Virologic Outcomes with Lenacapavir in People with HIV: A Multi-Center Real-World Study

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ID: 320368
2026
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Abstract
Abstract Background Lenacapavir (LEN), a first-in-class long-acting HIV-1 capsid inhibitor, has demonstrated potent antiviral activity in heavily treatment-experienced (HTE) people with HIV (PWH) in clinical trials, but real-world data remain limited. We describe outcomes from six U.S. HIV clinics using LEN-based regimens in a largely HTE cohort of PWH to assess virologic response, regimen potency, and tolerability. Methods We conducted a multi-center retrospective cohort study of adults with HIV who initiated LEN between November 2020 and June 2025 at six clinics in Chicago, IL and Pittsburgh, PA. Demographic, clinical, and genotypic data were abstracted from electronic health records. Virologic suppression was defined as HIV viral load (VL) <200 copies/mL. Stanford genotypic susceptibility scores (S-GSS) were calculated to assess regimen potency. Wilcoxon signed-rank tests compared ART pill burden and regimen potency before and after LEN initiation. Results Seventy PWH initiated LEN. Median follow-up was 12 months. At baseline, 18 (26%) PWH with available genotypes had multi-drug-resistant (MDR) HIV, 54% had unsuppressed virus. Among 38 PWH with unsuppressed virus, 34 (89%) achieved viral suppression, and none of the PWH with suppressed HIV experienced rebound. LEN significantly improved regimen potency (p<0.00005) and reduced daily pill burden from two to one tablet (p<0.00005). Injection site reactions occurred in 30% and led to discontinuation in one person. Conclusions In this real-world cohort, LEN-based regimens achieved high rates of virologic suppression, improved regimen activity, and reduced pill burden with good tolerability. LEN represents a promising salvage therapy for PWH, warranting equitable and implementation-focused integration into HIV care.
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Authors Christopher Kaperak, Yijia Li, Beverly E. Sha, Mônica Merçon, Karen Montes, Fatima Sanes, Shivanjali Shankaran, Mariam Aziz, Catherine Creticos, Nancy Glick, Bijou R. Hunt, Sharon Sam, Paul Djuricich, Andrew Merker, Aniruddha Hazra
Journal Open forum infectious diseases
Year 2026
DOI
10.1093/ofid/ofag425
URL
https://doi.org/10.1093/ofid/ofag425
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