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Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Black Americans With HIV-1: A Randomized Phase 3b, Multicenter, Open-Label Study.

Authors
  • Hagins, Debbie1
  • Kumar, Princy2
  • Saag, Michael3
  • Wurapa, Anson K4
  • Brar, Indira5
  • Berger, Daniel6
  • Osiyemi, Olayemi7
  • Hileman, Corrilynn O8
  • Ramgopal, Moti N9
  • McDonald, Cheryl10
  • Blair, Christiana11
  • Andreatta, Kristen11
  • Collins, Sean E11
  • Brainard, Diana M11
  • Martin, Hal11
  • 1 Chatham CARE Center, Savannah, GA.
  • 2 Department of Medicine, Georgetown University, Washington, DC.
  • 3 Department of Medicine, University of Alabama at Birmingham, Birmingham, AL.
  • 4 Infectious Disease Specialists of Atlanta, Atlanta, GA.
  • 5 Department of Medicine, Henry Ford Hospital, Detroit, MI.
  • 6 Northstar Medical Center, Chicago, IL.
  • 7 Triple O Research Institute, West Palm Beach, FL.
  • 8 Case Western Reserve University, Cleveland, OH.
  • 9 Midway Immunology and Research Center, Fort Pierce, FL.
  • 10 Tarrant County Infectious Disease Associates, Fort Worth, TX; and.
  • 11 Gilead Sciences, Inc., Foster City, CA.
Type
Published Article
Journal
Journal of acquired immune deficiency syndromes (1999)
Publication Date
Sep 01, 2021
Volume
88
Issue
1
Pages
86–95
Identifiers
DOI: 10.1097/QAI.0000000000002731
PMID: 34397746
Source
Medline
Language
English
License
Unknown

Abstract

With the highest rates of HIV/AIDS in the United States, Black Americans are still underrepresented in HIV medical research. BRAAVE (NCT03631732) is a randomized, phase 3b, multicenter, open-label US study. Adults identifying as Black or African American and virologically suppressed on 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus third agent were randomized (2:1) to switch to open-label bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) once daily or stay on baseline regimen (SBR) for 24 weeks, after which SBR had delayed switch to B/F/TAF. Resistance to non-NRTIs, protease inhibitors, and/or NRTIs was permitted; integrase strand transfer inhibitor resistance was exclusionary. Primary endpoint was proportion of participants with HIV-1 RNA ≥50 copies/mL at week 24 (snapshot algorithm; noninferiority margin of 6%). Of 558 screened, 495 were randomized/treated (B/F/TAF n = 330; SBR n = 165). Overall, 32% were ciswomen, 2% transwomen, and 10% had an M184V/I mutation. At week 24, 0.6% on B/F/TAF vs 1.8% on SBR had HIV-1 RNA ≥50 copies/mL (difference -1.2%; 95% confidence interval -4.8% to 0.9%), demonstrating noninferiority of B/F/TAF vs SBR. Proportions with HIV-1 RNA <50 copies/mL at week 24 were 96% B/F/TAF and 95% SBR and remained high at week 48. No participant had treatment-emergent resistance to study drug. Treatments were well tolerated. Study drug-related adverse events, mostly grade 1, occurred in 10% of participants on B/F/TAF through week 48 and led to discontinuation in 9 participants through week 48. For Black Americans with HIV, switching to B/F/TAF was noninferior to continuing a variety of regimens, including those with pre-existing NRTI mutations. Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.

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