California-based Gilead Sciences said its phase III clinical trial of investigational antiretroviral agent elvitegravir, an oral integrase inhibitor being evaluated for the treatment of HIV-1 infection in treatment-experienced patients, met its primary objective.
The primary endpoint was non-inferiority at week 48 of elvitegravir, dosed once daily, compared to raltegravir, dosed twice daily, each administered with a background regimen that includes a ritonavir-boosted protease inhibitor (PI) and a second antiretroviral agent. Responses at 48 weeks of elvitegravir met the statistical criteria of non-inferiority as compared to raltegravir based on the proportion of subjects who achieved and maintained HIV RNA levels (viral load) of less than 50 copies/mL. Discontinuation rates due to adverse events were comparable in both arms of the study. Gilead plans to submit these data for presentation at a scientific conference later this year.