Gilead announces Sunlenca granted FDA approval in multidrug resistant HIV

Gilead Sciences announced that Sunlenca, in combination with other antiretroviral, has been granted approval by the U.S. Food and Drug Administration for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant HIV-1 infection. Sunlenca has a multi-stage mechanism of action distinguishable from other currently approved classes of antiviral agents and no known cross resistance exhibited in vitro to other existing drug classes, Gilead said. Sunlenca offers a new, twice-yearly treatment option for adults with HIV that is not adequately controlled by their current treatment regimen. The FDA approval for Sunlenca is supported by data from the Phase 2/3 CAPELLA trial, which evaluated lenacapavir in combination with an optimized background regimen in people with multi-drug resistant HIV-1 who are heavily treatment experienced. CAPELLA participants had undergone previous treatment with a median of nine antiretroviral medications. In this patient population with significant unmet medical need, 83% of participants randomly allocated to receive lenacapavir in addition to an optimized background regimen achieved an undetectable viral load at Week 52. Additionally, these participants achieved a mean increase in CD4 count of 82 cells/microL. These data were presented at the 29th Conference on Retroviruses and Opportunistic Infections.