"The European Commission has granted marketing authorization for Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), formally approving Atripla for commercialization in the 27 countries of the European Union, as well as in Norway and Iceland.

"Historically, HIV treatment regimens have been a challenge for many patients since they often combine multiple medications with complex dosing schedules," said Brian Gazzard, MD, Clinical Research Director, Chelsea and Westminster Hospital, London. "Atripla combines three clinically proven and well-established anti-HIV medicines in a single once-daily pill and represents an important step forward in dosing simplification."

"Atripla has been approved in the European Union for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels less than 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harbored virus strains with mutations conferring significant resistance to any of the three components contained in Atripla prior to initiation of their first antiretroviral treatment regimen.

"Efavirenz is marketed by Bristol-Myers Squibb Company under the tradename Sustiva in the United States, Canada and six European countries (France, Republic of Ireland, Germany, Italy, Spain and the United Kingdom). Efavirenz is commercialized by Merck & Co., Inc, through its affiliate Merck Sharp & Dohme (MSD) Limited under the tradename Stocrin in all other countries within the European Union and many countries outside of the United States.

"Emtricitabine and tenofovir disoproxil fumarate are commercialized by Gilead Sciences, Inc. under the tradenames Emtriva and Viread, respectively, and are commonly prescribed together as a once-daily, fixed-dose tablet, marketed under the tradename Truvada for use as part of combination therapy.

"The marketing authorization application for Atripla in the European Union was filed by a three-way joint venture based in Ireland called Bristol-Myers Squibb Gilead Sciences and Merck Sharp & Dohme Limited.

"Atripla is currently the first and only once-daily, single tablet regimen approved for the treatment of HIV-1 infection in adults in the United States for use either as stand-alone therapy or in combination with other antiretroviral agents. Atripla was approved by the U.S. Food and Drug Administration in July 2006 and has since become the most-prescribed treatment regimen for patients starting HIV therapy in the United States."