Infectious and Tropical Diseases Unit, Padua University Hospital, 35128 Padua, Italy.
Infectious Diseases Unit, Department of Medical Sciences, University of Turin, Amedeo di Savoia Hospital, 10149 Turin, Italy.
Viruses. 2023 Aug 15;15(8):1740. doi: 10.3390/v15081740.
Clinical trials and real-life studies have granted the efficacy and safety of dolutegravir and lamivudine (DTG/3TC) in naïve and experienced people living with HIV (PLWH), but there are no long-term data in elderly people. We herein describe our real-life cohort of PLWH who were ≥65 years of age (PLWH ≥ 65) who started or were switched to DTG/3TC, single-tablet regimen, or DTG plus 3TC.
We considered laboratory/clinical parameter changes from the baseline to the last follow-up time point available for each person by the paired Wilcoxon test and analyzed factors associated with virological failure (VF) and discontinuation.
We included 112 PLWH with a median age of 66 (IQR: 65-70) years, 77.6% males; 84.8% of people had multimorbidity, 34.8% were on polypharmacy, and only 5.4% were naïve to treatment. Reasons to be switched to DTG/3TC were: abacavir removal (38.7%), treatment simplification (33.1%), and PI discontinuation (28.2%). The median treatment durability was 6 (IQR: 5.4-7) years. No significant changes were detected in metabolic, renal, immunological, or cardiovascular biomarkers during follow-up. HIV RNA undetectability was maintained in 104 (92.8%) individuals for whom follow-up evaluation was available. We observed eight discontinuations (two deaths, two VFs, two early intolerances, one significant weight gain, and one switch to long-acting therapy). No factors were significantly associated with VF or discontinuation.
This is the first study on DTG/3TC in PLWH ≥ 65 with a follow-up longer than 5 years. DTG/3TC was found to be safe and effective, neutral on metabolic parameters, and with a low discontinuation rate for toxicity or VF.
临床试验和真实世界研究已经证实了在初治和有治疗经验的 HIV 感染者（PLWH）中，使用多替拉韦和拉米夫定（DTG/3TC）的疗效和安全性，但在老年人中尚无长期数据。在此，我们描述了我们的真实世界队列，其中包括≥65 岁（PLWH≥65）开始或转换为 DTG/3TC、单一片剂方案或 DTG 加 3TC 的 PLWH。
我们通过配对 Wilcoxon 检验考虑了从基线到每个人最后一次可获得的随访时间点的实验室/临床参数变化，并分析了与病毒学失败（VF）和停药相关的因素。
我们纳入了 112 名中位年龄为 66（IQR：65-70）岁的 PLWH，其中 77.6%为男性；84.8%的人患有多种合并症，34.8%正在服用多种药物，只有 5.4%的人是初治。转换为 DTG/3TC 的原因是：阿巴卡韦去除（38.7%）、治疗简化（33.1%）和 PI 停药（28.2%）。中位治疗持续时间为 6（IQR：5.4-7）年。在随访期间，未检测到代谢、肾脏、免疫或心血管生物标志物的显著变化。对于可获得随访评估的 104 名（92.8%）个体，保持了 HIV RNA 不可检测性。我们观察到 8 例停药（2 例死亡、2 例 VF、2 例早期不耐受、1 例体重显著增加和 1 例转换为长效治疗）。没有任何因素与 VF 或停药显著相关。
这是第一项针对≥65 岁 PLWH 使用 DTG/3TC 的研究，随访时间超过 5 年。DTG/3TC 被发现是安全有效的，对代谢参数无影响，且因毒性或 VF 而停药的发生率较低。
