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FDA Approves Three-In-One HIV Combination Therapy

On July 12, 2006 the U.S. Food and Drug Administration (FDA) approved the first once-a-day,
three-drug combination tablet for the treatment of HIV. The new tablet combines the
antiretroviral drug Sustiva®, manufactured by Bristol-Myers Squibb, with the drugs Viread®
and Emtriva®, manufactured by Gilead Sciences, and sold together under the brand name

Atripla®, the three-in-one drug, has several potential advantages. Many believe that by
simplifying the treatment regimen to one pill a day, this new “cocktail” could significantly
improve patient adherence. In the past, it was common for patients battling HIV to take a
dizzying succession of pills, often 20 to 30 tablets daily. In addition, a single pill prescription
would help HIV patients avoid multiple co-payments at the pharmacy.

“This new product offers a welcome option for prescribers who follow the recommended
initiation of HIV-1 treatment with at least three highly active antiretroviral drugs, a regimen that
has the potential to significantly improve the condition of many patients, and help them adhere to
their regimen to help minimize the development of viral resistance,” said Steven Galson, MD,
MPH, Director of the FDA’s Center for Drug Evaluation and Research. “Because all three
components of Atripla® have been in use for some time, their characteristics and effects are well

Although the wholesale price for a 30-day supply of Atripla® is $1,150, it is not clear exactly
how much Atripla® will cost patients. Gilead Pharmaceuticals, a division of Gilead Sciences,
began U.S. marketing of the product in July 2006. 

Read the entire FDA news release>> 

Source: The Chicago Tribune, USA Today and FDA news release dated July 12, 2006


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