1046 - Week 48 Outcomes from the BRAAVE 2020 Study: A Randomized Switch to B/F/TAF in African American Adults with HIV

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Presenting Author(s)

Debbie P. Hagins

Family Medicine Specialist
Georgia Department of Public Health, Coastal Health District, Chatham CARE Center, Savannah, GA, USA
Savannah, Georgia
Disclosure: Gilead Sciences Inc. (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member)Janssen (Grant/Research Support)Merck (Consultant, Grant/Research Support, Advisor or Review Panel member)Viiv Healthcare (Consultant, Grant/Research Support, Advisor or Review Panel member)

Co-Author(s)

Princy N. Kumar

Professor, Medicine; Chief, Division of Infectious Diseases and Travel Medicine
Georgetown University Medical Center, Washington, DC, USA
Washington, District of Columbia
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
Michael Saag

Professor of Medicine, Director of the UAB Center for AIDS Research
University of Alabama at Birmingham
Birmingham, AL
Disclosure: Gilead Sciences Inc. (Consultant, Grant/Research Support, Scientific Research Study Investigator)Merck (Consultant, Grant/Research Support)Proteus (Grant/Research Support)Viiv Healthcare (Consultant, Grant/Research Support)
AW

Anson K. Wurapa

Infectios Disease Specialist
Infectious Disease Specialists of Atlanta
Atlanta, GA
Disclosure: Gilead Sciences Inc. (Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member)GlaxoSmithKline (Grant/Research Support)Janssen (Grant/Research Support, Advisor or Review Panel member)Pfizer (Grant/Research Support)
Indira Brar

Associate Clinical Professor Wayne State School of Medicine
Henry Ford Hospital
Detroit, Michigan
Disclosure: Gilead (Speaker's Bureau)janssen (Speaker's Bureau)ViiV (Speaker's Bureau)
DB

Daniel Berger

Practicing Physician
Northstar Medical Center
Chicago, Illinois
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
Olayemi Osiyemi

President
Triple O Research Institute
West Palm Beach, Florida
Disclosure: GlaxoSmithKline (Advisor or Review Panel member, Speaker's Bureau)ViiV Healthcare (Advisor or Review Panel member, Speaker's Bureau)
CH

Corrilynn Hileman

Associate Professor
Case Western Reserve University School of Medicine
Cleveland, Ohio
Disclosure: Gilead Sciences Inc. (Consultant, Scientific Research Study Investigator)
Moti Ramgopal

Medical Director
Midway Specialty Care Center
Fort Pierce, Florida
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
CM

Cheryl McDonald

Infectious Disease Specialist
Tarrant County Infectious Disease Associate
Fort Worth, TX
Disclosure: Gilead Sciences Inc. (Grant/Research Support, Scientific Research Study Investigator, Speaker's Bureau)Janssen (Grant/Research Support)Merck (Grant/Research Support, Speaker's Bureau)Viiv Healthcare (Grant/Research Support)
CB

Christiana Blair

Director
Gilead Sciences Inc.
Foster City, California
Disclosure: Gilead Sciences (Employee, Shareholder)
Kristen Andreatta

Research Scientist
Gilead Sciences, Inc.
Foster City, CA
Disclosure: Gilead Sciences (Employee, Shareholder)
SC

Sean E. Collins

Senior Director
Gilead Sciences
Foster CIty, California
Disclosure: Gilead Sciences (Employee)
Diana M. Brainard

SVP, Therapeutic Area Head, Virology
Gilead Sciences Inc.
Foster City, CA
Disclosure: Gilead Sciences (Employee)
HM

Hal Martin

Exec Director, Virology Clinical Research
Gilead Sciences
Foster City, California
Disclosure: Gilead Sciences Inc. (Employee, Shareholder)

Background: Black Americans are disproportionately impacted by HIV. The BRAAVE 2020 study, evaluated the safety and efficacy of switching to the guidelines-recommended single-tablet regimen bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) in Black adults through week (W) 48.

Methods: Adults with HIV who self-identified as Black or African American and were virologically suppressed on 2 NRTIs plus a 3^rd agent were randomized (2:1) to switch to open-label B/F/TAF once daily or stay on their baseline regimen (SBR). Prior virologic failure was allowed except failure on an INSTI. Prior resistance to NNRTIs, PIs and/or NRTIs was permitted except K65R/E/N, ≥3 thymidine analog mutations or T69-insertions. Primary INSTI-resistance was excluded. SBR participants switched to B/F/TAF at W24. Efficacy was assessed at the W24 (1^○ endpoint, noninferiority margin 6%) and at W48 as the proportion with HIV-1 RNA ≥ 50 c/mL by FDA Snapshot and by changes in CD4 count. Safety was assessed by adverse events (AE) and lab results.

Results: 495 were randomized and treated (B/F/TAF n=330, SBR n=165): 32% cis women, 2% transgender women, median age 49 y (range 18-79), 10% had pre-existing M184V/I mutation (Table 1), and 62% lived in the US South. At W24, 1% (2/328) on B/F/TAF vs 2% (3/165) on SBR had HIV-1 RNA ≥50 c/mL (difference -1.2%; 95% CI -4.8% to 0.9%) demonstrating noninferiority of B/F/TAF; 2 with pre-existing primary INSTI resistance were excluded from analysis. 163 assigned to SBR completed W24 and switched to B/F/TAF (SBR to B/F/TAF). At W48 1% (3/328) originally randomized to B/F/TAF and 0 SBR to B/F/TAF had HIV-1 RNA ≥ 50 c/mL (Table 2). The presence of baseline NRTI resistance did not affect the efficacy of B/F/TAF. No treatment emergent resistance was detected. The mean (SD) changes in CD4 were +7 cells/mm³ (189) for B/F/TAF and -8 cells/mm³ (159) for SBR to B/F/TAF. Median (IQR) weight increased 0.9 kg (-1.5, 4.1) and 0.6 kg (-1.0, 3.1) for B/F/TAF and SBR to B/F/TAF groups, respectively. Study drug-related AEs occurred in 10% of participants while on B/F/TAF; most were grade 1.Table 1.

Table 2.

Conclusion: Switching to B/F/TAF was highly effective for Black adults regardless of baseline regimen or pre-existing NRTI resistance and was associated with few treatment related AEs or discontinuations.