New drug to treat chronic hepatitis B

Mar 30 2005

The U.S. Food and Drug Administration (FDA) has given approval for a new drug to treat the potentially life-threatening disease Chronic hepatitis B.

The drug, Baraclude, which should be available shortly, is an oral antiviral therapy specially designed to block the replication of hepatitis B virus (HBV) in the body by interfering with the virus's ability to infect cells.

Thousands of people die each year from primary liver cancer and most of these are caused by chronic hepatitis B. In the United States, more than one million people have developed chronic hepatitis B infection and more than 5,000 Americans die from hepatitis B and hepatitis B-related liver complications each year.

Timothy Block, Ph.D., president, Hepatitis B Foundation and professor, Drexel Medical College says that despite the alarming statistics, only a small proportion of diagnosed chronic hepatitis B patients in the U.S. are currently receiving treatment for their disease and the new drug provides a new option for therapy.

Peter R. Dolan, chairman and chief executive officer for Bristol-Myers Squibb, says the approval means they will now be able to address other areas of medical need, and build on their experience in fighting cancer, HIV/AIDS, schizophrenia and other diseases. Baraclude is the company's fourth new pharmaceutical approved in less than two and a half years, and has the potential to help many adult patients with chronic hepatitis B infection. It is an important step forward for patients and for the company.

Robert Gish, M.D., medical director of the California Pacific Medical Center's Liver Transplant Program, says that Baraclude has shown in clinical trials, greater levels of viral suppression compared to lamivudine (the most commonly used oral antiviral therapy for the treatment of chronic hepatitis B), after 48 weeks of treatment, and is an important new medication for the treatment of chronic hepatitis B.

The clinical trial program was the largest-ever conducted in chronic hepatitis B, and the first to compare two antivirals.

Baraclude is a nucleoside analogue and in the trials showed significant improvements compared to lamivudine in liver histology and the most common side effects were headache, tiredness, dizziness, and nausea.