Risk of clinical events in virologically suppressed people with HIV switching to a two-drug regimen vs. remaining on a three-drug regimen: a target trial emulation

作者：Cristina Mussini, Andrea Giacomelli, Eugenia Quiros-Roldan, Valentina Mazzotta, Antonio Di Biagio, Andrea De Vito, Andrea Costantini, Gabriella d’Ettorre, Andrea Giacometti, Alessandra Vergori, Alessandro Tavelli, Vincenzo Malagnino, Antonella Castagna, Johanna Chester, Andrea Antinori, Antonella d’Arminio Monforte, Alessandro Cozzi‐Lepri, C Abeli, Guido Accardo, Loredana Alessio, Spinello Antinori, Matteo Augello, Lorenzo Badia, Alessandra Bandera, V Barocci, Filippo Bartalesi, Alessandro Bartoloni, Matteo Bassetti, Giuliana Battagin, Sabrina Blanchi, Nicoletta Bobbio, Sara Irene Bonelli, Paolo Bonfanti, Valeria Bono, Stefano Bonora, Beatrice Borchi, Andrea Calcagno, Guido Calleri, Valeria Calvino, Marta Camici, G Canavesi, Diana Canetti, M Capozzi, Stefania Carrara, Antonio Cascio, Anna Maria Cattelan, Roberto Cauda, Francesca Ceccherini‐Silberstein, Benedetto Maurizio Celesia, Massimo Cernuschi, Adriana Cervo, Luchino Chessa, Antonella Cingolani, Paola Cinque, Ilaria Coledan, Laura Comi, Nicola Coppola, Romina Corsini, Maria Luisa Cosmaro, Maria Vittoria Cossu, Cecilia Costa, Silvia Cretella, Sarah Dal Zoppo, S De Benedittis, Cosmo Del Borgo, V L Del Negro, Serena Dell’Isola, Giavanni Di Filippo, Cinzia Di Giuli, Giovanni Di Perri, Sara Diotallevi, Elke Erne, Vincenzo Esposito, Massimiliano Fabbiani, Katia Falasca, Iuri Fanti, Massimo Farinella, Sergio Ferrara, Emanuela Focà, Rosa Fontana Del Vecchio, Daniela Francisci, Antonina Franco, Francesco Maria Fusco, Marisa Fusto, Roberta Gagliardini, Ivan Gentile, Nicola Gianotti, Laura Gianserra, Massimo Giotta, Enrico Girardi, Andrea Gori, Silvia Graziano, Giovanni Guaraldi, Giancarlo Iaiani, R Iardino, Alessia Lai, Silvia Lamonica, Simone Lanini, Giovanni Lapadula, Alessandra Latini, C Lazzaretti, Adriano Lazzarin, Davide Leoni, Miriam Lichtner, Sergio Lo Caputo, Riccardo Lolatto, Angela Londero, Giordano Madeddu, Paolo Maggi, Franco Maggiolo, Giulia Mancarella, Giulia Marchetti, Cristina Marelli, Raffaella Marocco, Salvatore Martini, Claudio Maria Mastroianni, Ilaria Mastrorosa, M Menozzi, Barbara Menzaghi, Daniela Messeri, Ivano Mezzaroma, Eugenia Milano, Maria Cristina Moioli, Chiara Molteni, Annalisa Mondi, Francesca Montagnani, Stefano Nicolè, Silvia Nozza, Giuseppe Nunnari, Giancarlo Orofino, Angelo Pan, Giustino Parruti, Jessica Paulicelli, G Pellicanò, Carlo Federico Perno, A Perziano, Francesco Pes, Laura Pezzati, Stefania Piconi, A. Pieri, Carmela Pinnetti, Maria Maddalena Plazzi, Nicoletta Policek, Emanuele Pontali, Gianluca Prota, Massimo Puoti, Marco Rivano Capparuccia, Viviana Rizzo, A Rodano’, Roberto Rossotti, Roberta Rovito, Stefano Rusconi, Daria Russo, Ylenia Russotto, Vincenzo Sangiovanni, N Sangiovanni, Maria Mercedes Santoro, Carmen Rita Santoro, Annalisa Saracino, Loredana Sarmati, Elisabetta Schiaroli, Daniela Segala, Federica Sozio, Vincenzo Spagnuolo, Nicola Squillace, Giulio Starnini, C Stingone, Claudia Suardi, Barbara Suligoi, Valentina Svicher, Lucia Taramasso, Carlo Tascini, Camilla Tincati, Carlo Torti, Maurizio Trizzino, Silvia Truffa, Jacopo Vecchiet, Pierluigi Viale, Donatella Vincenti, F von Schloesser · 发表于：EClinicalMedicine · 年份：2025 · DOI：10.1016/j.eclinm.2025.103368 · 被引用次数：2 · 研究领域：HIV/AIDS drug development and treatment、HIV-related health complications and treatments、HIV/AIDS Research and Interventions

Background: Guidelines support the switch to a two-drug regimen (2DR) in virologically suppressed people with HIV (PWH) on a three-drug regimen (3DR). Randomized clinical trials have not included clinical outcomes in study endpoints. We provide estimates of 3-year clinical risk by means of a target trial emulation using the data of a large cohort of PWH in Italy. Methods: PWH from the Icona Foundation Study who were virologically suppressed (HIV-RNA ≤50 copies/mL) for ≥6 months on a 3DR on or after November 2014, were enrolled (database closure on July 31, 2024). PWH were classified according to therapeutic strategies: switching to 2DR (protease inhibitors or dolutegravir plus lamivudine or dolutegravir plus rilpivirine) or remaining on 3DR (any combination). The primary endpoint was the time to the first clinical composite event (cardiovascular disease [CVD], cancer [AIDS and non-AIDS related], or death). We calculated the difference in 3-year risk between therapeutic strategies, estimated using a weighted non-parametric Kaplan-Meier estimator. Findings: 7672 participants entered the analysis: 629 (8.2%) switching to 2DR and 7043 (91.8%) remaining on 3DR. Over the 3-year follow-up, 408 events were registered (64 CVD, 234 cancer, and 110 deaths). The 3-year adjusted risk estimate was 2.55 (95% CI 1.72, 5.33) in 2DR vs. 4.69 (95% CI 4.48, 6.17) in 3DR. The difference (-2.15% [95% CI -3.56%, -0.20%]) in favor of 2DR was mainly driven by events of non-AIDS related cancer and mor...