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Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants (BRAAVE 2020)

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ClinicalTrials.gov Identifier: NCT03631732
Recruitment Status : Active, not recruiting
First Posted : August 15, 2018
Results First Posted : August 27, 2020
Last Update Posted : August 27, 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: B/F/TAF
Drug: NRTIs
Drug: Third Agent
Enrollment 496
Recruitment Details Participants were enrolled at study centers in the United States. The first participant was screened on 28 August 2018. The last Week 48 study visit occurred on 04 Feb 2020.
Pre-assignment Details

The following NRTIs & 3rd agents were allowed:

NRTIs:abacavir, emtricitabine, lamivudine, tenofovir alafenamide, tenofovir disoproxil fumarate, zidovudine;

3rd agents:delavirdine,efavirenz, nevirapine, rilpivirine,dolutegravir, elvitegravir,raltegravir, doravirine, atazanavir, darunavir, lopinavir, nelfinavir, saquinavir, tipranavir, maraviroc

Arm/Group Title B/F/TAF Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF
Hide Arm/Group Description Participants received fixed dose combination (FDC) tablet of bictegravir /emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) orally once daily for 48 weeks, without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first. Participants stayed on baseline regimen consisting of 2 nucleos(t)Ide reverse transcriptase inhibitors (NRTIs) and a third agent (each taken as prescribed) for 24 weeks administered orally once daily with a delayed switch to FDC tablet of B/F/TAF (50/200/25 mg) administered orally, once daily until Week 48 without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first.
Period Title: Overall Study
Started 331 165
Completed 31 12
Not Completed 300 153
Reason Not Completed
Randomized and Never Treated             1             0
Still in Study             285             148
Adverse Event             3             0
Death             1             0
Lack of Efficacy             1             0
Investigator's Discretion             1             0
Withdrew consent             3             4
Lost to Follow-up             5             1
Arm/Group Title B/F/TAF Stay on Baseline Regimen/ Delayed B/F/TAF Total
Hide Arm/Group Description Participants received FDC tablet of B/F/TAF (50/200/25 mg) orally once daily for 48 weeks, without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first. Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily, with a delayed switch to FDC tablet of B/F/TAF (50/200/25 mg) administered orally, once daily until Week 48 without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first. Total of all reporting groups
Overall Number of Baseline Participants 330 165 495
Hide Baseline Analysis Population Description
The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 330 participants 165 participants 495 participants
47  (12.3) 48  (12.2) 47  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 165 participants 495 participants
Female 101 55 156
Male 229 110 339
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 165 participants 495 participants
Hispanic or Latino 15 5 20
Not Hispanic or Latino 315 160 475
Unknown or Not Reported 0 0 0
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 165 participants 495 participants
Black or African American 285 154 439
Other 45 11 56
HIV-1 RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 165 participants 495 participants
< 50 copies/mL 325 163 488
≥ 50 copies/mL 5 2 7
CD4+ Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 330 participants 165 participants 495 participants
765  (313.4) 757  (323.0) 763  (316.3)
1.Primary Outcome
Title Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set
Hide Description The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 24 were analyzed using the snapshot algorithm, which defined 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 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set [included all participants who were randomized into the study, and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1), and did not have pre-existing integrase strand transfer inhibitor resistance-associated mutations (based on historical data)] in B/F/TAF and SBR groups were analyzed.
Arm/Group Title B/F/TAF Stay on Baseline Regimen (SBR)
Hide Arm/Group Description:
Participants received FDC tablet of B/F/TAF (50/200/25 mg) orally once daily for 48 weeks, without regard to food.
Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.
Overall Number of Participants Analyzed 328 165
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.6
(0.1 to 2.2)
1.8
(0.4 to 5.2)
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 B/F/TAF is non-inferior to SBR if the upper bound of the 2-sided 95% CI of the difference between treatment groups [B/F/TAF - SBR] in the percentage of participants with HIV-1 RNA ≥ 50 copies/mL is less than 6% (i.e., a margin of 6% is applied to non-inferiority assessment).
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-4.8 to 0.9
Estimation Comments Differences in percentages of participants with HIV-1 RNA >= 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.
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 0.3399
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set
Hide Description The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 48 were analyzed using the snapshot algorithm, which defined 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set in the B/F/TAF and the Delayed B/F/TAF groups with available data were analyzed.
Arm/Group Title B/F/TAF Delayed B/F/TAF
Hide Arm/Group Description:
Participants randomized to B/F/TAF arm received FDC tablet of B/F/TAF (50/200/25 mg) orally once daily for 48 weeks, without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first.
Participants in SBR group who switched to B/F/TAF group at Week 24 received B/F/TAF (50/200/25 mg) FDC tablet orally, once daily until Week 48 without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first.
Overall Number of Participants Analyzed 328 163
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.9
(0.2 to 2.6)
0
(0.0 to 2.2)
3.Secondary Outcome
Title Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set
Hide Description The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 24 were analyzed using the snapshot algorithm, which defined 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 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set in the B/F/TAF and SBR groups were analyzed.
Arm/Group Title B/F/TAF Stay on Baseline Regimen (SBR)
Hide Arm/Group Description:
Participants received FDC tablet of B/F/TAF (50/200/25 mg) orally once daily for 48 weeks, without regard to food.
Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.
Overall Number of Participants Analyzed 328 165
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.3
(93.7 to 98.1)
94.5
(89.9 to 97.5)
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 B/F/TAF is non-inferior to SBR if the lower bound of the 2-sided 95% CI of the difference between treatment groups [B/F/TAF - SBR] in the percentage of participants with HIV-1 RNA < 50 copies/mL is greater than -10% (i.e., a margin of 10% is applied to non-inferiority assessment).
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 1.8
Confidence Interval (2-Sided) 95%
-2.0 to 6.8
Estimation Comments Differences in percentages of participants with HIV-1 RNA < 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.
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 0.3532
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Week 24 Per Protocol Analysis Set
Hide Description The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 24 were analyzed using the snapshot algorithm, which defined 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 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Week 24 Per Protocol Analysis Set [included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1), and had not committed any major protocol violation, including the violation of key entry criteria] in the B/F/TAF and SBR groups were analyzed.
Arm/Group Title B/F/TAF Stay on Baseline Regimen (SBR)
Hide Arm/Group Description:
Participants received FDC tablet of B/F/TAF (50/200/25 mg) orally once daily for 48 weeks, without regard to food.
Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.
Overall Number of Participants Analyzed 306 148
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
99.3
(97.7 to 99.9)
98.0
(94.2 to 99.6)
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 B/F/TAF is non-inferior to SBR if the lower bound of the 2-sided 95% CI of the difference between treatment groups [B/F/TAF - SBR] in the percentage of participants with HIV-1 RNA < 50 copies/mL is greater than -10% (i.e., a margin of 10% is applied to non-inferiority assessment).
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-1.0 to 5.3
Estimation Comments Differences in percentages of participants with HIV-1 RNA < 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.
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 0.3356
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set
Hide Description The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 48 were analyzed using the snapshot algorithm, which defined 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set in the B/F/TAF and the Delayed B/F/TAF groups with available data were analyzed.
Arm/Group Title B/F/TAF Delayed B/F/TAF
Hide Arm/Group Description:
Participants randomized to B/F/TAF arm received FDC tablet of B/F/TAF (50/200/25 mg) orally once daily for 48 weeks, without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first.
Participants in SBR group who switched to B/F/TAF group at Week 24 received B/F/TAF (50/200/25 mg) FDC tablet orally, once daily until Week 48 without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first.
Overall Number of Participants Analyzed 328 163
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
94.5
(91.5 to 96.7)
96.9
(93.0 to 99.0)
6.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 24: Full Analysis Set
Hide Description The analysis includes values up to 1 day after permanent discontinuation of study treatment.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set in the B/F/TAF and SBR groups with available data were analyzed.
Arm/Group Title B/F/TAF Stay on Baseline Regimen (SBR)
Hide Arm/Group Description:
Participants received FDC tablet of B/F/TAF (50/200/25 mg) orally once daily for 48 weeks, without regard to food.
Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.
Overall Number of Participants Analyzed 319 156
Mean (Standard Deviation)
Unit of Measure: cells/uL
13  (209.3) 1  (171.2)
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 Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5618
Comments [Not Specified]
Method ANOVA
Comments P-value was calculated from ANOVA model with treatment as a fixed effect.
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 11
Confidence Interval (2-Sided) 95%
-27 to 49
Estimation Comments Difference in LSM (Least square mean) and its 95% C.I. was calculated from ANOVA model with treatment as a fixed effect.
7.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 24: Week 24 Per Protocol Analysis Set
Hide Description The analysis includes values up to 1 day after permanent discontinuation of study treatment.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Week 24 Per Protocol Analysis Set in the B/F/TAF and SBR groups with available data were analyzed.
Arm/Group Title B/F/TAF Stay on Baseline Regimen (SBR)
Hide Arm/Group Description:
Participants received FDC tablet of B/F/TAF (50/200/25 mg) orally once daily for 48 weeks, without regard to food.
Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.
Overall Number of Participants Analyzed 305 144
Mean (Standard Deviation)
Unit of Measure: cells/uL
13  (210.1) 4  (171.3)
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 Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6632
Comments [Not Specified]
Method ANOVA
Comments P-value was calculated from ANOVA model with treatment as a fixed effect.
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 9
Confidence Interval (2-Sided) 95%
-31 to 48
Estimation Comments Difference in LSM and its 95% C.I. was calculated from ANOVA model with treatment as a fixed effect.
8.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 48: Full Analysis Set
Hide Description The analysis includes values up to 1 day after permanent discontinuation of study treatment. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set in the B/F/TAF and the Delayed B/F/TAF groups with available data were analyzed.
Arm/Group Title B/F/TAF Delayed B/F/TAF
Hide Arm/Group Description:
Participants received FDC tablet of B/F/TAF (50/200/25 mg) orally once daily for 48 weeks, without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first.
Participants in SBR group who switched to B/F/TAF group at Week 24 received B/F/TAF (50/200/25 mg) FDC tablet orally, once daily until Week 48 without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first.
Overall Number of Participants Analyzed 309 159
Mean (Standard Deviation)
Unit of Measure: cells/uL
7  (188.6) -8  (159.2)
Time Frame First dose date up to Week 48 data cut
Adverse Event Reporting Description The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1).
 
Arm/Group Title B/F/TAF up to Week 24 SBR up to Week 24 B/F/TAF After Week 24 Delayed B/F/TAF
Hide Arm/Group Description Participants received FDC tablet of B/F/TAF (50/200/25 mg) orally once daily for 24 weeks, without regard to food. Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily. Participants received FDC tablet of B/F/TAF (50/200/25 mg) orally once daily from Week 24 to Week 48, without regard to food. Participants in SBR group who switched to B/F/TAF group at Week 24 received B/F/TAF (50/200/25 mg) FDC tablet orally, once daily until Week 48 without regard to food.
All-Cause Mortality
B/F/TAF up to Week 24 SBR up to Week 24 B/F/TAF After Week 24 Delayed B/F/TAF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/330 (0.00%)   0/165 (0.00%)   1/319 (0.31%)   0/163 (0.00%) 
Hide Serious Adverse Events
B/F/TAF up to Week 24 SBR up to Week 24 B/F/TAF After Week 24 Delayed B/F/TAF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/330 (3.94%)   7/165 (4.24%)   15/319 (4.70%)   5/163 (3.07%) 
Blood and lymphatic system disorders         
Pancytopenia  1  0/330 (0.00%)  1/165 (0.61%)  0/319 (0.00%)  0/163 (0.00%) 
Cardiac disorders         
Acute myocardial infarction  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  1/163 (0.61%) 
Ventricular tachycardia  1  1/330 (0.30%)  0/165 (0.00%)  0/319 (0.00%)  0/163 (0.00%) 
Endocrine disorders         
Adrenal insufficiency  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Gastrointestinal disorders         
Colitis  1  0/330 (0.00%)  1/165 (0.61%)  0/319 (0.00%)  0/163 (0.00%) 
Vomiting  1  2/330 (0.61%)  0/165 (0.00%)  0/319 (0.00%)  0/163 (0.00%) 
General disorders         
Chest pain  1  0/330 (0.00%)  0/165 (0.00%)  2/319 (0.63%)  0/163 (0.00%) 
Complication associated with device  1  0/330 (0.00%)  0/165 (0.00%)  0/319 (0.00%)  1/163 (0.61%) 
Infections and infestations         
Anal abscess  1  1/330 (0.30%)  1/165 (0.61%)  0/319 (0.00%)  0/163 (0.00%) 
Anorectal infection  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Bronchitis  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Burn infection  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Cellulitis  1  0/330 (0.00%)  0/165 (0.00%)  0/319 (0.00%)  1/163 (0.61%) 
Diarrhoea infectious  1  0/330 (0.00%)  1/165 (0.61%)  0/319 (0.00%)  0/163 (0.00%) 
Neurosyphilis  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Pharyngitis bacterial  1  0/330 (0.00%)  1/165 (0.61%)  0/319 (0.00%)  0/163 (0.00%) 
Pneumonia  1  0/330 (0.00%)  1/165 (0.61%)  0/319 (0.00%)  0/163 (0.00%) 
Urinary tract infection  1  1/330 (0.30%)  0/165 (0.00%)  0/319 (0.00%)  0/163 (0.00%) 
Injury, poisoning and procedural complications         
Fall  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Upper limb fracture  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Metabolism and nutrition disorders         
Hyperglycaemia  1  0/330 (0.00%)  0/165 (0.00%)  0/319 (0.00%)  1/163 (0.61%) 
Hyperglycaemic hyperosmolar nonketotic syndrome  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Hypoglycaemia  1  2/330 (0.61%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Colon cancer  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Lung adenocarcinoma  1  1/330 (0.30%)  0/165 (0.00%)  0/319 (0.00%)  0/163 (0.00%) 
Metastases to spine  1  1/330 (0.30%)  0/165 (0.00%)  0/319 (0.00%)  0/163 (0.00%) 
Prostate cancer  1  1/330 (0.30%)  0/165 (0.00%)  0/319 (0.00%)  0/163 (0.00%) 
Nervous system disorders         
Cerebrovascular accident  1  1/330 (0.30%)  1/165 (0.61%)  0/319 (0.00%)  0/163 (0.00%) 
Facial paralysis  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Headache  1  1/330 (0.30%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Lacunar infarction  1  0/330 (0.00%)  0/165 (0.00%)  0/319 (0.00%)  1/163 (0.61%) 
Seizure  1  0/330 (0.00%)  1/165 (0.61%)  0/319 (0.00%)  0/163 (0.00%) 
Subarachnoid haemorrhage  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Syncope  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Vertebral artery dissection  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Psychiatric disorders         
Bipolar I disorder  1  0/330 (0.00%)  0/165 (0.00%)  0/319 (0.00%)  1/163 (0.61%) 
Confusional state  1  1/330 (0.30%)  0/165 (0.00%)  0/319 (0.00%)  0/163 (0.00%) 
Homicidal ideation  1  1/330 (0.30%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Suicidal ideation  1  2/330 (0.61%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Renal and urinary disorders         
Acute kidney injury  1  2/330 (0.61%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Haematuria  1  1/330 (0.30%)  0/165 (0.00%)  0/319 (0.00%)  0/163 (0.00%) 
Urinary tract obstruction  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Chronic obstructive pulmonary disease  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (0.00%) 
Skin and subcutaneous tissue disorders         
Angioedema  1  0/330 (0.00%)  0/165 (0.00%)  0/319 (0.00%)  1/163 (0.61%) 
Vascular disorders         
Hypovolaemic shock  1  0/330 (0.00%)  0/165 (0.00%)  1/319 (0.31%)  0/163 (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 up to Week 24 SBR up to Week 24 B/F/TAF After Week 24 Delayed B/F/TAF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/330 (6.06%)   6/165 (3.64%)   12/319 (3.76%)   9/163 (5.52%) 
Infections and infestations         
Upper respiratory tract infection  1  20/330 (6.06%)  6/165 (3.64%)  12/319 (3.76%)  9/163 (5.52%) 
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: NCT03631732    
Other Study ID Numbers: GS-US-380-4580
First Submitted: August 13, 2018
First Posted: August 15, 2018
Results First Submitted: August 12, 2020
Results First Posted: August 27, 2020
Last Update Posted: August 27, 2020