BICOLDER研究- IMEA 057: 65岁及以上艾滋病病毒感染者改用比替替韦/恩曲他滨/替诺福韦阿拉胺治疗

IF 4 3区医学 Q1 INFECTIOUS DISEASES

Journal of Infection and Public Health Pub Date : 2025-09-01 DOI:10.1016/j.jiph.2025.102946

Minh P. Lê , Clotilde Allavena , Véronique Joly , Lambert Assoumou , Valentina Isernia , Faiza Ajana , Didier Neau , Diane Descamps , Charlotte Charpentier , Aïda Benalycherif , Bao Phung , Gilles Peytavin , Roland Landman , BICOLDER-IMEA 057 study group

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引用次数: 0

摘要

背景：多种药物治疗和合并症在老年HIV感染者（PWH）中很常见，并且通常与不良事件（ae）和药物-药物相互作用（ddi）的发生率升高有关。本研究的目的是评估比替格拉韦/恩曲他滨/替诺福韦alafenamide (B/F/TAF)，一种限制DDIs的抗逆转录病毒（ARV）治疗在病毒学控制的老年PWH人群中的有效性、安全性和实用性。材料和方法本研究是一项前瞻性、多中心、单臂研究，在65岁以上的HIV-1控制的PWH中进行，这些PWH从利托那韦或cobicistat增强方案切换到B/F/TAF。主要终点是参与者在第24周维持血浆HIV-1 RNA <； 50拷贝/mL的比例。次要终点包括生物学终点、合并症（Charlson）和衰弱（Fried）评分。给出中位数（IQR）结果。结果24例69岁（67 ~ 73岁），79.2% 为白人，进行意向治疗分析。75% %的参与者接受依维替韦/共存司他为基础的方案。在第24周和第48周，91.7 %的参与者保持血浆HIV-1 RNA <； 50拷贝/mL。一名参与者在第12周因病毒学失败而停止研究治疗，可能与AE后的依从性问题有关。6名参与者报告了药物相关不良事件，其中1人在第4周（噩梦/情绪障碍）停药。没有危及生命的突发事件或死亡报告。与基线相比，体重、合并症、肾脏参数、心血管风险或W48时的虚弱评分没有明显变化。据报道，总胆固醇和甘油三酯轻度下降。结论B/F/TAF对于有长期HIV感染史、多种合并症和合用药物的老年PWH患者安全有效。

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Switch to bictegravir/emtricitabine/tenofovir alafenamide in people living with HIV aged 65 years or older: BICOLDER study – IMEA 057

Background

Polymedication and comorbidities are frequent in aging people with HIV (PWH) and often associated with elevated incidences of adverse events (AEs) and drug-drug interactions (DDIs). The objective of this study was to evaluate the efficacy, safety and practicality of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), an antiretroviral (ARV) therapy with limited DDIs, in an elderly virologically-controlled PWH population.

Materials and methods

This study was prospective, multicentric, single-arm conducted in HIV-1 controlled PWH aged over 65 years who switched from a ritonavir- or cobicistat-boosted containing regimen to B/F/TAF. The primary outcome was the proportion of participants maintaining plasma HIV-1 RNA < 50 copies/mL at Week24. Secondary endpoints included biological endpoints and co-morbidity (Charlson) and frailty (Fried) scores. Median (IQR) results are presented.

Results

24 participants aged 69 years (67−73), 79.2 % Caucasian, were analyzed in the intention-to-treat analysis. 75 % of participants were receiving an elvitegravir/cobicistat based regimen. At week24 and week48, 91.7 % of participants maintained a plasma HIV-1 RNA < 50 copies/mL. Study treatment was discontinued in one participant due to virologic failure at week12, possibly related to adherence issues following AE. Drug-related AEs were reported in 6 participants, with one discontinuation at week4 (nightmare/mood disorder). No life-threatening AEs or deaths were reported. No significant modifications from baseline were reported in weight, co-morbidities, kidney parameters, cardiovascular risk or frailty scores at W48. A mild decrease of total cholesterol and triglycerides was reported.

Conclusions

The findings indicate that B/F/TAF is both safe and effective for elderly PWH patients with a prolonged and documented history of HIV infection, multiple co-morbidities and concomitant medication.

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来源期刊

Journal of Infection and Public Health PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH -INFECTIOUS DISEASES

CiteScore

13.10

自引率

1.50%

发文量

203

审稿时长

96 days

期刊介绍： The Journal of Infection and Public Health, first official journal of the Saudi Arabian Ministry of National Guard Health Affairs, King Saud Bin Abdulaziz University for Health Sciences and the Saudi Association for Public Health, aims to be the foremost scientific, peer-reviewed journal encompassing infection prevention and control, microbiology, infectious diseases, public health and the application of healthcare epidemiology to the evaluation of health outcomes. The point of view of the journal is that infection and public health are closely intertwined and that advances in one area will have positive consequences on the other. The journal will be useful to all health professionals who are partners in the management of patients with communicable diseases, keeping them up to date. The journal is proud to have an international and diverse editorial board that will assist and facilitate the publication of articles that reflect a global view on infection control and public health, as well as emphasizing our focus on supporting the needs of public health practitioners. It is our aim to improve healthcare by reducing risk of infection and related adverse outcomes by critical review, selection, and dissemination of new and relevant information in the field of infection control, public health and infectious diseases in all healthcare settings and the community.