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news.Gilead Sciences has received marketing authorization by the European Commission for Eviplera (emtricitabine/rilpivirine/tenofovir disoproxil), a once-daily single-tablet regimen to treat HIV-1 infection in antiretroviral treatment-naive adults.
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Following the authorization, Eviplera will be made commercially available in all 27 countries of the European Union (EU).
Eviplera combines Gilead’s Truvada, a fixed-dose combination of the two nucleoside reverse transcriptase inhibitors emtricitabine 200 mg and tenofovir disoproxil 245 mg, and Tibotec Pharmaceuticals’ rilpivirine 25 mg.
The authorization of the drug is backed by 48-week data from two Phase 3 double-blind, active controlled, randomized studies (ECHO and THRIVE) conducted by Tibotec which demonstrated the safety and efficacy of rilpivirine compared to efavirenz in treatment-naïve HIV-infected adults.
Gilead signed a license and collaboration agreement with Tibotec for the development and commercialization of this single-tablet regimen in July 2009.