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Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naïve 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: NCT02607930
Recruitment Status : Active, not recruiting
First Posted : November 18, 2015
Results First Posted : July 23, 2018
Last Update Posted : April 28, 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: ABC/DTG/3TC
Drug: B/F/TAF
Drug: ABC/DTG/3TC Placebo
Drug: B/F/TAF Placebo
Enrollment 631
Recruitment Details Participants were enrolled at study centers in Europe, Canada, Dominican Republic, and United States. The first participant was screened on 13 November 2015. The last Week 144 study visit occurred on 14 May 2019.
Pre-assignment Details 739 participants were screened.
Arm/Group Title B/F/TAF ABC/DTG/3TC
Hide Arm/Group Description

Blinded Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) (ABC/DTG/3TC) 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: Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for 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 316 315
Completed 0 0
Not Completed 316 315
Reason Not Completed
Randomized and Never Treated             2             0
Still in Study             263             269
Adverse Event             0             4
Death             2             1
Investigator's Discretion             6             2
Non-Compliance with Study Drug             3             5
Protocol Violation             2             3
Withdrew Consent             14             15
Lost to Follow-up             24             16
Arm/Group Title B/F/TAF ABC/DTG/3TC Total
Hide Arm/Group Description

Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC 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: ABC/DTG/3TC (600/50/300 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 314 315 629
Hide Baseline Analysis Population Description
Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 314 participants 315 participants 629 participants
34  (10.9) 34  (10.8) 34  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 315 participants 629 participants
Female 29 33 62
Male 285 282 567
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 315 participants 629 participants
American Indian or Alaska Native 2 4 6
Asian 6 10 16
Black 114 112 226
Native Hawaiian or Pacific Islander 1 2 3
White 180 179 359
Other 9 8 17
Not Permitted 2 0 2
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 315 participants 629 participants
Hispanic or Latino 72 65 137
Not Hispanic or Latino 240 249 489
Not Permitted 2 1 3
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Canada Number Analyzed 314 participants 315 participants 629 participants
18 15 33
Belgium Number Analyzed 314 participants 315 participants 629 participants
4 2 6
United States Number Analyzed 314 participants 315 participants 629 participants
228 233 461
Dominican Republic Number Analyzed 314 participants 315 participants 629 participants
2 1 3
Italy Number Analyzed 314 participants 315 participants 629 participants
7 11 18
United Kingdom Number Analyzed 314 participants 315 participants 629 participants
20 11 31
France Number Analyzed 314 participants 315 participants 629 participants
11 10 21
Germany Number Analyzed 314 participants 315 participants 629 participants
4 9 13
Spain Number Analyzed 314 participants 315 participants 629 participants
20 23 43
HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 314 participants 315 participants 629 participants
4.41  (0.647) 4.42  (0.685) 4.42  (0.665)
HIV-1 RNA Categories  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 315 participants 629 participants
≤ 100,000 copies/mL 261 265 526
> 100,000 ≤ 400,000 copies/mL 45 38 83
> 400,000 copies/mL 8 12 20
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  Cells/µL
Number Analyzed 314 participants 315 participants 629 participants
453  (220.8) 476  (231.4) 464  (226.3)
CD4 Cell Count Categories  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 315 participants 629 participants
< 50 Cells/µL 7 10 17
≥ 50 to < 200 Cells/µL 29 22 51
≥ 200 to < 350 Cells/µL 69 58 127
≥ 350 to < 500 Cells/µL 87 91 178
≥ 500 Cells/µL 122 134 256
Hip Bone Mineral Density (BMD)   [1] 
Mean (Standard Deviation)
Unit of measure:  G/cm^2
Number Analyzed 300 participants 297 participants 597 participants
1.048  (0.1572) 1.057  (0.1520) 1.052  (0.1546)
[1]
Measure Analysis Population Description: The Hip Dual-energy X-ray Absorptiometry (DXA) Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had non-missing values for baseline hip BMD.
Spine BMD   [1] 
Mean (Standard Deviation)
Unit of measure:  G/cm^2
Number Analyzed 304 participants 299 participants 603 participants
1.139  (0.1847) 1.142  (0.1713) 1.140  (0.1780)
[1]
Measure Analysis Population Description: The Spine DXA Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing values for baseline spine BMD.
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 ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 314 315
Measure Type: Number
Unit of Measure: percentage of participants
92.4 93.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
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 -0.6
Confidence Interval (2-Sided) 95.002%
-4.8 to 3.6
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, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
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 ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 314 315
Measure Type: Number
Unit of Measure: percentage of participants
87.9 89.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
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%
-6.9 to 3.1
Estimation Comments Differences in percentages of participants between groups and their 95% 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, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
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 ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 314 315
Measure Type: Number
Unit of Measure: percentage of participants
81.5 84.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -2.6
Confidence Interval (2-Sided) 95%
-8.5 to 3.4
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, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
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 ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 314 315
Measure Type: Number
Unit of Measure: percentage of participants
87.6 87.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-4.8 to 5.6
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, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
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 ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 314 315
Measure Type: Number
Unit of Measure: percentage of participants
83.4 84.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-6.9 to 4.6
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, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
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 ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 314 315
Measure Type: Number
Unit of Measure: percentage of participants
78.0 82.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-10.5 to 2.1
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, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
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 ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 295 302
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-3.11  (0.641) -3.07  (0.738)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
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 -0.03
Confidence Interval (2-Sided) 95%
-0.12 to 0.06
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 ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 279 288
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-3.09  (0.643) -3.10  (0.705)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.09 to 0.09
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 ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 260 269
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-3.11  (0.639) -3.10  (0.681)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.08 to 0.10
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 ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 294 300
Mean (Standard Deviation)
Unit of Measure: cells/µL
235  (185.8) 228  (188.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
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 6
Confidence Interval (2-Sided) 95%
-24 to 36
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 ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 276 286
Mean (Standard Deviation)
Unit of Measure: cells/µL
287  (206.9) 288  (246.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
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 -1
Confidence Interval (2-Sided) 95%
-39 to 36
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 ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 255 260
Mean (Standard Deviation)
Unit of Measure: cells/µL
299  (224.9) 317  (219.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
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 -20
Confidence Interval (2-Sided) 95%
-59 to 18
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 Change From Baseline in Hip 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 DXA Analysis Set with available data were analyzed.
Arm/Group Title B/F/TAF ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 278 281
Mean (Standard Deviation)
Unit of Measure: percentage change
-0.802  (2.3280) -1.148  (2.5126)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.346
Confidence Interval (2-Sided) 95%
-0.057 to 0.748
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage 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 B/F/TAF ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 250 257
Mean (Standard Deviation)
Unit of Measure: percentage change
-1.128  (2.7702) -1.262  (2.8524)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.135
Confidence Interval (2-Sided) 95%
-0.356 to 0.625
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage Change From Baseline in Hip BMD at Week 144
Hide Description [Not Specified]
Time Frame Baseline; Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Hip DXA Analysis Set with available data were analyzed.
Arm/Group Title B/F/TAF ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 236 240
Mean (Standard Deviation)
Unit of Measure: percentage change
-1.020  (3.7638) -1.291  (3.1140)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.271
Confidence Interval (2-Sided) 95%
-0.351 to 0.893
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage 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 with available data were analyzed.
Arm/Group Title B/F/TAF ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 284 285
Mean (Standard Deviation)
Unit of Measure: percentage change
-0.772  (3.2228) -0.552  (3.0956)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.221
Confidence Interval (2-Sided) 95%
-0.741 to 0.300
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Percentage 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 B/F/TAF ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 256 258
Mean (Standard Deviation)
Unit of Measure: percentage change
-0.705  (3.8721) -0.219  (3.5159)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.485
Confidence Interval (2-Sided) 95%
-1.126 to 0.155
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage Change From Baseline in Spine BMD at Week 144
Hide Description [Not Specified]
Time Frame Baseline; Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Spine DXA Analysis Set with available data were analyzed.
Arm/Group Title B/F/TAF ABC/DTG/3TC
Hide Arm/Group Description:
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Overall Number of Participants Analyzed 243 244
Mean (Standard Deviation)
Unit of Measure: percentage change
-0.371  (4.4369) 0.035  (3.5182)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.406
Confidence Interval (2-Sided) 95%
-1.119 to 0.307
Estimation Comments [Not Specified]
19.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
20.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
21.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
22.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 ABC/DTG/3TC
Hide Arm/Group Description

Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC 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: ABC/DTG/3TC (600/50/300 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 ABC/DTG/3TC
Affected / at Risk (%) Affected / at Risk (%)
Total   2/314 (0.64%)   1/315 (0.32%) 
Hide Serious Adverse Events
B/F/TAF ABC/DTG/3TC
Affected / at Risk (%) Affected / at Risk (%)
Total   41/314 (13.06%)   53/315 (16.83%) 
Blood and lymphatic system disorders     
Anaemia  1  2/314 (0.64%)  0/315 (0.00%) 
Anaemia of chronic disease  1  1/314 (0.32%)  0/315 (0.00%) 
Febrile neutropenia  1  0/314 (0.00%)  1/315 (0.32%) 
Cardiac disorders     
Atrial fibrillation  1  1/314 (0.32%)  0/315 (0.00%) 
Cardiac failure acute  1  0/314 (0.00%)  1/315 (0.32%) 
Myocardial infarction  1  0/314 (0.00%)  1/315 (0.32%) 
Ventricular tachycardia  1  0/314 (0.00%)  1/315 (0.32%) 
Ear and labyrinth disorders     
Middle ear adhesions  1  0/314 (0.00%)  1/315 (0.32%) 
Vertigo  1  1/314 (0.32%)  0/315 (0.00%) 
Endocrine disorders     
Goitre  1  1/314 (0.32%)  0/315 (0.00%) 
Eye disorders     
Keratitis  1  0/314 (0.00%)  1/315 (0.32%) 
Gastrointestinal disorders     
Abdominal hernia  1  1/314 (0.32%)  0/315 (0.00%) 
Abdominal incarcerated hernia  1  0/314 (0.00%)  1/315 (0.32%) 
Abdominal pain  1  0/314 (0.00%)  1/315 (0.32%) 
Constipation  1  0/314 (0.00%)  1/315 (0.32%) 
Diarrhoea  1  0/314 (0.00%)  1/315 (0.32%) 
Gastrointestinal haemorrhage  1  0/314 (0.00%)  1/315 (0.32%) 
Haematemesis  1  2/314 (0.64%)  0/315 (0.00%) 
Haematochezia  1  0/314 (0.00%)  1/315 (0.32%) 
Haemorrhoids thrombosed  1  0/314 (0.00%)  1/315 (0.32%) 
Lower gastrointestinal haemorrhage  1  0/314 (0.00%)  1/315 (0.32%) 
Nausea  1  0/314 (0.00%)  1/315 (0.32%) 
Oesophageal food impaction  1  1/314 (0.32%)  0/315 (0.00%) 
Pancreatitis acute  1  1/314 (0.32%)  2/315 (0.63%) 
Small intestinal obstruction  1  0/314 (0.00%)  1/315 (0.32%) 
Steatorrhoea  1  0/314 (0.00%)  1/315 (0.32%) 
Vomiting  1  0/314 (0.00%)  1/315 (0.32%) 
General disorders     
Chest discomfort  1  0/314 (0.00%)  1/315 (0.32%) 
Chest pain  1  1/314 (0.32%)  1/315 (0.32%) 
Pyrexia  1  1/314 (0.32%)  1/315 (0.32%) 
Hepatobiliary disorders     
Hepatitis acute  1  1/314 (0.32%)  0/315 (0.00%) 
Hepatocellular injury  1  1/314 (0.32%)  0/315 (0.00%) 
Infections and infestations     
Abdominal wall abscess  1  1/314 (0.32%)  0/315 (0.00%) 
Abscess limb  1  2/314 (0.64%)  2/315 (0.63%) 
Anal abscess  1  0/314 (0.00%)  1/315 (0.32%) 
Appendicitis  1  3/314 (0.96%)  2/315 (0.63%) 
Appendicitis perforated  1  1/314 (0.32%)  0/315 (0.00%) 
Bacteraemia  1  0/314 (0.00%)  1/315 (0.32%) 
Breast abscess  1  0/314 (0.00%)  1/315 (0.32%) 
Bronchitis  1  0/314 (0.00%)  1/315 (0.32%) 
Cellulitis  1  1/314 (0.32%)  0/315 (0.00%) 
Diverticulitis  1  0/314 (0.00%)  1/315 (0.32%) 
Fungaemia  1  0/314 (0.00%)  1/315 (0.32%) 
Gastroenteritis  1  0/314 (0.00%)  2/315 (0.63%) 
Gastroenteritis viral  1  0/314 (0.00%)  1/315 (0.32%) 
Gonococcal infection  1  0/314 (0.00%)  1/315 (0.32%) 
Gonorrhoea  1  1/314 (0.32%)  0/315 (0.00%) 
Groin abscess  1  0/314 (0.00%)  1/315 (0.32%) 
Hepatitis A  1  0/314 (0.00%)  2/315 (0.63%) 
Influenza  1  0/314 (0.00%)  1/315 (0.32%) 
Injection site cellulitis  1  0/314 (0.00%)  1/315 (0.32%) 
Localised infection  1  0/314 (0.00%)  1/315 (0.32%) 
Mastoiditis  1  1/314 (0.32%)  0/315 (0.00%) 
Meningitis cryptococcal  1  1/314 (0.32%)  0/315 (0.00%) 
Mycobacterium avium complex infection  1  1/314 (0.32%)  0/315 (0.00%) 
Neurosyphilis  1  1/314 (0.32%)  2/315 (0.63%) 
Orchitis  1  1/314 (0.32%)  0/315 (0.00%) 
Osteomyelitis  1  0/314 (0.00%)  1/315 (0.32%) 
Perirectal abscess  1  0/314 (0.00%)  1/315 (0.32%) 
Pharyngeal abscess  1  1/314 (0.32%)  0/315 (0.00%) 
Pneumonia  1  1/314 (0.32%)  1/315 (0.32%) 
Pneumonia bacterial  1  0/314 (0.00%)  1/315 (0.32%) 
Sepsis  1  0/314 (0.00%)  2/315 (0.63%) 
Soft tissue infection  1  1/314 (0.32%)  0/315 (0.00%) 
Tracheobronchitis  1  0/314 (0.00%)  1/315 (0.32%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  1/314 (0.32%)  0/315 (0.00%) 
Acetabulum fracture  1  0/314 (0.00%)  1/315 (0.32%) 
Alcohol poisoning  1  1/314 (0.32%)  0/315 (0.00%) 
Femur fracture  1  0/314 (0.00%)  1/315 (0.32%) 
Joint dislocation  1  0/314 (0.00%)  1/315 (0.32%) 
Limb injury  1  1/314 (0.32%)  1/315 (0.32%) 
Lower limb fracture  1  0/314 (0.00%)  1/315 (0.32%) 
Overdose  1  2/314 (0.64%)  0/315 (0.00%) 
Postoperative ileus  1  0/314 (0.00%)  1/315 (0.32%) 
Road traffic accident  1  0/314 (0.00%)  3/315 (0.95%) 
Spinal fracture  1  0/314 (0.00%)  1/315 (0.32%) 
Toxicity to various agents  1  0/314 (0.00%)  2/315 (0.63%) 
Investigations     
Anticoagulation drug level above therapeutic  1  0/314 (0.00%)  1/315 (0.32%) 
Psychiatric evaluation  1  0/314 (0.00%)  1/315 (0.32%) 
White blood cell count increased  1  0/314 (0.00%)  1/315 (0.32%) 
Metabolism and nutrition disorders     
Dehydration  1  0/314 (0.00%)  1/315 (0.32%) 
Diabetes mellitus inadequate control  1  0/314 (0.00%)  1/315 (0.32%) 
Diabetic ketoacidosis  1  1/314 (0.32%)  0/315 (0.00%) 
Hyperkalaemia  1  0/314 (0.00%)  1/315 (0.32%) 
Musculoskeletal and connective tissue disorders     
Gouty arthritis  1  0/314 (0.00%)  1/315 (0.32%) 
Intervertebral disc protrusion  1  0/314 (0.00%)  1/315 (0.32%) 
Neck pain  1  0/314 (0.00%)  1/315 (0.32%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
High-grade B-cell lymphoma  1  0/314 (0.00%)  2/315 (0.63%) 
Hodgkin's disease  1  1/314 (0.32%)  0/315 (0.00%) 
Lipoma  1  1/314 (0.32%)  0/315 (0.00%) 
Nervous system disorders     
Generalised tonic-clonic seizure  1  1/314 (0.32%)  0/315 (0.00%) 
Headache  1  0/314 (0.00%)  1/315 (0.32%) 
Seizure  1  0/314 (0.00%)  1/315 (0.32%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  1/314 (0.32%)  0/315 (0.00%) 
Psychiatric disorders     
Anxiety  1  1/314 (0.32%)  0/315 (0.00%) 
Bipolar I disorder  1  1/314 (0.32%)  0/315 (0.00%) 
Borderline personality disorder  1  1/314 (0.32%)  1/315 (0.32%) 
Delirium tremens  1  1/314 (0.32%)  0/315 (0.00%) 
Depression  1  0/314 (0.00%)  2/315 (0.63%) 
Intentional self-injury  1  1/314 (0.32%)  0/315 (0.00%) 
Major depression  1  3/314 (0.96%)  0/315 (0.00%) 
Mental disorder  1  1/314 (0.32%)  0/315 (0.00%) 
Psychotic disorder  1  1/314 (0.32%)  1/315 (0.32%) 
Schizophrenia  1  0/314 (0.00%)  1/315 (0.32%) 
Suicidal ideation  1  3/314 (0.96%)  3/315 (0.95%) 
Suicide attempt  1  2/314 (0.64%)  1/315 (0.32%) 
Renal and urinary disorders     
Acute kidney injury  1  0/314 (0.00%)  1/315 (0.32%) 
Chronic kidney disease  1  0/314 (0.00%)  1/315 (0.32%) 
End stage renal disease  1  0/314 (0.00%)  1/315 (0.32%) 
Renal failure  1  0/314 (0.00%)  1/315 (0.32%) 
Reproductive system and breast disorders     
Testicular mass  1  1/314 (0.32%)  0/315 (0.00%) 
Testicular pain  1  1/314 (0.32%)  0/315 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/314 (0.00%)  1/315 (0.32%) 
Nasal turbinate hypertrophy  1  1/314 (0.32%)  0/315 (0.00%) 
Pulmonary embolism  1  1/314 (0.32%)  1/315 (0.32%) 
Pulmonary oedema  1  0/314 (0.00%)  1/315 (0.32%) 
Respiratory failure  1  0/314 (0.00%)  1/315 (0.32%) 
Vascular disorders     
Deep vein thrombosis  1  1/314 (0.32%)  0/315 (0.00%) 
Hypotension  1  0/314 (0.00%)  1/315 (0.32%) 
Peripheral ischaemia  1  0/314 (0.00%)  1/315 (0.32%) 
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 ABC/DTG/3TC
Affected / at Risk (%) Affected / at Risk (%)
Total   258/314 (82.17%)   275/315 (87.30%) 
Gastrointestinal disorders     
Abdominal pain  1  18/314 (5.73%)  21/315 (6.67%) 
Constipation  1  14/314 (4.46%)  17/315 (5.40%) 
Diarrhoea  1  54/314 (17.20%)  57/315 (18.10%) 
Nausea  1  38/314 (12.10%)  76/315 (24.13%) 
Vomiting  1  16/314 (5.10%)  24/315 (7.62%) 
General disorders     
Fatigue  1  33/314 (10.51%)  38/315 (12.06%) 
Pyrexia  1  15/314 (4.78%)  18/315 (5.71%) 
Immune system disorders     
Seasonal allergy  1  8/314 (2.55%)  16/315 (5.08%) 
Infections and infestations     
Bronchitis  1  20/314 (6.37%)  30/315 (9.52%) 
Chlamydial infection  1  21/314 (6.69%)  13/315 (4.13%) 
Gastroenteritis  1  16/314 (5.10%)  22/315 (6.98%) 
Gonorrhoea  1  22/314 (7.01%)  21/315 (6.67%) 
Influenza  1  19/314 (6.05%)  15/315 (4.76%) 
Nasopharyngitis  1  40/314 (12.74%)  52/315 (16.51%) 
Pharyngitis  1  16/314 (5.10%)  22/315 (6.98%) 
Proctitis chlamydial  1  11/314 (3.50%)  26/315 (8.25%) 
Proctitis gonococcal  1  13/314 (4.14%)  18/315 (5.71%) 
Sinusitis  1  13/314 (4.14%)  23/315 (7.30%) 
Syphilis  1  39/314 (12.42%)  49/315 (15.56%) 
Upper respiratory tract infection  1  43/314 (13.69%)  59/315 (18.73%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  23/314 (7.32%)  29/315 (9.21%) 
Back pain  1  34/314 (10.83%)  38/315 (12.06%) 
Musculoskeletal pain  1  13/314 (4.14%)  16/315 (5.08%) 
Pain in extremity  1  16/314 (5.10%)  12/315 (3.81%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anogenital warts  1  10/314 (3.18%)  19/315 (6.03%) 
Nervous system disorders     
Dizziness  1  9/314 (2.87%)  19/315 (6.03%) 
Headache  1  44/314 (14.01%)  56/315 (17.78%) 
Psychiatric disorders     
Anxiety  1  28/314 (8.92%)  20/315 (6.35%) 
Depression  1  18/314 (5.73%)  26/315 (8.25%) 
Insomnia  1  25/314 (7.96%)  35/315 (11.11%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  34/314 (10.83%)  20/315 (6.35%) 
Oropharyngeal pain  1  21/314 (6.69%)  35/315 (11.11%) 
Skin and subcutaneous tissue disorders     
Rash  1  26/314 (8.28%)  24/315 (7.62%) 
Vascular disorders     
Hypertension  1  23/314 (7.32%)  15/315 (4.76%) 
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-naïve 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.
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: NCT02607930    
Other Study ID Numbers: GS-US-380-1489
2015-004024-54 ( EudraCT Number )
First Submitted: November 10, 2015
First Posted: November 18, 2015
Results First Submitted: May 2, 2018
Results First Posted: July 23, 2018
Last Update Posted: April 28, 2020