Patients treated with Baraclude showed significant improvement in the liver inflammation caused by HBV and an improvement in the degree of liver fibrosis. A higher percentage of patients showed significant improvement when treated with Baraclude compared to lamivudine.

Chronic hepatitis B is a serious disease that can occur when the hepatitis B virus (HBV) attacks the liver. It can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure and death.

Approximately 1.25 million Americans are chronically infected with the HBV virus, according to the Centers for Disease Control and Prevention.

Baraclude is an oral antiviral therapy specifically designed to block the replication of HBV in the body by interfering with the virus’s ability to infect cells. It will be available in the United States as early as April 8, 2005, says the manufacturer.

Comparison to Lamivudine

FDA based its approval of Baraclude on the results of three studies that compared Baraclude to another anti-viral drug, lamivudine.

Patients treated with Baraclude showed significant improvement in the liver inflammation caused by HBV and an improvement in the degree of liver fibrosis in all three clinical studies.

In addition, a higher percentage of patients showed significant improvement when treated with Baraclude compared to lamivudine.

Discontinuation Can Cause Severe Effects

The major adverse events associated with the use of Baraclude were of the type typically seen with HBV therapy. They include severe, acute exacerbation of hepatitis B after discontinuation of Baraclude, headache, abdominal pain, diarrhea, fatigue and dizziness.

The labeling for Baraclude states that patients who discontinue its use should be monitored at repeated intervals over a period of time for liver function.

Bristol-Myers Squibb has committed to conducting a large post-marketing study of Baraclude (entecavir) to evaluate the risks of cancers and liver related complications.