FDA approves Sunlenca for 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. 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 II/III 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% (n=30/36) of participants randomly allocated to receive lenacapavir in addition to an optimized background regimen achieved an undetectable viral load (<50 copies ml) at week 52. additionally, these participants achieved a mean increase in cd4 count of 82 cells µl. these data were presented at the 29th conference on retroviruses and opportunistic infections (virtual croi 2022).