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BACKGROUND: Once-weekly oral islatravir plus lenacapavir (ISL+LEN) has the potential to address adherence challenges with daily HIV-1 treatment. OBJECTIVE: To evaluate efficacy and safety of once-weekly ISL+LEN. DESIGN: Phase 2, randomized, open-label, active-controlled study. (ClinialTrials.gov: NCT05052996). SETTING: 44 U.S. sites. PARTICIPANTS: Adults with HIV-1 RNA viral load of less than 50 copies/mL receiving daily bictegravir, emtricitabine, and tenofovir alafenamide combination (B/F/TAF) for 24 weeks or more. INTERVENTION: Once-weekly oral ISL, 2 mg, plus LEN, 300 mg, or daily oral B/F/TAF. MEASUREMENTS: T-cell and lymphocyte count changes (weeks 12, 24, and 48). RESULTS: T cells or lymphocytes. LIMITATION: Open-label, modest sample size, and only U.S.-based participants. CONCLUSION: Once-weekly oral ISL+LEN maintained high rates of virologic suppression through week 48 and was not associated with any treatment-related grade 3 or greater or serious AEs. PRIMARY FUNDING SOURCE: Gilead Sciences, Inc.
Colson et al. (Mon,) studied this question.