.00%) 
Haemorrhoids  1  1/320 (0.31%)  1/325 (0.31%) 
Nausea  1  0/320 (0.00%)  1/325 (0.31%) 
Pancreatitis acute  1  2/320 (0.63%)  0/325 (0.00%) 
Proctalgia  1  1/320 (0.31%)  0/325 (0.00%) 
Proctitis  1  1/320 (0.31%)  0/325 (0.00%) 
Rectal haemorrhage  1  0/320 (0.00%)  2/325 (0.62%) 
Upper gastrointestinal haemorrhage  1  1/320 (0.31%)  0/325 (0.00%) 
Vomiting  1  1/320 (0.31%)  1/325 (0.31%) 
General disorders     
Chest pain  1  1/320 (0.31%)  0/325 (0.00%) 
Death  1  0/320 (0.00%)  2/325 (0.62%) 
Hyperthermia  1  1/320 (0.31%)  0/325 (0.00%) 
Multiple organ dysfunction syndrome  1  1/320 (0.31%)  0/325 (0.00%) 
Oedema peripheral  1  1/320 (0.31%)  0/325 (0.00%) 
Pyrexia  1  1/320 (0.31%)  0/325 (0.00%) 
Systemic inflammatory response syndrome  1  1/320 (0.31%)  0/325 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute  1  1/320 (0.31%)  0/325 (0.00%) 
Infections and infestations     
Abscess neck  1  1/320 (0.31%)  0/325 (0.00%) 
Amoebic dysentery  1  1/320 (0.31%)  0/325 (0.00%) 
Anal abscess  1  3/320 (0.94%)  0/325 (0.00%) 
Anal infection  1  1/320 (0.31%)  0/325 (0.00%) 
Appendicitis  1  3/320 (0.94%)  2/325 (0.62%) 
Bacterial infection  1  0/320 (0.00%)  1/325 (0.31%) 
Blister infected  1  0/320 (0.00%)  1/325 (0.31%) 
Cellulitis  1  6/320 (1.88%)  1/325 (0.31%) 
Endocarditis  1  1/320 (0.31%)  0/325 (0.00%) 
Enteritis infectious  1  1/320 (0.31%)  0/325 (0.00%) 
Erysipelas  1  1/320 (0.31%)  0/325 (0.00%) 
Escherichia bacteraemia  1  1/320 (0.31%)  0/325 (0.00%) 
Eye infection syphilitic  1  0/320 (0.00%)  1/325 (0.31%) 
Gastroenteritis  1  1/320 (0.31%)  0/325 (0.00%) 
Gastroenteritis shigella  1  1/320 (0.31%)  0/325 (0.00%) 
Hepatitis A  1  1/320 (0.31%)  0/325 (0.00%) 
Herpes zoster  1  1/320 (0.31%)  0/325 (0.00%) 
Influenza  1  1/320 (0.31%)  0/325 (0.00%) 
Localised infection  1  0/320 (0.00%)  1/325 (0.31%) 
Orchitis  1  0/320 (0.00%)  1/325 (0.31%) 
Pharyngitis streptococcal  1  1/320 (0.31%)  0/325 (0.00%) 
Pneumonia  1  0/320 (0.00%)  4/325 (1.23%) 
Pneumonia parainfluenzae viral  1  0/320 (0.00%)  1/325 (0.31%) 
Pyelonephritis  1  1/320 (0.31%)  0/325 (0.00%) 
Sepsis  1  1/320 (0.31%)  2/325 (0.62%) 
Septic shock  1  1/320 (0.31%)  0/325 (0.00%) 
Shigella infection  1  2/320 (0.63%)  0/325 (0.00%) 
Skin infection  1  0/320 (0.00%)  1/325 (0.31%) 
Staphylococcal infection  1  1/320 (0.31%)  0/325 (0.00%) 
Subcutaneous abscess  1  1/320 (0.31%)  1/325 (0.31%) 
Urinary tract infection  1  1/320 (0.31%)  0/325 (0.00%) 
Urosepsis  1  1/320 (0.31%)  0/325 (0.00%) 
Wound infection  1  0/320 (0.00%)  1/325 (0.31%) 
Injury, poisoning and procedural complications     
Alcohol poisoning  1  0/320 (0.00%)  1/325 (0.31%) 
Concussion  1  0/320 (0.00%)  1/325 (0.31%) 
Fall  1  1/320 (0.31%)  0/325 (0.00%) 
Foot fracture  1  0/320 (0.00%)  1/325 (0.31%) 
Gun shot wound  1  1/320 (0.31%)  0/325 (0.00%) 
Hand fracture  1  1/320 (0.31%)  0/325 (0.00%) 
Head injury  1  0/320 (0.00%)  1/325 (0.31%) 
Heat stroke  1  1/320 (0.31%)  0/325 (0.00%) 
Radius fracture  1  0/320 (0.00%)  1/325 (0.31%) 
Rectal injury  1  1/320 (0.31%)  0/325 (0.00%) 
Road traffic accident  1  0/320 (0.00%)  2/325 (0.62%) 
Subdural haematoma  1  1/320 (0.31%)  0/325 (0.00%) 
Tendon injury  1  0/320 (0.00%)  1/325 (0.31%) 
Toxicity to various agents  1  0/320 (0.00%)  1/325 (0.31%) 
Ulna fracture  1  0/320 (0.00%)  1/325 (0.31%) 
Investigations     
Transaminases increased  1  1/320 (0.31%)  0/325 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/320 (0.31%)  0/325 (0.00%) 
Diabetes mellitus inadequate control  1  1/320 (0.31%)  0/325 (0.00%) 
Fluid overload  1  1/320 (0.31%)  0/325 (0.00%) 
Hyperglycaemia  1  1/320 (0.31%)  0/325 (0.00%) 
Hyperkalaemia  1  1/320 (0.31%)  0/325 (0.00%) 
Hypoglycaemia  1  1/320 (0.31%)  0/325 (0.00%) 
Hypokalaemia  1  1/320 (0.31%)  0/325 (0.00%) 
Metabolic acidosis  1  1/320 (0.31%)  0/325 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/320 (0.31%)  0/325 (0.00%) 
Back pain  1  1/320 (0.31%)  0/325 (0.00%) 
Intervertebral disc protrusion  1  2/320 (0.63%)  0/325 (0.00%) 
Muscle haemorrhage  1  0/320 (0.00%)  1/325 (0.31%) 
Pain in extremity  1  1/320 (0.31%)  0/325 (0.00%) 
Rhabdomyolysis  1  3/320 (0.94%)  0/325 (0.00%) 
Vertebral foraminal stenosis  1  1/320 (0.31%)  0/325 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma gastric  1  1/320 (0.31%)  0/325 (0.00%) 
Anogenital warts  1  1/320 (0.31%)  0/325 (0.00%) 
B-cell lymphoma  1  0/320 (0.00%)  1/325 (0.31%) 
Central nervous system lymphoma  1  1/320 (0.31%)  0/325 (0.00%) 
Colon cancer  1  1/320 (0.31%)  0/325 (0.00%) 
Invasive ductal breast carcinoma  1  1/320 (0.31%)  0/325 (0.00%) 
Lymphoma  1  0/320 (0.00%)  1/325 (0.31%) 
Pleomorphic adenoma  1  0/320 (0.00%)  1/325 (0.31%) 
Prostate cancer  1  0/320 (0.00%)  1/325 (0.31%) 
Nervous system disorders     
Cerebrovascular accident  1  0/320 (0.00%)  2/325 (0.62%) 
Cubital tunnel syndrome  1  0/320 (0.00%)  1/325 (0.31%) 
Dizziness  1  1/320 (0.31%)  0/325 (0.00%) 
Headache  1  1/320 (0.31%)  0/325 (0.00%) 
Ischaemic stroke  1  0/320 (0.00%)  1/325 (0.31%) 
Loss of consciousness  1  1/320 (0.31%)  0/325 (0.00%) 
Seizure  1  1/320 (0.31%)  0/325 (0.00%) 
Syncope  1  1/320 (0.31%)  0/325 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion incomplete  1  1/320 (0.31%)  0/325 (0.00%) 
Psychiatric disorders     
Acute psychosis  1  0/320 (0.00%)  1/325 (0.31%) 
Bipolar disorder  1  0/320 (0.00%)  1/325 (0.31%) 
Depression  1  1/320 (0.31%)  1/325 (0.31%) 
Depression suicidal  1  1/320 (0.31%)  1/325 (0.31%) 
Drug abuse  1  1/320 (0.31%)  1/325 (0.31%) 
Major depression  1  1/320 (0.31%)  0/325 (0.00%) 
Psychotic disorder  1  0/320 (0.00%)  1/325 (0.31%) 
Seasonal affective disorder  1  0/320 (0.00%)  1/325 (0.31%) 
Stress  1  0/320 (0.00%)  1/325 (0.31%) 
Substance-induced psychotic disorder  1  0/320 (0.00%)  1/325 (0.31%) 
Suicide attempt  1  2/320 (0.63%)  1/325 (0.31%) 
Renal and urinary disorders     
Acute kidney injury  1  3/320 (0.94%)  1/325 (0.31%) 
Chronic kidney disease  1  1/320 (0.31%)  0/325 (0.00%) 
Haematuria  1  0/320 (0.00%)  1/325 (0.31%) 
Reproductive system and breast disorders     
Ovarian cyst  1  0/320 (0.00%)  1/325 (0.31%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/320 (0.31%)  0/325 (0.00%) 
Chronic obstructive pulmonary disease  1  0/320 (0.00%)  1/325 (0.31%) 
Cough  1  0/320 (0.00%)  1/325 (0.31%) 
Dyspnoea  1  1/320 (0.31%)  2/325 (0.62%) 
Interstitial lung disease  1  0/320 (0.00%)  1/325 (0.31%) 
Pneumothorax  1  1/320 (0.31%)  0/325 (0.00%) 
Pulmonary embolism  1  1/320 (0.31%)  1/325 (0.31%) 
Pulmonary mass  1  1/320 (0.31%)  0/325 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin ulcer  1  0/320 (0.00%)  1/325 (0.31%) 
Vascular disorders     
Deep vein thrombosis  1  2/320 (0.63%)  2/325 (0.62%) 
Hypertensive crisis  1  0/320 (0.00%)  1/325 (0.31%) 
Peripheral ischaemia  1  1/320 (0.31%)  0/325 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
B/F/TAF DTG + F/TAF
Affected / at Risk (%) Affected / at Risk (%)
Total   246/320 (76.88%)   258/325 (79.38%) 
Blood and lymphatic system disorders     
Lymphadenopathy  1  23/320 (7.19%)  23/325 (7.08%) 
Gastrointestinal disorders     
Abdominal pain  1  23/320 (7.19%)  19/325 (5.85%) 
Abdominal pain upper  1  16/320 (5.00%)  12/325 (3.69%) 
Diarrhoea  1  65/320 (20.31%)  52/325 (16.00%) 
Dyspepsia  1  20/320 (6.25%)  13/325 (4.00%) 
Nausea  1  31/320 (9.69%)  42/325 (12.92%) 
Vomiting  1  23/320 (7.19%)  20/325 (6.15%) 
General disorders     
Fatigue  1  28/320 (8.75%)  36/325 (11.08%) 
Pyrexia  1  21/320 (6.56%)  30/325 (9.23%) 
Infections and infestations     
Bronchitis  1  15/320 (4.69%)  27/325 (8.31%) 
Chlamydial infection  1  12/320 (3.75%)  26/325 (8.00%) 
Gastroenteritis  1  14/320 (4.38%)  18/325 (5.54%) 
Gonorrhoea  1  18/320 (5.63%)  23/325 (7.08%) 
Influenza  1  26/320 (8.13%)  21/325 (6.46%) 
Nasopharyngitis  1  50/320 (15.63%)  62/325 (19.08%) 
Pharyngitis  1  23/320 (7.19%)  9/325 (2.77%) 
Sinusitis  1  24/320 (7.50%)  11/325 (3.38%) 
Syphilis  1  33/320 (10.31%)  31/325 (9.54%) 
Upper respiratory tract infection  1  43/320 (13.44%)  52/325 (16.00%) 
Urinary tract infection  1  17/320 (5.31%)  12/325 (3.69%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  27/320 (8.44%)  23/325 (7.08%) 
Back pain  1  28/320 (8.75%)  38/325 (11.69%) 
Musculoskeletal pain  1  9/320 (2.81%)  18/325 (5.54%) 
Pain in extremity  1  24/320 (7.50%)  11/325 (3.38%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anogenital warts  1  16/320 (5.00%)  12/325 (3.69%) 
Nervous system disorders     
Dizziness  1  16/320 (5.00%)  19/325 (5.85%) 
Headache  1  55/320 (17.19%)  57/325 (17.54%) 
Psychiatric disorders     
Anxiety  1  16/320 (5.00%)  25/325 (7.69%) 
Depression  1  20/320 (6.25%)  25/325 (7.69%) 
Insomnia  1  29/320 (9.06%)  24/325 (7.38%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  25/320 (7.81%)  28/325 (8.62%) 
Nasal congestion  1  16/320 (5.00%)  9/325 (2.77%) 
Oropharyngeal pain  1  20/320 (6.25%)  18/325 (5.54%) 
Skin and subcutaneous tissue disorders     
Rash  1  14/320 (4.38%)  23/325 (7.08%) 
Vascular disorders     
Hypertension  1  18/320 (5.63%)  20/325 (6.15%) 
1
Term from vocabulary, MedDRA 22.0
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
Publications of Results:
Acosta R, Willkom M, Martin R, Chang S, Liu X, Hedskog C, et al. Low-frequency resistance variants in ART-naive participants do not affect bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) triple therapy outcome. [Poster MOPEB242]. 10th IAS Conference on HIV Science (IAS 2019); 2019 July 21-24; Mexico City, Mexico.
Johnson M, Taylor S, Wei X, Collins SE, Martin H. Hepatic Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide [Poster P061]. 25th Annual Conference of the British HIV Association; 2019 02-05 April; Bournemouth, United Kingdom.
Gupta S, Mills A, Brinson C, Workowski K, Clarke A, Antinori A, et al. 96 Week Efficacy and Safety of B/F/TAF in Treatment-Naïve Adults and Adults ≥50 Years [Poster 502]. CROI 2019; 2019 04-07 March; Seattle, WA.
Acosta R, White K, Garner W, Wei X, Andreatta K, Willkom M, et al. HIV-1 subtype (B or non-B) had no impact on the efficacy of B/F/TAF or resistance development in five phase 3 treatment-naïve or switch studies. [Poster THPEB077]. 22nd International AIDS Conference; 2018 July 23-27; Amsterdam, Netherlands.
White K, Kulkarni R, Willkom M, Martin R, Chang S, Wei X, et al. Pooled week 48 efficacy and baseline resistance: B/F/TAF in treatment-naive patients. [Poster 532]. Conference on Retroviruses and Opportunistic Infections; 2018 March 4-7; Boston, USA.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02607956    
Other Study ID Numbers: GS-US-380-1490
2015-003988-10 ( EudraCT Number )
First Submitted: November 10, 2015
First Posted: November 18, 2015
Results First Submitted: May 3, 2018
Results First Posted: June 6, 2018
Last Update Posted: April 29, 2020