FDA approves Stribild ( Gilead Sciences) for treatment of HIV-1 Infection - 29-Aug-2012

Gilead Sciences,announced that the FDA has approved Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults. Stribild, referred to as “Quad” prior to FDA approval, combines four compounds in one daily tablet: elvitegravir, an integrase inhibitor; cobicistat, a pharmacoenhancing agent; emtricitabine and tenofovir disoproxil fumarate.

The approval of Stribild is supported by 48-week data from two pivotal Phase III studies in which the single tablet regimen met its primary objective of non-inferiority compared to Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) (Study 102) and to a regimen containing ritonavir-boosted atazanavir plus Truvada (emtricitabine/tenofovir disoproxil fumarate) (Study 103). This approval is also supported by Chemistry, Manufacturing and Controls (CMC) information on the individual components of Stribild and the co-formulated single tablet regimen.