{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,11]],"date-time":"2026-10-11T12:39:49Z","timestamp":1791722389274,"version":"4.3.4"},"reference-count":46,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2025,9,2]],"date-time":"2025-09-02T00:00:00Z","timestamp":1756771200000},"content-version":"vor","delay-in-days":4,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,8,29]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Prospective national cohort study (ItaPrEP) on oral PrEP users (PrUs) in eight Italian centers (September 2017\u2013November 2023) that could partially provide free drug supplies. IRs of HIV and STIs, and Kaplan\u2013Meier 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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\u20130.436). IR\/100 PYFU were 13.1 (95%CI:11.7\u201314.5) for syphilis, 23.8 (95% CI: 22\u201325.7) for chlamydia, and 24.2 (95% CI: 22.4\u201326.1) for gonorrhea. The 2-year probability of poor adherence and discontinuation was 57.9% (95% CI: 54.8\u201361.0) and 37.1% (95% CI: 34.3\u201340.1), respectively.<\/jats:p>\n                  <jats:p>Chemsex and switching schedule were associated with poor adherence, unlike a high educational level. Age &amp;gt;40 years, free drug supplies, and laboratory monitoring were associated with a lower risk of discontinuation, while chemsex was associated with a higher risk.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>In this Italian oral PrEP program, the HIV incidence was lower than that observed in pivotal clinical trials in high-risk populations and close to that of observational real-life studies. Identifying fragile groups (youngest, low educational level, and chemsex users) and addressing barriers (free drugs and monitoring) are key to targeting strategies to improve oral PrEP implementation.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ofid\/ofaf539","type":"journal-article","created":{"date-parts":[[2025,9,2]],"date-time":"2025-09-02T13:53:51Z","timestamp":1756821231000},"source":"Crossref","is-referenced-by-count":17,"title":["HIV Oral Pre-exposure Prophylaxis Effectiveness, Adherence, and Discontinuation in an Italian Multicentric Access Program: ItaPrEP Study"],"prefix":"10.1093","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0240-7504","authenticated-orcid":false,"given":"Valentina","family":"Mazzotta","sequence":"first","affiliation":[{"name":"HIV\/AIDS Unit, Department of Clinical Infectious Diseases, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS , Rome ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrico","family":"Caruso","sequence":"additional","affiliation":[{"name":"Milano Checkpoint , Milano ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5899-451X","authenticated-orcid":false,"given":"Alessandro","family":"Tavelli","sequence":"additional","affiliation":[{"name":"Icona Foundation , Milan ,","place":["Italy"]},{"name":"National PhD Programme in One Health Approaches to Infectious Diseases and Life Science Research, Department of Public Health, Experimental and Forensic Medicine, University of Pavia , Pavia ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6127-0045","authenticated-orcid":false,"given":"Rozenn","family":"Esvan","sequence":"additional","affiliation":[{"name":"HIV\/AIDS Unit, Department of Clinical Infectious Diseases, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS , Rome ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6743-4001","authenticated-orcid":false,"given":"Simone","family":"Lanini","sequence":"additional","affiliation":[{"name":"Infectious Diseases Clinic, Department of Medicine (DAME), University of Udine , Udine ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7996-8345","authenticated-orcid":false,"given":"Giulia","family":"Micheli","sequence":"additional","affiliation":[{"name":"HIV\/AIDS Unit, Department of Clinical Infectious Diseases, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS , Rome ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Davide","family":"Moschese","sequence":"additional","affiliation":[{"name":"Milano Checkpoint , Milano ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"De Bona","sequence":"additional","affiliation":[{"name":"Infectious Diseases Unit, ASST Santi Paolo e Carlo, University of Milan , Milan ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandro","family":"Mattioli","sequence":"additional","affiliation":[{"name":"PLUS aps (BLQ Checkpoint) , Bologna ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniele","family":"Calzavara","sequence":"additional","affiliation":[{"name":"Milano Checkpoint , Milano ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9040-2000","authenticated-orcid":false,"given":"Federico","family":"De Zottis","sequence":"additional","affiliation":[{"name":"HIV\/AIDS Unit, Department of Clinical Infectious Diseases, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS , Rome ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniele","family":"Tesoro","sequence":"additional","affiliation":[{"name":"Infectious Diseases Unit, ASST Santi Paolo e Carlo, University of Milan , Milan ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5694-1158","authenticated-orcid":false,"given":"Lorenzo","family":"Badia","sequence":"additional","affiliation":[{"name":"PLUS aps (BLQ Checkpoint) , Bologna ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2673-2731","authenticated-orcid":false,"given":"Silvia","family":"Nozza","sequence":"additional","affiliation":[{"name":"Infectious Diseases Unit, IRCCS San Raffaele Scientific Institute , Milan ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonella","family":"Cingolani","sequence":"additional","affiliation":[{"name":"Infectious Diseases Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of the Sacred Heart , Rome ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Bianchi","sequence":"additional","affiliation":[{"name":"Milano Checkpoint , Milano ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita","family":"Bellagamba","sequence":"additional","affiliation":[{"name":"HIV\/AIDS Unit, Department of Clinical Infectious Diseases, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS , Rome ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salvatore","family":"Cecere","sequence":"additional","affiliation":[{"name":"PLUS aps (BLQ Checkpoint) , Bologna ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-9031-619X","authenticated-orcid":false,"given":"Alessandro","family":"Giacinta","sequence":"additional","affiliation":[{"name":"HIV\/AIDS Unit, Department of Clinical Infectious Diseases, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS , Rome ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicoletta","family":"Frattini","sequence":"additional","affiliation":[{"name":"Milano Checkpoint , Milano ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8124-7368","authenticated-orcid":false,"given":"Alessandra","family":"Oliva","sequence":"additional","affiliation":[{"name":"HIV\/AIDS Unit, Department of Clinical Infectious Diseases, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS , Rome ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Repossi","sequence":"additional","affiliation":[{"name":"Milano Checkpoint , Milano ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4965-8789","authenticated-orcid":false,"given":"Roberto","family":"Rossotti","sequence":"additional","affiliation":[{"name":"Infectious Diseases Unit, ASST Grande Ospedale Metropolitano Niguarda , Milan ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-7990-8439","authenticated-orcid":false,"given":"Marco","family":"Ridolfi","sequence":"additional","affiliation":[{"name":"Department of Public Health and Infectious Diseases, Sapienza University , Rome ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudio Maria","family":"Mastroianni","sequence":"additional","affiliation":[{"name":"Department of Public Health and Infectious Diseases, Sapienza University , Rome ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Torti","sequence":"additional","affiliation":[{"name":"Infectious Diseases Unit, Fondazione Policlinico Universitario A. 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