Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Black Americans With HIV-1: A Randomized Phase 3b, Multicenter, Open-Label Study.
Adenine
/ therapeutic use
Adolescent
Adult
Black or African American
Aged
Alanine
/ therapeutic use
Amides
/ therapeutic use
Anti-HIV Agents
/ therapeutic use
Drug Combinations
Emtricitabine
/ therapeutic use
Female
HIV Infections
/ drug therapy
HIV Seropositivity
HIV-1
/ drug effects
Heterocyclic Compounds, 3-Ring
/ therapeutic use
Heterocyclic Compounds, 4 or More Rings
/ therapeutic use
Humans
Male
Middle Aged
Piperazines
/ therapeutic use
Pyridones
/ therapeutic use
RNA
/ therapeutic use
Tenofovir
/ analogs & derivatives
United States
/ epidemiology
Viral Load
/ drug effects
Journal
Journal of acquired immune deficiency syndromes (1999)
ISSN: 1944-7884
Titre abrégé: J Acquir Immune Defic Syndr
Pays: United States
ID NLM: 100892005
Informations de publication
Date de publication:
01 09 2021
01 09 2021
Historique:
received:
16
11
2020
accepted:
17
03
2021
entrez:
16
8
2021
pubmed:
17
8
2021
medline:
31
12
2021
Statut:
ppublish
Résumé
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.
Sections du résumé
BACKGROUND
With the highest rates of HIV/AIDS in the United States, Black Americans are still underrepresented in HIV medical research.
SETTING
BRAAVE (NCT03631732) is a randomized, phase 3b, multicenter, open-label US study.
METHODS
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%).
RESULTS
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.
CONCLUSIONS
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.
Identifiants
pubmed: 34397746
doi: 10.1097/QAI.0000000000002731
pii: 00126334-202109010-00012
pmc: PMC8357046
doi:
Substances chimiques
Amides
0
Anti-HIV Agents
0
Drug Combinations
0
Heterocyclic Compounds, 3-Ring
0
Heterocyclic Compounds, 4 or More Rings
0
Piperazines
0
Pyridones
0
RNA
63231-63-0
bictegravir
8GB79LOJ07
Tenofovir
99YXE507IL
tenofovir alafenamide
EL9943AG5J
Emtricitabine
G70B4ETF4S
Adenine
JAC85A2161
Alanine
OF5P57N2ZX
Banques de données
ClinicalTrials.gov
['NCT03631732']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
86-95Informations de copyright
Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.
Déclaration de conflit d'intérêts
P.K. reports grants from Gilead Sciences, Inc. (Gilead), GlaxoSmithKline (GSK), Merck, and Theratechnologies, has received personal fees for participating in advisory boards for GSK, Merck, and Theratechnologies, and is a shareholder of stock from Gilead, GSK, Johnson & Johnson, Merck, and Pfizer. M.S. has received research grants and support awarded to his institution from Gilead, Merck, and ViiV Healthcare. A.K.W. has received research grants from Gilead, Janssen, Pfizer, and GSK and has served on advisory boards for Gilead and Janssen. I.B. has received speakers' bureau honoraria from Gilead, ViiV, and Janssen. C.O.H. has received grant support from the National Institutes of Health (K23HL116209) and has served as consultant to Gilead Sciences. M.N.R. has served on the speakers' bureau for Gilead, Janssen, AbbVie, and Allergan and has consulted for Gilead, ViiV, and Merck. C.M. reports receiving research grants from Gilead, Janssen, Merck, and ViiV and speaker's bureau income from Gilead and Merck. C.B., K.A., S.E.C., D.M.B., and H.M. are employees of Gilead and shareholders of Gilead stock. The remaining authors have no conflicts of interest to disclose.
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