Same-day initiation of bictegravir/emtricitabine/tenofovir alafenamide: Week 48 results of the FAST study—IMEA 055. (20th January 2023)

• Record Type: Journal Article
• Authors: Bachelard, Antoine; Isernia, Valentina; Charpentier, Charlotte; Benalycherif, Aida; Mora, Marion; Donadille, Cécile; Duvivier, Claudine; Lacombe, Karine; El Mouhebb, Mayssam; Spire, Bruno; Landman, Roland; Descamps, Diane; Peytavin, Gilles; Assoumou, Lambert; Ghosn, Jade
• Is Part Of: Journal of antimicrobial chemotherapy. Volume 78:Number 3(2023)
• Page Start: 769
• Page End: 778
• Publication Date: 2023-01-20
• Subjects: Anti-infective agents -- Periodicals; Chemotherapy -- Periodicals; 615.58
• DOI: 10.1093/jac/dkad008
• Languages: English
• ISSNs: 0305-7453

Abstract

Abstract: Background: Initiating same-day ART for newly HIV-diagnosed individuals reduces secondary HIV transmissions and the risk of them being lost to follow-up between diagnosis and initiation of ART. Methods: The FAST study was a national, prospective, single-arm study assessing the efficacy, safety and feasibility of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in a same-day initiation model. ART had to be started on the first medical appointment, before any laboratory results were available. Participants completed a self-administered questionnaire at each visit including a HIV anxiety 5-point Likert scale. The primary outcome was the proportion of participants in the ITT population with plasma HIV RNA (pVL) < 50 copies/mL at Week (W) 24 using the FDA Snapshot algorithm. Results: Overall, 112 participants were included in the ITT population. During follow-up, seven participants discontinued the study drug but remained on the study, and seven others discontinued follow-up. According to FDA Snapshot analysis, at W24 and W48, 90/112, (80.4%; 95% CI: 71.8–87.3) and 95/112 (84.8%; 95% CI: 76.8–90.9) of participants achieved pVL < 50 copies/mL, respectively. The protocol-defined virological failure (PDVF, 2 consecutive pVL ≥ 50 copies/mL as of W24) was observed in 11/112 (9.8%) at W24 and 14/112 (12.5%) at W48. No emergent resistance-associated mutation was detected in those with PDVF at W24 and W48. BIC/FTC/TAF was well tolerated through to W48, with a low incidence of grade 3–4 adverse events (15/100 person-years). Patient opinion of same-day treatment initiation and continuing BIC/FTC/TAF was very favourable. Conclusions: These results suggest that BIC/FTC/TAF is safe, effective and well accepted for same-day initiation.