Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women: A Randomized, Open-Label, Multicenter, Active-Controlled, Phase 3, Noninferiority Trial

Autor: Ploenchan Chetchotisakd, Cissy Kityo, Khuanchai Supparatpinyo, Anchalee Avihingsanon, Evgeny Voronin, Tariro Makadzange, Huyen Cao, Jeffrey L. Stephens, Rima Acosta, Edwin DeJesus, Vadim Pokrovsky, Natalya Gankina, Erin Quirk, Ellen Koenig, Hal Martin, Hui Wang, Debbie Hagins
Přispěvatelé: Global Health, Graduate School, AII - Infectious diseases, APH - Personalized Medicine, APH - Quality of Care
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: Journal of acquired immune deficiency syndromes (1999), 82(3), 321-328. Lippincott Williams and Wilkins
ISSN: 1525-4135
Popis: BACKGROUND: Bictegravir, coformulated with emtricitabine/tenofovir alafenamide as a fixed-dose combination (B/F/TAF), is recommended for treatment of HIV-1-infection. Multiple studies of B/F/TAF in treatment-naive and virologically suppressed cohorts have shown high efficacy and tolerability with no treatment-emergent resistance through 48 weeks. Participants in these studies have been predominantly men. We report 48-week results from a phase 3 study evaluating switching to B/F/TAF, specifically in a globally distributed trial population of women. METHODS: In this multicenter, randomized, open-label, active-controlled, noninferiority trial (ClinicalTrials.gov NCT02652624), women living with HIV who were virologically suppressed (HIV-1 RNA levels
Databáze: OpenAIRE