Once-a-Day Three-Drug Pill for HIV

In a landmark achievement, three drug companies have combined their resources to produce a new drug for HIV-1 that combines three widely used antiretroviral drugs in a single tablet.

Called Atripla, the drug combines the active ingredients of Sustiva (efavirenz), Emtriva (emtricitabine), and Viread (tenofovir disoproxil fumarate). Bristol-Myers Squibb (New York, NY, USA) and Gilead Sciences (Foster City, CA, USA) have formed a joint venture to commercialize Atripla in the United States. In certain territories, Merck (Whitehouse Station, NJ, USA) holds the rights to efavirenz.

The three companies collaborated on the development of the new combination drug. Atripla will be available in the United States as a new product approved under a new drug application (NDA) and can be considered for purchase for use in 15 other countries under the U.S. President's Emergency Plan for AIDS Relief. Atripla was approved in less than three months under the fast track program of the U.S. Food and Drug Administration (FDA).

"Today's approval is a significant example of drug developers and FDA clearing the way to quickly deliver quality, life-saving HIV/AIDS drugs to people who desperately need them in the United States and abroad,” said Andrew C. von Eschenbach, M.D., acting commissioner of food and drugs at the FDA. "Fixed-dose combination products are an important tool in improving the quality of health care in developing nations.”


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