Digestive Diseases News
Winter 2009

NIH Hosts Consensus Conference on Hepatitis B Management

At a recent consensus development conference, a 12-member panel of experts, tasked by the National Institutes of Health (NIH) to identify strategies for managing hepatitis B, recommended studies to assess the long-term effectiveness of current treatments and urged routine screening programs for immigrants arriving from countries where the hepatitis B prevalence rate is greater than 2 percent.

“While there is little controversy about the use of the hepatitis B vaccine and other preventive measures against this disease, there is considerable controversy about its treatment,” said National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Director Griffin P. Rodgers, M.D., M.A.C.P. “This controversy is really the reason for and the focus of this consensus development conference.”

The conference was part of the NIH Consensus Development Program, which was established in 1977 to review controversial topics in medicine and public health in an unbiased, impartial manner. At the conference’s conclusion, the consensus panel issued a 25-page consensus statement based on a systematic review of the literature by the U.S. Agency for Healthcare Research and Quality (AHRQ) and expert testimony at the conference.

The panel reported that more than 400 million people worldwide are living with chronic hepatitis B, contributing to more than 500,000 deaths per year. In the United States, more than 1 million people have chronic hepatitis B, with hepatitis B-related hospitalization costs running more than $1 billion annually. Between 47 and 70 percent of U.S. residents with chronic hepatitis B were born outside the United States.

Which people should be treated, according to the panel, depends on the phase of the disease and other factors, including age, pregnancy status, sex, concomitant immunosuppressive or cancer therapies, coinfection with other forms of viral hepatitis or with HIV, hepatitis B viral genotype, family history of hepatocellular carcinoma, and alcohol abuse.

The panel concluded that patients with acute liver failure, decompensated cirrhosis, or compensated cirrhosis and increased risk of developing complications should be treated with antiviral therapy. Therapy may be indicated in other cases due to a combination of disease activity and other factors, such as age.

The panel cited data showing that the odds of spontaneous clearance of the virus decreases after about age 40, thus increasing the likelihood of hepatitis B-related complications. If, by this age, a patient shows signs of being immune active—with high alanine transaminase levels and positive for the hepatitis B antigen—therapy to slow disease progression should be considered. Therapy is not indicated for patients in the immune tolerant or inactive carrier phases.

Hepatitis B is a liver disease spread through contact with infected blood or body fluids. Although the rate of new infections in the United States has dropped precipitously with the advent of vaccines, hepatitis B-related liver damage and hepatocellular carcinoma continue to be significant health problems.

People at greatest risk of hepatitis B are those born to infected mothers. Unless vaccinated at birth, the likelihood these people will develop chronic hepatitis B years later is greater than 90 percent. U.S. residents who were born in hepatitis B-endemic areas of the world are at greatest risk for chronic disease. Unvaccinated, U.S.-born populations at greatest risk include intravenous drug users and men who have sex with men.

Future Research

The greatest needs and opportunities for future hepatitis B research cited by the panel include

• multinational, population-based prospective cohort studies to further define the natural history of hepatitis B
• large, multicenter, placebo-controlled clinical trials of mono- and combination therapies
• elucidation of the role of viral replication in host response and carcinogenesis
• risk and benefit assessment of antiviral therapy
• studies of the quantitative and qualitative characteristics of the host immune response to chronic hepatitis B infection
• evaluation of the risks and benefits of screening for hepatocellular carcinoma in people with chronic hepatitis B

No optimal approach exists for monitoring the progression of hepatitis B and assessing outcomes, according to the panel. Hepatitis B can seemingly enter the inactive phase—measured by diminished viral load and the disappearance of viral antigen—only to resurface later for unknown reasons. In many cases, liver damage continues after all other signs point to inactive disease, which is often the case in people who were infected at birth. The panel suggested expanding research to improve current disease monitoring algorithms.

The panel also recommended more research to unveil factors affecting disease progression and carcinogenesis. The panel recognized the NIDDK’s plans to launch the Hepatitis B Clinical Research Network—an effort to accelerate clinical and translational research toward effective and practical hepatitis B therapies. The consensus statement recommendations are expected to inform the network’s research agenda.

The panel’s consensus statement—an independent report and not a policy statement of the NIH or the Federal Government—was published in the January 20, 2008, issue of Annals of Internal Medicine. The consensus statement, AHRQ literature review, and full webcast of the consensus conference are available at www.consensus.nih.gov/2008/2008HepatitisBCDC120main.htm.

The NIH has conducted more than 100 consensus development conferences addressing a wide range of issues. Information about the NIH Consensus Development Program is available at http://consensus.nih.gov/ABOUTCDP.htm.

The NIDDK has health information about hepatitis B at www.digestive.niddk.nih.gov/ddiseases/pubs/hepatitis/index.htm.

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NIH Publication No. 09–4552
March 2009