The European Commission has approved Gilead Sciences' Stribild for marketing as the single tablet regimen for HIV-1 treatment in all 27 countries of the European Union.
Four of the Gilead's compounds elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, and tenofovir disoproxil (as fumarate) 245mg, are formulated into the complete single tablet regimen to be administered once a day.
The new single tablet regimen is indicated for HIV-1 infected adults who are new to antiretroviral treatment or are infected with HIV-1 without known mutations linked to resistance to any of the three antiretroviral agents in Stribild.
University of Bonn medicine professor and lead investigator in one of the Stribild pivotal studies, Jurgen Rockstroh said the single tablet regimens allow HIV patients to improve their health outcomes by taking treatment consistently every day.
"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," Rockstroh added.
The positive data from two pivotal Phase 3 studies of Stribild, Study 102 and Study 103, supported the approval.
Stribild met its primary objective of non-inferiority compared to Atripla in study 102 and to a regimen containing ritonavir-boosted atazanavir along with Truvada in study 103.
Gilead Sciences chairman and chief executive officer John Martin said, "We look forward to making Stribild available to HIV-treating physicians and their patients throughout the European Union as quickly as possible."
Stribild had already been approved for marketing in the US, Canada, Australia, South Korea, Japan and Turkey.
