Real-world effectiveness, safety, and health-related quality of life in people living with HIV receiving bictegravir/emtricitabine/tenofovir alafenamide—12-month results of the BICSTaR French cohort

IF 1.5 Q4 INFECTIOUS DISEASES

IJID regions Pub Date : 2025-06-17 DOI:10.1016/j.ijregi.2025.100685

Laurent Hocqueloux , Fabrice Bonnet , Claudine Duvivier , Matteo Vassallo , Franck Tollinchi , Pascale Leclercq , Marina Karmochkine , Hugues Cordel , Colin Deschanvres , Alicia C. Gordon , David Thorpe , Tali Cassidy , Francois Durand , Sabrinel Sahali , Olivier Robineau

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引用次数: 0

Abstract

Objectives

BICSTaR is a multinational, prospective, observational study that aimed to evaluate bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in HIV treatment-naïve (TN) and treatment-experienced (TE) participants in routine clinical practice.

Methods

Month 12 analysis of the French cohort with respect to virologic effectiveness, drug-related adverse events (DRAEs), emergence of resistance, body weight, and patient-reported outcomes using the HIV Symptom Index and the HIV Treatment Satisfaction Questionnaire.

Results

A total of 240 participants initiated B/F/TAF in January-July 2019 (56 TN, 184 TE), 79% of whom were male, with a median age of 50 years. At baseline, 63% (TN: 46%, TE: 68%) presented with comorbidities. At month 12, HIV-1 RNA was <50 cp/mL in 92% (43/47) of TN and 96% (134 of 139) of TE in missing = excluded analysis (discontinuation = failure analysis: TN: 92% [43 of 47], TE: 92% [134 of 146]). No major mutations associated with B/F/TAF resistance emerged. A total of 7% (16 of 240) discontinued B/F/TAF, including 4% (10 of 240) due to DRAEs and none for virologic reasons. DRAEs were reported in 13% (30 of 240) (no renal DRAE). The median changes in body weight were +6.5 kg in TN and +1.0 kg in TE. The number of bothersome symptoms decreased in the TN group, and treatment satisfaction significantly increased in the TE group.

Conclusions

These French real-world data confirm the effectiveness, safety, and tolerability of B/F/TAF in TN and TE participants with a high prevalence of comorbidities.

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接受比替替韦/恩曲他滨/替诺福韦阿拉芬胺治疗的HIV感染者的实际有效性、安全性和健康相关生活质量——BICSTaR法国队列研究的12个月结果

bicstar是一项跨国、前瞻性、观察性研究，旨在评估比替替韦/恩曲他滨/替诺福韦alafenamide （B/F/TAF）在HIV treatment-naïve （TN）和治疗经验（TE）参与者中的常规临床实践。方法使用HIV症状指数和HIV治疗满意度问卷对法国队列进行病毒学有效性、药物相关不良事件（DRAEs）、耐药性出现、体重和患者报告结果的分析。结果2019年1 - 7月，共有240名参与者（56名TN， 184名TE）启动B/F/TAF，其中79%为男性，中位年龄50岁。基线时，63% （TN: 46%, TE: 68%）出现合并症。在12个月时，在缺失=排除分析中，92%（43/47）的TN和96%（139 / 134）的TE中HIV-1 RNA为50 cp/mL（终止=失败分析：TN: 92% [47 / 43]， TE: 92%[146 / 134]）。未发现与B/F/TAF耐药相关的主要突变。总共有7%（240例中有16例）停用B/F/TAF，其中4%（240例中有10例）是由于DRAEs，没有一例是由于病毒学原因。有13%（240例中有30例）报告了DRAE（无肾脏DRAE）。TN组体重变化中位数为+6.5 kg， TE组为+1.0 kg。TN组恼人症状数量减少，TE组治疗满意度显著提高。结论：这些法国真实世界的数据证实了B/F/TAF在具有高患病率合并症的TN和TE患者中的有效性、安全性和耐受性。

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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