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The primary endpoint was time to treatment failure (TF), defined as virological failure (VF, two consecutive HIV-RNA of &amp;gt;50\u2005copies\/mL &amp;gt;6\u2005months after treatment initiation) or discontinuation due to toxicity\/lack virological control\/non-adherence or death for any cause. Secondary endpoints were time to treatment discontinuation for any reason (TD) and pure VF. Main exposures of interest were baseline CD4 and HIV-RNA, age, sex at birth and nation of birth. Standard survival analysis and Cox regression models were used.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 446 participants, after a median follow-up of 22\u2005months, 4.3% (n\u200a=\u200a19) experienced TF, the 3\u2005year cumulative probability was 5.8% (95% CI: 2.9%\u20138.7%). Baseline CD4 count was associated with a 3-fold higher risk of TF, which decreased after adjustments. Higher viral loads (&amp;gt;100\u200a000\u2005copies\/mL), age &amp;gt;50\u2005years and foreign-born status were also associated with an increased risk of TF. No differences in TF according to sex at birth were found. By 3\u2005years the probabilities of TD and VF were 13.4% (95% CI: 9.1%\u201317.6%) and 2.3% (95% CI: 0.19%\u20134.4%), respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In our real-world setting, the TF probability for first-line lamivudine\/dolutegravir was below 6% at 3\u2005years, lower than in randomized trials. Our data suggest that, as shown with other regimens, PWH starting lamivudine\/dolutegravir with CD4 count of \u2264200\u2005cells\/mm3, HIV-RNA of &amp;gt;100\u200a000\u2005copies\/mL, older age or foreign-born status may be at higher risk of TF, though larger studies are needed to qualify the magnitude of the effect.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jac\/dkaf345","type":"journal-article","created":{"date-parts":[[2025,9,13]],"date-time":"2025-09-13T11:45:09Z","timestamp":1757763909000},"page":"3082-3091","source":"Crossref","is-referenced-by-count":5,"title":["Effectiveness of first-line lamivudine\/dolutegravir antiretroviral therapy in persons with HIV: real-life data from the ICONA Foundation cohort"],"prefix":"10.1093","volume":"80","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6944-0686","authenticated-orcid":false,"given":"Alessandra","family":"Vergori","sequence":"first","affiliation":[{"name":"Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS , Rome ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Cozzi-Lepri","sequence":"additional","affiliation":[{"name":"Centre for Clinical Research, Epidemiology, Modelling and Evaluation (CREME), Institute for Global Health, UCL , London ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergio","family":"Lo Caputo","sequence":"additional","affiliation":[{"name":"Infection Diseases Unit, Department of Medical and Surgical Sciences, University of Foggia , Foggia ,","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\/0000-0002-0240-7504","authenticated-orcid":false,"given":"Valentina","family":"Mazzotta","sequence":"additional","affiliation":[{"name":"Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS , Rome ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabetta","family":"Schiaroli","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, University of Perugia , Perugia ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giancarlo","family":"Orofino","sequence":"additional","affiliation":[{"name":"Division I of Infectious and Tropical Diseases, ASL Citt\u00e0 di Torino , Turin ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Mussini","sequence":"additional","affiliation":[{"name":"Infectious Diseases Unit, Azienda Ospedaliero-Universitaria Policlinico di Modena, University of Modena and Reggio Emilia, School of Medicine , Modena ,","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, Italy; IRCCS Ospedale San Raffaele Universit\u00e0 Vita-Salute, Milan ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonella","family":"Cingolani","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Fondazione Policlinico Universitario A. 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