BICSTaR观察队列中关键人群24个月的有效性和安全性:比替格拉韦/恩曲他滨/替诺福韦阿拉那胺在HIV患者的临床应用

IF 1.7 4区 医学 Q3 INFECTIOUS DISEASES
HIV Research & Clinical Practice Pub Date : 2025-12-01 Epub Date: 2025-02-12 DOI:10.1080/25787489.2025.2456890
Benoit Trottier, Chia-Jui Yang, Dai Watanabe, Giulia Marchetti, Daniel Elbirt, Eoghan De Barra, Alper Gündüz, Sun Hee Lee, Roger Vogelmann, Olivier Robineau, Chiaw Yee Choy, Marvin Berrevoets, Alison Uriel, David Thorpe, Marion Heinzkill, Andrea Marongiu, Johanna Ramroth, Lisa D'Amato, Josep Mallolas
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引用次数: 0

摘要

背景:BICSTaR是一项观察性队列研究,评估了BICtegravir /恩曲他滨/替诺福韦alafenamide (B/F/TAF)在treatment-naïve (TN)和治疗经验(TE) HIV感染者中的有效性和安全性。目的:为整个队列提供24个月的最终汇总结果。方法:前瞻性数据来自14个国家的常规临床实践中的TN和TE成人HIV启动B/F/TAF(数据收集:2018年6月25日- 2023年12月29日)。24个月时的结果包括病毒学抑制(HIV-1 RNA)结果:在纳入的2074名参与者中(483名TN, 1591名TE),大多数是男性(85%),白人(70%),并且有≥1个合并症(66%)。中位(Q1, Q3)年龄为45岁(35,54岁)。在24个月时,94%的TN参与者和96%的TE参与者有HIV-1 RNA p。结论:B/F/TAF在24个月的时间里普遍耐受良好,在广泛的HIV感染者中观察到高效率和持久性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Bictegravir/emtricitabine/tenofovir alafenamide in clinical practice for people with HIV: final 24-month effectiveness and safety outcomes in key populations in the observational BICSTaR cohort.

Background: BICtegravir Single Tablet Regimen (BICSTaR) is an observational cohort study evaluating the effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve (TN) and treatment-experienced (TE) people with HIV.

Objective: To present final pooled 24-month outcomes for the full cohort.

Methods: Prospective data were pooled from TN and TE adults with HIV initiating B/F/TAF in routine clinical practice across 14 countries (data collection: 25/06/2018-29/12/2023). Outcomes at 24 months included virologic suppression (HIV-1 RNA <50 copies/mL), immunologic effectiveness (change in CD4 cell count and CD4/CD8 ratio), persistence, and safety. Outcomes were also analysed in key populations.

Results: Of 2,074 (483 TN, 1,591 TE) participants included, most were male (85%), White (70%), and had ≥1 comorbidity (66%). Median (Q1, Q3) age was 45 (35, 54) years. At 24 months, 94% of TN and 96% of TE participants had HIV-1 RNA <50 copies/mL (missing = excluded analysis). These values were 88% and 86%, respectively, in a discontinuation = failure analysis. Effectiveness remained high across all key populations at 24 months. Median (Q1, Q3) CD4 count increased by 257 (127, 447) cells/µL in TN and 40 (-70, 153) cells/µL in TE participants (both p < 0.001). There was no reported treatment-emergent resistance to B/F/TAF. Persistence was high at 24 months (TN, 95%; TE, 91%). Drug-related adverse events occurred in 11% of TN and 12% of TE participants, leading to B/F/TAF discontinuation in 5%.

Conclusions: B/F/TAF was generally well tolerated over 24 months, with high effectiveness and persistence observed among a broad range of people with HIV.

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CiteScore
2.90
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