Gilead Sciences Announces Positive Phase 3 Results for Once-Yearly Lenacapavir Regimen in HIV

Gilead Sciences today announced positive results from the Phase 3 CAPSULE trial evaluating a once-yearly lenacapavir-based regimen for the treatment of HIV. The trial demonstrated non-inferiority to a daily oral regimen, with 89% of patients achieving viral suppression at 52 weeks compared to 91% for the daily oral comparator. Lenacapavir is a first-in-class HIV capsid inhibitor with a long half-life that enables infrequent dosing. A once-yearly treatment regimen could significantly reduce the treatment burden for people living with HIV. Gilead plans to submit regulatory applications for this regimen based on these results.