Lazzaro Alessandro, Recchia Gregorio Egidio, Alessi Federica, Santinelli Letizia, Battistini Luigi, Morcos Julieta, Romano Francesco, Bugani Ginevra, Maddaloni Luca, Caruso Sara, D'Amico Marta, Mezzaroma Ivano, Falciano Mario, Fimiani Caterina, Sfara Germana, Leone Maria Gemma, Turriziani Ombretta, Mastroianni Claudio Maria, d'Ettorre Gabriella
Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.
Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy.
Antimicrob Agents Chemother. 2025 Apr 2;69(4):e0081524. doi: 10.1128/aac.00815-24. Epub 2025 Feb 18.
Doravirine (DOR) is a novel antiretroviral agent with a favorable resistance profile and high tolerability. However, evidence is limited on DOR among elderly people living with HIV (PLWH) and whether it might modulate chronic inflammation. We aimed to investigate the efficacy, safety, and tolerability of DOR as a switching strategy among elderly PLWH and its impact on chronic inflammation in a real-life setting. We recruited a cohort of ART-experienced PLWH undergoing a therapeutic switch to a DOR-based regimen under virologic control (defined as HIV-RNA <200 copies/mL), regardless of the previous ART regimen. The primary objective was the evaluation of the rate of virologic control at 48 weeks post-switch. Secondary objectives included analyzing immune and metabolic outcomes. Plasmatic hs-CRP, IL-6, and D-dimer levels were measured as chronic inflammation markers. Overall, 150 PLWH were screened, and 147 were enrolled into the study. A total of 134 PLWH completed the follow-up. The rate of virological control was 96.1% (122/134; : 91.0%-98.7%) in the per-protocol analysis. After 48 weeks from the switch, we recorded significant reductions in serum fasting glycemia ( 0.019), triglycerides ( 0.024), and total cholesterol/HDL ratio ( 0.017); no clinically significant differences were detected in the body weight and BMI, as long as in immune, hepatic, and renal profiles. A significant reduction in IL-6 ( 0.019) and hs-CRP ( 0.019) was observed. DOR is an effective and safe treatment choice for elderly PLWH. The intriguing modulatory effect of DOR-based regimens on chronic systemic inflammation deserves further investigation.
多拉韦林（DOR）是一种新型抗逆转录病毒药物，具有良好的耐药性和高耐受性。然而，关于老年艾滋病毒感染者（PLWH）使用多拉韦林的证据有限，以及它是否能调节慢性炎症也尚不明确。我们旨在研究多拉韦林作为一种转换策略在老年PLWH中的疗效、安全性和耐受性，以及其在现实生活环境中对慢性炎症的影响。我们招募了一组有抗逆转录病毒治疗经验的PLWH，他们在病毒学控制（定义为HIV-RNA<200拷贝/毫升）下接受治疗转换，采用基于多拉韦林的治疗方案，无论之前的抗逆转录病毒治疗方案如何。主要目标是评估转换后48周的病毒学控制率。次要目标包括分析免疫和代谢结果。测量血浆高敏C反应蛋白（hs-CRP）、白细胞介素-6（IL-6）和D-二聚体水平作为慢性炎症标志物。总体而言，筛查了150名PLWH，147名被纳入研究。共有134名PLWH完成了随访。在意向性分析中，病毒学控制率为96.1%（122/134；91.0%-98.7%）。转换后48周，我们记录到血清空腹血糖（0.019）、甘油三酯（0.024）和总胆固醇/高密度脂蛋白比值（0.017）显著降低；在体重、体重指数以及免疫、肝脏和肾脏指标方面未检测到临床显著差异。观察到IL-6（0.019）和hs-CRP（0.019）显著降低。多拉韦林是老年PLWH的一种有效且安全的治疗选择。基于多拉韦林的治疗方案对慢性全身炎症的有趣调节作用值得进一步研究。
