Phase 3 Trial Update of Gilead's Antiretroviral Quad Regimen for HIV-1
Gilead Sciences announced full Phase 3 clinical trial results from pivotal Study 102 demonstrating that the Quad, a once-daily single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection, is non-inferior to Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) after 48 weeks of therapy in treatment-naïve adults.
Study 102 was a randomized (1:1), double-blind clinical trial comparing the efficacy, safety and tolerability of the Quad (elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) (n=348) vs. Atripla (efavirenz 600mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) (n=352) among HIV-infected treatment-naïve adults with HIV RNA levels ≥5,000 copies/mL.
The study found that at 48 weeks of treatment, 88% of Quad patients compared to 84% of Atripla patients achieved HIV RNA (viral load) <50 copies/mL, based on the FDA snapshot algorithm (95% CI for the difference: -1.6% to 8.8%; predefined criterion for non-inferiority was a lower bound of a two sided 95% CI of -12%).
The Quad contains four Gilead compounds in a complete once-daily, single-tablet regimen: elvitegravir, an integrase inhibitor; cobicistat, a “boosting” agent that enables elvitegravir once-daily dosing; and Truvada.
For more information call (800) GILEAD-5 or visit www.gilead.com.