New protease inhibitor atazanavir approved

AIDS Treatment News, June 27, 2003

On June 20 the FDA approved the new once-a-day protease inhibitor atazanavir (brand name Reyataz), manufactured by Bristol-Myers Squibb. Atazanavir has little effect on the blood lipids cholesterol and triglycerides, and on May 13 the FDA's advisory committee of outside experts had unanimously recommended approval (see AIDS Treatment News #391, May 30, 2003). Atazanavir can be taken as two pills once daily with food. In patients who have already had extensive HIV treatment, atazanavir may need to be "boosted" with a low dose of ritonavir (Norvir[R]) to maintain atazanavir blood levels (a reduced dose of atazanavir is recommended in this case; see Web site below to check current information). As with all other current antiretrovirals, atazanavir must be used as part of a combination regimen.

The advisory committee had some concern that the FDA was not be able to review all the data on treatment-experienced patients before the legal deadline for drug approval.

On June 20 Bristol-Myers Squibb, the manufacturer of atazanavir, issued a press release including the following cautions:

"Do not take REYATAZ if you are taking the following medicines: ergot derivatives, Versed(R), Halcion(R), Orap(R), Propulsid(R), Camptosar(R), Vascor(R), Crixivan(R), Mevacor(R), Zocor(R), Rifampin, St. John's wort, AcipHex(R), Nexium(R), Prevacid(R), Prilosec(R) or Protonix(R). [Not a complete list -- JSJ] Do not use Viagra(R) while you are taking REYATAZ without first speaking with your healthcare provider. Discuss all prescription, non-prescription and herbal products you are taking or plan to take with your healthcare provider.

"Increases in indirect bilirubin (bilirubin is made by the liver) have been reported in patients taking REYATAZ. This may result in yellowing of the skin and/or eyes. These symptoms usually go away after you stop taking REYATAZ.

"Changes in the way your heart beats may occur when taking REYATAZ. If you get dizzy or lightheaded these could be symptoms of a heart problem. An increase of lactic acid in the blood (lactic acidosis), which can cause death, has been reported in patients taking REYATAZ with other anti-HIV medicines called nucleoside analogues. In some patients taking protease inhibitors, increased bleeding (in patients with hemophilia), diabetes and high blood sugar have occurred. If you have liver disease, including hepatitis B or C, your liver disease may get worse when you take anti-HIV medicines like REYATAZ."

For a current copy of the atazanavir "labeling" (information for doctors), see the full prescribing information at http://www.reyataz.com/. Always use a current copy of the prescribing information, especially for a newly approved drug, since it will change as new information becomes available.