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Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected 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: NCT02603107
Recruitment Status : Completed
First Posted : November 11, 2015
Results First Posted : June 6, 2018
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1 Infection
Interventions Drug: RTV
Drug: ATV
Drug: DRV
Drug: COBI
Drug: ATV/co
Drug: DRV/co
Drug: FTC/TDF
Drug: ABC/3TC
Drug: B/F/TAF
Enrollment 578
Recruitment Details Participants were enrolled at study sites in Dominican Republic, North America, Australia, and Europe. The first participant was screened on 20 November 2015. The last study visit occurred on 23 December 2019.
Pre-assignment Details 707 participants were screened.
Arm/Group Title B/F/TAF Stay on Baseline Regimen (SBR)
Hide Arm/Group Description

Randomized Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed-dose combination (FDC) tablet orally once daily for at least 48 weeks, without regard to food.

Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first.

Randomized Phase: Participants remained on current antiretroviral (ARV) regimen consisting of ritonavir (RTV)-boosted or cobicistat (COBI)-boosted atazanavir (ATV) or darunavir (DRV), plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) FDC tablet or abacavir/lamivudine (ABC/3TC) (600/300 mg) FDC tablet administered orally once daily for at least 48 weeks with food.

Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first.
Period Title: Randomized Phase
Started 290 287
Completed 275 266
Not Completed 15 21
Reason Not Completed
Withdrew consent             8             15
Lost to Follow-up             1             3
Adverse Event             2             0
Death             1             1
Non-compliance with study drug             1             1
Investigator's discretion             0             1
Lack of Efficacy             1             0
Protocol Violation             1             0
Period Title: Optional Extension Phase
Started 272 [1] 245 [2]
Completed 263 232
Not Completed 9 13
Reason Not Completed
Lost to Follow-up             3             3
Withdrew consent             3             2
Investigator's discretion             2             2
Pregnancy             0             3
Adverse Event             0             2
Not treated in extension phase             0             1
Protocol Violation             1             0
[1]
3 participants who completed the Randomized Phase did not continue in the Optional Extension Phase.
[2]
21 participants who completed the Randomized Phase did not continue in the Optional Extension Phase.
Arm/Group Title B/F/TAF Stay on Baseline Regimen (SBR) Total
Hide Arm/Group Description

Randomized Phase: B/F/TAF (50/200/25 mg) FDC tablet administered orally once daily for at least 48 weeks without regard to food.

Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first.

Randomized Phase: Participants remained on current ARV regimen consisting of RTV or COBI boosted ATV or DRV, plus either FTC/TDF (200/300 mg) FDC tablets or ABC/3TC (600/300 mg) FDC tablet administered orally once daily for at least 48 weeks with food.

Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first.

 Total of all reporting groups
Overall Number of Baseline Participants 290 287 577
Hide Baseline Analysis Population Description
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 290 participants 287 participants 577 participants
47  (10.5) 46  (10.5) 46  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 290 participants 287 participants 577 participants
Female
47
  16.2%
53
  18.5%
100
  17.3%
Male
243
  83.8%
234
  81.5%
477
  82.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 290 participants 287 participants 577 participants
American Indian or Alaska Native
3
   1.0%
3
   1.0%
6
   1.0%
Asian
6
   2.1%
10
   3.5%
16
   2.8%
Black
79
  27.2%
72
  25.1%
151
  26.2%
Native Hawaiian or Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
White
188
  64.8%
190
  66.2%
378
  65.5%
Other
14
   4.8%
12
   4.2%
26
   4.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 290 participants 287 participants 577 participants
Hispanic or Latino
60
  20.7%
47
  16.4%
107
  18.5%
Not Hispanic or Latino
230
  79.3%
240
  83.6%
470
  81.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 290 participants 287 participants 577 participants
Australia
15
   5.2%
16
   5.6%
31
   5.4%
Canada
18
   6.2%
15
   5.2%
33
   5.7%
Belgium
2
   0.7%
3
   1.0%
5
   0.9%
France
17
   5.9%
17
   5.9%
34
   5.9%
Germany
28
   9.7%
33
  11.5%
61
  10.6%
Italy
3
   1.0%
5
   1.7%
8
   1.4%
Spain
6
   2.1%
4
   1.4%
10
   1.7%
United Kingdom
31
  10.7%
23
   8.0%
54
   9.4%
United States
166
  57.2%
164
  57.1%
330
  57.2%
Dominican Republic
4
   1.4%
7
   2.4%
11
   1.9%
HIV-1 RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 290 participants 287 participants 577 participants
< 50 copies/mL
285
  98.3%
277
  96.5%
562
  97.4%
≥ 50 copies/mL
5
   1.7%
10
   3.5%
15
   2.6%
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/μL
Number Analyzed 290 participants 287 participants 577 participants
669  (303.4) 657  (285.0) 663  (294.2)
CD4 Cell Count Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 290 participants 287 participants 577 participants
< 50 cells/μL
0
   0.0%
0
   0.0%
0
   0.0%
≥ 50 to < 200 cells/μL
4
   1.4%
8
   2.8%
12
   2.1%
≥ 200 to < 350 cells/μL
26
   9.0%
30
  10.5%
56
   9.7%
≥ 350 to < 500 cells/μL
62
  21.4%
60
  20.9%
122
  21.1%
≥ 500 cells/μL
198
  68.3%
189
  65.9%
387
  67.1%
HIV Disease Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 290 participants 287 participants 577 participants
Asymptomatic
240
  82.8%
234
  81.5%
474
  82.1%
Symptomatic HIV Infection
16
   5.5%
20
   7.0%
36
   6.2%
Acquired Immunodeficiency Syndrome (AIDS)
34
  11.7%
33
  11.5%
67
  11.6%
Prior ARV Regimen  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 290 participants 287 participants 577 participants
Boosted ATV + ABC/3TC
21
   7.2%
23
   8.0%
44
   7.6%
Boosted DRV + ABC/3TC
24
   8.3%
21
   7.3%
45
   7.8%
Boosted ATV + FTC/TDF
105
  36.2%
110
  38.3%
215
  37.3%
Boosted DRV + FTC/TDF
140
  48.3%
133
  46.3%
273
  47.3%
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
Hide Description The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all participants who were randomized into the study and received at least 1 dose of study drug.
Arm/Group Title B/F/TAF Stay on Baseline Regimen (SBR)
Hide Arm/Group Description:
Randomized Phase: B/F/TAF (50/200/25 mg) FDC tablet administered orally once daily for at least 48 weeks without regard to food.
Randomized Phase: Participants remained on current ARV regimen consisting of RTV or COBI boosted ATV or DRV, plus either FTC/TDF (200/300 mg) FDC tablet or ABC/3TC (600/300 mg) FDC tablet administered orally once daily for at least 48 weeks with food.
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: percentage of participants
1.7 1.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, Stay on Baseline Regimen (SBR)
Comments The null hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 in the B/F/TAF group was at least 4% higher than the rate in the SBR group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL in the B/F/TAF group was less than 4% higher than that in the SBR group.
Type of Statistical Test Non-Inferiority
Comments A sample size of 520 participants (260 participants per treatment group) would provide at least 90% power to establish a non-inferiority margin of 4% in the Week 48 response rate (HIV-1 RNA ≥ 50 copies/mL) between the 2 treatment groups. Sample size was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a 1-sided 0.025 level.
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -0.0
Confidence Interval (2-Sided) 95.002%
-2.5 to 2.5
Estimation Comments The difference in percentages and its 95.002% confidence interval (CI) 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, Stay on Baseline Regimen (SBR)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title B/F/TAF Stay on Baseline Regimen (SBR)
Hide Arm/Group Description:
Randomized Phase: B/F/TAF (50/200/25 mg) FDC tablet administered orally once daily for at least 48 weeks without regard to food.
Randomized Phase: Participants remained on current ARV regimen consisting of RTV or COBI boosted ATV or DRV, plus either FTC/TDF (200/300 mg) FDC tablet or ABC/3TC (600/300 mg) FDC tablet administered orally once daily for at least 48 weeks with food.
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: percentage of participants
92.1 88.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, Stay on Baseline Regimen (SBR)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The non-inferiority of B/F/TAF would be established if the lower bound of the 2-sided 95.002% CI of the difference between the treatment groups (B/F/TAF group - SBR 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 3.2
Confidence Interval (2-Sided) 95.002%
-1.6 to 8.2
Estimation Comments The difference in percentages and its 95.002% confidence interval (CI) 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, Stay on Baseline Regimen (SBR)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
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 to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title B/F/TAF Stay on Baseline Regimen (SBR)
Hide Arm/Group Description:
Randomized Phase: B/F/TAF (50/200/25 mg) FDC tablet administered orally once daily for at least 48 weeks without regard to food.
Randomized Phase: Participants remained on current ARV regimen consisting of RTV or COBI boosted ATV or DRV, plus either FTC/TDF (200/300 mg) FDC tablet or ABC/3TC (600/300 mg) FDC tablet administered orally once daily for at least 48 weeks with food.
Overall Number of Participants Analyzed 265 256
Mean (Standard Deviation)
Unit of Measure: cells/μL
25  (151.2) 0  (159.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B/F/TAF, Stay on Baseline Regimen (SBR)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.068
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Means (LSM)
Estimated Value 25
Confidence Interval (2-Sided) 95%
-2 to 52
Estimation Comments [Not Specified]
Time Frame From the first dose date up to last dose date (maximum: 181 weeks) plus 30 days
Adverse Event Reporting Description Safety 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 (Randomized Phase) Stay on Baseline Regimen (SBR) (Randomized Phase) Extension B/F/TAF From B/F/TAF Extension B/F/TAF From SBR
Hide Arm/Group Description Randomized Phase: B/F/TAF (50/200/25 mg) FDC tablet administered orally once daily for at least 48 weeks without regard to food. Randomized Phase: Participants remained on current ARV regimen consisting of RTV or COBI boosted ATV or DRV, plus either FTC/TDF (200/300 mg) FDC tablet or ABC/3TC (600/300 mg) FDC tablet administered orally once daily for at least 48 weeks with food. After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first. After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF for up to 96 additional weeks or until the product became accessible to participants through an access program, or until Gilead Sciences elected to discontinue the study in that country, whichever occurred first.
All-Cause Mortality
B/F/TAF (Randomized Phase) Stay on Baseline Regimen (SBR) (Randomized Phase) Extension B/F/TAF From B/F/TAF Extension B/F/TAF From SBR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/290 (0.34%)   1/287 (0.35%)   0/272 (0.00%)   1/244 (0.41%) 
Hide Serious Adverse Events
B/F/TAF (Randomized Phase) Stay on Baseline Regimen (SBR) (Randomized Phase) Extension B/F/TAF From B/F/TAF Extension B/F/TAF From SBR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/290 (5.86%)   21/287 (7.32%)   20/272 (7.35%)   29/244 (11.89%) 
Blood and lymphatic system disorders         
Lymphadenitis † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Cardiac disorders         
Acute myocardial infarction † 1  1/290 (0.34%)  1/287 (0.35%)  1/272 (0.37%)  0/244 (0.00%) 
Atrial fibrillation † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  1/244 (0.41%) 
Bradycardia † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Coronary artery stenosis † 1  1/290 (0.34%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Myocardial infarction † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  1/244 (0.41%) 
Myocardial ischaemia † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Myxomatous mitral valve degeneration † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Sinus node dysfunction † 1  1/290 (0.34%)  0/287 (0.00%)  0/272 (0.00%)  0/244 (0.00%) 
Eye disorders         
Optic disc disorder † 1  1/290 (0.34%)  0/287 (0.00%)  0/272 (0.00%)  0/244 (0.00%) 
Gastrointestinal disorders         
Abdominal pain † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Anal fistula † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Diarrhoea † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Diverticular perforation † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Enterocutaneous fistula † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Lower gastrointestinal haemorrhage † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Small intestinal obstruction † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
General disorders         
Chest pain † 1  1/290 (0.34%)  1/287 (0.35%)  0/272 (0.00%)  1/244 (0.41%) 
Oedema peripheral † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Hepatobiliary disorders         
Biliary dyskinesia † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Cholelithiasis † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Infections and infestations         
Abscess limb † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Acute hepatitis C † 1  1/290 (0.34%)  0/287 (0.00%)  0/272 (0.00%)  0/244 (0.00%) 
Anal abscess † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Appendicitis † 1  0/290 (0.00%)  1/287 (0.35%)  1/272 (0.37%)  1/244 (0.41%) 
Bronchitis † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Cellulitis † 1  1/290 (0.34%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Diverticulitis † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  1/244 (0.41%) 
Erysipelas † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  1/244 (0.41%) 
Hepatitis A † 1  2/290 (0.69%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Hepatitis C † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Infection † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Influenza † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Localised infection † 1  0/290 (0.00%)  1/287 (0.35%)  1/272 (0.37%)  0/244 (0.00%) 
Neurosyphilis † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Osteomyelitis † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Osteomyelitis chronic † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Pneumonia † 1  1/290 (0.34%)  0/287 (0.00%)  1/272 (0.37%)  1/244 (0.41%) 
Pyelonephritis † 1  1/290 (0.34%)  0/287 (0.00%)  0/272 (0.00%)  0/244 (0.00%) 
Pyelonephritis acute † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Stoma site abscess † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Upper respiratory tract infection † 1  1/290 (0.34%)  0/287 (0.00%)  0/272 (0.00%)  0/244 (0.00%) 
Urinary tract infection † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Urinary tract infection bacterial † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Injury, poisoning and procedural complications         
Accident † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Acetabulum fracture † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Head injury † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Humerus fracture † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Joint dislocation † 1  1/290 (0.34%)  0/287 (0.00%)  0/272 (0.00%)  0/244 (0.00%) 
Radius fracture † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Skin laceration † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Tibia fracture † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  1/244 (0.41%) 
Upper limb fracture † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Osteoarthritis † 1  1/290 (0.34%)  0/287 (0.00%)  0/272 (0.00%)  0/244 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Anogenital warts † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Bladder neoplasm † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Brain cancer metastatic † 1  1/290 (0.34%)  0/287 (0.00%)  0/272 (0.00%)  0/244 (0.00%) 
Lung neoplasm malignant † 1  1/290 (0.34%)  0/287 (0.00%)  0/272 (0.00%)  0/244 (0.00%) 
Uterine leiomyoma † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Nervous system disorders         
Carotid artery stenosis † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Cerebral infarction † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Cervical radiculopathy † 1  1/290 (0.34%)  0/287 (0.00%)  0/272 (0.00%)  0/244 (0.00%) 
Metabolic encephalopathy † 1  1/290 (0.34%)  0/287 (0.00%)  0/272 (0.00%)  0/244 (0.00%) 
Thrombotic stroke † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  2/244 (0.82%) 
Foetal death † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Psychiatric disorders         
Alcohol abuse † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Alcoholism † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Anxiety † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Mania † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Schizoaffective disorder † 1  1/290 (0.34%)  0/287 (0.00%)  0/272 (0.00%)  0/244 (0.00%) 
Schizophrenia † 1  1/290 (0.34%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Suicidal ideation † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Suicide attempt † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  1/244 (0.41%) 
Renal and urinary disorders         
Acute kidney injury † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  1/244 (0.41%) 
Ureteric stenosis † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  1/244 (0.41%) 
Ureterolithiasis † 1  1/290 (0.34%)  0/287 (0.00%)  0/272 (0.00%)  0/244 (0.00%) 
Reproductive system and breast disorders         
Pelvic haematoma † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Priapism † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Asthma † 1  1/290 (0.34%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Dyspnoea † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Sleep apnoea syndrome † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Social circumstances         
Physical assault † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Surgical and medical procedures         
Hip arthroplasty † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Vascular disorders         
Deep vein thrombosis † 1  0/290 (0.00%)  0/287 (0.00%)  0/272 (0.00%)  1/244 (0.41%) 
Hypertensive crisis † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Hypotension † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
Hypovolaemic shock † 1  0/290 (0.00%)  1/287 (0.35%)  0/272 (0.00%)  0/244 (0.00%) 
Peripheral artery stenosis † 1  0/290 (0.00%)  0/287 (0.00%)  1/272 (0.37%)  0/244 (0.00%) 
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%
B/F/TAF (Randomized Phase) Stay on Baseline Regimen (SBR) (Randomized Phase) Extension B/F/TAF From B/F/TAF Extension B/F/TAF From SBR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   117/290 (40.34%)   126/287 (43.90%)   108/272 (39.71%)   113/244 (46.31%) 
Gastrointestinal disorders         
Diarrhoea † 1  24/290 (8.28%)  17/287 (5.92%)  19/272 (6.99%)  12/244 (4.92%) 
Infections and infestations         
Influenza † 1  7/290 (2.41%)  12/287 (4.18%)  10/272 (3.68%)  15/244 (6.15%) 
Nasopharyngitis † 1  23/290 (7.93%)  35/287 (12.20%)  24/272 (8.82%)  38/244 (15.57%) 
Syphilis † 1  9/290 (3.10%)  11/287 (3.83%)  14/272 (5.15%)  14/244 (5.74%) 
Upper respiratory tract infection † 1  23/290 (7.93%)  24/287 (8.36%)  24/272 (8.82%)  27/244 (11.07%) 
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  15/290 (5.17%)  16/287 (5.57%)  12/272 (4.41%)  9/244 (3.69%) 
Back pain † 1  13/290 (4.48%)  19/287 (6.62%)  15/272 (5.51%)  13/244 (5.33%) 
Nervous system disorders         
Headache † 1  34/290 (11.72%)  14/287 (4.88%)  13/272 (4.78%)  17/244 (6.97%) 
Respiratory, thoracic and mediastinal disorders         
Cough † 1  12/290 (4.14%)  9/287 (3.14%)  14/272 (5.15%)  8/244 (3.28%) 
1
Term from vocabulary, MedDRA (22.1)
†
Indicates events were collected by systematic assessment
[Not Specified]
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:
Daar ES, DeJesus E, Ruane P, Crofoot G, Oguchi G, Creticos C, Rockstroh JK, Molina JM, Koenig E, Liu YP, Custodio J, Andreatta K, Graham H, Cheng A, Martin H, Quirk E. Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48 week results of a randomised, open-label, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2018 Jul;5(7):e347-e356. doi: 10.1016/S2352-3018(18)30091-2. Epub 2018 Jun 18.
Andreatta K, Willkom M, Martin R, Chang S, Wei L, Liu H, Liu YP, Graham H, Quirk E, Martin H, White KL. Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I. J Antimicrob Chemother. 2019 Dec 1;74(12):3555-3564. doi: 10.1093/jac/dkz347. Erratum In: J Antimicrob Chemother. 2019 Dec 1;74(12):3646-3647.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02603107    
Other Study ID Numbers: GS-US-380-1878
2015-004011-20 ( EudraCT Number )
First Submitted: November 10, 2015
First Posted: November 11, 2015
Results First Submitted: May 3, 2018
Results First Posted: June 6, 2018
Last Update Posted: December 29, 2020