FDA Approves First Once-Daily Protease Inhibitor for AIDS

The first once-a-day protease inhibitor to treat AIDS has received government approval. Manufactured by Bristol-Myers Squibb, Reyataz requires just a once-daily dose of two pills, taken with food -- in addition to whatever older medications patients take as part of their daily cocktail.

Protease inhibitors -- powerful type of drug that revolutionized HIV care in the mid 1990s -- taken with older AIDS medicines suppress HIV enough to allow many patients to stay healthier for years longer. But the drug cocktails require patients to swallow handfuls of pills several times each day.

Currently, there are six other protease inhibitors on the market, but all require taking pills two or three times a day. Reyataz, known chemically as atazanavir, appears to work as well as other protease inhibitors. But a common side effect of other protease inhibitors is a rise in cholesterol -- and Reyataz does not appear to cause that problem for some reason, the Food and Drug Administration said.

However, Reyataz can cause up to 24 percent of patients to experience jaundice, a yellowing of the skin or eyes. It seems to quit when patients stop taking the drug, and does not appear to be associated with liver injury, according to the FDA. Other side effects from Reyataz include infection, nausea, headache, and diarrhea.

The FDA approved the use of Reyataz as part of combination HIV therapy on Friday. Bristol-Myers plans for the drug to hit pharmacy shelves next month. But the company would not reveal the drug's price, saying only that it would be competitive with other protease inhibitors.

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