Lê Minh P, Allavena Clotilde, Joly Véronique, Assoumou Lambert, Isernia Valentina, Ajana Faiza, Neau Didier, Descamps Diane, Charpentier Charlotte, Benalycherif Aïda, Phung Bao, Peytavin Gilles, Landman Roland
AP-HP, Hospital Bichat-Claude Bernard, Pharmacology Laboratory, IAME UMR 1137 INSERM, Université Paris Cité, France.
Hotel Dieu Hospital, Infectious and Tropical Diseases Department, Nantes, France.
J Infect Public Health. 2025 Nov;18(11):102946. doi: 10.1016/j.jiph.2025.102946. Epub 2025 Sep 1.
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.
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.
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.
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.
多重用药和合并症在老年艾滋病毒感染者（PWH）中很常见，并且常常与不良事件（AE）和药物相互作用（DDI）的发生率升高相关。本研究的目的是评估比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺（B/F/TAF）（一种具有有限药物相互作用的抗逆转录病毒（ARV）疗法）在老年病毒学得到控制的PWH人群中的疗效、安全性和实用性。
本研究是一项前瞻性、多中心、单臂研究，针对年龄超过65岁、从含利托那韦或考比司他增强方案转换为B/F/TAF的HIV-1得到控制的PWH开展。主要结局是在第24周时血浆HIV-1 RNA<50拷贝/mL的参与者比例。次要终点包括生物学终点以及合并症（查尔森）和衰弱（弗里德）评分。呈现中位数（四分位间距）结果。
在意向性分析中分析了24名年龄为69岁（67-73岁）、79.2%为白种人的参与者。75%的参与者正在接受基于elvitegravir/考比司他的方案。在第24周和第48周时，91.7%的参与者血浆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，这可能与不良事件后的依从性问题有关。6名参与者报告了与药物相关的不良事件，其中一名在第4周（噩梦/情绪障碍）停止治疗。未报告危及生命的不良事件或死亡。在第48周时，体重、合并症、肾脏参数、心血管风险或衰弱评分与基线相比均无显著变化。报告总胆固醇和甘油三酯轻度下降。
研究结果表明，B/F/TAF对于有长期且有记录的HIV感染病史、多种合并症和同时用药的老年PWH患者而言既安全又有效。
