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Nov 29, 2011

EC Clears Gilead’s Single-Pill Triple-Drug HIV-1 Therapy

  • The European Commission approved Gilead Sciences’ Eviplera® (emtricitabine/rilpivirine/tenofovir disoproxil) single-tablet therapy for treating HIV-1 infection in antiretroviral treatment-naive adults with a viral load of no more than 100,000 HIV-1 RNA copies/mL. The drug combination comprises Gilead’s own Truvada®, a fixed-dose combination of emtricitabine 200 mg and tenofovir disoproxil 234 mg, with Tibotec Pharmaceuticals’ rilpivirine 25 mg, which is marketed by Janssen Cilag as Edurant®.

    Clearance of Eviplera in Europe follows FDA approval of the same drug combination, tradenamed Complera®, in August. Regulatory review in Europe was was based on data from two Phase III active-controlled studies, Echo and Thrive, conducted by Tibotec to evaluate rilpivirine therapy in comparison with efavirenz in treatment-naive HIV-infected adults. In both studies patients were also receiving two nucleosides/nucleotides, in most cases Truvada. Gilead conducted a bioequivalence study demonstrating that the co-formulated single-tablet regimen achieved the same drug levels in the blood as emtricitabine plus rilpivirine plus tenofovir disoproxil fumarate administered separately.

    Gilead and Tibotec inked a license and collaboration agreement for development of the triple-drug single pill in July 2009. Under terms of the deal Gilead has the primary responsibility for manufacturing, registration, distribution, and commercialization of the product in the U.S., Canada, Brazil, the EU, Australia, and New Zealand. Tibotec will commercialize rilpivirine as a single agent, and holds rights to co-detail the single-tablet regimen in the same territories. The NNRTI rilpivirine was itself granted FDA approval in May this year.

    An agreement between the firms has been finalized for the rest of the world. Gilead will be responsible for the registration, distribution, and commercialization of the single-tablet regimen in certain European countries, Latin America, and the Caribbean. Tibotec will shoulder responsibility for all countries outside of the Gilead markets.

    Gilead’s anti-HIV pipeline includes three Phase III-stage candidates: the integrase inhibitor elvitegravir, a PK enhancer cobicistat, and an integrase single-tablet quad regimen comprising elvitegravir, FTC, TDF, and cobicistat. A nucleotide reverse transcriptase inhibitor GS7340 is in Phase I development. Gilead already markets a portfolio of single and combination anti-HIV therapies.

    Tibotec has three marketed anti-HIV products: darunavir (TMC114), etravirine (TMC125), and rilpivirine. 


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