Top 5 HIV Stories from CROI 2025: New Treatments, HIV Remission Insights, and More

Moupali Das, MD, MPH, presented results from a Phase 1 study of two once-yearly intramuscular (IM) formulations of lenacapavir for HIV pre-exposure prophylaxis (PrEP). Both formulations demonstrated strong pharmacokinetic profiles, with lenacapavir concentrations sustained above the 95% effective threshold for over 56 weeks, outlasting the twice-yearly subcutaneous (SC) formulation. The median trough concentrations at Week 52 for the once-yearly formulations were 57 ng/mL and 65.6 ng/mL, compared to 23.4 ng/mL for the SC version. Additionally, peak plasma concentrations were significantly higher for the once-yearly formulations (247 ng/mL and 336 ng/mL) compared to the twice-yearly SC formulation (67.3 ng/mL). These findings indicate that the once-yearly formulations of lenacapavir not only last longer but also maintain higher plasma concentrations, suggesting enhanced efficacy and potential for improved HIV prevention. The study also confirmed that the formulations were well-tolerated, with injection site pain being the most common mild-to-moderate adverse event.