Phase 3 Trial of Weekly Oral Islatravir-Lenacapavir for HIV-1 Treatment.
N Engl J MedJul 29, 2026 (epub)
Clinical ResearchInfectious Diseases
Jürgen K Rockstroh, Moti N Ramgopal, Adrian Curran Fàbregas et al.
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In 30 seconds
This phase 3 randomized controlled trial evaluated the efficacy and safety of once-weekly oral islatravir-lenacapavir (ISL/LEN) compared to once-daily bictegravir-emtricitabine-tenofovir alafenamide (B/F/TAF) in adults with virologically suppressed HIV-1. Conducted across 12 countries, the study found that at week 48, no participants in the ISL/LEN group had an HIV-1 RNA level of 50 copies per milliliter or higher, demonstrating noninferiority to B/F/TAF.
Key findings
- At week 48, no participants in the ISL/LEN group had an HIV-1 RNA level of 50 copies per milliliter or higher.
- In the B/F/TAF group, 1 participant (0.3%) had an HIV-1 RNA level of 50 copies per milliliter or higher.
- 93.4% of participants in the ISL/LEN group maintained an HIV-1 RNA level of less than 50 copies per milliliter.
- The mean change in CD4+ T-cell count at week 48 was -10 cells per microliter with ISL/LEN.
Why it matters
This study highlights the potential of long-acting oral regimens for HIV-1 treatment, which may improve adherence and patient outcomes by reducing the frequency of dosing.