Abstract
BACKGROUND: Older people living with HIV (PWH) are disproportionately affected by an increasing burden of comorbidities. There are few clinical trials of switching antiretrovirals in this population, particularly in Africa. METHODS: In this open-label randomized trial, virally suppressed PWH aged ≥60 years were randomized 1:1 to switch to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) or to continue their current antiretroviral regimen (CAR) at two sites in Kenya. Participants had bone mineral density (BMD) measurement at baseline, and at weeks 24 and 48. Calcium and vitamin D supplementation was provided to all participants beginning partway through the study because of high rates of osteoporosis identified at baseline. The primary endpoints were proportion of participants with plasma HIV-1 RNA of ≥50 copies/mL at week 48 using the US Food and Drug Administration snapshot algorithm, a non-inferiority margin of 4%, and the percentage change in the lumbar spine BMD at week 48. We report the primary efficacy, BMD and safety analysis at week 48. The study is continuing to week 96. RESULTS: Between March and July 2022, we enrolled 520 participants with 260 randomized to switch to B/F/TAF and 260 to continue CAR and were included in intention-to-treat analysis. At week 48, 1.9% (5/260) of participants had HIV-1 RNA ≥ 50 copies/mL in the B/F/TAF arm and 2.7% (7/260) in the CAR arm (treatment difference [95% CI], -0.8% [-3.4 to 1.8]), indicating non-inferiority. Change in lumbar spine BMD at week 48 was +2.18% in the B/F/TAF arm and 0.68% in the CAR arm (difference 1.51, CI .27-2.76, P .017). Treatment-related grade 3 or 4 adverse events were similar across arms (16.9% on B/F/TAF; 14.2% on CAR). Fifteen participants had grade 3 or 4 AEs leading to study drug discontinuation, all in the CAR arm due to declining kidney function. More participants on B/F/TAF developed incident dyslipidemia compared with participants on CAR (23% on B/F/TAF; 14% on CAR; P .015). CONCLUSIONS: Switch to B/F/TAF was non-inferior to CAR and safe in an African population aged ≥60 years.