Phase 3 Trial of Gilead's Antiretroviral Quad Regimen for HIV-1

Gilead Sciences announced results from its Phase 3 clinical study of an investigational, fixed-dose, single-tablet Quad regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for treatment-naive HIV-1 patients. Study results showed that the Quad regimen met its primary endpoint, which was non-inferiority at week 48 as compared to Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate; Bristol-Myers Squibb and Gilead). The primary endpoint analysis indicated that 88% of patients in the Quad arm compared to 84% in the Atripla (95% CI for the difference: -1.6% to 8.8%) achieved HIV RNA of <50 copies/mL through week 48.

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