High efficacy of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in Black adults in the United States, including those with pre-existing HIV resistance and suboptimal adherence.
Humans
HIV Infections
/ drug therapy
Tenofovir
/ therapeutic use
Male
Female
Emtricitabine
/ therapeutic use
Drug Resistance, Viral
/ genetics
Anti-HIV Agents
/ therapeutic use
Adult
United States
Pyridones
/ therapeutic use
Middle Aged
Piperazines
/ therapeutic use
Heterocyclic Compounds, 4 or More Rings
/ therapeutic use
HIV-1
/ drug effects
Medication Adherence
/ statistics & numerical data
Black or African American
Drug Combinations
Heterocyclic Compounds, 3-Ring
/ therapeutic use
Adenine
/ analogs & derivatives
Amides
/ therapeutic use
Treatment Outcome
Alanine
/ therapeutic use
Viral Load
/ drug effects
anti‐retrovirus drug
combination therapy
human immunodeficiency virus
resistance
Journal
Journal of medical virology
ISSN: 1096-9071
Titre abrégé: J Med Virol
Pays: United States
ID NLM: 7705876
Informations de publication
Date de publication:
Oct 2024
Oct 2024
Historique:
revised:
24
07
2024
received:
15
05
2024
accepted:
20
08
2024
medline:
7
10
2024
pubmed:
7
10
2024
entrez:
7
10
2024
Statut:
ppublish
Résumé
BRAAVE (NCT03631732), a Phase 3b, multicenter, open-label US study, demonstrated the efficacy of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) among Black individuals with suppressed HIV through 48 weeks. Here, 72-week resistance, adherence, and virologic outcomes are presented. Enrollment criteria permitted nonnucleoside reverse transcriptase inhibitor (NNRTI)-resistance (R), protease inhibitor (PI)-R, and certain nucleos(t)ide reverse transcriptase inhibitor (NRTI)-R (M184V/I allowed; ≥3 thymidine analog mutations [TAMs] excluded); but excluded primary integrase strand transfer inhibitor (INSTI)-R. Pre-existing resistance was determined using historical genotypes and retrospective baseline proviral DNA genotyping. Adherence, virologic outcomes, and viral blips were assessed. Of 489 participants receiving B/F/TAF with ≥1 post-switch HIV-1 RNA measurement: pre-existing NRTI-R (15% of participants), M184V/I (11%), ≥1 TAMs (8%), NNRTI-R (22%), and PI-R (13%) were observed; pre-existing INSTI-R substitutions (2%) were detected post-randomization; mean viral blip frequency was 0.9% across all timepoints (unassociated with virologic failure); 24% of participants had <95% adherence (98% of whom had HIV-1 RNA <50 copies/mL at last visit); none had treatment-emergent study-drug resistance. Overall, 99% of participants, including all with baseline NRTI-R/INSTI-R, had HIV-1 RNA <50 copies/mL at the last visit, demonstrating that B/F/TAF maintained virologic suppression through 72 weeks regardless of pre-existing resistance, viral blips, and suboptimal adherence.
Substances chimiques
Tenofovir
99YXE507IL
Emtricitabine
G70B4ETF4S
Anti-HIV Agents
0
Pyridones
0
Piperazines
0
Heterocyclic Compounds, 4 or More Rings
0
bictegravir
8GB79LOJ07
Drug Combinations
0
Heterocyclic Compounds, 3-Ring
0
Adenine
JAC85A2161
Amides
0
Alanine
OF5P57N2ZX
tenofovir alafenamide
EL9943AG5J
bictegravir, emtricitabine, tenofovir alafenamide, drug combination
0
Types de publication
Journal Article
Multicenter Study
Clinical Trial, Phase III
Langues
eng
Sous-ensembles de citation
IM
Pagination
e29899Subventions
Organisme : Gilead Sciences, Inc.
Informations de copyright
© 2024 Gilead Sciences, Inc. and The Author(s). Journal of Medical Virology published by Wiley Periodicals LLC.
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