Gilead Sciences’ pivotal Phase 3 PURPOSE 1 trial has revealed compelling efficacy and safety results for lenacapavir, a novel twice-yearly injectable HIV-1 capsid inhibitor.
In the interim analysis, lenacapavir showed remarkable efficacy, with zero HIV infections reported among participants. This translated to 100% efficacy and superiority over background HIV incidence. It also outperformed daily oral Truvada in preventing HIV infections.
The trial revealed that participants had consistently high adherence to twice-yearly lenacapavir injections. In contrast, adherence to daily oral PrEP was often poor. This suggests that lenacapavir could potentially improve PrEP uptake and persistence, crucial factors in reducing HIV infections.
PURPOSE 1 included a diverse population, including pregnant women and adolescents. The results demonstrated lenacapavir’s safety and efficacy across various demographic and behavioral characteristics.
Gilead is committed to ensuring swift and equitable access to lenacapavir PrEP in countries with the highest HIV burden. They have developed an access strategy that prioritizes regulatory approvals in these areas.
The efficacy and tolerability of twice-yearly lenacapavir, coupled with its superior adherence profile, indicate its potential to revolutionize HIV prevention. If approved, it could become the first and only biannual PrEP choice, offering a convenient and discreet option to combat the spread of HIV worldwide.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
