Xiaoyan Yang, Xiaoxin Xie, Yanhua Fu, Lin Gan, Shujing Ma, Hai Long
{"title":"比特拉韦/恩曲他滨/替诺福韦-阿拉非那酰胺对晚期HIV-1感染者的有效性和安全性。","authors":"Xiaoyan Yang, Xiaoxin Xie, Yanhua Fu, Lin Gan, Shujing Ma, Hai Long","doi":"10.1093/ofid/ofae630","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) have been demonstrated in treatment-naive clinical trials. However, real-world evidence for this regimen in late-presenting patients with HIV-1 (PWH) is lacking. We investigated the virologic and safety outcomes of BIC/FTC/TAF in late-presenting PWH.</p><p><strong>Methods: </strong>This retrospective cohort analysis consisted of late-presenting PWH who initiated an antiretroviral regimen of BIC/FTC/TAF between June 2021 and June 2023. Treatment effectiveness, defined as HIV-1 RNA <50 copies/mL, was analyzed. Changes in immunologic, metabolic, liver, and renal parameters were evaluated. Late-presenting PWH were defined as surviving PWH with CD4 <200 cells/μL or surviving patients who met the criteria for AIDS-defining conditions with a CD4 ranging from 200 to 499 cells/μL.</p><p><strong>Results: </strong>A total of 130 participants were included in the study. At week 48, 93.8% (122/130) of the patients achieved HIV-1 RNA levels <50 copies/mL. CD4 increased by 150.0 cells/μL, and CD4/CD8 increased by 0.16 (<i>P</i> < .001). Sixteen (12.3%) participants experienced adverse events, and 6 (4.6%) experienced drug-related adverse events. None of the participants discontinued treatment due to either a lack of effectiveness or adverse events.</p><p><strong>Conclusions: </strong>BIC/FTC/TAF demonstrated robust virologic suppression and tolerability in patients presenting late in the course of HIV infection.</p>","PeriodicalId":19517,"journal":{"name":"Open Forum Infectious Diseases","volume":"11 11","pages":"ofae630"},"PeriodicalIF":3.8000,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11540140/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Late-Presenting People With HIV-1 Infection.\",\"authors\":\"Xiaoyan Yang, Xiaoxin Xie, Yanhua Fu, Lin Gan, Shujing Ma, Hai Long\",\"doi\":\"10.1093/ofid/ofae630\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) have been demonstrated in treatment-naive clinical trials. However, real-world evidence for this regimen in late-presenting patients with HIV-1 (PWH) is lacking. We investigated the virologic and safety outcomes of BIC/FTC/TAF in late-presenting PWH.</p><p><strong>Methods: </strong>This retrospective cohort analysis consisted of late-presenting PWH who initiated an antiretroviral regimen of BIC/FTC/TAF between June 2021 and June 2023. Treatment effectiveness, defined as HIV-1 RNA <50 copies/mL, was analyzed. Changes in immunologic, metabolic, liver, and renal parameters were evaluated. Late-presenting PWH were defined as surviving PWH with CD4 <200 cells/μL or surviving patients who met the criteria for AIDS-defining conditions with a CD4 ranging from 200 to 499 cells/μL.</p><p><strong>Results: </strong>A total of 130 participants were included in the study. At week 48, 93.8% (122/130) of the patients achieved HIV-1 RNA levels <50 copies/mL. CD4 increased by 150.0 cells/μL, and CD4/CD8 increased by 0.16 (<i>P</i> < .001). Sixteen (12.3%) participants experienced adverse events, and 6 (4.6%) experienced drug-related adverse events. 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Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Late-Presenting People With HIV-1 Infection.
Background: The efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) have been demonstrated in treatment-naive clinical trials. However, real-world evidence for this regimen in late-presenting patients with HIV-1 (PWH) is lacking. We investigated the virologic and safety outcomes of BIC/FTC/TAF in late-presenting PWH.
Methods: This retrospective cohort analysis consisted of late-presenting PWH who initiated an antiretroviral regimen of BIC/FTC/TAF between June 2021 and June 2023. Treatment effectiveness, defined as HIV-1 RNA <50 copies/mL, was analyzed. Changes in immunologic, metabolic, liver, and renal parameters were evaluated. Late-presenting PWH were defined as surviving PWH with CD4 <200 cells/μL or surviving patients who met the criteria for AIDS-defining conditions with a CD4 ranging from 200 to 499 cells/μL.
Results: A total of 130 participants were included in the study. At week 48, 93.8% (122/130) of the patients achieved HIV-1 RNA levels <50 copies/mL. CD4 increased by 150.0 cells/μL, and CD4/CD8 increased by 0.16 (P < .001). Sixteen (12.3%) participants experienced adverse events, and 6 (4.6%) experienced drug-related adverse events. None of the participants discontinued treatment due to either a lack of effectiveness or adverse events.
Conclusions: BIC/FTC/TAF demonstrated robust virologic suppression and tolerability in patients presenting late in the course of HIV infection.
期刊介绍：
Open Forum Infectious Diseases provides a global forum for the publication of clinical, translational, and basic research findings in a fully open access, online journal environment. The journal reflects the broad diversity of the field of infectious diseases, and focuses on the intersection of biomedical science and clinical practice, with a particular emphasis on knowledge that holds the potential to improve patient care in populations around the world. Fully peer-reviewed, OFID supports the international community of infectious diseases experts by providing a venue for articles that further the understanding of all aspects of infectious diseases.
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