Food and Drug Administration OKs Chronic Hepatitis B Drug

On Friday, the Food and Drug Administration approved adefovir dipivoxil for use by patients with hepatitis B. The new drug therapy will be sold by Gilead Sciences Inc. as Hepsera, and the drug maker will begin shipping the drug as early as this week. Adefovir dipivoxil is the first new therapy in years for the estimated 1.2 million Americans who have the infection. Interferon and lamivudine are the only other medicines available to hepatitis B patients. But some patients become resistant to one drug, while others cannot tolerate the side effects of the other. Doctors have long wanted another option.

Adefovir originally was tested as a possible treatment for HIV, but the FDA rejected that use because the high doses required proved toxic to patients' kidneys. The drug was tested in far lower doses for hepatitis B. It did not cure the infection, but studies concluded that liver cirrhosis improved in 56 percent to 66 percent of patients testing the drug.

A Gilead spokesperson said a patient would take one tablet per day. Although studies showed that a ten-milligram daily dose did not lead to it outright, kidney damage is still a potential side effect. By a more conservative measurement, up to 5 percent of patients who used adefovir for a year showed early signs of some toxicity, according to the studies.

Back to other CDC news for September 23, 2002

Previous Updates