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.
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. - In: JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY. - ISSN 0305-7453. - 79:6(2024), pp. 1279-1288. [10.1093/jac/dkae081]
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
Mussini, Cristina;
2024
Abstract
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.
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