Once-Weekly Oral Islatravir Plus Lenacapavir Versus Daily Oral Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Persons With HIV-1

作者：Amy E. Colson, Gordon E. Crofoot, Peter Ruane, Moti Ramgopal, Alexandra W. Dretler, Ronald Nahass, Gary I. Sinclair, Mezgebe Berhe, Afsoon Roberts, Shauna Applin, Cynthia Brinson, DT Jayaweera, Kimberly Workowski, F. Shihadeh, Shanyu Liu, Stephanie O. Klopfer, Cyril Llamoso, Sharline Madera, Hadas Dvory‐Sobol, Martin S. Rhee, Elizabeth G. Rhee, Jared M. Baeten, Joseph J. Eron · 发表于：Annals of Internal Medicine · 年份：2025 · DOI：10.7326/annals-25-01939 · 被引用次数：8 · 研究领域：HIV/AIDS drug development and treatment、HIV-related health complications and treatments、HIV Research and Treatment

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.