Same-day initiation of bictegravir/emtricitabine/tenofovir alafenamide: Week 48 results of the FAST study—IMEA 055
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 ,   FAST study group, Landman Roland , Ghosn Jade , Mora Marion , Assoumou Lambert , Peytavin Gilles , Descamps Diane , Charpentier Charlotte , Bachelard Antoine , Préau Marie , Sahali Sabrinel , Benalycherif Aïda , Godin Ophelia , Soulié Cathia , Valantin Marc-Antoine , Zucman David , Fadli Amina , Fourn Erwan , Farfour Eric , Abel Sylvie , Cabié André , Cabras Ornella , Cuzin Lise , Fagour Laurence , Pierre-François Sandrine , Pialoux Gilles , Adda Anne , Chas Julie , Siguier Martin , Palacios Christia , Agher Nouara , Chabrol Amelie , Gabas Thomas , Pires Elisabete Gomes , Touam Fatima , Duvivier Claudine , Cornavin Pauline , Ajana Faiza , Robineau Olivier , Bernard Louis , Gras Guillaume , Brouillet Guillaume , Bourgault Olivier , Touitou Irit , Naqvi Alissa , Goubin Pascale , Ricci Anne , Verdon Renaud , Tramoni Christine , Reynes Jacques , Lepuils Séverine , Neau Didier , Charles Carole , Piroth Lionel , Tran Christian , Valin Nadia , Lacombe Karine , Julia Zélie , Legac Sylvie , Bachelard Antoine , Ghosn Jade 
Published: January 2023

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) &lt; 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 &lt; 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.