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news.Gilead Sciences has received the US Food and Drug Administration (FDA) approval for Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) as a treatment for HIV-1 infection in treatment-naive adults.
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Complera, which mixes three antiretroviral medications in one daily tablet, contains Gilead‘s Truvada and Tibotec Pharmaceuticals’ non-nucleoside reverse transcriptase inhibitor, rilpivirine.
The FDA approval is supported by the results from two Phase 3 studies (Echo and Thrive) that investigated the efficacy and safety of rilpivirine compared to efavirenz among treatment-naïve HIV-1 infected adults.
Gilead first entered into a license and collaboration agreement with Tibotec for the development and commercialization of Complera in July 2009.
Gilead chairman and CEO John Martin said Complera is the second complete single-tablet regimen that the company has introduced, and it represents a collaboration between two organizations that share a vision of simplifying HIV therapy for patients.