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Same-day initiation of bictegravir/emtricitabine/tenofovir alafenamide: Week 48 results of the FAST study—IMEA 055

2023; Oxford University Press; Volume: 78; Issue: 3 Linguagem: Inglês

10.1093/jac/dkad008

1460-2091

Antoine Bachelard, Valentina Isernia, Charlotte Charpentier, Aı̈da Benalychérif, Marion Mora, Cécile Donadille, Claudine Duvivier, Karine Lacombe, Mayssam El Mouhebb, Bruno Spire, Roland Landman, Diane Descamps, Gilles Peytavin, Lambert Assoumou, Jade Ghosn, Roland Landman, Jade Ghosn, Marion Mora, Lambert Assoumou, Gilles Peytavin, Diane Descamps, Charlotte Charpentier, Antoine Bachelard, Marie Préau, Sabrinel Sahali, Aı̈da Benalychérif, O. Godin, Cathia Soulié, Marc‐Antoine Valantin, David Zucman, Amina Fadli, Erwan Fourn, Éric Farfour, Sylvie Abel, André Cabie, Ornella Cabras, Lise Cuzin, Laurence Fagour, Sandrine Pierre-François, G. Pialoux, Anne Adda, Julie Chas, Martin Siguier, Christia Palacios, Nouara Agher, Amélie Chabrol, Thomas Gabas, Elisabete Gomes Pires, Fatima Touam, Claudine Duvivier, Pauline Cornavin, Faïza Ajana, Olivier Robineau, Louis Bernard, Guillaume Gras, Guillaume Brouillet, Olivier Bourgault, Isabelle Touitou, Alissa Naqvi, Pascale Goubin, Anne Ricci, Renaud Verdon, Christine Tramoni, Jacques Reynes, Séverine Lepuils, D. Neau, Carole Charles, Lionel Piroth, Christian Tran, Nadia Valin, Karine Lacombe, Zélie Julia, Sylvie LeGac, Antoine Bachelard, Jade Ghosn,

HIV Research and Treatment

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.