Adherence to once-daily regimens remains a challenge for individuals living with HIV. To address this, a phase 3 randomized clinical trial compared the safety and efficacy of switching to once-weekly oral islatravir-lenacapavir (ISL/LEN) with continuing once-daily oral bictegravir-emtricitabine-tenofovir alafenamide (B/F/TAF) in 607 adults with HIV-1 who had maintained virologic suppression for at least 6 months while receiving B/F/TAF. At week 48, no participants in the ISL/LEN group had an HIV-1 RNA level of 50 copies/mL or higher compared with 1 participant in the B/F/TAF group.
An HIV-1 RNA level below 50 copies/mL was observed in 284 (93.4%) participants receiving ISL/LEN and 280 (92.4%) receiving B/F/TAF. The mean change in CD4+ T-cell count was -10 cells/µL with ISL/LEN and -18 cells/µL with B/F/TAF. The study regimen was discontinued because of adverse events in 6 participants…
