{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T01:10:46Z","timestamp":1784164246942,"version":"3.55.0"},"reference-count":11,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2024,10,30]],"date-time":"2024-10-30T00:00:00Z","timestamp":1730246400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100010877","name":"ViiV Healthcare","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100010877","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,1,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>We compared the effectiveness and safety of bictegravir\/emtricitabine\/tenofovir alafenamide fumarate (BIC\/FTC\/TAF) and dolutegravir plus lamivudine (DTG\u200a+\u200a3TC) in our cohort of treatment-naive people with HIV (PWH).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In a multicentre cohort of treatment-naive PWH starting a first-line regimen with either dolutegravir plus lamivudine or BIC\/FTC\/TAF, Kaplan\u2013Meier survival analysis was used to estimate time to virological failure (VF) and time to treatment discontinuation (TD), whereas Cox regression was used to evaluate predictors of VF and TD. Changes in CD4+ cell count were assessed via non-parametric tests, and linear regression analyses were performed to explore predictors of CD4+ cell count changes.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>One hundred and seventy individuals were included: 66 started dolutegravir plus lamivudine (DTG group) and 104 started BIC\/FTC\/TAF (BIC group). During follow-up, we observed two VFs in the DTG group [1.7 per 100 person-years of follow-up (PYFU)] and two in the BIC group (1.7 per 100 PYFU). Estimated probability of remaining free from VF at Week 144 was 95.9% in the DTG group and 95.2% in the BIC group (log-rank P\u200a=\u200a0.955). Four TDs were observed in the DTG group (3.4 per 100 PYFU) and 21 in the BIC group (17.6 per 100 PYFU). Estimated probability of maintaining the study regimen at Week 144 was 90.3% in the DTG group and 70.0% in the BIC group; individuals in the BIC group had a higher probability of TD (log-rank P\u200a=\u200a0.003). In both groups, the CD4+ count improved significantly during follow-up.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Our study shows that both strategies are effective and safe, with few VFs and TDs due to tolerability issues.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jac\/dkae392","type":"journal-article","created":{"date-parts":[[2024,10,31]],"date-time":"2024-10-31T06:12:42Z","timestamp":1730355162000},"page":"175-177","source":"Crossref","is-referenced-by-count":7,"title":["Comparing the long-term effectiveness and safety of dolutegravir\/lamivudine versus bictegravir\/emtricitabine\/tenofovir alafenamide fumarate as first-line regimens: a real life multicentre cohort"],"prefix":"10.1093","volume":"80","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5941-883X","authenticated-orcid":false,"given":"Arturo","family":"Ciccullo","sequence":"first","affiliation":[{"name":"Infectious Diseases Unit, San Salvatore Hospital , L\u2019Aquila ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4623-9976","authenticated-orcid":false,"given":"Gianmaria","family":"Baldin","sequence":"additional","affiliation":[{"name":"Infectious Diseases Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adriana","family":"Cervo","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Azienda Ospedaliero-Universitaria of Modena , Modena ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Davide","family":"Moschese","sequence":"additional","affiliation":[{"name":"I Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital , 20157 Milan ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Filippo","family":"Lagi","sequence":"additional","affiliation":[{"name":"Infectious and Tropical Diseases Unit, Careggi University Hospital , Florence ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Vittoria","family":"Cossu","sequence":"additional","affiliation":[{"name":"I Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital , 20157 Milan ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Grimaldi","sequence":"additional","affiliation":[{"name":"Infectious Diseases Unit, San Salvatore Hospital , L\u2019Aquila ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3685-4289","authenticated-orcid":false,"given":"Andrea","family":"Giacomelli","sequence":"additional","affiliation":[{"name":"I Division of Infectious Diseases, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital , Milano ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0375-9990","authenticated-orcid":false,"given":"Stefano","family":"Rusconi","sequence":"additional","affiliation":[{"name":"Infectious Diseases Unit, ASST Ovest Milanese, Legnano General Hospital , Legnano ,","place":["Italy"]},{"name":"DIBIC, University of Milan , Milan ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0385-0903","authenticated-orcid":false,"given":"Gaetana","family":"Sterrantino","sequence":"additional","affiliation":[{"name":"Infectious and Tropical Diseases Unit, Careggi University Hospital , Florence ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7910-021X","authenticated-orcid":false,"given":"Alberto","family":"Borghetti","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, Infectious Diseases Unit, University of Pisa , Pisa ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0569-9407","authenticated-orcid":false,"given":"Spinello","family":"Antinori","sequence":"additional","affiliation":[{"name":"I Division of Infectious Diseases, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital , Milano ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Mussini","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Azienda Ospedaliero-Universitaria of Modena , Modena ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simona","family":"Di Giambenedetto","sequence":"additional","affiliation":[{"name":"Infectious Diseases Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,10,30]]},"reference":[{"key":"2025010309480973000_dkae392-B1","author":"European AIDS Clinical Society"},{"key":"2025010309480973000_dkae392-B2","author":"Panel on Antiretroviral Guidelines for Adults and Adolescents"},{"key":"2025010309480973000_dkae392-B3","doi-asserted-by":"publisher","first-page":"e389","DOI":"10.1016\/S2352-3018(20)30099-0","article-title":"Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials","volume":"7","author":"Orkin","year":"2020","journal-title":"Lancet HIV"},{"key":"2025010309480973000_dkae392-B4","doi-asserted-by":"publisher","first-page":"39","DOI":"10.1097\/QAD.0000000000003070","article-title":"Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy-naive adults with HIV-1 infection","volume":"36","author":"Cahn","year":"2022","journal-title":"AIDS"},{"key":"2025010309480973000_dkae392-B5","doi-asserted-by":"publisher","first-page":"486","DOI":"10.1089\/aid.2020.0276","article-title":"Efficacy and safety of dolutegravir plus lamivudine as a first-line regimen in clinical practice","volume":"37","author":"Ciccullo","year":"2021","journal-title":"AIDS Res Hum Retroviruses"},{"key":"2025010309480973000_dkae392-B6","doi-asserted-by":"publisher","first-page":"e029960","DOI":"10.1136\/bmjopen-2019-029960","article-title":"Cohort profile: the Observational cohort for the study of DOlutegravir in Antiretroviral Combination REgimens (ODOACRE)","volume":"9","author":"Ciccullo","year":"2019","journal-title":"BMJ Open"},{"key":"2025010309480973000_dkae392-B7","doi-asserted-by":"publisher","first-page":"106343","DOI":"10.1016\/j.ijantimicag.2021.106343","article-title":"HIV-1 integrase strand transfer inhibitors: a review of current drugs, recent advances and drug resistance","volume":"57","author":"Mbhele","year":"2021","journal-title":"Int J Antimicrob Agents"},{"key":"2025010309480973000_dkae392-B8","doi-asserted-by":"publisher","first-page":"683","DOI":"10.1080\/14740338.2020.1764531","article-title":"Nothing is perfect: the safety issues of integrase inhibitor regimens","volume":"19","author":"Sc\u00e9vola","year":"2020","journal-title":"Expert Opin Drug Saf"},{"key":"2025010309480973000_dkae392-B9","doi-asserted-by":"publisher","first-page":"1423","DOI":"10.1093\/jac\/dkad102","article-title":"Effectiveness and tolerability of dolutegravir\/lamivudine for the treatment of HIV-1 infection in clinical practice","volume":"78","author":"Su\u00e1rez-Garc\u00eda","year":"2023","journal-title":"J Antimicrob Chemother"},{"key":"2025010309480973000_dkae392-B10","doi-asserted-by":"publisher","first-page":"440","DOI":"10.1111\/hiv.13593","article-title":"Twelve-month effectiveness and safety of bictegravir\/emtricitabine\/tenofovir alafenamide in people with HIV: real-world insights from BICSTaR cohorts","volume":"25","author":"Esser","year":"2024","journal-title":"HIV Med"},{"key":"2025010309480973000_dkae392-B11","doi-asserted-by":"publisher","first-page":"211","DOI":"10.1080\/14787210.2023.2292544","article-title":"Efficacy and safety of bictegravir\/emtricitabine\/tenofovir alafenamide fumarate for adult patients with human immunodeficiency virus-1 in China: a retrospective real-world cohort study","volume":"22","author":"Gan","year":"2024","journal-title":"Expert Rev Anti Infect Ther"}],"container-title":["Journal of Antimicrobial Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jac\/article-pdf\/80\/1\/175\/60250235\/dkae392.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jac\/article-pdf\/80\/1\/175\/60250235\/dkae392.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,1,3]],"date-time":"2025-01-03T09:48:20Z","timestamp":1735897700000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jac\/article\/80\/1\/175\/7852960"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10,30]]},"references-count":11,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,10,30]]},"published-print":{"date-parts":[[2025,1,3]]}},"URL":"https:\/\/doi.org\/10.1093\/jac\/dkae392","relation":{},"ISSN":["0305-7453","1460-2091"],"issn-type":[{"value":"0305-7453","type":"print"},{"value":"1460-2091","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,1]]},"published":{"date-parts":[[2024,10,30]]}}}