Gilead Sciences announced that the FDA has approved Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults.

Stribild, previously referred to as “Quad”, combines four compounds in one daily tablet: elvitegravir 150mg, an integrase inhibitor; cobicistat 150mg, a pharmacoenhancing agent; emtricitabine 200mg, a reverse transcriptase inhibitor; and tenofovir disoproxil fumarate 300mg, a reverse transcriptase and polymerase inhibitor.

The approval was based on data from two Phase 3 studies (Study 102 and 103) in which the single tablet regimen met its primary objective of non-inferiority compared to Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate; Bristol-Myers Squibb and Gilead) and to a regimen containing ritonavir-boosted atazanavir plus Truvada (emtricitabine/tenofovir disoproxil fumarate; Gilead Sciences).

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