Published 2024 | Version v1
Publication

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

d'Arminio Monforte, Antonella
Tavelli, Alessandro
Di Biagio, Antonio
Sarmati, Loredana
Marchetti, Giulia C
Bai, Francesca
Cingolani, Antonella
Quiros Roldan, Eugenio
Mussini, Cristina
Lichtner, Miriam
Vergori, Alessandra
Piconi, Stefania
Orofino, Giancarlo
Fusco, Francesco Maria
Bandera, Alessandra
Nozza, Silvia
Castagna, Antonella
Antinori, Andrea
d'Arminio Monforte, A
Antinori, A
Antinori, S
Castagna, A
Cauda, R
Di Perri, G
Girardi, E
Iardino, R
Lazzarin, A
Marchetti, G C
Mussini, C
Quiros-Roldan, E
Sarmati, L
Suligoi, B
von Schloesser, F
Viale, P
d'Arminio Monforte, A
Antinori, A
Castagna, A
Ceccherini-Silberstein, F
Cingolani, A
Cozzi-Lepri, A
Di Biagio, A
Girardi, E
Gori, A
Lo Caputo, S
Marchetti, G
Maggiolo, F
Mussini, C
Puoti, M
Perno, C F
Torti, C
Antinori, A
Bai, F
Bandera, A
Bonora, S
Calcagno, A
Canetti, D
Castagna, A
Ceccherini-Silberstein, F
Cervo, A
Cingolani, A
Cinque, P
Cozzi-Lepri, A
d'Arminio Monforte, A
Di Biagio, A
Gagliardini, R
Giacomelli, A
Girardi, E
Gianotti, N
Gori, A
Guaraldi, G
Lanini, S
Lapadula, G
Lichtner, M
Lai, A
Lo Caputo, S
Madeddu, G
Maggiolo, F
Malagnino, V
Marchetti, G
Mondi, A
Mazzotta, V
Mussini, C
Nozza, S
Perno, C F
Piconi, S
Pinnetti, C
Puoti, M
Quiros Roldan, E
Rossotti, R
Rusconi, S
Santoro, M M
Saracino, A
Sarmati, L
Spagnuolo, V
Squillace, N
Svicher, V
Taramasso, L
Torti, C
Vergori, A
Cozzi-Lepri, A
De Benedittis, S
Fanti, I
Giotta, M
Rodano', A
Tavelli, A
Bove, A
Cernuschi, M
Cosmaro, L
Errico, M
Perziano, A
Calvino, V
Augello, M
Carrara, S
Graziano, S
Prota, G
Truffa, S
Vincenti, D
Rovito, R
Giacometti, A
Costantini, A
Barocci, V
Saracino, A
Santoro, C
Milano, E
Comi, L
Suardi, C
Viale, P
Badia, L
Cretella, S
Erne, E M
Pieri, A
Quiros Roldan, E
Focà, E
Minardi, C
Menzaghi, B
Abeli, C
Chessa, L
Pes, F
Maggi, P
Alessio, L
Cacopardo, B
Celesia, B
Vecchiet, J
Falasca, K
Pan, A
Dal Zoppo, S
Segala, D
Di Pietro, M A
Costa, C
Lo Caputo, S
Ferrara, S
Bassetti, M
Pontali, E
Blanchi, S
Bobbio, N
Mazzarello, G
Lichtner, M
Fondaco, L
Piconi, S
Molteni, C
Rusconi, S
Canavesi, G
Nunnari, G
Pellicanò, G
Marchetti, G
Antinori, S
Rizzardini, G
Puoti, M
Castagna, A
Bandera, A
Bono, V
Cossu, M V
Giacomelli, A
Lolatto, R
Moioli, M C
Pezzati, L
Diotallevi, S
Tincati, C
Mussini, C
Puzzolante, C
Bonfanti, P
Lapadula, G
Sangiovanni, V
Gentile, I
Esposito, V
Coppola, N
Fusco, F M
Di Filippo, G
Rizzo, V
Sangiovanni, N
Martini, S
Cattelan, A M
Leoni, D
Cascio, A
Colomba, C
Francisci, D
Schiaroli, E
Parruti, G
Sozio, F
Blanc, P
Bonelli, S I
Lazzaretti, C
Corsini, R
Antinori, A
Cauda, R
Mastroianni, C
Sarmati, L
Latini, A
Cingolani, A
Mazzotta, V
Lamonica, S
Capozzi, M
Mondi, A
Rivano Capparuccia, M
Iaiani, G
Stingone, C
Gianserra, L
Paulicelli, J
Plazzi, M M
d'Ettore, G
Fusto, M
Coledan, I
Madeddu, G
De Vito, A
Fabbiani, M
Montagnani, F
Franco, A
Fontana Del Vecchio, R
Pasticci, B M
Di Giuli, C
Orofino, G C
Calleri, G
Di Perri, G
Bonora, S
Accardo, G
Tascini, C
Londero, A
Manfrin, V
Battagin, G
Starnini, G
Farinacci, D
null, null
Others:
d'Arminio Monforte, Antonella
Tavelli, Alessandro
Di Biagio, Antonio
Sarmati, Loredana
Marchetti, Giulia C
Bai, Francesca
Cingolani, Antonella
Quiros Roldan, Eugenio
Mussini, Cristina
Lichtner, Miriam
Vergori, Alessandra
Piconi, Stefania
Orofino, Giancarlo
Fusco, Francesco Maria
Bandera, Alessandra
Nozza, Silvia
Castagna, Antonella
Antinori, Andrea
d'Arminio Monforte, A
Antinori, A
Antinori, S
Castagna, A
Cauda, R
Di Perri, G
Girardi, E
Iardino, R
Lazzarin, A
Marchetti, G C
Mussini, C
Quiros-Roldan, E
Sarmati, L
Suligoi, B
von Schloesser, F
Viale, P
d'Arminio Monforte, A
Antinori, A
Castagna, A
Ceccherini-Silberstein, F
Cingolani, A
Cozzi-Lepri, A
Di Biagio, A
Girardi, E
Gori, A
Lo Caputo, S
Marchetti, G
Maggiolo, F
Mussini, C
Puoti, M
Perno, C F
Torti, C
Antinori, A
Bai, F
Bandera, A
Bonora, S
Calcagno, A
Canetti, D
Castagna, A
Ceccherini-Silberstein, F
Cervo, A
Cingolani, A
Cinque, P
Cozzi-Lepri, A
d'Arminio Monforte, A
Di Biagio, A
Gagliardini, R
Giacomelli, A
Girardi, E
Gianotti, N
Gori, A
Guaraldi, G
Lanini, S
Lapadula, G
Lichtner, M
Lai, A
Lo Caputo, S
Madeddu, G
Maggiolo, F
Malagnino, V
Marchetti, G
Mondi, A
Mazzotta, V
Mussini, C
Nozza, S
Perno, C F
Piconi, S
Pinnetti, C
Puoti, M
Quiros Roldan, E
Rossotti, R
Rusconi, S
Santoro, M M
Saracino, A
Sarmati, L
Spagnuolo, V
Squillace, N
Svicher, V
Taramasso, L
Torti, C
Vergori, A
Cozzi-Lepri, A
De Benedittis, S
Fanti, I
Giotta, M
Rodano', A
Tavelli, A
Bove, A
Cernuschi, M
Cosmaro, L
Errico, M
Perziano, A
Calvino, V
Augello, M
Carrara, S
Graziano, S
Prota, G
Truffa, S
Vincenti, D
Rovito, R
Giacometti, A
Costantini, A
Barocci, V
Saracino, A
Santoro, C
Milano, E
Comi, L
Suardi, C
Viale, P
Badia, L
Cretella, S
Erne, E M
Pieri, A
Quiros Roldan, E
Focà, E
Minardi, C
Menzaghi, B
Abeli, C
Chessa, L
Pes, F
Maggi, P
Alessio, L
Cacopardo, B
Celesia, B
Vecchiet, J
Falasca, K
Pan, A
Dal Zoppo, S
Segala, D
Di Pietro, M A
Costa, C
Lo Caputo, S
Ferrara, S
Bassetti, M
Pontali, E
Blanchi, S
Bobbio, N
Mazzarello, G
Lichtner, M
Fondaco, L
Piconi, S
Molteni, C
Rusconi, S
Canavesi, G
Nunnari, G
Pellicanò, G
Marchetti, G
Antinori, S
Rizzardini, G
Puoti, M
Castagna, A
Bandera, A
Bono, V
Cossu, M V
Giacomelli, A
Lolatto, R
Moioli, M C
Pezzati, L
Diotallevi, S
Tincati, C
Mussini, C
Puzzolante, C
Bonfanti, P
Lapadula, G
Sangiovanni, V
Gentile, I
Esposito, V
Coppola, N
Fusco, F M
Di Filippo, G
Rizzo, V
Sangiovanni, N
Martini, S
Cattelan, A M
Leoni, D
Cascio, A
Colomba, C
Francisci, D
Schiaroli, E
Parruti, G
Sozio, F
Blanc, P
Bonelli, S I
Lazzaretti, C
Corsini, R
Antinori, A
Cauda, R
Mastroianni, C
Sarmati, L
Latini, A
Cingolani, A
Mazzotta, V
Lamonica, S
Capozzi, M
Mondi, A
Rivano Capparuccia, M
Iaiani, G
Stingone, C
Gianserra, L
Paulicelli, J
Plazzi, M M
D'Ettore, G
Fusto, M
Coledan, I
Madeddu, G
De Vito, A
Fabbiani, M
Montagnani, F
Franco, A
Fontana Del Vecchio, R
Pasticci, B M
Di Giuli, C
Orofino, G C
Calleri, G
Di Perri, G
Bonora, S
Accardo, G
Tascini, C
Londero, A
Manfrin, V
Battagin, G
Starnini, G
Farinacci, D
Null, Null

Description

Objectives: 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. Methods: 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. Results: 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. Conclusions: 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.

Additional details

Created:
July 3, 2024
Modified:
July 3, 2024