Same-day initiation of bictegravir/emtricitabine/tenofovir alafenamide: Week 48 results of the FAST study-IMEA 055.
Journal
The Journal of antimicrobial chemotherapy
ISSN: 1460-2091
Titre abrégé: J Antimicrob Chemother
Pays: England
ID NLM: 7513617
Informations de publication
Date de publication:
02 03 2023
02 03 2023
Historique:
received:
25
10
2022
accepted:
03
01
2023
pubmed:
21
1
2023
medline:
4
3
2023
entrez:
20
1
2023
Statut:
ppublish
Résumé
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. 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. 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. These results suggest that BIC/FTC/TAF is safe, effective and well accepted for same-day initiation.
Sections du résumé
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.
Identifiants
pubmed: 36659824
pii: 6993679
doi: 10.1093/jac/dkad008
doi:
Substances chimiques
tenofovir alafenamide
EL9943AG5J
bictegravir
8GB79LOJ07
Emtricitabine
G70B4ETF4S
Adenine
JAC85A2161
Alanine
OF5P57N2ZX
Pyridones
0
Drug Combinations
0
Heterocyclic Compounds, 4 or More Rings
0
Anti-HIV Agents
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
769-778Investigateurs
Roland Landman
(R)
Jade Ghosn
(J)
Marion Mora
(M)
Lambert Assoumou
(L)
Gilles Peytavin
(G)
Diane Descamps
(D)
Charlotte Charpentier
(C)
Antoine Bachelard
(A)
Marie Préau
(M)
Sabrinel Sahali
(S)
Aïda Benalycherif
(A)
Ophelia Godin
(O)
Cathia Soulié
(C)
Marc-Antoine Valantin
(MA)
David Zucman
(D)
Amina Fadli
(A)
Erwan Fourn
(E)
Eric Farfour
(E)
Sylvie Abel
(S)
André Cabié
(A)
Ornella Cabras
(O)
Lise Cuzin
(L)
Laurence Fagour
(L)
Sandrine Pierre-François
(S)
Gilles Pialoux
(G)
Anne Adda
(A)
Julie Chas
(J)
Martin Siguier
(M)
Christia Palacios
(C)
Nouara Agher
(N)
Amelie Chabrol
(A)
Thomas Gabas
(T)
Elisabete Gomes Pires
(EG)
Fatima Touam
(F)
Claudine Duvivier
(C)
Pauline Cornavin
(P)
Faiza Ajana
(F)
Olivier Robineau
(O)
Louis Bernard
(L)
Guillaume Gras
(G)
Guillaume Brouillet
(G)
Olivier Bourgault
(O)
Irit Touitou
(I)
Alissa Naqvi
(A)
Pascale Goubin
(P)
Anne Ricci
(A)
Renaud Verdon
(R)
Christine Tramoni
(C)
Jacques Reynes
(J)
Séverine Lepuils
(S)
Didier Neau
(D)
Carole Charles
(C)
Lionel Piroth
(L)
Christian Tran
(C)
Nadia Valin
(N)
Karine Lacombe
(K)
Zélie Julia
(Z)
Sylvie Legac
(S)
Antoine Bachelard
(A)
Jade Ghosn
(J)
Informations de copyright
© The Author(s) 2023. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.