Atazanavir Background Documents Available

Atazanavir (brand name Reyataz™) is a new protease inhibitor developed by Bristol-Myers Squibb that is likely to be approved soon. A May 13, 2003 hearing of the FDA's Antiviral Drugs Advisory Committee decided that the drug has been proven safe and effective, and recommended approval.

Atazanavir, taken once per day, caused much less cholesterol and triglyceride problems than the other protease inhibitors with which it has been compared; however, this improvement did not seem to translate to less lipodystrophy, in the limited data now available. Atazanavir may need to be "boosted" with a small dose of ritonavir in order to be most effective with experienced patients. And some drug interactions will need to be watched carefully to prevent excessive blood levels of atazanavir, which could cause potentially serious changes in heart rhythm.

For much more extensive information on atazanavir see the two documents prepared for the May 13 hearing -- one by the FDA staff, the other by Bristol-Myers Squibb. They are at: www.fda.gov/ohrms/dockets/ac/03/briefing/3950b1.htm.

Remember that this information was current as of May 2003, and will become obsolete as new data become available.

ISSN # 1052-4207

Copyright 2003 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.