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European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
Date:10/18/2007

r 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 (FDA) in July 2006 and has since become the most-prescribed treatment regimen for patients starting HIV therapy in the United States.

The FDA also granted approval of an alternate tradedress of ATRIPLA for developing countries, where ATRIPLA is being made available as a white-colored tablet to distinguish it from the salmon-colored version currently available in the United States. In August 2006, Gilead and Merck established an agreement for distribution of the product in developing countries, and in March 2007, the World Health Organization added ATRIPLA to its Model List of Essential Medicines.

Important Product Safety Information About ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), Emtriva (emtricitabine), Viread (tenofovir disoproxil fumarate [DF]) and Truvada (emtricitabine/tenofovir DF) in the United States

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals.

Emtriva, Viread, Truvada and ATRIPLA are not approved for the treatment of chronic hepatitis B virus (HBV) infection and their safety and efficacy have not been established in patients co-infected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Viread or Emtriva, which are components of Truvada and ATRIPLA. In some of these patients treated with Emtriva, the exacerbations of hepatitis B were associated with liver decompensation and liver failure. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are co-infected with HIV and HBV and discontinue Truvada o
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SOURCE Bristol-Myers Squibb
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