European Commission Approves Stribild®, a New Single Tablet Regimen for the Treatment of HIV-1 Infection

Gilead Sciences GILD today 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-naïve 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. “Single tablet regimens make it easier for HIV patients to take their treatment consistently every day, which may improve their health outcomes,” said Jürgen 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.