Dolutegravir-based regimens in treatment-naive and treatment-experienced aging populations: analyses of 6 phase III clinical trials. Issue 2 (13th July 2021)

• Record Type: Journal Article
• Authors: Spinelli, Frank; Prakash, Manyu; Slater, Jill; van der Kolk, Mike; Bassani, Niccolò; Grove, Richard; Wynne, Brian; van Wyk, Jean; Clark, Andrew
• Is Part Of: HIV research & clinical practice. Volume 22:Issue 2(2021)
• Page Start: 46
• Page End: 54
• Publication Date: 2021-07-13
• Subjects: integrase strand transfer inhibitor -- virologic suppression -- antiretroviral therapy -- comorbidities -- polypharmacy -- older adults living with HIV; HIV Infections -- therapy; Acquired Immunodeficiency Syndrome -- therapy; Clinical Trials as Topic; Clinical Medicine; AIDS (Disease) -- Treatment -- Periodicals; AIDS (Disease) -- Treatment; Periodicals; Periodical; 616.9792
• DOI: 10.1080/25787489.2021.1941672
• Languages: English
• ISSNs: 2578-7489

Abstract

Abstract : Background: Older adults living with HIV (OALWH) are a growing population facing unique challenges to successful antiretroviral therapy. Objective: To assess efficacy and safety profiles of antiretroviral regimens, including those containing dolutegravir, in OALWH. Methods: Combined data from 6 phase III/IIIb trials in treatment-naive (ARIA, FLAMINGO, SINGLE, SPRING-2; N = 2634) and treatment-experienced (DAWNING, SAILING; N = 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. Results: 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 3 ; treatment experienced, 70–100% and 105–156 cells/mm 3, respectively). There were no major differences in safety outcomes in each age group. Conclusions: 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.