Long-term outcome of dolutegravir-containing regimens according to sex: data from the ICONA study

作者：Antonella d’Arminio Monforte, Alessandro Tavelli, Matteo Sala, Annalisa Mondi, Stefano Rusconi, Spinello Antinori, Massimo Puoti, Benedetto Maurizio Celesia, Lucia Taramasso, Annalisa Saracino, Andrea Antinori, Alessandro Cozzi‐Lepri, Antonella d’Arminio Monforte, Andrea Antinori, Spinello Antinori, Antonella Castagna, Francesco Castelli, Roberto Cauda, Giampaolo Perri, Enrico Girardi, R Iardino, Adriano Lazzarin, Giulia Marchetti, C Mussini, Loredana Sarmati, F von Schloesser, Pierluigi Viale, Antonella d’Arminio Monforte, Andrea Antinori, Antonella Castagna, F Ceccherini-Silberstein, Antonella Cingolani, Alessandro Cozzi‐Lepri, Enrico Girardi, Andrea Gori, Sergio Lo Caputo, Giulia Marchetti, F Maggiolo, C Mussini, Massimo Puoti, Carlo Federico Perno, Chiara Agrati, Andrea Antinori, Francesca Bai, Alessandra Bandera, Stefano Bonora, Andrea Calcagno, D Cannetti, Antonella Castagna, F Ceccherini-Silberstein, A Cervo, S Cicalini, Antonella Cingolani, Paola Cinque, Alessandro Cozzi‐Lepri, Antonella d’Arminio Monforte, Antonio Di Biagio, Roberta Gagliardini, Andrea Giacomelli, Enrico Girardi, Nicola Gianotti, Andrea Gori, Giovanni Guaraldi, Simone Lanini, Giuseppe Lapadula, Miriam Lichtner, Alessia Lai, Sergio Lo Caputo, Giordano Madeddu, F Maggiolo, Vincenzo Malagnino, Giulia Marchetti, 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, Alessandra Vergori, Francesca Bovis, Alessandro Cozzi‐Lepri, Iuri Fanti, Matteo Ponzano, A Rodano’, Alessandro Tavelli, Albert Bové, Massimo Cernuschi, L Cosmaro, Massimiliano Errico, A Perziano, Valeria Calvino, Silvia Carrara, Silvia Graziano, Gennaro Prota, S Truffa, Donatella Vincenti, Y D’Errico, Andrea Giacometti, Andrea Costantini, V Barocci, Annalisa Saracino, Carmen Rita Santoro, Eugenio Milano, F Maggiolo, Claudia Suardi, Pierluigi Viale, Lorenzo Badia, Lucia Cretella, 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, Francesca Vichi, Massimo Antonio Di Pietro, Teresa Santantonio, Sergio Ferrara, Matteo Bassetti, Emanuele Pontali, A. Alessandrini, Nicoletta Bobbio, Giovanni Mazzarello, Miriam Lichtner, Laura Fondaco, Stefania Piconi, Chiara Molteni, Alessandro Chiodera, P Milini, Giuseppe Nunnari, Giovanni Francesco Pellicanò, Antonella d’Arminio Monforte, Spinello Antinori, Adriano Lazzarin, Giuliano Rizzardini, Massimo Puoti, Andrea Gori, Antonella Castagna, Alessandra Bandera, Valeria Bono, Maria Vittoria Cossu, Andrea Giacomelli, Riccardo Lolatto, M C Moioli, Laura Pezzati, Camilla Tincati, C Mussini, Cinzia Puzzolante, Paolo Bonfanti, Giuseppe Lapadula, Vincenzo Sangiovanni, Ivan Gentile, Vincenzo Esposito, Francesco Maria Fusco, Giovanni Di Filippo, Viviana Rizzo, N Sangiovanni, Anna Maria Cattelan, Serena Marinello, Antonio Cascio, Claudia Colomba, Daniela Francisci, Elisabetta Schiaroli, Giustino Parruti, F Sozio, P. Blanc, A Vivarelli, C Lazzaretti, R Corsini, Massimo Andreoni, Andrea Antinori, Roberto Cauda, Claudio Maria Mastroianni, 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, M Cecchetto, Franco Viviani, Giordano Madeddu, Andrea De Vito, Massimiliano Fabbiani, Francesca Montagnani, Anaïs Franco‐Romero, Rosario Vecchio, B M Pasticci, C Di Giuli, GC Orofino, Guido Calleri, Giampaolo Perri, Stefano Bonora, Giacomo Accardo, Carlo Tascini, Alejandra Londero, Vinicio Manfrin, Giuliana Battagin, Giulio Starnini, A Ialungo · 发表于：Journal of Antimicrobial Chemotherapy · 年份：2023 · DOI：10.1093/jac/dkad026 · 被引用次数：10 · 研究领域：HIV/AIDS drug development and treatment、HIV/AIDS Research and Interventions、HIV-related health complications and treatments

OBJECTIVES: To compare the long-term risk of treatment failure of dolutegravir-based ART in men and women in a real-life setting. PATIENTS AND METHODS: Persons living with HIV (PLWH) from the ICONA cohort were included if they had started dolutegravir in a two- or three-drug regimen as ART-naive or as virologically controlled ART-experienced. The primary endpoint was time to treatment failure (virological/clinical failure or dolutegravir discontinuation). Secondary endpoints were: time to dolutegravir discontinuation due to toxicity and to neuropsychiatric adverse events; and time to virological failure. Cox regression analyses focused on differences in outcomes by sex. RESULTS: A total of 2304 PLWH (15% women) initiated dolutegravir-based therapy from ART-naive, and 1916 (19.8% women) while experienced. After a median follow-up of 2.2 (IQR: 0.9-3.9) years in ART-naive and 2.4 (IQR: 1.1-4.3) years in experienced, the 4-year cumulative probability of treatment failure was 33% (95% CI 30.5-35.1) and 20% (95% CI 17.8-22.3), respectively. In the multivariable analyses, in ART-naive the risk of treatment failure was higher for women, but not different after excluding women discontinuing dolutegravir for pregnancy concerns. We also observed a higher risk of discontinuation for toxicity in women (ART-naives: Adjusted Hazard Ratio (AHR): 1.56%; 95% CI: 1.03-2.37; ART-experienced: AHR: 1.53%; 95% CI: 1.01-2.32), although the absolute 4-year probability was low: 7.7% (95% CI 6.5-9.2) i...