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Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed

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: NCT02603120
Recruitment Status : Completed
First Posted : November 11, 2015
Results First Posted : July 23, 2018
Last Update Posted : November 12, 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 567
Recruitment Details Participants were enrolled at study sites in North America, Europe, and Australia. The first participant was screened on 11 November 2015. The last study visit occurred on 23 October 2019.
Pre-assignment Details 646 participants were screened.
Arm/Group Title B/F/TAF ABC/DTG/3TC
Hide Arm/Group Description

Double-Blind Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) tablet + abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) placebo orally once daily for at least 48 weeks, without regard to food.

Open-label (OL) Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.

OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Period Title: Double-Blind Treatment Phase
Started 284 283
Completed 265 267
Not Completed 19 16
Reason Not Completed
Withdrew consent             4             8
Adverse Event             3             3
Lost to Follow-up             4             2
Death             2             0
Investigator's discretion             2             0
Pregnancy             1             1
Non-compliance with study drug             1             0
Did not receive study drug             2             2
Period Title: OL Extension B/F/TAF Treatment Phase
Started 259 265
Completed 254 254
Not Completed 5 11
Reason Not Completed
Lost to Follow-up             3             4
Investigator's discretion             1             2
Withdrew consent             1             2
Adverse Event             0             1
Death             0             1
Lack of Efficacy             0             1
Arm/Group Title B/F/TAF ABC/DTG/3TC Total
Hide Arm/Group Description

Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.

OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.

OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Total of all reporting groups
Overall Number of Baseline Participants 282 281 563
Hide Baseline Analysis Population Description
The Safety Analysis Set included 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 282 participants 281 participants 563 participants
46  (11.1) 45  (11.5) 45  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 282 participants 281 participants 563 participants
Female
35
  12.4%
29
  10.3%
64
  11.4%
Male
247
  87.6%
252
  89.7%
499
  88.6%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 282 participants 281 participants 563 participants
American Indian or Alaska Native
2
   0.7%
2
   0.7%
4
   0.7%
Asian
9
   3.2%
9
   3.2%
18
   3.2%
Black
59
  20.9%
62
  22.1%
121
  21.5%
Native Hawaiian or Pacific Islander
3
   1.1%
0
   0.0%
3
   0.5%
White
206
  73.0%
202
  71.9%
408
  72.5%
Other
3
   1.1%
3
   1.1%
6
   1.1%
Not Permitted
0
   0.0%
3
   1.1%
3
   0.5%
[1]
Measure Description: Not Permitted = local regulators did not allow collection of race or ethnicity information.
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 282 participants 281 participants 563 participants
Hispanic or Latino
46
  16.3%
52
  18.5%
98
  17.4%
Not Hispanic or Latino
236
  83.7%
227
  80.8%
463
  82.2%
Not Permitted
0
   0.0%
2
   0.7%
2
   0.4%
[1]
Measure Description: Not Permitted = local regulators did not allow collection of race or ethnicity information
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 282 participants 281 participants 563 participants
Canada
13
   4.6%
22
   7.8%
35
   6.2%
Belgium
1
   0.4%
1
   0.4%
2
   0.4%
United States
203
  72.0%
198
  70.5%
401
  71.2%
Italy
1
   0.4%
1
   0.4%
2
   0.4%
United Kingdom
3
   1.1%
3
   1.1%
6
   1.1%
France
4
   1.4%
8
   2.8%
12
   2.1%
Germany
17
   6.0%
11
   3.9%
28
   5.0%
Spain
31
  11.0%
31
  11.0%
62
  11.0%
Australia
9
   3.2%
6
   2.1%
15
   2.7%
HIV-1 RNA Categories  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 282 participants 281 participants 563 participants
< 50 copies/mL
278
  98.6%
272
  96.8%
550
  97.7%
≥ 50 copies/mL
4
   1.4%
9
   3.2%
13
   2.3%
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  cell/µL
Number Analyzed 282 participants 281 participants 563 participants
752  (302.2) 694  (291.6) 723  (298.1)
CD4 Cell Count Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 282 participants 281 participants 563 participants
≥ 50 to < 200 cells/μL
6
   2.1%
4
   1.4%
10
   1.8%
≥ 200 to < 350 cells/μL
16
   5.7%
30
  10.7%
46
   8.2%
≥ 350 to < 500 cells/μL
33
  11.7%
42
  14.9%
75
  13.3%
≥ 500 cells/μL
227
  80.5%
205
  73.0%
432
  76.7%
1.Primary Outcome
Title Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified 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
The Full Analysis Set included 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:

Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.

OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.

OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Overall Number of Participants Analyzed 282 281
Measure Type: Number
Unit of Measure: percentage of participants
1.1 0.4
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 size of 260 participants per treatment group would provide at least 90% power to detect a noninferiority margin of 4% in difference in percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48, between B/F/TAF group and ABC/DTG/3TC group. Sample size was based on assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48 and that the non-inferiority margin is 4%, and that the significance level of the test is at a one-sided 0.025 level.
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 0.7
Confidence Interval (2-Sided) 95.002%
-1.0 to 2.8
Estimation Comments The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.
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 0.62
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL 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
Participants in the Full Analysis were analyzed.
Arm/Group Title B/F/TAF ABC/DTG/3TC
Hide Arm/Group Description:

Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.

OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.

OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Overall Number of Participants Analyzed 282 281
Measure Type: Number
Unit of Measure: percentage of participants
93.6 95.0
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 It would be concluded that B/F/TAF is noninferior to ABC/DTG/3TC if the lower bound of the 2-sided 95.002% CI of the difference between treatment groups (B/F/TAF group -ABC/DTG/3TC group) in the percentage of participants with HIV-1 RNA < 50 copies/mL is greater than -10%.
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -1.4
Confidence Interval (2-Sided) 95.002%
-5.5 to 2.6
Estimation Comments The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.
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 .59
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.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:

Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.

OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.

OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Overall Number of Participants Analyzed 265 267
Mean (Standard Deviation)
Unit of Measure: cells/µL
-31  (181.3) 4  (191.0)
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 0.031
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -35
Confidence Interval (2-Sided) 95%
-67 to -3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Spine Bone Mineral Density (BMD) at Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The Spine dual X-ray absorptiometry (DXA) analysis Set included participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline spine BMD values.
Arm/Group Title B/F/TAF ABC/DTG/3TC
Hide Arm/Group Description:

Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.

OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.

OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Overall Number of Participants Analyzed 256 262
Mean (Standard Deviation)
Unit of Measure: g/cm^2
1.124  (0.1833) 1.103  (0.1548)
5.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:

Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.

OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.

OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Overall Number of Participants Analyzed 233 244
Mean (Standard Deviation)
Unit of Measure: percentage change
0.692  (3.1296) 0.416  (2.9973)
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 0.33
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value 0.276
Confidence Interval (2-Sided) 95%
-0.275 to 0.827
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Hip Bone Mineral Density at Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The Hip DXA Analysis Set included participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline hip BMD values.
Arm/Group Title B/F/TAF ABC/DTG/3TC
Hide Arm/Group Description:

Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.

OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.

OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Overall Number of Participants Analyzed 256 265
Mean (Standard Deviation)
Unit of Measure: g/cm^2
1.006  (0.1471) 0.996  (0.1363)
7.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:

Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.

OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.

OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Overall Number of Participants Analyzed 229 242
Mean (Standard Deviation)
Unit of Measure: percentage change
0.156  (2.2138) 0.299  (2.1077)
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 0.47
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -0.143
Confidence Interval (2-Sided) 95%
-0.534 to 0.248
Estimation Comments [Not Specified]
Time Frame First dose date up to 169 weeks plus 30 days
Adverse Event Reporting Description The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
 
Arm/Group Title Double-Blind: B/F/TAF Double-Blind: ABC/DTG/3TC Open-label Extension: B/F/TAF From B/F/TAF Open-label Extension: B/F/TAF From ABC/DTG/3TC
Hide Arm/Group Description B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. Participants who received B/F/TAF in double-blind phase and from country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase. Participants who received ABC/DTG/3TC in double-blind phase and from country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
All-Cause Mortality
Double-Blind: B/F/TAF Double-Blind: ABC/DTG/3TC Open-label Extension: B/F/TAF From B/F/TAF Open-label Extension: B/F/TAF From ABC/DTG/3TC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/282 (0.71%)   0/281 (0.00%)   1/259 (0.39%)   1/265 (0.38%) 
Hide Serious Adverse Events
Double-Blind: B/F/TAF Double-Blind: ABC/DTG/3TC Open-label Extension: B/F/TAF From B/F/TAF Open-label Extension: B/F/TAF From ABC/DTG/3TC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/282 (6.03%)   26/281 (9.25%)   24/259 (9.27%)   11/265 (4.15%) 
Cardiac disorders         
Acute coronary syndrome  1  1/282 (0.35%)  1/281 (0.36%)  0/259 (0.00%)  1/265 (0.38%) 
Acute myocardial infarction  1  1/282 (0.35%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Atrial fibrillation  1  0/282 (0.00%)  2/281 (0.71%)  0/259 (0.00%)  0/265 (0.00%) 
Hypertensive heart disease  1  0/282 (0.00%)  0/281 (0.00%)  0/259 (0.00%)  1/265 (0.38%) 
Congenital, familial and genetic disorders         
Myocardial bridging  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Eye disorders         
Macular detachment  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Retinal detachment  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Vitreous haemorrhage  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Colitis ulcerative  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Diarrhoea  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Duodenal ulcer  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Gastric ulcer  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Haemorrhoidal haemorrhage  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Hiatus hernia  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Inguinal hernia  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Intestinal obstruction  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Umbilical hernia  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
General disorders         
Drug withdrawal syndrome  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Sudden cardiac death  1  1/282 (0.35%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Hepatobiliary disorders         
Bile duct stone  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Cholecystitis  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Cholecystitis acute  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Infections and infestations         
Abscess limb  1  0/282 (0.00%)  2/281 (0.71%)  0/259 (0.00%)  1/265 (0.38%) 
Acute hepatitis C  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Anal abscess  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Appendicitis  1  0/282 (0.00%)  1/281 (0.36%)  1/259 (0.39%)  0/265 (0.00%) 
Cellulitis  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Cellulitis of male external genital organ  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Endocarditis  1  1/282 (0.35%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Escherichia infection  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Eye infection syphilitic  1  1/282 (0.35%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Gastroenteritis viral  1  0/282 (0.00%)  0/281 (0.00%)  0/259 (0.00%)  1/265 (0.38%) 
Herpes zoster  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Influenza  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Large intestine infection  1  1/282 (0.35%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Lymphadenitis bacterial  1  1/282 (0.35%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Osteomyelitis  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Pneumonia  1  0/282 (0.00%)  0/281 (0.00%)  0/259 (0.00%)  1/265 (0.38%) 
Post procedural sepsis  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Respiratory syncytial virus infection  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Shigella infection  1  0/282 (0.00%)  1/281 (0.36%)  1/259 (0.39%)  0/265 (0.00%) 
Tooth abscess  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Wound infection  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Injury, poisoning and procedural complications         
Alcohol poisoning  1  1/282 (0.35%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Ankle fracture  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  1/265 (0.38%) 
Femur fracture  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Head injury  1  0/282 (0.00%)  0/281 (0.00%)  0/259 (0.00%)  1/265 (0.38%) 
Intentional overdose  1  2/282 (0.71%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Overdose  1  2/282 (0.71%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Skin laceration  1  1/282 (0.35%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Toxicity to various agents  1  1/282 (0.35%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Upper limb fracture  1  1/282 (0.35%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Wrist fracture  1  1/282 (0.35%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Metabolism and nutrition disorders         
Hyponatraemia  1  1/282 (0.35%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Hypovolaemia  1  1/282 (0.35%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Musculoskeletal and connective tissue disorders         
Myalgia  1  1/282 (0.35%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Osteoarthritis  1  0/282 (0.00%)  0/281 (0.00%)  0/259 (0.00%)  1/265 (0.38%) 
Spinal stenosis  1  1/282 (0.35%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Brain cancer metastatic  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Lung adenocarcinoma  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Malignant neoplasm of thymus  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Meningioma  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Testicular seminoma (pure) stage I  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Nervous system disorders         
Cerebrovascular accident  1  1/282 (0.35%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Epilepsy  1  0/282 (0.00%)  0/281 (0.00%)  0/259 (0.00%)  1/265 (0.38%) 
Hemiplegic migraine  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Vertebrobasilar insufficiency  1  1/282 (0.35%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Psychiatric disorders         
Abnormal behaviour  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Alcohol abuse  1  1/282 (0.35%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Anxiety  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Bipolar disorder  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Depression suicidal  1  1/282 (0.35%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Paranoia  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Schizophrenia  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Self-injurious ideation  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Substance abuse  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Suicidal ideation  1  2/282 (0.71%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Suicide attempt  1  2/282 (0.71%)  0/281 (0.00%)  0/259 (0.00%)  0/265 (0.00%) 
Renal and urinary disorders         
Acute kidney injury  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Haematuria  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Nephrolithiasis  1  0/282 (0.00%)  1/281 (0.36%)  0/259 (0.00%)  0/265 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  0/282 (0.00%)  0/281 (0.00%)  0/259 (0.00%)  1/265 (0.38%) 
Dyspnoea  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Pneumothorax  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  0/265 (0.00%) 
Pulmonary embolism  1  0/282 (0.00%)  0/281 (0.00%)  1/259 (0.39%)  1/265 (0.38%) 
Vascular disorders         
Deep vein thrombosis  1  0/282 (0.00%)  0/281 (0.00%)  0/259 (0.00%)  1/265 (0.38%) 
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Double-Blind: B/F/TAF Double-Blind: ABC/DTG/3TC Open-label Extension: B/F/TAF From B/F/TAF Open-label Extension: B/F/TAF From ABC/DTG/3TC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   122/282 (43.26%)   132/281 (46.98%)   84/259 (32.43%)   82/265 (30.94%) 
Gastrointestinal disorders         
Diarrhoea  1  26/282 (9.22%)  18/281 (6.41%)  20/259 (7.72%)  11/265 (4.15%) 
Nausea  1  6/282 (2.13%)  16/281 (5.69%)  3/259 (1.16%)  1/265 (0.38%) 
Infections and infestations         
Bronchitis  1  11/282 (3.90%)  15/281 (5.34%)  11/259 (4.25%)  8/265 (3.02%) 
Nasopharyngitis  1  21/282 (7.45%)  22/281 (7.83%)  20/259 (7.72%)  22/265 (8.30%) 
Sinusitis  1  11/282 (3.90%)  15/281 (5.34%)  9/259 (3.47%)  13/265 (4.91%) 
Upper respiratory tract infection  1  34/282 (12.06%)  32/281 (11.39%)  22/259 (8.49%)  26/265 (9.81%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  21/282 (7.45%)  18/281 (6.41%)  8/259 (3.09%)  6/265 (2.26%) 
Back pain  1  13/282 (4.61%)  13/281 (4.63%)  13/259 (5.02%)  6/265 (2.26%) 
Nervous system disorders         
Headache  1  19/282 (6.74%)  23/281 (8.19%)  5/259 (1.93%)  9/265 (3.40%) 
Psychiatric disorders         
Insomnia  1  9/282 (3.19%)  22/281 (7.83%)  1/259 (0.39%)  7/265 (2.64%) 
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02603120    
Other Study ID Numbers: GS-US-380-1844
2015-004025-14 ( EudraCT Number )
First Submitted: November 10, 2015
First Posted: November 11, 2015
Results First Submitted: May 1, 2018
Results First Posted: July 23, 2018
Last Update Posted: November 12, 2020