R A Passerotto, F Lamanna, P F Salvo, V Iannone, R J Steiner, A Carbone, D Farinacci, A D'Angelillo, G Baldin, A Ciccullo, S Di Giambenedetto, C Torti, A Borghetti
{"title":"bictegravir/emtricitabine/替诺福韦alafenamide (BIC/FTC/TAF)作为病毒学抑制患者切换策略的有效性:来自单中心队列的真实世界数据","authors":"R A Passerotto, F Lamanna, P F Salvo, V Iannone, R J Steiner, A Carbone, D Farinacci, A D'Angelillo, G Baldin, A Ciccullo, S Di Giambenedetto, C Torti, A Borghetti","doi":"10.1177/13596535241306467","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>BIC/FTC/TAF showed efficacy and tolerability in randomized trials as a switch strategy in virologically-suppressed people living with HIV. We evaluated its effectiveness in a real-life setting.</p><p><strong>Methods: </strong>A retrospective monocentric cohort including 431 virologically-suppressed (HIV-RNA <50 copies/ml) people switching to BIC/FTC/TAF in the period 2018-2022 was evaluated. Probabilities of virological failure (VF, i.e.2 consecutive HIV-RNA ≥50 copies/ml or a single HIV-RNA ≥200 copies/ml) and of treatment discontinuation (TD) were estimated by Kaplan-Meier, and predictors of both outcomes were identified through multivariable Cox regression. Analysis-of-variance for repeated measures was used to examine changes in CD4 count and CD4-to-CD8 ratio.</p><p><strong>Results: </strong>Overall, 16 VF occurred during 22 months of median follow-up time. Estimated probabilities of VF at 1, 2 and 3 years were 2.0% (95% CI 1.04.2%), 2.9% (95% CI 1.5%-5.6%) and 5.5% (95% CI 3.2%-9.2%), respectively. Caucasian ethnicity and a history of previous VF independently predicted VF. TD occurred in 42 cases, predominantly for simplification. One discontinuation due to VF was reported. No predictors of discontinuation were identified. An increase in CD4-to-CD8 ratio over 3 years was evidenced (<i>p</i> < 0.001). Total cholesterol decreased over 3 years (<i>p</i> < 0.001). Triglycerides did not significantly change (<i>p</i> = 0.465).</p><p><strong>Conclusions: </strong>BIC/FTC/TAF demonstrated high effectiveness, tolerability and safety.</p>","PeriodicalId":8364,"journal":{"name":"Antiviral Therapy","volume":"29 6","pages":"13596535241306467"},"PeriodicalIF":1.3000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effectiveness of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as switch strategy in virologically-suppressed patients: real world data from a monocentric cohort.\",\"authors\":\"R A Passerotto, F Lamanna, P F Salvo, V Iannone, R J Steiner, A Carbone, D Farinacci, A D'Angelillo, G Baldin, A Ciccullo, S Di Giambenedetto, C Torti, A Borghetti\",\"doi\":\"10.1177/13596535241306467\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>BIC/FTC/TAF showed efficacy and tolerability in randomized trials as a switch strategy in virologically-suppressed people living with HIV. We evaluated its effectiveness in a real-life setting.</p><p><strong>Methods: </strong>A retrospective monocentric cohort including 431 virologically-suppressed (HIV-RNA <50 copies/ml) people switching to BIC/FTC/TAF in the period 2018-2022 was evaluated. Probabilities of virological failure (VF, i.e.2 consecutive HIV-RNA ≥50 copies/ml or a single HIV-RNA ≥200 copies/ml) and of treatment discontinuation (TD) were estimated by Kaplan-Meier, and predictors of both outcomes were identified through multivariable Cox regression. Analysis-of-variance for repeated measures was used to examine changes in CD4 count and CD4-to-CD8 ratio.</p><p><strong>Results: </strong>Overall, 16 VF occurred during 22 months of median follow-up time. Estimated probabilities of VF at 1, 2 and 3 years were 2.0% (95% CI 1.04.2%), 2.9% (95% CI 1.5%-5.6%) and 5.5% (95% CI 3.2%-9.2%), respectively. Caucasian ethnicity and a history of previous VF independently predicted VF. TD occurred in 42 cases, predominantly for simplification. One discontinuation due to VF was reported. No predictors of discontinuation were identified. An increase in CD4-to-CD8 ratio over 3 years was evidenced (<i>p</i> < 0.001). Total cholesterol decreased over 3 years (<i>p</i> < 0.001). 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引用次数: 0
摘要
在随机试验中,BIC/FTC/TAF作为一种切换策略在病毒学抑制的HIV感染者中显示出疗效和耐受性。我们在现实生活中评估了它的有效性。方法:一项包括431例病毒学抑制(HIV-RNA)患者的回顾性单中心队列研究结果:总体而言,在22个月的中位随访时间内发生了16例VF。估计1、2和3年发生VF的概率分别为2.0% (95% CI 1.04.2%)、2.9% (95% CI 1.5%-5.6%)和5.5% (95% CI 3.2%-9.2%)。高加索人种和既往VF病史独立预测VF。42例发生TD,主要是简化。据报道,有一例因VF而中止。没有发现停药的预测因素。cd4 / cd8比值在3年内增加(p < 0.001)。总胆固醇在3年内下降(p < 0.001)。甘油三酯无显著变化(p = 0.465)。结论:BIC/FTC/TAF具有良好的疗效、耐受性和安全性。
Effectiveness of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as switch strategy in virologically-suppressed patients: real world data from a monocentric cohort.
Introduction: BIC/FTC/TAF showed efficacy and tolerability in randomized trials as a switch strategy in virologically-suppressed people living with HIV. We evaluated its effectiveness in a real-life setting.
Methods: A retrospective monocentric cohort including 431 virologically-suppressed (HIV-RNA <50 copies/ml) people switching to BIC/FTC/TAF in the period 2018-2022 was evaluated. Probabilities of virological failure (VF, i.e.2 consecutive HIV-RNA ≥50 copies/ml or a single HIV-RNA ≥200 copies/ml) and of treatment discontinuation (TD) were estimated by Kaplan-Meier, and predictors of both outcomes were identified through multivariable Cox regression. Analysis-of-variance for repeated measures was used to examine changes in CD4 count and CD4-to-CD8 ratio.
Results: Overall, 16 VF occurred during 22 months of median follow-up time. Estimated probabilities of VF at 1, 2 and 3 years were 2.0% (95% CI 1.04.2%), 2.9% (95% CI 1.5%-5.6%) and 5.5% (95% CI 3.2%-9.2%), respectively. Caucasian ethnicity and a history of previous VF independently predicted VF. TD occurred in 42 cases, predominantly for simplification. One discontinuation due to VF was reported. No predictors of discontinuation were identified. An increase in CD4-to-CD8 ratio over 3 years was evidenced (p < 0.001). Total cholesterol decreased over 3 years (p < 0.001). Triglycerides did not significantly change (p = 0.465).
Conclusions: BIC/FTC/TAF demonstrated high effectiveness, tolerability and safety.
期刊介绍:
Antiviral Therapy (an official publication of the International Society of Antiviral Research) is an international, peer-reviewed journal devoted to publishing articles on the clinical development and use of antiviral agents and vaccines, and the treatment of all viral diseases. Antiviral Therapy is one of the leading journals in virology and infectious diseases.
The journal is comprehensive, and publishes articles concerning all clinical aspects of antiviral therapy. It features editorials, original research papers, specially commissioned review articles, letters and book reviews. The journal is aimed at physicians and specialists interested in clinical and basic research.