Committee Recommends Approval of Atripla in Europe
A European committee has recommended that Atripla be approved for use in the European Union, according to a report by AIDSmap.
The European Medicine Agency’s (EMEA) Committee for Medicinal Products for Human Use recommended approval of Atripla, a three-in-one tablet containing Sustiva/Stocrin (efavirenz), Viread (tenofovir) and Emtriva (emtricitabine), on October 19 for use in people relatively new to HIV treatment. The EMEA is similar to the U.S. Food and Drug Administration (FDA) but approves drugs for use throughout the European Union rather than a single country.
The recommendation for approval came with certain restrictions, however. The committee said that Atripla should be used only in patients who have maintained viral loads below 50 copies/ml (an undetectable viral load) on their current antiretroviral regimen for at least three months. The agency also cautions that Atripla not be used by people who have experienced virological failure with an earlier treatment combination or who have resistance to any of the drugs in Atripla.
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