Gilead lenacapavir meets primary endpoint in mid-stage HIV study

• Gilead Sciences announced top-line results from Phase 2/3 CAPELLA trial evaluating lenacapavir (GS-6207), a capsid inhibitor, in heavily treatment-experienced people with multidrug resistant HIV-1 infection.
• The study found that 88% of participants receiving lenacapavir (n=21/24) experienced at least 0.5 log (66%) reduction in HIV-1 viral load by the end of 14 days of functional monotherapy as compared with 17% on placebo.
• Additionally, the lenacapavir group achieved a statistically significant greater mean change in viral load versus placebo.
• Lenacapavir was generally safe and well-tolerated, with no serious adverse events related to study drug observed and no study drug discontinuations.
• Following the 14-day functional monotherapy period, all participants are offered open-label lenacapavir added to an optimized background regimen in an ongoing maintenance period of the study evaluating the subcutaneous administration of lenacapavir every six months as well as the safety and efficacy of lenacapavir in addition to an optimized background regimen at Weeks 26 and 52.
• https://seekingalpha.com/news/3637488-gileads-lenacapavir-meets-primary-endpoint-in-mid-stage-hiv-study