Effectiveness and predictors of treatment discontinuation of long-acting cabotegravir/rilpivirine in virologically suppressed people with HIV: real-life data from the Icona Cohort

作者：Roberta Gagliardini, S De Benedittis, Alessandro Tavelli, Giuseppe Lapadula, Valentina Mazzotta, Elena Bruzzesi, Adriana Cervo, Giorgia Carrozzo, Annalisa Saracino, Stefano Rusconi, Giulia Marchetti, Francesca Ceccherini‐Silberstein, Andrea Antinori, Antonella d’Arminio Monforte, Camilla Muccini, Antonella d’Arminio Monforte, Andrea Antinori, Spinello Antinori, Antonella Castagna, Roberto Cauda, Giampaolo Perri, Enrico Girardi, R Iardino, Adriano Lazzarin, Giulia Marchetti, C Mussini, Eugenia Quirós-Roldán, Loredana Sarmati, Barbara Suligoi, F von Schloesser, P. 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, 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, A Giacomelli, Enrico Girardi, Nicola Gianotti, Andrea Gori, Giovanni 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, S De Benedittis, Iuri Fanti, M Giotta, Cécilia Marelli, A Rodano, Alessandro Tavelli, Massimo Cernuschi, L Cosmaro, A Perziano, Valeria Calvino, Danilo Russo, M Farinella, Nicoletta Policek, V L Del Negro, Matteo Augello, Silvia Carrara, Silvia Graziano, Gennaro Prota, S Truffa, Donatella Vincenti, Roberta Rovito, Hossein Sadeghi, Andrea Giacometti, Andrea Costantini, V Barocci, Annalisa Saracino, Carmen Rita Santoro, Eugenio Milano, Laura Comi, Claudia Suardi, P. Viale, Leonardo Badia, Silvia Cretella, E M Erne, A Pieri, Eugenia Quirós-Roldán, Emanuele Focà, B Menzaghi, C Abeli, Luchino Chessa, Francesco Pes, Paolo Maggi, Loredana Alessio, Giuseppe Nunnari, Benedetto Maurizio Celesia, Jacopo Vecchiet, Katia Falasca, Angelo Pan, Sarah Dal Zoppo, Daniela Segala, Filippo Bartalesi, Cecilia Costa, Sergio Lo Caputo, Sergio Ferrara, Matteo Bassetti, Emanuele Pontali, Sophie Blanchi, Nicoletta Bobbio, Cosmo Del Borgo, R. Marocco, G Mancarella, Stefania Piconi, Chiara Molteni, Stefano Rusconi, G Canavesi, Giovanni Francesco Pellicanò, G Marchetti, Spinello Antinori, Gloria Montenegro Rizzardini, Massimo Puoti, Antonella Castagna, Alessandra Bandera, Valeria Bono, Maria Vittoria Cossu, A Giacomelli, Riccardo Lolatto, M C Moioli, Laura Pezzati, S Diotallevi, Camilla Tincati, C Mussini, M Menozzi, Paolo Bonfanti, Giuseppe Lapadula, Vincenzo Sangiovanni, Ivan Gentile, Vincenzo Esposito, Nicola Coppola, Francesco Maria Fusco, Giovanni Di Filippo, Vincent Rizzo, N Sangiovanni, Salvatore Martini, Anna Maria Cattelan, D Leoni, Antonio Cascio, Marcello Trizzino, Daniela Francisci, Elisabetta Schiaroli, Giustino Parruti, Federica Sozio, D Messeri, Sara Irene Bonelli, C Lazzaretti, R Corsini, Andrea Antinori, Roberto Cauda, Claudio Maria Mastroianni, Loredana Sarmati, Alessandra Latini, Antonella Cingolani, Ilaria Mastrorosa, Silvia Lamonica, M Capozzi, Marta Camici, Ivano Mezzaroma, Marco Rivano Capparuccia, Giancarlo Iaiani, C Stingone, L Gianserra, Jessica Paulicelli, Maria Maddalena Plazzi, G d’Ettore, Marisa Fusto, Miriam Lichtner, I Coledan, Giordano Madeddu, Andrea De Vito, Massimiliano Fabbiani, Francesca Montagnani, Alfredo Franco‐Obregón, Rosario Vecchio, Daniela Francisci, C Di Giuli, Giancarlo Orofino, Guido Calleri, Giampaolo Perri, Stefano Bonora, Giacomo Accardo, Carlo Tascini, Alejandra Londero, Giuliana Battagin, S Nicolè, Giulio Starnini, Serena Dell’Isola · 发表于：Journal of Antimicrobial Chemotherapy · 年份：2025 · DOI：10.1093/jac/dkaf184 · 被引用次数：15 · 研究领域：HIV/AIDS drug development and treatment、HIV-related health complications and treatments、HIV Research and Treatment

BACKGROUND: Phase 3 studies have shown long-acting (LA) cabotegravir/rilpivirine to be effective and tolerable as maintenance therapy in people with HIV (PWH). However, real-life data on their effectiveness are limited. METHODS: All PWH enrolled in the Icona Cohort who started LA cabotegravir/rilpivirine with HIV-RNA < 50 copies/mL were included. Times to treatment discontinuation (TD) and to virological failure (VF50, two consecutive HIV-RNA >50 copies/mL or one >1000 copies/mL followed by ART switch) were estimated by the Kaplan-Meier method. Cox regression models, adjusted for age, sex and mode of HIV transmission and stratified by the centre, were employed. RESULTS: Overall, 583 PWH started LA cabotegravir/rilpivirine. Six VF50 were observed, with a 1 year estimated cumulative probability of virological failure of 1.2% (95% CI, 0.5%-3.0%). Resistance-associated mutations for rilpivirine and cabotegravir were detected in 3/4 and 4/4 participants with VF50, respectively, for which the genotypic resistance test was performed.The 1 year cumulative probability of TD was 11.4% (95% CI, 8.6%-14.9%), mainly caused by toxicity/adverse events (73.2%). Multivariable analysis identified heterosexual intercourse and IV drug use as significant risk factors for TD compared with MSM. CONCLUSIONS: This analysis demonstrated the short-term effectiveness of cabotegravir/rilpivirine in a real-life setting showing minimal incidence of virological failure but a notable probability of discontin...