With five drugs currently approved for chronic hepatitis B, there is a tremendous need for clear guidance so doctors and patients can make the best treatment choice possible. To address the current controversies in the management and treatment of hepatitis B, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) convened a special workshop April 6-8, 2006, in Bethesda, MD.

The Hepatitis B Foundation (HBF) was proud to co-sponsor the NIH meeting with the American Association for the Study of Liver Diseases (AASLD), which attracted more than 400 thought leaders from the U.S. and abroad. The first and last NIH meeting to address hepatitis B treatment was held in 2000, when there was only one approved drug.

Although there was vigorous debate on every issue, the experts all agreed that resistance to the currently available oral drugs is a key concern in the treatment of hepatitis B.

The take home message to drug makers and clinicians: make hepatitis B therapy irresistible and treat in a way that doesn’t create drug resistance!

“The problem of resistance is widespread in the treatment of bacterial infections and AIDS, and is a major public health problem that we need to avoid with hepatitis B,” says Timothy Block, Ph.D., HBF president, and one of the expert panelists at the NIH meeting. “Resistant virus can emerge in a person treated and render the drug ineffective, leaving the patient vulnerable to the progression of liver disease.”

According to Jay Hoofnagle, M.D., meeting organizer and director, Division of Digestive Diseases and Nutrition of NIDDK, hepatitis B remains an important cause of disability and death from liver disease in the U.S. and abroad, despite the availability of a highly effective vaccine to prevent hepatitis B and five drugs to treat the disease. “With 400 million people worldwide who are chronically infected with hepatitis B and at increased risk for developing serious liver disease and/or liver cancer, interest in the management of the disease is of great health concern,” said Dr. Hoofnagle in his opening statements.

The NIH meeting, which did not address experimental therapies, tried to determine which approved drugs are most appropriate for different patient populations. With powerful new drugs, there continue to be many controversial treatment questions: if and when should liver biopsy be used in treatment decisions; how low should hepatitis B viral loads go; and what should be the treatment endpoints.

“Keep the message simple,” urged Anna Lok, M.D., professor, University of Michigan and meeting co-organizer, and Robert Gish, M.D., professor, California Pacific Medical Center, “to ensure the best care”. Dr. Hoofnagle promised the organizers would as they prepare a formal summary for publication.

Although the conclusions are not binding, the NIH summary recommendations generally serve as a basis for national practice guidelines that are followed by the medical community. Hence, the report from this hepatitis B meeting will have great importance.

HBV treatment issues are complicated, but the general consensus at the meeting was one of optimism. “At one time experts thought it was impossible to treat viral infections, but now we have a myriad of options for HIV, and five approved therapies for hepatitis B, with more in the pipeline,” concluded Dr. Hoofnagle.

BInformed, Summer 2006.