{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T11:19:43Z","timestamp":1788779983137,"version":"build-2803163510"},"reference-count":33,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2025,6,1]],"date-time":"2025-06-01T00:00:00Z","timestamp":1748736000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,6,1]],"date-time":"2025-06-01T00:00:00Z","timestamp":1748736000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2025,3,11]],"date-time":"2025-03-11T00:00:00Z","timestamp":1741651200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003196","name":"Ministry of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008897","name":"Janssen Pharmaceutica","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008897","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","ijidonline.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["International Journal of Infectious Diseases"],"published-print":{"date-parts":[[2025,6]]},"DOI":"10.1016\/j.ijid.2025.107883","type":"journal-article","created":{"date-parts":[[2025,3,13]],"date-time":"2025-03-13T21:11:36Z","timestamp":1741900296000},"page":"107883","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":3,"special_numbering":"C","title":["Effectiveness of dolutegravir-based vs boosted darunavir-based first-line 3-drug regimens in people with HIV with advanced disease: A trial emulation"],"prefix":"10.1016","volume":"155","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6351-2623","authenticated-orcid":false,"given":"Roberta","family":"Gagliardini","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Giacomelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Mussini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen R.","family":"Cole","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessie K.","family":"Edwards","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmela","family":"Pinnetti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Raimondi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Spinello","family":"Antinori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Nozza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valentina","family":"Mazzotta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulia Carla","family":"Marchetti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergio","family":"Lo Caputo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Tavelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonella","family":"d'Arminio Monforte","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Antinori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Cozzi-Lepri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.ijid.2025.107883_bib0001","unstructured":"Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. Available at: https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/adult-and-adolescent-arv. Accessed 22 July 2024."},{"key":"10.1016\/j.ijid.2025.107883_bib0002","unstructured":"EACS Guidelines version 12.0, October 2023. Available at: https:\/\/www.eacsociety.org\/media\/guidelines-12.0.pdf . Accessed 15 September 2024."},{"key":"10.1016\/j.ijid.2025.107883_bib0003","doi-asserted-by":"crossref","first-page":"101991","DOI":"10.1016\/j.eclinm.2023.101991","article-title":"Bictegravir\/emtricitabine\/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trials","volume":"11","author":"Sax","year":"2023","journal-title":"EClinicalMedicine"},{"issue":"9936","key":"10.1016\/j.ijid.2025.107883_bib0004","doi-asserted-by":"crossref","first-page":"2222","DOI":"10.1016\/S0140-6736(14)60084-2","article-title":"Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study","volume":"383","author":"Clotet","year":"2014","journal-title":"Lancet"},{"issue":"9","key":"10.1016\/j.ijid.2025.107883_bib0005","doi-asserted-by":"crossref","first-page":"e410","DOI":"10.1016\/S2352-3018(16)30016-9","article-title":"Integrase inhibitor versus protease inhibitor based regimen for HIV-1 infected women (WAVES): a randomised, controlled, double-blind, phase 3 study","volume":"3","author":"Squires","year":"2016","journal-title":"Lancet HIV"},{"issue":"11","key":"10.1016\/j.ijid.2025.107883_bib0006","doi-asserted-by":"crossref","first-page":"1431","DOI":"10.1097\/QAD.0000000000001817","article-title":"A week-48 randomized phase-3 trial of darunavir\/cobicistat\/emtricitabine\/tenofovir alafenamide in treatment-naive HIV-1 patients","volume":"32","author":"Eron","year":"2018","journal-title":"AIDS"},{"issue":"9","key":"10.1016\/j.ijid.2025.107883_bib0007","doi-asserted-by":"crossref","first-page":"816","DOI":"10.1056\/NEJMoa1904340","article-title":"Dolutegravir-based or low-dose efavirenz\u2013based regimen for the treatment of HIV-1","volume":"381","author":"Kouanfack","year":"2019","journal-title":"N Engl J Med"},{"issue":"1","key":"10.1016\/j.ijid.2025.107883_bib0008","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1111\/j.1468-1293.2012.01060.x","article-title":"Final 192-week efficacy and safety of once-daily darunavir\/ritonavir compared with lopinavir\/ritonavir in HIV-1-infected treatment-na\u00efve patients in the ARTEMIS trial","volume":"14","author":"Orkin","year":"2013","journal-title":"HIV Med"},{"key":"10.1016\/j.ijid.2025.107883_bib0009","unstructured":"The Late Presenter Treatment Optimisation Study (LAPTOP). ID NCT03696160. Available at: https:\/\/clinicaltrials.gov\/study\/NCT03696160. Accessed 15 December 2024."},{"key":"10.1016\/j.ijid.2025.107883_bib0010","series-title":"2022 data","article-title":"Prevention and Control\/WHO Regional Office for Europe. HIV\/AIDS surveillance in Europe 2023","year":"2023"},{"key":"10.1016\/j.ijid.2025.107883_bib0011","doi-asserted-by":"crossref","DOI":"10.1016\/j.ijid.2024.106995","article-title":"Persistent poor clinical outcomes of people living with HIV presenting with AIDS and late HIV diagnosis \u2013 results from the ICONA cohort in Italy, 2009-2022","volume":"142","author":"Mondi","year":"2024","journal-title":"Int J Infect Dis"},{"issue":"11","key":"10.1016\/j.ijid.2025.107883_bib0012","doi-asserted-by":"crossref","first-page":"1184","DOI":"10.1111\/hiv.13440","article-title":"Epidemiology, comorbidities at diagnosis and outcomes associated with HIV late diagnosis from 2010 to 2019 in a Belgian reference centre: a retrospective study","volume":"23","year":"2022","journal-title":"HIV Med"},{"issue":"5","key":"10.1016\/j.ijid.2025.107883_bib0013","doi-asserted-by":"crossref","first-page":"289","DOI":"10.1111\/j.1468-1293.2010.00881.x","article-title":"Responses to highly active antiretroviral therapy and clinical events in patients with a low CD4 cell count: late presenters vs. late starters","volume":"12","author":"Waters","year":"2011","journal-title":"HIV Med"},{"issue":"5","key":"10.1016\/j.ijid.2025.107883_bib0014","doi-asserted-by":"crossref","first-page":"1123","DOI":"10.3390\/v15051123","article-title":"Efficacy and durability of dolutegravir- or darunavir-based regimens in ART-na\u00efve AIDS- or late-presenting HIV-infected patients","volume":"15","author":"Fabbiani","year":"2023","journal-title":"Viruses"},{"issue":"1","key":"10.1016\/j.ijid.2025.107883_bib0015","doi-asserted-by":"crossref","first-page":"47","DOI":"10.1111\/hiv.12962","article-title":"Antiretroviral treatment outcomes among late HIV presenters initiating treatment with integrase inhibitors or protease inhibitors","volume":"22","author":"Schuettfort","year":"2021","journal-title":"HIV Med"},{"issue":"8","key":"10.1016\/j.ijid.2025.107883_bib0016","doi-asserted-by":"crossref","first-page":"1283","DOI":"10.1097\/QAD.0000000000002891","article-title":"Late presentation for HIV impairs immunological but not virological response to antiretroviral treatment","volume":"35","author":"Rava","year":"2021","journal-title":"AIDS"},{"issue":"1","key":"10.1016\/j.ijid.2025.107883_bib0017","doi-asserted-by":"crossref","first-page":"108","DOI":"10.1093\/jac\/dkac361","article-title":"Mortality and immunovirological outcomes in patients with advanced HIV disease on their first antiretroviral treatment: differential impact of antiretroviral regimens","volume":"78","author":"Burgos","year":"2023","journal-title":"J Antimicrob Chemother"},{"key":"10.1016\/j.ijid.2025.107883_bib0018","unstructured":"Miro J.M., Torres F., Manzardo C., Bonfill E., Falc\u00f3 V., Domingo P., et al. Dolutegravir vs darunavir\/r-based art in very advanced patients: 48-week results. Conference on Retroviruses and Opportunistic Infections (CROI) 2021. Available at: https:\/\/www.croiconference.org\/abstract\/dolutegravir-vs-darunavir-r-based-art-in-very-advanced-patients-48-week-results\/ Accessed 15 September 2024."},{"key":"10.1016\/j.ijid.2025.107883_bib0019","doi-asserted-by":"crossref","first-page":"1302710","DOI":"10.3389\/fmed.2024.1302710","article-title":"Outcomes of severely ill patients with AIDS treated with efavirenz or dolutegravir: a multicenter, observational study","volume":"28","author":"Brites","year":"2024","journal-title":"Front Med (Lausanne)"},{"issue":"3","key":"10.1016\/j.ijid.2025.107883_bib0020","doi-asserted-by":"crossref","first-page":"ofac018","DOI":"10.1093\/ofid\/ofac018","article-title":"Advanced HIV infection in treatment-na\u00efve individuals: effectiveness and persistence of recommended 3-drug regimens","volume":"9","author":"Mounzer","year":"2022","journal-title":"Open Forum Infect Dis"},{"issue":"1","key":"10.1016\/j.ijid.2025.107883_bib0021","doi-asserted-by":"crossref","first-page":"61","DOI":"10.1111\/j.1468-1293.2010.00857.x","article-title":"Late presentation of HIV infection: a consensus definition","volume":"12","author":"Antinori","year":"2011","journal-title":"HIV Med"},{"issue":"3","key":"10.1016\/j.ijid.2025.107883_bib0022","doi-asserted-by":"crossref","first-page":"211","DOI":"10.1007\/s10654-019-00494-6","article-title":"Principles of confounder selection","volume":"34","author":"VanderWeele","year":"2019","journal-title":"Eur J Epidemiol"},{"issue":"7","key":"10.1016\/j.ijid.2025.107883_bib0023","doi-asserted-by":"crossref","first-page":"E1408","DOI":"10.1093\/cid\/ciaa1037","article-title":"Clinical effectiveness of integrase strand transfer inhibitor\u2013based antiretroviral regimens among adults with human immunodeficiency virus: a collaboration of cohort studies in the United States and Canada","volume":"73","author":"Lu","year":"2021","journal-title":"Clin Infect Dis"},{"issue":"4","key":"10.1016\/j.ijid.2025.107883_bib0024","doi-asserted-by":"crossref","first-page":"268","DOI":"10.7326\/M16-2607","article-title":"Sensitivity analysis in observational research: introducing the E-value","volume":"167","author":"VanderWeele","year":"2017","journal-title":"Ann Intern Med"},{"key":"10.1016\/j.ijid.2025.107883_bib0025","doi-asserted-by":"crossref","DOI":"10.1016\/j.eclinm.2022.101600","article-title":"Determinants of long-term survival in late HIV presenters: the prospective PISCIS cohort study","volume":"52","author":"Martin-Iguacel","year":"2022","journal-title":"EClinicalMedicine"},{"issue":"2","key":"10.1016\/j.ijid.2025.107883_bib0026","doi-asserted-by":"crossref","first-page":"129","DOI":"10.1089\/aid.2015.0379","article-title":"Late presentation HIV\/AIDS is still a challenge in Brazil and worldwide","volume":"34","author":"Komninakis","year":"2017","journal-title":"AIDS Res Hum Retroviruses"},{"key":"10.1016\/j.ijid.2025.107883_bib0027","doi-asserted-by":"crossref","first-page":"534","DOI":"10.1186\/s12879-019-4156-3","article-title":"Late presentation of HIV positive adults and its predictors to HIV\/AIDS care in Ethiopia: a systematic review and meta-analysis","volume":"17","author":"Belay","year":"2019","journal-title":"BMC Infect Dis"},{"key":"10.1016\/j.ijid.2025.107883_bib0028","series-title":"HIV treatment-interim guidance","article-title":"Updated recommendations on first-line and second-line antiretroviral regimens and post-exposure prophylaxis and recommendations on early infant diagnosis of HIV","year":"2018"},{"key":"10.1016\/j.ijid.2025.107883_bib0029","unstructured":"Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence EMA 2024. Available at: https:\/\/www.ema.europa.eu\/en\/reflection-paper-use-real-world-data-non-interventional-studies-generate-real-world-evidence-scientific-guideline Accessed 15 December 2024."},{"key":"10.1016\/j.ijid.2025.107883_bib0030","doi-asserted-by":"crossref","unstructured":"Hern\u00e1n MA, Brumback B. Robins J.M Marginal structural models to estimate the causal effect of Zidovudine on the survival of HIV-positive men. The multicenter AIDS cohort study and bias of standard methods. Epidemiology (Cambridge, Mass.) 11(5):561\u201370.","DOI":"10.1097\/00001648-200009000-00012"},{"issue":"7","key":"10.1016\/j.ijid.2025.107883_bib0031","doi-asserted-by":"crossref","first-page":"687","DOI":"10.1093\/aje\/kwg206","article-title":"Effect of highly active antiretroviral therapy on time to acquired immunodeficiency syndrome or death using marginal structural models","volume":"158","author":"Cole","year":"2003","journal-title":"Am J Epidemiol"},{"issue":"454","key":"10.1016\/j.ijid.2025.107883_bib0032","doi-asserted-by":"crossref","first-page":"440","DOI":"10.1198\/016214501753168154","article-title":"Marginal structural models to estimate the joint causal effect of nonrandomized treatments","volume":"96","author":"Hern\u00e1n","year":"2001","journal-title":"J Am Stat Assoc"},{"issue":"8","key":"10.1016\/j.ijid.2025.107883_bib0033","doi-asserted-by":"crossref","first-page":"1569","DOI":"10.1093\/aje\/kwz100","article-title":"Effect estimates in randomized trials and observational studies: comparing apples with apples","volume":"188","author":"Lodi","year":"2019","journal-title":"Am J Epidemiol"}],"container-title":["International Journal of Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1201971225001067?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1201971225001067?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,2,4]],"date-time":"2026-02-04T11:41:50Z","timestamp":1770205310000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1201971225001067"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6]]},"references-count":33,"alternative-id":["S1201971225001067"],"URL":"https:\/\/doi.org\/10.1016\/j.ijid.2025.107883","relation":{},"ISSN":["1201-9712"],"issn-type":[{"value":"1201-9712","type":"print"}],"subject":[],"published":{"date-parts":[[2025,6]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Effectiveness of dolutegravir-based vs boosted darunavir-based first-line 3-drug regimens in people with HIV with advanced disease: A trial emulation","name":"articletitle","label":"Article Title"},{"value":"International Journal of Infectious Diseases","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.ijid.2025.107883","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2025 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases.","name":"copyright","label":"Copyright"}],"article-number":"107883"}}