Spinelli Frank, Prakash Manyu, Slater Jill, van der Kolk Mike, Bassani Niccolò, Grove Richard, Wynne Brian, van Wyk Jean, Clark Andrew
ViiV Healthcare, Research Triangle Park, NC, USA.
ViiV Healthcare, Brentford, UK.
HIV Res Clin Pract. 2021 Apr;22(2):46-54. doi: 10.1080/25787489.2021.1941672. Epub 2021 Jun 28.
Older adults living with HIV (OALWH) are a growing population facing unique challenges to successful antiretroviral therapy. To assess efficacy and safety profiles of antiretroviral regimens, including those containing dolutegravir, in OALWH. Combined data from 6 phase III/IIIb trials in treatment-naive (ARIA, FLAMINGO, SINGLE, SPRING-2; = 2634) and treatment-experienced (DAWNING, SAILING; = 1339) participants receiving dolutegravir- or non-dolutegravir-based regimens were analyzed by age (<50, ≥50 to <65, and ≥65 years). Baseline data included comorbidities and numbers of concomitant medications. Week 48 efficacy outcomes included virologic response (HIV-1 RNA <50 copies/mL) and CD4+ cell count change from baseline. Safety outcomes included incidence of adverse events (AEs), serious AEs, and AE-related withdrawals. Use of ≥5 concomitant medications was more frequently reported among treatment-naive and treatment-experienced participants aged ≥50 to <65 (30% [90/296] and 25% [57/227], respectively) and ≥65 years (43% [10/23] and 29% [4/14]) than among those aged <50 years (13% [310/2315] and 11% [118/1098]). Comorbidities were more prevalent in the older age groups. For dolutegravir-based regimens, Week 48 rates of virologic response and change in CD4+ cell count were similar across age groups (treatment naive, 80-87% and 234-251 cells/mm; treatment experienced, 70-100% and 105-156 cells/mm, respectively). There were no major differences in safety outcomes in each age group. In these analyses of combined phase III/IIIb trial data, efficacy and safety of dolutegravir-based regimens were generally similar across age groups in treatment-naive or treatment-experienced participants. Polypharmacy and comorbidities were more common among OALWH than those aged <50 years.
感染艾滋病毒的老年人（OALWH）数量不断增加，他们在成功接受抗逆转录病毒治疗方面面临独特挑战。旨在评估抗逆转录病毒治疗方案（包括含有多替拉韦的方案）在OALWH中的疗效和安全性。对6项III期/IIIb期试验的数据进行了合并分析，这些试验的受试者为初治（ARIA、FLAMINGO、SINGLE、SPRING - 2；n = 2634）和经治（DAWNING、SAILING；n = 1339）参与者，他们接受了基于多替拉韦或非多替拉韦的治疗方案，并按年龄（<50岁、≥50至<65岁和≥65岁）进行分析。基线数据包括合并症和同时服用药物的数量。第48周的疗效结果包括病毒学应答（HIV - 1 RNA<50拷贝/mL）和CD4 +细胞计数相对于基线的变化。安全性结果包括不良事件（AE）、严重AE的发生率以及与AE相关的停药情况。在年龄≥50至<65岁的初治和经治参与者中（分别为30%[90/296]和25%[57/227]）以及≥65岁的参与者中（分别为43%[10/23]和29%[4/14]），报告使用≥5种合并用药的情况比<50岁的参与者（分别为13%[310/2315]和11%[118/1098]）更为频繁。合并症在老年人群中更为普遍。对于基于多替拉韦的治疗方案，各年龄组第48周的病毒学应答率和CD4 +细胞计数变化相似（初治者中分别为80 - 87%和234 - 251个细胞/mm³；经治者中分别为70 - 100%和105 - 156个细胞/mm³）。各年龄组的安全性结果无重大差异。在这些III期/IIIb期试验合并数据的分析中，基于多替拉韦的治疗方案在初治或经治参与者中的疗效和安全性在各年龄组中总体相似。多重用药和合并症在OALWH中比<50岁的人群更为常见。
