Study to Evaluate Switching From a Regimen of Two Nucleos... | NCT03631732

NCT03631732

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B/F/TAF	Experimental	Participants will receive B/F/TAF (50/200/25 mg) FDC tablet 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.	Drug: B/F/TAF
Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF	Active Comparator	Participants will stay on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks with a delayed switch to B/F/TAF (50/200/25 mg) FDC tablet 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.	Drug: B/F/TAF Drug: NRTIs Drug: Third Agent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
B/F/TAF	Drug	50/200/25 mg FDC tablets administered orally once daily without regard to food	B/F/TAF Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 24 was 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.	Week 24

Secondary Outcomes

Measure	Description	Time Frame
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	The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 48 was 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.

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Self-describes as Black, African American, or mixed race, including Black
Currently receiving an antiretrovirals (ARV) regimen other than FDC of B/F/TAF that consists of any two NRTIs + allowed 3rd agent for ≥ 6 months
Allowed 3rd agents include any FDA-approved INSTI, with the exception of bictegravir, any FDA-approved NNRTI with the exception of etravirine, protease inhibitors or the CCR5 antagonist, maraviroc
If the baseline 3rd agent is dolutegravir, dosing other than 50 mg once daily is excluded
Baseline regimens containing investigational drugs or > 2 classes of ARVs are not permitted, with the exception of the pharmacologic enhancers cobicistat (taken with elvitegravir or a PI), or ritonavir (taken with a PI)
Have no documented or suspected resistance to INSTIs and no history of virologic failure on an INSTI containing regimen (2 consecutive HIV-1 RNA ≥ 50 copies/mL after achieving <50 copies/mL while on an INSTI-containing regimen)
History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded
Documented plasma HIV-1 RNA < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months and at least the last two HIV-1 RNA measurements prior to the Screening visit
HIV-1 RNA levels < 50 copies/mL at Screening
Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance

Key Exclusion Criteria:

History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R),T69-insertions, or K65R/E/N in RT
No desire to switch from current ARVs
An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding)
Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
Malignancy within 5 years of screening other than cutaneous Kaposi's sarcoma, completely resected non -melanoma skin cancer (basal cell carcinoma or non-invasive cutaneous squamous carcinoma), or completely resected carcinoma in-situ of the cervix (CIN 3) or anus (AIN 3). A prior malignancy treated with curative therapy and for which there has been no evidence of disease for at least five years prior to screening is allowed
Current alcohol or substance use judged by the Investigator to potentially interfere with participant study compliance
Active, serious infections (other than HIV-1 infection) requiring antibiotic or antifungal therapy within 30 days prior to Day 1
Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial
Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements
Known hypersensitivity to FDC of B/F/TAF tablets, their metabolites, or formulation excipient
Females who are pregnant (as confirmed by positive serum pregnancy test)
Females who are breastfeeding
Acute hepatitis in the 30 days prior to randomization
Active tuberculosis infection.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts/Locations Module

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Alabama Medical Group, PC

References Module

Citations

PubMed Identifier	Type	Citation
	Result	Andreatta K, D'Antoni ML, Chang S, Parvangada A, Martin R, Blair C, et al. Preexisting Resistance and Week 48 Virologic Outcomes after Switching to B/F/TAF in African American Adults With HIV [Presentation]. IDWeek Virtual; 2020b 21-25 October.
	Result	Hagins D, Kumar P, Saag M, Wurapa AK, Brar I, Berger D, Osiyemi O, Hileman CO, Ramgopol M, McDonald C, Blair C, Andreatta K, Collins SE, Brainard D, Martin H. Week-48 Outcomes From the BRAAVE 2020 Study: a Randomized Switch to B/F/TAF in African-American Adults With HIV, IDWeek 2020, October 21-25. Abstract 1046.
	Result	Andreatta K, D'Antoni ML, Chang S, Martin R, Blair C, Collins SE, et al. Preexisting Resistance and B/F/TAF Switch Efficacy in African Americans [Poster 509]. Conference on Retroviruses and Opportunistic Infections (CROI); 2020b 08-11 March; Boston, MA.
	Result	Hagins D, Kumar P, Saag M, Wurapa AK, Brar I, Berger D, Osiyemi O, Hileman CO, Ramgopol M, McDonald C, Blair C, Andreatta K, Collins SE, Brainard D, Martin H. Randomized Switch to B/F/TAF in African American Adults with HIV. Conference on Retroviruses and Opportunistic Infections 2020, March 7-11, Boston MA. Abstract 2979.
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IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	B/F/TAF	Participants received bictegravir /emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed dose combination (FDC) tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 27, 2018	Jul 14, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

FG000331 subjects
FG001165 subjects

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 Information

ID	Title	Description
BG000	B/F/TAF	Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
BG001	Stay on Baseline Regimen/ Delayed B/F/TAF	Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks with a delayed switch to B/F/TAF (50/200/25 mg) FDC tablet administered orally, once daily until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00047± 12.3 BG00148± 12.2 BG00247± 12.2

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000101 BG00155 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00015 BG0015 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0000 BG0010 BG002

HIV-1 RNA Category

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
< 50 copies/mL	BG000325 BG001163 BG002

CD4+ Cell Count

Mean

Standard Deviation

cells/µL

Title

Denominators

Categories

Title	Measurements
	BG000765± 313.4 BG001757± 323.0 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 24 was 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.

Participants in 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.

Posted

Number

95% Confidence Interval

percentage of participants

Week 24

ID	Title	Description
OG000	B/F/TAF	Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.
OG001	Stay on Baseline Regimen (SBR)	Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.

Units	Counts
Participants	OG000328 OG001165

Title

Denominators

Categories

Title	Measurements
	OG0000.6(0.1 to 2.2) OG0011.8(0.4 to 5.2)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Difference in percentages	-1.2			2-Sided	95	-4.8	0.9			Differences in percentages of participants with HIV-1 RNA >= 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.		Non-Inferiority	B/F/TAF is non-inferior to SBR if the upper bound of the 2-sided 95% confidence interval (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).

Secondary

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

The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 48 was 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.

Participants in the Full Analysis Set in the B/F/TAF and the Delayed B/F/TAF groups with available data were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Week 48

ID	Title	Description
OG000	B/F/TAF	Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
OG001	Delayed B/F/TAF	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 from Week 24 until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.

Secondary

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

The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 24 was 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.

Participants in the Full Analysis Set in the B/F/TAF and SBR groups were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Week 24

ID	Title	Description
OG000	B/F/TAF	Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.
OG001	Stay on Baseline Regimen (SBR)	Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.

Units	Counts
Participants

Secondary

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

Participants in 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.

Posted

Number

95% Confidence Interval

percentage of participants

Week 24

ID	Title	Description
OG000	B/F/TAF	Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.
OG001	Stay on Baseline Regimen (SBR)	Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.

Secondary

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

The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 48 was 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.

Participants in the Full Analysis Set in the B/F/TAF and the Delayed B/F/TAF groups with available data were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Week 48

ID	Title	Description
OG000	B/F/TAF	Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
OG001	Delayed B/F/TAF	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 from Week 24 until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.

Secondary

Change From Baseline in CD4+ Cell Count at Week 24: Full Analysis Set

The analysis includes values up to 1 day after permanent discontinuation of study treatment.

Participants in the Full Analysis Set in the B/F/TAF and SBR groups with available data were analyzed.

Posted

Mean

Standard Deviation

cells/uL

Baseline to Week 24

ID	Title	Description
OG000	B/F/TAF	Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.
OG001	Stay on Baseline Regimen (SBR)	Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in CD4+ Cell Count at Week 24: Week 24 Per Protocol Analysis Set

The analysis includes values up to 1 day after permanent discontinuation of study treatment.

Participants in the Week 24 Per Protocol Analysis Set in the B/F/TAF and SBR groups with available data were analyzed.

Posted

Mean

Standard Deviation

cells/uL

Baseline to Week 24

ID	Title	Description
OG000	B/F/TAF	Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.
OG001	Stay on Baseline Regimen (SBR)	Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in CD4+ Cell Count at Week 48: Full Analysis Set

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.

Participants in the Full Analysis Set in the B/F/TAF and the Delayed B/F/TAF groups with available data were analyzed.

Posted

Mean

Standard Deviation

cells/uL

Baseline to Week 48

ID	Title	Description
OG000	B/F/TAF	Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
OG001	Delayed B/F/TAF	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 from Week 24 until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.

Secondary

Percentage of Participants Experiencing Treatment-Emergent Adverse Events

An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A treatment-emergent adverse event was defined as any adverse event with onset date on or after the study treatment start date and no later than 30 days after the study drug stop date; or any adverse event leading to study drug discontinuation.

The B/F/TAF (BVY) Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of BVY study drug.

Posted

Number

percentage of participants

First B/F/TAF dose date up to Week 72 plus 30 days

ID	Title	Description
OG000	B/F/TAF	Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
OG001	Delayed B/F/TAF	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 from Week 24 until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.

Secondary

Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormalities

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Severity grades were defined by 'Gilead Grading Scale for Severity of AEs and Laboratory Abnormalities'.

Participants in the BVY Safety Analysis Set with available data were analyzed.

Posted

Number

percentage of participants

First B/F/TAF dose date up to Week 72 plus 30 days

ID	Title	Description
OG000	B/F/TAF	Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.
OG001	Delayed B/F/TAF	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 from Week 24 until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	B/F/TAF up to Week 24	Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 24 weeks, without regard to food.	1	331	13	330	38	330
EG001	SBR up to Week 24	Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.	0	165	7	165	13	165
EG002	B/F/TAF After Week 24	Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily from Week 24 to Week 48, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.	2	319	20	319	53	319
EG003	Delayed B/F/TAF	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 from Week 24 until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.	0	163	7	163	26	163

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pancytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected165 at risk EG0020 affected319 at risk EG0030 affected163 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected165 at risk EG0020 affected319 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected165 at risk EG0020 affected319 at risk EG003
Gastric stenosis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0020 affected319 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected330 at risk EG0010 affected165 at risk EG0020 affected319 at risk EG003
Chest pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0022 affected319 at risk EG003
Complication associated with device	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0020 affected319 at risk EG003
Anal abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected330 at risk EG0011 affected165 at risk EG0020 affected319 at risk EG003
Anorectal infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Bronchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Burn infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0020 affected319 at risk EG003
Covid-19	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0023 affected319 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected165 at risk EG0020 affected319 at risk EG003
Neurosyphilis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Pharyngitis bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected165 at risk EG0020 affected319 at risk EG003
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected165 at risk EG0021 affected319 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected165 at risk EG0020 affected319 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0020 affected319 at risk EG003
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected165 at risk EG0020 affected319 at risk EG003
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected165 at risk EG0020 affected319 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected165 at risk EG0020 affected319 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0020 affected319 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected330 at risk EG0011 affected165 at risk EG0020 affected319 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Lacunar infarction	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0020 affected319 at risk EG003
Seizure	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0011 affected165 at risk EG0020 affected319 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Syncope	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Vertebral artery dissection	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Bipolar I disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0020 affected319 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected165 at risk EG0020 affected319 at risk EG003
Homicidal ideation	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected330 at risk EG0010 affected165 at risk EG0020 affected319 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0020 affected319 at risk EG003
Hypovolaemic shock	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected330 at risk EG0010 affected165 at risk EG0021 affected319 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00011 affected330 at risk EG0015 affected165 at risk EG0024 affected319 at risk EG0039 affected163 at risk
Syphilis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0004 affected330 at risk EG0011 affected165 at risk EG00218 affected319 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00020 affected330 at risk EG0016 affected165 at risk EG00217 affected319 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0005 affected330 at risk EG0012 affected165 at risk EG00216 affected319 at risk EG003

ID	Term
C000654125	bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Units	Counts
Participants	OG000329 OG001163