Long-term outcomes of bictegravir/emtricitabine/tenofovir alafenamide as first-line therapy and as switch strategy in virologically suppressed persons with HIV: data from the ICONA cohort.
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:
06 Apr 2024
06 Apr 2024
Historique:
received:
22
12
2023
accepted:
06
03
2024
medline:
6
4
2024
pubmed:
6
4
2024
entrez:
6
4
2024
Statut:
aheadofprint
Résumé
To assess the effectiveness of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) among people poorly represented in clinical trials and potentially at higher risk of suboptimal response to ART. Observational cohort study on persons with HIV (PWH) enrolled in ICONA who started BIC/FTC/TAF as initial therapy or as switching regimen while virologically suppressed. Primary endpoint was time to treatment failure (TF): new AIDS/death or virological failure (VF) or discontinuation for toxicity/failure. Secondary endpoints were time to treatment discontinuation for toxicity (TDT) and to VF. Groups of interest were those aged >50 years, female sex, and advanced HIV disease at first ART start. Probability of the events overall and according to groups and adjusted HR for every endpoint were calculated by Kaplan-Meier curves and Cox regression models. Nine hundred and thirty-three ART-naive and 1655 ART-experienced PWH initiated BIC/FTC/TAF. Over a median follow-up of 69.8 weeks, 89 (9.6%) PWH at their first regimen experienced TF. PWH aged >50 years had 1.83-fold (95% CI: 1.19-2.83) higher risk of TF; PWH with advanced HIV disease had 2.21-fold (95% CI: 1.53-3.82) higher risk; there were no differences in TF according to sex.Over a median follow-up of 146.3 weeks, 109 (6.6%) out of 1655 switching PWH experienced TF; no differences were found in the risk of TF, TDT and VF according to groups of interest. Overall, BIC/FTC/TAF is well tolerated and virologically effective in the real-world scenario for ART-naive and -experienced PWH. Older ART-naive PWH and those with advanced HIV disease may respond less well as the burden of diseases might compromise treatment efficacy.
Identifiants
pubmed: 38581349
pii: 7641723
doi: 10.1093/jac/dkae081
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Icona Foundation
Organisme : ViiV Healthcare
Organisme : Merck Sharpe & Dohme
Organisme : Gilead Sciences
Investigateurs
A d'Arminio Monforte
(A)
A Antinori
(A)
S Antinori
(S)
A Castagna
(A)
R Cauda
(R)
G Di Perri
(G)
E Girardi
(E)
R Iardino
(R)
A Lazzarin
(A)
G C Marchetti
(GC)
C Mussini
(C)
E Quiros-Roldan
(E)
L Sarmati
(L)
B Suligoi
(B)
F von Schloesser
(F)
P Viale
(P)
A d'Arminio Monforte
(A)
A Antinori
(A)
A Castagna
(A)
F Ceccherini-Silberstein
(F)
A Cingolani
(A)
A Cozzi-Lepri
(A)
A Di Biagio
(A)
E Girardi
(E)
A Gori
(A)
S Lo Caputo
(S)
G Marchetti
(G)
F Maggiolo
(F)
C Mussini
(C)
M Puoti
(M)
C F Perno
(CF)
C Torti
(C)
A Antinori
(A)
F Bai
(F)
A Bandera
(A)
S Bonora
(S)
A Calcagno
(A)
D Canetti
(D)
A Castagna
(A)
F Ceccherini-Silberstein
(F)
A Cervo
(A)
A Cingolani
(A)
P Cinque
(P)
A Cozzi-Lepri
(A)
A d'Arminio Monforte
(A)
A Di Biagio
(A)
R Gagliardini
(R)
A Giacomelli
(A)
E Girardi
(E)
N Gianotti
(N)
A Gori
(A)
G Guaraldi
(G)
S Lanini
(S)
G Lapadula
(G)
M Lichtner
(M)
A Lai
(A)
S Lo Caputo
(S)
G Madeddu
(G)
F Maggiolo
(F)
V Malagnino
(V)
G Marchetti
(G)
A Mondi
(A)
V Mazzotta
(V)
C Mussini
(C)
S Nozza
(S)
C F Perno
(CF)
S Piconi
(S)
C Pinnetti
(C)
M Puoti
(M)
E Quiros Roldan
(E)
R Rossotti
(R)
S Rusconi
(S)
M M Santoro
(MM)
A Saracino
(A)
L Sarmati
(L)
V Spagnuolo
(V)
N Squillace
(N)
V Svicher
(V)
L Taramasso
(L)
C Torti
(C)
A Vergori
(A)
A Cozzi-Lepri
(A)
S De Benedittis
(S)
I Fanti
(I)
M Giotta
(M)
A Rodano'
(A)
A Tavelli
(A)
A Bove
(A)
M Cernuschi
(M)
L Cosmaro
(L)
M Errico
(M)
A Perziano
(A)
V Calvino
(V)
M Augello
(M)
S Carrara
(S)
S Graziano
(S)
G Prota
(G)
S Truffa
(S)
D Vincenti
(D)
R Rovito
(R)
A Giacometti
(A)
A Costantini
(A)
V Barocci
(V)
A Saracino
(A)
C Santoro
(C)
E Milano
(E)
L Comi
(L)
C Suardi
(C)
P Viale
(P)
L Badia
(L)
S Cretella
(S)
E M Erne
(EM)
A Pieri
(A)
E Quiros Roldan
(E)
E Focà
(E)
C Minardi
(C)
B Menzaghi
(B)
C Abeli
(C)
L Chessa
(L)
F Pes
(F)
P Maggi
(P)
L Alessio
(L)
B Cacopardo
(B)
B Celesia
(B)
J Vecchiet
(J)
K Falasca
(K)
A Pan
(A)
S Dal Zoppo
(S)
D Segala
(D)
M A Di Pietro
(MA)
C Costa
(C)
S Lo Caputo
(S)
S Ferrara
(S)
M Bassetti
(M)
E Pontali
(E)
S Blanchi
(S)
N Bobbio
(N)
G Mazzarello
(G)
M Lichtner
(M)
L Fondaco
(L)
S Piconi
(S)
C Molteni
(C)
S Rusconi
(S)
G Canavesi
(G)
G Nunnari
(G)
G Pellicanò
(G)
G Marchetti
(G)
S Antinori
(S)
G Rizzardini
(G)
M Puoti
(M)
A Castagna
(A)
A Bandera
(A)
V Bono
(V)
M V Cossu
(MV)
A Giacomelli
(A)
R Lolatto
(R)
M C Moioli
(MC)
L Pezzati
(L)
S Diotallevi
(S)
C Tincati
(C)
C Mussini
(C)
C Puzzolante
(C)
P Bonfanti
(P)
G Lapadula
(G)
V Sangiovanni
(V)
I Gentile
(I)
V Esposito
(V)
N Coppola
(N)
F M Fusco
(FM)
G Di Filippo
(G)
V Rizzo
(V)
N Sangiovanni
(N)
S Martini
(S)
A M Cattelan
(AM)
D Leoni
(D)
A Cascio
(A)
C Colomba
(C)
D Francisci
(D)
E Schiaroli
(E)
G Parruti
(G)
F Sozio
(F)
P Blanc
(P)
S I Bonelli
(SI)
C Lazzaretti
(C)
R Corsini
(R)
A Antinori
(A)
R Cauda
(R)
C Mastroianni
(C)
L Sarmati
(L)
A Latini
(A)
A Cingolani
(A)
V Mazzotta
(V)
S Lamonica
(S)
M Capozzi
(M)
A Mondi
(A)
M Rivano Capparuccia
(M)
G Iaiani
(G)
C Stingone
(C)
L Gianserra
(L)
J Paulicelli
(J)
M M Plazzi
(MM)
G d'Ettore
(G)
M Fusto
(M)
I Coledan
(I)
G Madeddu
(G)
A De Vito
(A)
M Fabbiani
(M)
F Montagnani
(F)
A Franco
(A)
R Fontana Del Vecchio
(R)
B M Pasticci
(BM)
C Di Giuli
(C)
G C Orofino
(GC)
G Calleri
(G)
G Di Perri
(G)
S Bonora
(S)
G Accardo
(G)
C Tascini
(C)
A Londero
(A)
V Manfrin
(V)
G Battagin
(G)
G Starnini
(G)
D Farinacci
(D)
Informations de copyright
© The Author(s) 2024. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.