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Health

FDA panel recommends approval of hepatitis B treatment

graphic October 7, 1998
Web posted at: 2:12 p.m. EDT (1812 GMT)

WASHINGTON (CNN)-- An advisory committee of the U.S. Food and Drug Adminstration recommended approval of the first ever oral treatment for hepatitis B virus on Tuesday.

The drug, Lamivudine, is also known as Epivir or 3TC. It has been shown in year-long clinical trials to reduce liver inflammation and delay scarring of the liver cause by the disease.

Lamivudine is not a cure, but it blocks infected cell replication. It is currently approved for treatment of HIV.

Approximately a million Americans are infected with hepatitis B and there are about 140,000 new infections each year. The virus is spread through sexual contact or contaminated needles and blood products.

Chronic hepatitis B can lead to cirrhosis of the liver and liver cancer.

Until now, the only treatment for hepatitis B has been an intravenous drug called Interferon, but it is generally not well-tolerated.

Lamivudine is a product of Glaxo Wellcome. Common side effects included respiratory infection, headache, abdominal pain and fatigue.

From CNN Medical Producer Laura Viddy

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