Gilead's Investigational Antiretroviral Elvitegravir Once Daily Non-Inferior to Raltegravir Twice Daily at 48 Weeks

Gilead Sciences, Inc. GILD today announced Phase III clinical trial results from the pivotal Study 145 showing that its investigational antiretroviral elvitegravir, a novel oral integrase inhibitor being evaluated for the treatment of HIV-1 infection, was non-inferior to the integrase inhibitor raltegravir after 48 weeks of therapy in treatment-experienced patients. In the study, elvitegravir (150 mg or 85 mg) dosed once daily was compared to raltegravir (400 mg) dosed twice daily. Each integrase inhibitor was administered with a background regimen that included a ritonavir-boosted protease inhibitor and a second antiretroviral. These data are being presented today in a late-breaker session (LB# WELBB05) at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2011) in Rome, Italy. “Because many treatment-experienced HIV patients have developed resistance to currently available antiretrovirals, identifying novel therapeutic options from the integrase inhibitor class is critical,” said Professor Jean-Michel Molina, MD, PhD, principal investigator, Hôpital Saint Louis in Paris and University of Paris 7. “These data suggest that elvitegravir may be an effective option for patients and may also have the potential for more convenient, once-daily dosing as part of combination HIV therapy.”