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National Institutes of Health Convenes Meeting to Determine Who to Treat and How to Treat Hepatitis B

Experts Agree Key Issue in Hepatitis B Treatment is to Avoid Drug Resistance

The National Institutes of Health (NIH) convened on April 6-8 a national meeting in Bethesda, MD, to address current controversies in the management and treatment of hepatitis B and to make recommendations on directions for future research. Although there was vigorous debate on every issue, the experts all agreed that resistance to the currently approved drugs is a key concern in the treatment of hepatitis B. Their message to drug makers and caregivers: treat in a way that doesn’t create drug resistance. Sponsors of the three day meeting included the National Institute of Diabetes and Digestive and Kidney Diseases, part of the NIH; the American Association for the Study of Liver Diseases; and the Hepatitis B Foundation.

“The problem of resistance is widespread in the treatment of bacterial infections and AIDS, and is a major public health significance that we need to avoid with hepatitis B,” says Timothy Block, Ph.D., president of the Hepatitis B Foundation, and one of the expert speakers 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. Hence, the Hepatitis B Foundation has consistently urged officials to give clear guidance to caregivers about how and when to use the available drugs for hepatitis B,” he added.

Despite the availability of a highly effective and safe vaccine to prevent hepatitis B and five different antiviral agents to treat the disease, hepatitis B remains an important cause of disability and death from liver disease in the United States and abroad. With 400 million people worldwide who are chronically infected with hepatitis B and living at increased risk for developing serious liver disease and/or liver cancer, interest in the management of the disease is of great health concern. Since the current approved drugs do not work in half the affected people, new approaches, however, are still needed, noted several experts.

Speakers and organizers of the NIH "Management of Chronic Hepatitis B: 2006" (April 7, 2006).

The NIH meeting, which dealt only with the five approved medications, not experimental ones, tried to determine which therapies 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 histological, virological and clinical endpoints for treatment. Although the conclusions of the meeting are not binding, doctors and public health officials throughout the country look to the NIH for expert, rational guidelines.

“Keep the message simple,” urged Anna Lok, M.D., professor, University of Michigan, and
Robert Gish, M.D., professor, California Pacific Medical Center, during the wrap-up session of the meeting. Jay Hoofnagle, M.D., director, Division of Digestive Diseases and Nutrition of NIDDK and lead organizer, promised the NIH would. A formal statement from the meeting organizers will be issued and published in leading medical journals. The summary recommendations from these NIH meetings generally serve as a basis for national practice guidelines, and thus, have great importance in the medical community.

Although treatment issues are complicated, the general consensus among the more than 400 thought leaders from the U.S., Europe and China was one of great 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.

Expert panel discussion at the NIH Hepatitis B meeting (April 7, 2006).