2013 JUN 10 (NewsRx) -- By a News Reporter-Staff News Editor at AIDS Weekly -- Gilead Sciences, Inc. (Nasdaq: GILD) announced that the European Commission has granted marketing authorization for Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg), a single tablet regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naive or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild. This approval allows for the marketing of Stribild in all 27 countries of the European Union (see also Pharmaceutical Companies).
"Single tablet regimens make it easier for HIV patients to take their treatment consistently every day, which may improve their health outcomes," said Jurgen Rockstroh, MD, Professor of Medicine, University of Bonn, Germany and a lead investigator for one of the Stribild pivotal studies. "Stribild is a highly effective and well tolerated HIV treatment regimen, and is an important addition to the growing arsenal of simplified therapies in Europe."
This approval is supported by 48-week data from two pivotal Phase 3 studies in which Stribild met its primary objective of non-inferiority compared to Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg) (Study 102) and to a regimen containing ritonavir-boosted atazanavir plus Truvada® (emtricitabine/tenofovir disoproxil (as fumarate)) (Study 103).
"We look forward to making Stribild available to HIV-treating physicians and their patients throughout the European Union as quickly as possible," said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences.
Stribild is also approved in the United States, Canada, Australia, South Korea, Japan and Turkey.
Stribild is the third single tablet HIV regimen developed by Gilead to become available in Europe. The first, Atripla, was approved in the European Union in 2007 and is marketed by Gilead in partnership with Bristol-Myers Squibb and Merck & Co. The second, Eviplera®? (emtricitabine/rilpivirine/tenofovir disoproxil (as fumarate) 245 mg)), is marketed by Gilead and Janssen R&D Ireland and received European marketing authorization in November 2011. About Stribild Stribild contains four Gilead compounds in a complete once-daily, single tablet regimen: elvitegravir 150 mg; cobicistat 150 mg; emtricitabine 200 mg; and tenofovir disoproxil (as fumarate) 245 mg.
Elvitegravir is a member of the integrase inhibitor class of antiretroviral compounds. Integrase inhibitors interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells. Elvitegravir was licensed by Gilead from Japan Tobacco Inc. (JT) in March 2005. Under the terms of Gilead's agreement with JT, Gilead has exclusive rights to develop and commercialize elvitegravir in all countries of the world, excluding Japan, where JT retains rights.
Cobicistat is Gilead's proprietary potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body.
Marketing applications for elvitegravir and cobicistat as standalone agents are currently under review in the European Union. In the United States, on April 29, 2013, Gilead announced it had received Complete Response Letters from the U.S. Food and Drug Administration (FDA) on its New Drug Applications for elvitegravir and cobicistat as standalone agents. The company is working to address the questions raised in FDA's letters as quickly as possible.
Elvitegravir and cobicistat as standalone agents are investigational products and their safety and efficacy have not yet been established. EU Important Product Information About Stribild Lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues. Lactic acidosis has a high mortality and patients at increased risk should be followed closely.
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