Gilead Sciences, Inc. announced top line Phase 3 clinical trial results showing that elvitegravir, an integrase inhibitor being uated for the treatment of HIV-1 infection, was non-inferior to the integrase inhibitor raltegravir after two years of therapy in treatment-experienced patients. Gilead plans to file for U.S. regulatory approval of elvitegravir in the second quarter of 2012.
These positive two-year data indicate that elvitegravir has the potential to be an important new once- daily treatment option for people living with HIV who have developed resistance to other therapies, said Norbert Bischofberger, PhD, utive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. In addition, we are very excited about elvitegravirs role as part of our new Quad single-tablet regimen, which is currently in U.S. regulatory review.
In the pivotal Phase 3 trial (Study 145), elvitegravir (150 mg or 85 mg) dosed once daily was compared to raltegravir (400 mg) dosed twice daily, each administered with a background regimen that included a ritonavir-boosted protease inhibitor (PI) and a second antiretroviral. After 96 weeks of treatment, 48 percent of patients receiving ritonavir-boosted elvitegravir achieved and maintained HIV RNA levels (viral load) less than 50 copies/mL, compared to 45 percent of patients receiving raltegravir, based on the Time to Loss of Virologic Response algorithm (TLOVR) (95 percent CI for the difference: -4.6 percent to 9.9 percent). Discontinuation rates due to adverse events, and safety and resistance profiles were comparable in both arms of the study. Gilead plans to submit these data for presentation to a scientific conference in 2012.