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news.Gilead Sciences has received positive opinion from the European Medicines Agency (EMA) for its marketing authorization application (MAA) of Eviplera as a treatment for HIV-1 infection in antiretroviral-naive adults with a viral load less than or equal to 100,000 HIV-1 RNA copies/ml.
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Single-tablet regimen, Eviplera, combines Gilead’s Truvada (emtricitabine and tenofovir disoproxil (as fumarate)) with Tibotec Pharmaceuticals’ non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine (as hydrochloride)).
The submission of the application was backed by the results from two Phase 3 trials, (Echo and Thrive), which was conducted by Tibotec to investigate the safety and efficacy of rilpivirine compared to efavirenz in treatment-naive HIV-1 infected adults.
A bioequivalence study conducted by Gilead demonstrated that the co-formulated single-tablet regimen achieved the same levels of medication in the blood as emtricitabine plus rilpivirine plus tenofovir disoproxil fumarate.