WASHINGTON, July 13, 2006 (AFP) - The first once-a-day, one-pill treatment for HIV-AIDS will be available for use in the United States next week, the US Food and Drug Administration said Thursday.
Atripla, a combination of three widely used anti-retroviral drugs, was fast-tracked by the FDA and will be made available for purchase in 15 other countries under a US international AIDS relief program, an FDA statement said.
The first AIDS treatment of its kind in the world was made possible by an unusual collaboration among pharmaceutical firms holding rights to the drugs: Bristol-Myers Squibb, Gilead Sciences and Merck, the FDA said.
"Atripla was approved in under three months under FDA's fast-track program. The manufacturer plans to make the drug available for purchase in the United States within 96 hours," an FDA statement said.
Atripla -- which combines efavirenz (sold as Sustiva), emtricitabine (Emtriva) and tenofovir disoproxil fumarate (Viread) -- will be made available outside the United States under the President's Emergency Plan for AIDS Relief, the FDA said.
The FDA approved Sustiva (from Bristol-Myers Squibb) in 1998, and Viread and Emtriva (from Gilead Sciences) in 2001 and 2003, respectively.
"Bristol-Myers Squibb and Gilead Sciences have formed a joint venture to commercialize Atripla in the United States. The collaboration is the first of its kind in the field of HIV/AIDS," the statement said.
Noting that Merck holds the rights to efavirenz "in certain territories," the FDA added that: "All three will work together to ensure the product is available to patients and physicians."
A 10-month study of 244 HIV-positive adults showed that in 80 percent of cases, a combination of the three drugs sharply reduced the virus and boosted the number of infection-fighting CD4 cells, the statement said.
More than a million people live with HIV or AIDS in the United States, where 40,000 new cases are diagnosed each year.
The drug will also be made available in 15 countries covered by President George W. Bush's AIDS plan: Botswana, Ethiopia, Guyana, Haiti, Ivory Coast, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Vietnam and Zambia.
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