FDA last week approved lenacapavir (Sunlenca, Gilead), the first of a new capsid inhibitor class, for combination therapy in heavily treatment-experienced adults with multidrug-resistant (MDR) HIV-1 infection. After the starting dose is completed using oral and subcutaneous doses, lenacapavir is administered as subcutaneous injections once every 6 months. The drug has a multistage 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.
