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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

2024; Oxford University Press; Volume: 79; Issue: 6 Linguagem: Inglês

10.1093/jac/dkae081

1460-2091

Antonella d’Arminio Monforte, Alessandro Tavelli, Antonio Di Biagio, Loredana Sarmati, Giulia Marchetti, Francesca Bai, Antonella Cingolani, Eugenio Quiros Roldan, Cristina Mussini, Miriam Lichtner, Alessandra Vergori, Stefania Piconi, Giancarlo Orofino, Francesco Maria Fusco, Alessandra Bandera, Silvia Nozza, Antonella Castagna, Andrea Antinori, Antonella d’Arminio Monforte, Andrea Antinori, Spinello Antinori, Antonella Castagna, Roberto Cauda, Giovanni Di Perri, Enrico Girardi, Rosaria Iardino, Adriano Lazzarin, Giulia Marchetti, C Mussini, Eugenia Quirós-Roldán, Loredana Sarmati, Barbara Suligoi, F von Schloesser, Pierluigi Viale, Antonella d’Arminio Monforte, Andrea Antinori, Antonella Castagna, Francesca Ceccherini‐Silberstein, Antonella Cingolani, Alessandro Cozzi‐Lepri, Antonio Di Biagio, Enrico Girardi, Andrea Gori, Sergio Lo Caputo, G Marchetti, Franco Maggiolo, C Mussini, Massimo Puoti, Carlo Federico Perno, Carlo Torti, Andrea Antinori, Francesca Bai, Alessandra Bandera, Stefano Bonora, Andrea Calcagno, Diana Canetti, Antonella Castagna, Francesca Ceccherini‐Silberstein, A Cervo, Antonella Cingolani, Paola Cinque, Alessandro Cozzi‐Lepri, Antonella d’Arminio Monforte, Antonio Di Biagio, Roberta Gagliardini, Andrea Giacomelli, Enrico Girardi, Nicola Gianotti, Andrea Gori, G Guaraldi, Simone Lanini, Giuseppe Lapadula, Miriam Lichtner, Alessia Lai, Sergio Lo Caputo, Giordano Madeddu, Franco Maggiolo, Vincenzo Malagnino, G Marchetti, Annalisa Mondi, Valentina Mazzotta, C Mussini, Silvia Nozza, Carlo Federico Perno, Stefania Piconi, Carmela Pinnetti, Massimo Puoti, Eugenia Quirós-Roldán, Roberto Rossotti, Stefano Rusconi, Maria Mercedes Santoro, Annalisa Saracino, Loredana Sarmati, Vincenzo Spagnuolo, Nicola Squillace, Valentina Svicher, Lucia Taramasso, Carlo Torti, Alessandra Vergori, Alessandro Cozzi‐Lepri, Sara De Benedittis, Iuri Fanti, M. Giotta, A Rodano’, Alessandro Tavelli, Albert Bové, Massimo Cernuschi, L Cosmaro, Massimiliano Errico, A Perziano, Valeria Calvino, Matteo Augello, Silvia Carrara, Silvia Graziano, Gennaro Prota, S Truffa, Donatella Vincenti, Roberta Rovito, Andrea Giacometti, Andrea Costantini, V Barocci, Annalisa Saracino, Carmen Rita Santoro, Eugenio Milano, Laura Comi, Claudia Suardi, Pierluigi Viale, Lorenzo Badia, Silvia Cretella, E M Erne, A Pieri, Eugenia Quirós-Roldán, Emanuele Focà, C Minardi, Barbara Menzaghi, C Abeli, Luchino Chessa, Francesco Pes, Paolo Maggi, Loredana Alessio, Bruno Cacopardo, Benedetto Maurizio Celesia, Jacopo Vecchiet, Katia Falasca, Angelo Pan, Sarah Dal Zoppo, Daniela Segala, Massimo Antonio Di Pietro, Cecilia Costa, Sergio Lo Caputo, Sergio Ferrara, Matteo Bassetti, Emanuele Pontali, Sophie Blanchi, Nicoletta Bobbio, Giovanni Mazzarello, Miriam Lichtner, Laura Fondaco, Stefania Piconi, Chiara Molteni, Stefano Rusconi, G Canavesi, Giuseppe Nunnari, Giovanni Francesco Pellicanò, G Marchetti, Spinello Antinori, Giuliano Rizzardini, Massimo Puoti, Antonella Castagna, Alessandra Bandera, Valeria Bono, Maria Vittoria Cossu, Andrea Giacomelli, Riccardo Lolatto, M C Moioli, Laura Pezzati, S Diotallevi, Camilla Tincati, C Mussini, Cinzia Puzzolante, Paolo Bonfanti, Giuseppe Lapadula, Vincenzo Sangiovanni, Ivan Gentile, Vincenzo Esposito, Nicola Coppola, Francesco Maria Fusco, Giovanni Di Filippo, Viviana Rizzo, Nadia Sangiovanni, Salvatore Martini, Anna Maria Cattelan, D Leoni, Antonio Cascio, Claudia Colomba, Daniela Francisci, Elisabetta Schiaroli, Giustino Parruti, Federica Sozio, Pierluigi Blanc, Sara Irene Bonelli, C Lazzaretti, R Corsini, Andrea Antinori, Roberto Cauda, Claudio Maria Mastroianni, Loredana Sarmati, Alessandra Latini, Antonella Cingolani, Valentina Mazzotta, Silvia Lamonica, M Capozzi, Annalisa Mondi, Marco Rivano Capparuccia, Giancarlo Iaiani, C Stingone, L Gianserra, Jessica Paulicelli, Maria Maddalena Plazzi, G d’Ettore, Marisa Fusto, I Coledan, Giordano Madeddu, Andrea De Vito, Massimiliano Fabbiani, Francesca Montagnani, Anaïs Franco‐Romero, Rosario Vecchio, B M Pasticci, Giuliano Enzi, Giancarlo Orofino, Guido Calleri, Giovanni Di Perri, Stefano Bonora, Giacomo Accardo, Carlo Tascini, AP Londero, Vinicio Manfrin, Giuliana Battagin, Giulio Starnini, Damiano Farinacci,

HIV/AIDS Research and Interventions

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.