Gilead’s Once Yearly Lenacapavir Formulations Show Sustained Efficacy for HIV PrEP in Phase 1 Study
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…