New treatment for chronic hepatitis B

FDA Consumer, July-August, 2005

Baraclude (entecavir) tablets and oral solution have been approved to treat chronic hepatitis B in adults.

Chronic hepatitis B is a serious disease caused by the hepatitis B virus (HBV) that attacks the liver. The virus can cause lifelong infection, scarring of the liver, liver cancer, liver failure, and death. According to the Centers for Disease Control and Prevention, about 1.25 million Americans are chronically infected with the HBV virus.

Baraclude slows the progression of chronic hepatitis B by interfering with the reproduction of the virus. The FDA based its approval on the results of three studies in which Baraclude was compared to another antiviral drug, lamivudine. In all three studies, people treated with Baraclude showed significant improvement in the liver inflammation caused by HBV and an improvement in the degree of liver scarring. In addition, more people treated with Baraclude showed significant improvement than those treated with lamivudine.

The major side effects of Baraclude in the studies were of the type typically seen with HBV treatments. They include headache, abdominal pain, diarrhea, fatigue, dizziness, and a severe, brief worsening of hepatitis B after discontinuation of Baraclude.

Baraclude's sponsor, Bristol-Myers Squibb Co. of Wallingford, Conn., has committed to conducting a large post-marketing study of the drug to evaluate the risks of cancers and liver-related complications.