THURSDAY, July 13 (HealthDay News) -- The U.S. Food and Drug Administration approved Atripla tablets, the first once-a-day, single tablet fixed dose of three widely used antiretroviral drugs for the treatment of HIV-1.
Atripla combines Sustiva (efavirenz), Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate). It can be taken alone or in combination with other antiretroviral drugs that treat HIV-1 in adults. Approved in less than three months under the FDA's fast-track program, Atripla will be available for purchase in the United States within 96 hours.
"The approval of Atripla simplifies the treatment regimen for HIV-1-infected adults, and will potentially improve the ability of patients to adhere to treatment resulting in long-term effective control of HIV-1," said Andrew C. von Eschenbach, M.D., the FDA's acting commissioner of food and drugs, in a statement. "This offers a particularly important advantage for patients in many countries that are most affected by the AIDS epidemic and will also have a major impact in the U.S."
Bristol-Myers Squibb and Gilead Sciences will work together to commercialize Atripla in the United States. Merck holds the rights to efavirenz in certain territories. The new drug will have a black box warning noting that it can cause lactic acidosis. Other serious adverse events may include liver toxicity, renal impairment and depression.
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