Safety and efficacy of switching virally suppressed older adults (≥60 years) without prior confirmed virologic 8 failure from current antiretroviral regimen to bictegravir, emtricitabine and tenofovir alafenamide as treatment 9 for HIV-1 infection: week 96 results from a randomised, open-label, non-inferiority trial

Background Antiretroviral options for older people with HIV are limited by age-related comorbidities. We evaluated a switch strategy to maintain viral suppression while minimizing contribution to comorbidities. 4950 Methods In this open-label, randomised, non-inferiority trial conducted in Kenya, virally suppressed adults ≥60 years were randomised 1:1 to switch to bictegravir (50mg), emtricitabine (200mg), and tenofovir alafenamide (25mg) 54 daily, or continue current antiretroviral regimen (CAR). The co-primary endpoints at week, reported previously, were proportion of participants with VL ≥50 copies/mL with a 4% non-inferiority margin in the intention-to-treat exposed population, and mean percentage change in lumbar spine bone mineral density. Here we report key secondary endpoints of efficacy and safety at week. ClinicalTrials.gov NCT05243602.