Same-day initiation of bictegravir/emtricitabine/tenofovir alafenamide: Week 48 results of the FAST study-IMEA 055.
J Antimicrob Chemother
; 78(3): 769-778, 2023 03 02.
Article
in En
| MEDLINE
| ID: mdl-36659824
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)â<â50 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 pVLâ<â50 copies/mL, respectively. The protocol-defined virological failure (PDVF, 2 consecutive pVLâ≥â50 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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
HIV Infections
/
Anti-HIV Agents
Type of study:
Guideline
/
Observational_studies
/
Risk_factors_studies
Limits:
Humans
Language:
En
Journal:
J Antimicrob Chemother
Year:
2023
Document type:
Article
Affiliation country:
France