Gilead's Antiretroviral Regiment Meets 48-Week Primary Objective in Phase 3 Study

Gilead Sciences, Inc. GILD today announced that a Phase 3 clinical trial of its investigational fixed-dose, single-tablet “Quad” regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, being evaluated for HIV-1 infection in treatment-naïve patients, met its primary objective, which was non-inferiority at week 48 as compared to Atripla. The primary endpoint analysis indicated that 88 percent of patients in the Quad arm compared to 84 percent in the Atripla achieved HIV RNA of less than 50 copies/mL through week 48. The predefined criterion for non-inferiority was a lower bound of a two sided 95% CI of -12 percent.