Unit of Infectious Diseases, Department of Medical and Surgical Sciences, S.Orsola Hospital, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Unit of Microbiology, Department of Medical and Surgical Sciences, S.Orsola Hospital, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
AIDS Res Hum Retroviruses. 2024 Feb;40(2):73-79. doi: 10.1089/AID.2023.0046. Epub 2023 Jul 5.
Clinical trials of dual regimen dolutegravir/lamivudine (DOL/3TC) demonstrated potent efficacy and favorable safety in both antiretroviral therapy-naïve and -experienced patients, but data on older people are lacking. We aimed to evaluate virological efficacy and safety of DOL/3TC in suppressed older patients over a 12-month period. We performed a retrospective cohort study evaluating people living with HIV (PLWHIV) aged ≥65 years at our HIV Clinic who were switched to DOL/3TC. Eligible patients had baseline HIV-1 RNA <20 copies/mL, and no previous virological failures or known resistance mutations for lamivudine or dolutegravir. Inclusion criteria were met by 72 patients: 59 were men, median age was 69.2 years, and one or more comorbidities were present in 89% of patients. The most common reason for switch was simplification, followed by drug-drug interactions (DDIs) and toxicities. After 12 months, 64 (88.9%, by the intention-to-treat analysis) patients maintained HIV-1 RNA <20 copies/mL, and reasons for treatment failure were virological failure in three cases, adverse events in three, and missing data in two. Genotype resistance testing showed no resistance mutations for lamivudine or dolutegravir in subjects with virological failure. The number of potential DDIs decreased from 92 to 12 after switching to DOL/3TC, and a significant reduction in median total and low-density lipoprotein cholesterol was reported, while median change in body weight was not significant. In this real-life cohort, switching to DOL/3TC was associated with maintenance of virological control and good tolerability among persons aged >65 years, supporting use of this dual regimen in older PLWHIV.
临床试验表明，在初治和经治患者中，双药方案（多替拉韦/拉米夫定，DOL/3TC）具有强大的疗效和良好的安全性，但老年人的数据缺乏。我们旨在评估 DOL/3TC 在接受抑制治疗的老年患者中的病毒学疗效和安全性，为期 12 个月。我们进行了一项回顾性队列研究，评估了在我们的 HIV 诊所中年龄≥65 岁的 HIV 感染者（PLWHIV），这些患者被转换为 DOL/3TC。符合条件的患者基线时 HIV-1 RNA<20 拷贝/mL，且无先前拉米夫定或多替拉韦的病毒学失败或已知耐药突变。符合纳入标准的患者有 72 例：59 例为男性，中位年龄为 69.2 岁，89%的患者有 1 种或多种合并症。转换的最常见原因是简化治疗方案，其次是药物相互作用（DDI）和毒性。在 12 个月时，64 例（按意向治疗分析，88.9%）患者保持 HIV-1 RNA<20 拷贝/mL，治疗失败的原因是 3 例病毒学失败，3 例因不良事件，2 例因失访。基因型耐药检测显示病毒学失败患者中无拉米夫定或多替拉韦耐药突变。转换为 DOL/3TC 后，潜在的 DDI 数量从 92 项减少到 12 项，总胆固醇和低密度脂蛋白胆固醇中位数显著降低，而体重中位数变化无统计学意义。在这个真实世界的队列中，在年龄超过 65 岁的患者中，转换为 DOL/3TC 与维持病毒学控制和良好耐受性相关，支持在老年 PLWHIV 中使用这种双药方案。
