Twelve-month effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide in people with HIV: Real-world insights from BICSTaR cohorts

IF 2.8 3区医学 Q2 INFECTIOUS DISEASES HIV Medicine Pub Date : 2023-12-26 DOI:10.1111/hiv.13593

Stefan Esser, Jason Brunetta, Alexy Inciarte, Itzchak Levy, Antonella D'Arminio Monforte, John S. Lambert, Berend van Welzen, Katsuji Teruya, Marta Boffito, Chun-Eng Liu, Ozlem Altuntas Aydın, David Thorpe, Marion Heinzkill, Andrea Marongiu, Tali Cassidy, Richard Haubrich, Lisa D'Amato, Olivier Robineau

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Abstract

Background

Real-world evidence is an essential component of evidence-based medicine. The aim of the BICSTaR (BICtegravir Single Tablet Regimen) study is to assess effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in antiretroviral treatment-naïve (TN) and treatment-experienced (TE) people with HIV.

Methods

BICSTaR is a prospective, observational cohort study. Participants (≥18 years) are being followed for 24 months. A pooled analysis is presented at 12 months, with the primary endpoint of effectiveness (HIV-1 RNA <50 copies/mL) and secondary endpoints of safety and tolerability (as per protocol). An exploration of patient-reported outcome measures using standardized questionnaires is included.

Results

Between June 2018 and May 2021, 1552 people with HIV were enrolled across 12 countries. The analysed population comprised 1509 individuals (279 TN, 1230 TE); most were white (76%), male (84%) and had one or more comorbid conditions (68%). Median age was 47 years. After 12 months of B/F/TAF treatment, HIV-1 RNA was <50 copies/mL in 94% (221/236) of TN participants and 97% (977/1008) of TE participants. Median CD4 cell count increased by 214 cells/μL (p < 0.001) in TN participants and 13 cells/μL (p = 0.014) in TE participants; median CD4/CD8 ratios increased by 0.30 and 0.03, respectively (both p < 0.001). Persistence was high at 12 months (TN, 97%; TE, 95%). No resistance to B/F/TAF emerged. Study drug-related adverse events occurred in 13% of participants through 12 months, leading to B/F/TAF discontinuation in 6%.

Conclusions

The findings of this study provide robust real-world evidence to support the broad use of B/F/TAF in both TN and TE people with HIV.

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bictegravir/emtricitabine/tenofovir alafenamide 对 HIV 感染者 12 个月的有效性和安全性：来自 BICSTaR 队列的真实世界见解。

背景：真实世界的证据是循证医学的重要组成部分。BICSTaR（比替拉韦单片疗法）研究旨在评估比替拉韦/恩曲他滨/替诺福韦-阿拉非那胺（B/F/TAF）在抗逆转录病毒治疗无效（TN）和治疗经验丰富（TE）的艾滋病感染者中的有效性和安全性：BICSTaR 是一项前瞻性、观察性队列研究。对参与者（≥18 岁）进行了为期 24 个月的随访。在 12 个月时进行汇总分析，主要终点为有效性（HIV-1 RNA 结果）：2018 年 6 月至 2021 年 5 月期间，12 个国家共招募了 1552 名艾滋病毒感染者。分析人群包括 1509 人（279 TN，1230 TE）；大多数为白人（76%）、男性（84%），有一种或多种并发症（68%）。年龄中位数为 47 岁。经过 12 个月的 B/F/TAF 治疗后，HIV-1 RNA 为结论：这项研究的结果为在 TN 和 TE HIV 感染者中广泛使用 B/F/TAF 提供了有力的实际证据。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

HIV Medicine 医学-传染病学

CiteScore

5.10

自引率

10.00%

发文量

167

审稿时长

6-12 weeks

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.