Gundolf Schuettfort, Jan Borch, Alfonso Cabello, Maria Crusells, Miguel Górgolas, Eva Herrmann, Carmen Hidalgo-Tenorio, Juan Lopez, Rafael Mican, Roser Navarro-Soler, Eugenia Negredo, Sebastian Noe, Jordi Puig, Federico Pulido, Rosario Serrao, Juergen Rockstroh, Sergio Rodriguez, Christoph Stephan, Miguel Torralba, Diva Trigo, Maria Vehreschild, Annette E Haberl
{"title":"晚期诊断的艾滋病病毒感染者使用DTG/3TC或BIC/TAF/FTC开始抗逆转录病毒治疗：现实世界队列分析","authors":"Gundolf Schuettfort, Jan Borch, Alfonso Cabello, Maria Crusells, Miguel Górgolas, Eva Herrmann, Carmen Hidalgo-Tenorio, Juan Lopez, Rafael Mican, Roser Navarro-Soler, Eugenia Negredo, Sebastian Noe, Jordi Puig, Federico Pulido, Rosario Serrao, Juergen Rockstroh, Sergio Rodriguez, Christoph Stephan, Miguel Torralba, Diva Trigo, Maria Vehreschild, Annette E Haberl","doi":"10.1111/hiv.70119","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To investigate the efficacy and safety of first-line antiretroviral treatment (ART) with 2DR dolutegravir/lamivudine (DTG/3TC) versus 3DR bictegravir/tenofovir alafenamide/emtricitabine (BIC/TAF/FTC) in persons with low CD4 cell counts and/or an AIDS-defining disease.</p><p><strong>Design: </strong>Retrospective, multicentre, multinational study.</p><p><strong>Methods: </strong>We conducted a retrospective, multicentre, multinational analysis to investigate the virological response and discontinuation rate in people living with HIV starting first-line ART with a CD4 cell count <200/μL and/or an AIDS-defining condition. Proportions of discontinuations were compared using univariate analysis. Virological response was analyzed using FDA snapshot analysis (HIV-1 RNA <50 copies/mL at week 48).</p><p><strong>Results: </strong>Two hundred and fifty-nine people who were diagnosed late with HIV were included in the study. Sixty-nine of them were started on 2DR DTG/3TC and 190 on 3DR BIC/TAF/FTC. After matching 1 to 1 (matching criteria: age, sex, CD4 cell count, HI-viral load, Centers for Disease Control and Prevention (CDC) stage, n = 62 per group), the mean baseline CD4 cell count was 121/μL (standard deviation [SD] 65), including 21% presenting with an AIDS-defining condition. 96.2% and 91.8% of people living with HIV on 2DR and 3DR, respectively, had a viral load <50 copies/mL at week 48 (p = 0.244). No significant differences in discontinuation rates were observed at week 48 (5.5% in the 2DR and 9.4% in the 3DR group; p = 0.301).</p><p><strong>Conclusion: </strong>In a European cohort of people diagnosed late with HIV who started first-line ART either with 2DR DTG/3TC or 3DR BIC/TAF/FTC, there were no significant differences in virological response and discontinuation rates after 48 weeks of treatment. With respect to the relatively small sample size and the inherent constraints of the study design, the possibility of establishing causal inference remains limited, and prospective studies are needed to further investigate on this topic.</p>","PeriodicalId":13176,"journal":{"name":"HIV Medicine","volume":" ","pages":""},"PeriodicalIF":3.2000,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Antiretroviral treatment in people living with HIV with late diagnosis initiating ART with DTG/3TC or BIC/TAF/FTC: A real-world cohort analysis.\",\"authors\":\"Gundolf Schuettfort, Jan Borch, Alfonso Cabello, Maria Crusells, Miguel Górgolas, Eva Herrmann, Carmen Hidalgo-Tenorio, Juan Lopez, Rafael Mican, Roser Navarro-Soler, Eugenia Negredo, Sebastian Noe, Jordi Puig, Federico Pulido, Rosario Serrao, Juergen Rockstroh, Sergio Rodriguez, Christoph Stephan, Miguel Torralba, Diva Trigo, Maria Vehreschild, Annette E Haberl\",\"doi\":\"10.1111/hiv.70119\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To investigate the efficacy and safety of first-line antiretroviral treatment (ART) with 2DR dolutegravir/lamivudine (DTG/3TC) versus 3DR bictegravir/tenofovir alafenamide/emtricitabine (BIC/TAF/FTC) in persons with low CD4 cell counts and/or an AIDS-defining disease.</p><p><strong>Design: </strong>Retrospective, multicentre, multinational study.</p><p><strong>Methods: </strong>We conducted a retrospective, multicentre, multinational analysis to investigate the virological response and discontinuation rate in people living with HIV starting first-line ART with a CD4 cell count <200/μL and/or an AIDS-defining condition. Proportions of discontinuations were compared using univariate analysis. Virological response was analyzed using FDA snapshot analysis (HIV-1 RNA <50 copies/mL at week 48).</p><p><strong>Results: </strong>Two hundred and fifty-nine people who were diagnosed late with HIV were included in the study. Sixty-nine of them were started on 2DR DTG/3TC and 190 on 3DR BIC/TAF/FTC. After matching 1 to 1 (matching criteria: age, sex, CD4 cell count, HI-viral load, Centers for Disease Control and Prevention (CDC) stage, n = 62 per group), the mean baseline CD4 cell count was 121/μL (standard deviation [SD] 65), including 21% presenting with an AIDS-defining condition. 96.2% and 91.8% of people living with HIV on 2DR and 3DR, respectively, had a viral load <50 copies/mL at week 48 (p = 0.244). No significant differences in discontinuation rates were observed at week 48 (5.5% in the 2DR and 9.4% in the 3DR group; p = 0.301).</p><p><strong>Conclusion: </strong>In a European cohort of people diagnosed late with HIV who started first-line ART either with 2DR DTG/3TC or 3DR BIC/TAF/FTC, there were no significant differences in virological response and discontinuation rates after 48 weeks of treatment. With respect to the relatively small sample size and the inherent constraints of the study design, the possibility of establishing causal inference remains limited, and prospective studies are needed to further investigate on this topic.</p>\",\"PeriodicalId\":13176,\"journal\":{\"name\":\"HIV Medicine\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.2000,\"publicationDate\":\"2025-10-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"HIV Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/hiv.70119\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"HIV Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/hiv.70119","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
Antiretroviral treatment in people living with HIV with late diagnosis initiating ART with DTG/3TC or BIC/TAF/FTC: A real-world cohort analysis.
Objective: To investigate the efficacy and safety of first-line antiretroviral treatment (ART) with 2DR dolutegravir/lamivudine (DTG/3TC) versus 3DR bictegravir/tenofovir alafenamide/emtricitabine (BIC/TAF/FTC) in persons with low CD4 cell counts and/or an AIDS-defining disease.
Methods: We conducted a retrospective, multicentre, multinational analysis to investigate the virological response and discontinuation rate in people living with HIV starting first-line ART with a CD4 cell count <200/μL and/or an AIDS-defining condition. Proportions of discontinuations were compared using univariate analysis. Virological response was analyzed using FDA snapshot analysis (HIV-1 RNA <50 copies/mL at week 48).
Results: Two hundred and fifty-nine people who were diagnosed late with HIV were included in the study. Sixty-nine of them were started on 2DR DTG/3TC and 190 on 3DR BIC/TAF/FTC. After matching 1 to 1 (matching criteria: age, sex, CD4 cell count, HI-viral load, Centers for Disease Control and Prevention (CDC) stage, n = 62 per group), the mean baseline CD4 cell count was 121/μL (standard deviation [SD] 65), including 21% presenting with an AIDS-defining condition. 96.2% and 91.8% of people living with HIV on 2DR and 3DR, respectively, had a viral load <50 copies/mL at week 48 (p = 0.244). No significant differences in discontinuation rates were observed at week 48 (5.5% in the 2DR and 9.4% in the 3DR group; p = 0.301).
Conclusion: In a European cohort of people diagnosed late with HIV who started first-line ART either with 2DR DTG/3TC or 3DR BIC/TAF/FTC, there were no significant differences in virological response and discontinuation rates after 48 weeks of treatment. With respect to the relatively small sample size and the inherent constraints of the study design, the possibility of establishing causal inference remains limited, and prospective studies are needed to further investigate on this topic.
期刊介绍：
HIV Medicine aims to provide an alternative outlet for publication of international research papers in the field of HIV Medicine, embracing clinical, pharmocological, epidemiological, ethical, preclinical and in vitro studies. In addition, the journal will commission reviews and other feature articles. It will focus on evidence-based medicine as the mainstay of successful management of HIV and AIDS. The journal is specifically aimed at researchers and clinicians with responsibility for treating HIV seropositive patients.
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