FDA approves first once-daily protease inhibitor for AIDS
Friday, June 20th 2003, 12:00 am
By: News On 6
WASHINGTON (AP) _ The government has approved the first once-a-day protease inhibitor to treat the AIDS virus.
Protease inhibitors are a powerful type of drug that revolutionized HIV care in the mid-1990s. While they're not a cure, protease inhibitors taken together with older AIDS medicines suppress HIV enough to allow many patients to stay far healthier for years longer.
But these so-called drug cocktails require swallowing handfuls of pills several times a day.
The newest protease inhibitor, Reyataz, requires just a once-daily dose of two pills, taken with food _ plus whatever older medications patients take as part of their daily cocktail.
Six other protease inhibitors already are sold, but require taking several pills two or three times a day.
The Food and Drug Administration approved use of Reyataz as part of combination HIV therapy on Friday. Manufacturer Bristol-Myers Squibb said the drug, known chemically as atazanavir, would hit pharmacy shelves next month. The company refused to reveal the price, saying only that it would be competitive with other protease inhibitors.
Reyataz appears to work as well as other protease inhibitors. But a common side effect of other protease inhibitors is a rise in cholesterol _ and for some reason, Reyataz so far doesn't appear to cause that problem, the FDA said.
However, up to 24 percent of Reyataz patients can experience jaundice, a yellowing of the skin or eyes. It seems to quit when patients stop taking the drug, and doesn't appear to be associated with liver injury, the FDA said.
Other side effects include nausea, infection, headache and diarrhea.