{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,4]],"date-time":"2026-03-04T22:07:17Z","timestamp":1772662037764,"version":"3.50.1"},"reference-count":50,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2023,5,8]],"date-time":"2023-05-08T00:00:00Z","timestamp":1683504000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Viruses"],"abstract":"<jats:p>Background: Since limited data are available, we aimed to compare the efficacy and durability of dolutegravir and darunavir in advanced na\u00efve patients. Methods: Retrospective multicenter study including AIDS- or late-presenting (def. CD4 \u2264 200\/\u00b5L) HIV-infected patients starting dolutegravir or ritonavir\/cobicistat-boosted darunavir+2NRTIs. Patients were followed from the date of first-line therapy initiation (baseline, BL) to the discontinuation of darunavir or dolutegravir, or for a maximum of 36 months of follow-up. Results: Overall 308 patients (79.2% males, median age 43 years, 40.3% AIDS-presenters, median CD4 66 cells\/\u00b5L) were enrolled; 181 (58.8%) and 127 (41.2%) were treated with dolutegravir and darunavir, respectively. Incidence of treatment discontinuation (TD), virological failure (VF, defined as a single HIV-RNA &gt; 1000 cp\/mL or two consecutive HIV-RNA &gt; 50 cp\/mL after 6 months of therapy or after virological suppression had been achieved), treatment failure (the first of TD or VF), and optimal immunological recovery (defined as CD4 \u2265 500\/\u00b5L + CD4 \u2265 30% + CD4\/CD8 \u2265 1) were 21.9, 5.2, 25.6 and 1.4 per 100 person-years of follow-up, respectively, without significant differences between dolutegravir and darunavir (p &gt; 0.05 for all outcomes). However, a higher estimated probability of TD for central nervous system (CNS) toxicity (at 36 months: 11.7% vs. 0%, p = 0.002) was observed for dolutegravir, whereas darunavir showed a higher probability of TD for simplification (at 36 months: 21.3% vs. 5.7%, p = 0.046). Conclusions: Dolutegravir and darunavir showed similar efficacy in AIDS- and late-presenting patients. A higher risk of TD due to CNS toxicity was observed with dolutegravir, and a higher probability of treatment simplification with darunavir.<\/jats:p>","DOI":"10.3390\/v15051123","type":"journal-article","created":{"date-parts":[[2023,5,8]],"date-time":"2023-05-08T02:03:31Z","timestamp":1683511411000},"page":"1123","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Efficacy and Durability of Dolutegravir- or Darunavir-Based Regimens in ART-Na\u00efve AIDS- or Late-Presenting HIV-Infected Patients"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1343-812X","authenticated-orcid":false,"given":"Massimiliano","family":"Fabbiani","sequence":"first","affiliation":[{"name":"UOC Malattie Infettive e Tropicali, Azienda Ospedaliero-Universitaria Senese, 53100 Siena, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melissa","family":"Masini","sequence":"additional","affiliation":[{"name":"UOC Malattie Infettive, Azienda USL Toscana Sud Est, PO San Donato, 52100 Arezzo, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1659-9241","authenticated-orcid":false,"given":"Barbara","family":"Rossetti","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, AUSL Toscana Sud Est, Grosseto Hospital, 58100 Grosseto, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arturo","family":"Ciccullo","sequence":"additional","affiliation":[{"name":"Dipartimento di Sicurezza e Bioetica Sezione Malattie Infettive, Universit\u00e0 Cattolica del Sacro Cuore, 00168 Rome, Italy"},{"name":"UOC Malattie Infettive, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vanni","family":"Borghi","sequence":"additional","affiliation":[{"name":"Clinica Malattie Infettive e Tropicali, Azienda Ospedaliero Universitaria di Modena, 41100 Modena, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Filippo","family":"Lagi","sequence":"additional","affiliation":[{"name":"SOD Malattie Infettive e Tropicali, Azienda Ospedaliero-Universitaria Careggi, 50134 Firenze, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4633-1035","authenticated-orcid":false,"given":"Amedeo","family":"Capetti","sequence":"additional","affiliation":[{"name":"Divisione di Malattie Infettive, Dipartimento di Malattie Infettive, Ospedale Universitario Luigi Sacco, 20157 Milano, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manuela","family":"Colafigli","sequence":"additional","affiliation":[{"name":"Unit\u00e0 di Dermatologia Infettiva e Allergologia, Istituto S. Gallicano IRCCS, 00144 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesca","family":"Panza","sequence":"additional","affiliation":[{"name":"UOC Malattie Infettive e Tropicali, Azienda Ospedaliero-Universitaria Senese, 53100 Siena, Italy"},{"name":"Dipartimento di Biotecnologie Mediche, Universit\u00e0 degli Studi di Siena, 53100 Siena, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4623-9976","authenticated-orcid":false,"given":"Gianmaria","family":"Baldin","sequence":"additional","affiliation":[{"name":"Dipartimento di Sicurezza e Bioetica Sezione Malattie Infettive, Universit\u00e0 Cattolica del Sacro Cuore, 00168 Rome, Italy"},{"name":"UOC Malattie Infettive, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristina","family":"Mussini","sequence":"additional","affiliation":[{"name":"Clinica Malattie Infettive e Tropicali, Azienda Ospedaliero Universitaria di Modena, 41100 Modena, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0385-0903","authenticated-orcid":false,"given":"Gaetana","family":"Sterrantino","sequence":"additional","affiliation":[{"name":"Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9106-7742","authenticated-orcid":false,"given":"Damiano","family":"Farinacci","sequence":"additional","affiliation":[{"name":"Dipartimento di Sicurezza e Bioetica Sezione Malattie Infettive, Universit\u00e0 Cattolica del Sacro Cuore, 00168 Rome, Italy"},{"name":"UOC Malattie Infettive, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2267-1337","authenticated-orcid":false,"given":"Francesca","family":"Montagnani","sequence":"additional","affiliation":[{"name":"UOC Malattie Infettive e Tropicali, Azienda Ospedaliero-Universitaria Senese, 53100 Siena, Italy"},{"name":"Dipartimento di Biotecnologie Mediche, Universit\u00e0 degli Studi di Siena, 53100 Siena, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9519-8552","authenticated-orcid":false,"given":"Mario","family":"Tumbarello","sequence":"additional","affiliation":[{"name":"UOC Malattie Infettive e Tropicali, Azienda Ospedaliero-Universitaria Senese, 53100 Siena, Italy"},{"name":"Dipartimento di Biotecnologie Mediche, Universit\u00e0 degli Studi di Siena, 53100 Siena, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simona","family":"Di Giambenedetto","sequence":"additional","affiliation":[{"name":"Dipartimento di Sicurezza e Bioetica Sezione Malattie Infettive, Universit\u00e0 Cattolica del Sacro Cuore, 00168 Rome, Italy"},{"name":"UOC Malattie Infettive, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2023,5,8]]},"reference":[{"key":"ref_1","unstructured":"(2021, April 01). Panel on Antiretroviral Guidelines for Adults and Adolescents Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. Department of Health and Human Services, Available online: https:\/\/clinicalinfo.hiv.gov\/sites\/default\/files\/guidelines\/documents\/AdultandAdolescentGL.pdf."},{"key":"ref_2","unstructured":"(2022, September 22). EACS Secretariat EACS Guidelines Version 11.0. Available online: https:\/\/www.eacsociety.org\/media\/final2021eacsguidelinesv11.0_oct2021.pdf."},{"key":"ref_3","doi-asserted-by":"crossref","unstructured":"INSIGHT START Study Group (2015). Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N. Eng. J. 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