European Commission Approves Gilead, BMS, Merck Antiretroviral Atripla

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 20 Dec 2007 - 9:00 PDT

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The European Commission on Monday approved the once-daily antiretroviral drug Atripla -- which is manufactured jointly by Gilead Sciences, Bristol-Myers Squibb and Merck -- for sale in European Union countries, BBC News reports (Dreaper, BBC News, 12/17).

Atripla is composed of efavirenz, marketed by BMS and Merck, and the Gilead drugs emtricitabine and tenofovir. It is the first once-daily antiretroviral available to most people living with HIV in the E.U. (Kaiser Daily HIV/AIDS Report, 10/22). The drug, which was approved in the U.S. in 2006, will be available in the 27 countries of the European Union, as well as Iceland and Norway. Atripla was approved for use among adults with viral loads of less than 50 copies per milliliter of blood on their current combination therapies for more than three months (Gilead release, 12/17).

According to London's Guardian, the approval comes as the number of recorded new HIV cases in the European Union is increasing (Barriaux, Guardian, 12/17). A report released last month by the European Centre for Disease Prevention and Control found that the number of new HIV cases recorded in E.U. countries has nearly doubled from 28.8 cases per one million residents in 1999 to 57.5 cases per one million residents in 2006 (Kaiser Daily HIV/AIDS Report, 11/26).

Paul Carter, vice president of international commercial operations at Gilead, said the company is "trying to work with policymakers and opinion leaders in the HIV field to raise awareness" about the increasing number of new cases (Guardian, 12/17). He added that "Atripla will be available at a price which is in parity with the sum of its component parts." Simon Portsmouth, a London-based HIV consultant, said the approval is a "big advance" for HIV-positive people living in E.U. countries, adding that they "can just take this pill before they go to bed at night, and it doesn't take over their whole life" (BBC News, 12/17).

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