HIV Oral Pre-exposure Prophylaxis Effectiveness, Adherence, and Discontinuation in an Italian Multicentric Access Program: ItaPrEP Study

作者：Valentina Mazzotta, E Caruso, Alessandro Tavelli, Rozenn Esvan, Simone Lanini, Giulia Micheli, Davide Moschese, Anna De Bona, Sandro Mattioli, Daniele Calzavara, Federico De Zottis, Daniele Tesoro, Lorenzo Badia, Silvia Nozza, Antonella Cingolani, Alessandra Bianchi, Rita Bellagamba, S Cecere, Alessandro Giacinta, Nicoletta Frattini, Alessandra Oliva, Roberto Repossi, Roberto Rossotti, Marco Ridolfi, Claudio Maria Mastroianni, Carlo Torti, Giulia Marchetti, Antonella Castagna, Antonella d’Arminio Monforte, Massimo Cernuschi, Andrea Antinori · 发表于：Open Forum Infectious Diseases · 年份：2025 · DOI：10.1093/ofid/ofaf539 · 被引用次数：13 · 研究领域：HIV/AIDS Research and Interventions、Pneumocystis jirovecii pneumonia detection and treatment、HIV, Drug Use, Sexual Risk

Background: Italian oral pre-exposure prophylaxis (PrEP) implementation faced challenges until the drug reimbursement approval in 2023. National real-life data on effectiveness are lacking. This study aimed to report incidence rates (IR) of HIV and other sexually transmitted infections (STIs), along with probabilities and predictors of poor adherence and PrEP discontinuation. Methods: Prospective national cohort study (ItaPrEP) on oral PrEP users (PrUs) in eight Italian centers (September 2017-November 2023) that could partially provide free drug supplies. IRs of HIV and STIs, and Kaplan-Meier estimated probabilities of poor adherence and discontinuation were evaluated. Mixed-effect logistic models with random intercept on the center were used to explore the association between risk factors and poor adherence and discontinuation. Results: About 1758 PrUs were included, 98% MSM; five HIV seroconversions were observed with an IR 0.187/100 person-year follow-up (PYFU; 95% CI: 0.061-0.436). IR/100 PYFU were 13.1 (95%CI:11.7-14.5) for syphilis, 23.8 (95% CI: 22-25.7) for chlamydia, and 24.2 (95% CI: 22.4-26.1) for gonorrhea. The 2-year probability of poor adherence and discontinuation was 57.9% (95% CI: 54.8-61.0) and 37.1% (95% CI: 34.3-40.1), respectively.Chemsex and switching schedule were associated with poor adherence, unlike a high educational level. Age >40 years, free drug supplies, and laboratory monitoring were associated with a lower risk of discontinuation, while chems...