Week 96 Genotypic and Phenotypic Results of the Fostemsavir Phase 3 BRIGHTE Study in Heavily Treatment-Experienced Adults Living with Multidrug-Resistant HIV-1.
HIV-1
antiretroviral agents
attachment inhibitor
fostemsavir
heavily treatment experienced
multiple antiretroviral drug resistance
optimized background therapy
Journal
Antimicrobial agents and chemotherapy
ISSN: 1098-6596
Titre abrégé: Antimicrob Agents Chemother
Pays: United States
ID NLM: 0315061
Informations de publication
Date de publication:
21 06 2022
21 06 2022
Historique:
pubmed:
4
5
2022
medline:
24
6
2022
entrez:
3
5
2022
Statut:
ppublish
Résumé
In the phase 3 BRIGHTE study in heavily treatment-experienced adults with multidrug-resistant HIV-1, fostemsavir plus optimized background therapy (OBT) resulted in sustained rates of virologic suppression through 96 weeks. HIV-1 RNA <40 copies/mL was achieved in 163/272 (60%) Randomized Cohort (RC) participants (with 1 or 2 remaining approved fully active antiretrovirals) and 37/99 (37%) Non-randomized Cohort (NRC) participants (with 0 fully active antiretrovirals). Here we report genotypic and phenotypic analyses of HIV-1 samples from 63/272 (23%) RC participants and 49/99 (49%) NRC participants who met protocol-defined virologic failure (PDVF) criteria through Week 96. The incidence of PDVF was as expected in this difficult-to-treat patient population and, among RC participants, was comparable regardless of the presence of predefined gp120 amino acid substitutions that potentially influence phenotypic susceptibility to temsavir (S375H/I/M/N/T, M426L, M434I, M475I) or baseline temsavir 50% inhibitory concentration fold change (IC
Identifiants
pubmed: 35502922
doi: 10.1128/aac.01751-21
pmc: PMC9211436
doi:
Substances chimiques
Anti-HIV Agents
0
Organophosphates
0
Piperazines
0
fostemsavir
97IQ273H4L
Banques de données
ClinicalTrials.gov
['NCT02362503']
Types de publication
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0175121Subventions
Organisme : NCATS NIH HHS
ID : UL1 TR001863
Pays : United States
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