{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T16:24:35Z","timestamp":1787243075695,"version":"build-2736575974"},"reference-count":22,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:00:00Z","timestamp":1787011200000},"content-version":"vor","delay-in-days":17,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010877","name":"ViiV Healthcare","doi-asserted-by":"publisher","award":["213605"],"award-info":[{"award-number":["213605"]}],"id":[{"id":"10.13039\/100010877","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Despite demonstrated virological efficacy, real-world evidence on the long-term effectiveness of dolutegravir plus lamivudine (DTG\/3TC) in people living with HIV (PLWH) remains limited; this study assessed effectiveness, examining immunological response, resistance and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>CARAVEL was a French, prospective, noninterventional, single-arm, multicenter, 3-year cohort study in treatment-naive PLWH (TN-PLWH) and pretreated PLWH (PT-PLWH) receiving DTG\/3TC for the first time.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Forty-nine centers enrolled 304 participants: 56 TN-PLWH and 248 PT-PLWH. Effectiveness was evaluable in 49 (87%) TN-PLWH and 234 (94%) PT-PLWH. Initial virological suppression was attained for 44 (89.8%) TN-PLWH after 6 months of initiating DTG\/3TC, with a median time to virological suppression of 1.1 months (IQR 1.0 to 2.1), and no virological failure during the follow-up. After switching, 220 (94%) PT-PLWH maintained virological suppression. During the follow-up, 14 PT-PLWH did not maintain virological suppression: 5 due to intermittent viraemia, and 9 due to virological failure (VF). Among the 9 participants with VF, a genotypic resistance test was available for 3 participants of whom 1 developed 3TC resistance [M184V] in the context of nonadherence. DTG\/3TC was discontinued in 63 participants, mainly at their request (N = 40, 64.5%), as well as tolerability and VF. The average change in body weight over the follow-up was +2.0 (\u00b16.0) (P = .13) kg in TN-PLWH and \u22120.2 (\u00b16.5) (P = .78) kg in PT-PLWH, among participants with available data (N = 156).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These real-world data demonstrated high virological success and good safety after up to 3 years on DTG\/3TC in both TN-PLWH and PT-PLWH populations.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ofid\/ofag492","type":"journal-article","created":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T11:50:38Z","timestamp":1786535438000},"source":"Crossref","is-referenced-by-count":0,"title":["Evaluation of Real-World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir\/Lamivudine Fixed-Dose Combination in Treatment-Naive and Pretreated People Living With HIV Who are Virologically Suppressed, in Routine Clinical Care in France: Results From the CARAVEL Study"],"prefix":"10.1093","volume":"13","author":[{"given":"Patrick","family":"Philibert","sequence":"first","affiliation":[{"name":"Department of Infectious Diseases and Internal Medicine, H\u00f4pital Europ\u00e9en , Marseille ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"Charpentier","sequence":"additional","affiliation":[{"name":"Service de Virologie, AP-HP, H\u00f4pital Bichat-Claude Bernard, Universit\u00e9 Paris Cit\u00e9, INSERM, IAME , Paris ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nilakshani","family":"Naguleswaran","sequence":"additional","affiliation":[{"name":"Qualees , Paris ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Philippe","sequence":"additional","affiliation":[{"name":"Qualees , Paris ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9549-2498","authenticated-orcid":false,"given":"Roula","family":"Ajrouche","sequence":"additional","affiliation":[{"name":"Qualees , Paris ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8721-6431","authenticated-orcid":false,"given":"Laetitia","family":"Roustand","sequence":"additional","affiliation":[{"name":"GSK , Rueil-Malmaison ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Corinne","family":"Vouillot","sequence":"additional","affiliation":[{"name":"ViiV Healthcare , Rueil-Malmaison ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2264-4822","authenticated-orcid":false,"given":"Laurent","family":"Hocqueloux","sequence":"additional","affiliation":[{"name":"Department of Infectious and Tropical Diseases, CHU d\u2019Orl\u00e9ans , Orl\u00e9ans ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,8,18]]},"reference":[{"key":"2026082011364550400_ofag492-B1","doi-asserted-by":"crossref","first-page":"228","DOI":"10.1016\/j.jgar.2019.08.010","article-title":"Two-drug regimens with dolutegravir plus rilpivirine or lamivudine in HIV-1 treatment-na\u00efve, virologically-suppressed patients: latest evidence from the literature on their efficacy and safety","volume":"20","author":"Cento","year":"2020","journal-title":"J Glob Antimicrob Resist"},{"key":"2026082011364550400_ofag492-B2","doi-asserted-by":"crossref","first-page":"113","DOI":"10.18683\/germs.2017.1115","article-title":"2-Drug regimens in HIV treatment: pharmacological considerations","volume":"7","author":"Back","year":"2017","journal-title":"Germs"},{"key":"2026082011364550400_ofag492-B3","doi-asserted-by":"crossref","first-page":"1065","DOI":"10.1097\/QAD.0000000000001476","article-title":"Individualized antiretroviral therapeutic approaches: less can be more","volume":"31","author":"Katlama","year":"2017","journal-title":"AIDS"},{"key":"2026082011364550400_ofag492-B4","author":"European Medicines Agency"},{"key":"2026082011364550400_ofag492-B5","author":"US Food and Drug Administration"},{"key":"2026082011364550400_ofag492-B6","doi-asserted-by":"crossref","first-page":"1689","DOI":"10.1093\/cid\/cix1083","article-title":"ACTG A5353: a pilot study of dolutegravir plus lamivudine for initial treatment of Human Immunodeficiency Virus-1 (HIV-1)-infected participants with HIV-1 RNA&lt;500000 copies\/mL","volume":"66","author":"Taiwo","year":"2018","journal-title":"Clin Infect Dis"},{"key":"2026082011364550400_ofag492-B7","author":"Joly"},{"key":"2026082011364550400_ofag492-B8","doi-asserted-by":"crossref","first-page":"310","DOI":"10.1097\/QAI.0000000000002275","article-title":"Durable efficacy of dolutegravir plus lamivudine in antiretroviral treatment\u2013naive adults with HIV-1 infection: 96-week results from the GEMINI-1 and GEMINI-2 Randomized Clinical Trials","volume":"83","author":"Cahn","year":"2020","journal-title":"J Acquir Immune Defic Syndr"},{"key":"2026082011364550400_ofag492-B9","doi-asserted-by":"crossref","first-page":"720","DOI":"10.1093\/cid\/ciac130","article-title":"Efficacy and safety of switching to the 2-drug regimen dolutegravir\/lamivudine versus continuing a 3- or 4-drug regimen for maintaining virologic suppression in adults living with Human Immunodeficiency Virus 1 (HIV-1): week 48 results from the phase 3, noninferiority SALSA Randomized Trial","volume":"76","author":"Llibre","year":"2023","journal-title":"Clin Infect Dis"},{"key":"2026082011364550400_ofag492-B10","doi-asserted-by":"crossref","first-page":"1920","DOI":"10.1093\/cid\/ciz1243","article-title":"Efficacy and safety of switching to dolutegravir\/lamivudine fixed-dose 2-drug regimen vs continuing a tenofovir alafenamide-based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with Human Immunodeficiency Virus Type 1: phase 3, Randomized, Noninferiority TANGO Study","volume":"71","author":"van Wyk","year":"2020","journal-title":"Clin Infect Dis"},{"key":"2026082011364550400_ofag492-B11","doi-asserted-by":"crossref","first-page":"975","DOI":"10.1093\/cid\/ciac036","article-title":"Efficacy and safety of switching to dolutegravir\/lamivudine versus continuing a tenofovir alafenamide\u2013based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with Human Immunodeficiency Virus Type 1: results through week 144 from the phase 3, noninferiority TANGO Randomized Trial","volume":"75","author":"Osiyemi","year":"2022","journal-title":"Clin Infect Dis"},{"key":"2026082011364550400_ofag492-B12","doi-asserted-by":"crossref","first-page":"e473","DOI":"10.1016\/S2352-3018(25)00105-5","article-title":"Maintenance therapy with dolutegravir and lamivudine versus bictegravir, emtricitabine, and tenofovir alafenamide in people with HIV (PASO-DOBLE): 48-week results from a randomised, multicentre, open-label, non-inferiority trial","volume":"12","author":"Ryan","year":"2025","journal-title":"Lancet HIV"},{"key":"2026082011364550400_ofag492-B13","doi-asserted-by":"crossref","first-page":"122","DOI":"10.1093\/cid\/ciaf415","article-title":"Efficacy and safety of dual therapy with dolutegravir\/lamivudine in treatment-naive persons with CD4 counts &lt;200\/mm3: 48-week results of the DOLCE Study","volume":"82","author":"Figueroa","year":"2026","journal-title":"Clin Infect Dis"},{"key":"2026082011364550400_ofag492-B14","doi-asserted-by":"crossref","first-page":"e95","DOI":"10.1016\/S2352-3018(24)00294-7","article-title":"Efficacy of dolutegravir plus lamivudine in treatment-naive people living with HIV without baseline drug-resistance testing available (D2ARLING): 48-week results of a phase 4, randomised, open-label, non-inferiority trial","volume":"12","author":"Cordova","year":"2025","journal-title":"Lancet HIV"},{"key":"2026082011364550400_ofag492-B15","doi-asserted-by":"crossref","first-page":"875","DOI":"10.1007\/s40121-024-00950-1","article-title":"Real-world effectiveness of dolutegravir\/lamivudine in people with HIV-1 in test-and-treat settings or with high baseline viral loads: TANDEM Study Subgroup Analyses","volume":"13","author":"Benson","year":"2024","journal-title":"Infect Dis Ther"},{"key":"2026082011364550400_ofag492-B16","doi-asserted-by":"crossref","first-page":"357","DOI":"10.1007\/s40121-024-01103-0","article-title":"Real-world effectiveness and tolerability of dolutegravir and lamivudine 2-drug regimen in people living with HIV: systematic literature review and meta-analysis","volume":"14","author":"Fraysse","year":"2025","journal-title":"Infect Dis Ther"},{"key":"2026082011364550400_ofag492-B17","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1097\/QAD.0000000000003070","article-title":"Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy\u2014naive adults with HIV-1 infection","volume":"36","author":"Cahn","year":"2022","journal-title":"AIDS Lond Engl"},{"key":"2026082011364550400_ofag492-B18","doi-asserted-by":"crossref","first-page":"682","DOI":"10.1093\/jac\/dkae456","article-title":"Long-term effectiveness and tolerability of dolutegravir\/lamivudine in treatment-naive people with HIV: an analysis of a multicentre cohort at 96 weeks","volume":"80","author":"Su\u00e1rez-Garc\u00eda","year":"2025","journal-title":"J Antimicrob Chemother"},{"key":"2026082011364550400_ofag492-B19","doi-asserted-by":"crossref","first-page":"3533","DOI":"10.1007\/s10461-020-02929-8","article-title":"Patient-reported outcomes in ATLAS and FLAIR participants on long-acting regimens of cabotegravir and rilpivirine over 48 weeks","volume":"24","author":"Murray","year":"2020","journal-title":"AIDS Behav"},{"key":"2026082011364550400_ofag492-B20","doi-asserted-by":"crossref","first-page":"1646","DOI":"10.1093\/cid\/ciad020","article-title":"Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with human immunodeficiency virus 1 type 1 infection: 152-week results from ATLAS-2M, a randomized, open-label, phase 3b, noninferiority study","volume":"76","author":"Overton","year":"2023","journal-title":"Clin Infect Dis"},{"key":"2026082011364550400_ofag492-B21","doi-asserted-by":"crossref","first-page":"ofae560","DOI":"10.1093\/ofid\/ofae560","article-title":"Efficacy, safety, and tolerability of switching from bictegravir\/emtricitabine\/tenofovir alafenamide to dolutegravir\/lamivudine among adults with virologically suppressed HIV: the DYAD Study","volume":"11","author":"Rolle","year":"2024","journal-title":"Open Forum Infect Dis"},{"key":"2026082011364550400_ofag492-B22","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1186\/s12981-024-00604-9","article-title":"Efficacy and safety of switching to dolutegravir\/lamivudine in virologically suppressed people with HIV-1 aged\u226550 years: week 48 pooled results from the TANGO and SALSA studies","volume":"21","author":"Walmsley","year":"2024","journal-title":"AIDS Res Ther"}],"container-title":["Open Forum Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ofid\/advance-article-pdf\/doi\/10.1093\/ofid\/ofag492\/70681500\/ofag492.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ofid\/article-pdf\/13\/8\/ofag492\/70681500\/ofag492.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ofid\/article-pdf\/13\/8\/ofag492\/70681500\/ofag492.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T15:36:55Z","timestamp":1787240215000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ofid\/article\/doi\/10.1093\/ofid\/ofag492\/8763477"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,1]]},"references-count":22,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2026,8,1]]}},"URL":"https:\/\/doi.org\/10.1093\/ofid\/ofag492","relation":{},"ISSN":["2328-8957"],"issn-type":[{"value":"2328-8957","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,8]]},"published":{"date-parts":[[2026,8,1]]},"article-number":"ofag492"}}