Panel Advocates Improved Understanding
of Hepatitis B and Screening of High-Risk Populations
Note to Reporters: Press conference to be held at 2:00 p.m. EST today on the NIH campus in Bethesda, Maryland. Participate online via http://videocast.nih.gov
Management of hepatitis B is a challenge for physicians and patients due to an incomplete understanding of the disease course, complex treatment indications, and the lack of large studies focusing on important health outcomes. To examine these issues, the NIH convened an independent, impartial panel this week to weigh the available evidence on the management of hepatitis B.
While more than 95 percent of U.S. children are routinely vaccinated for hepatitis B, the vaccine does not protect individuals already infected with the virus. In unprotected individuals, acute infection with the hepatitis B virus is usually resolved by the bodyís immune system and does not cause long-term problems. The transition from acute to chronic infection appears to occur when the immune system does not effectively destroy and clear virus-infected cells.
A number of antiviral therapies approved by the U.S. Food and Drug Administration
are available for use in fighting chronic hepatitis B infection including interferons
and nucleos(t)ides. "We know that these therapies have positive effects
on indicators such as viral load, but further controlled trials are needed
to substantiate that these agents prevent disease progression to liver failure,
cancer, or death," explained panel chair Dr. Michael F. Sorrell, Professor
of Medicine at the University of Nebraska Medical Center.
To address this gap in the evidence, the panel recommended several avenues for future research. Among these, they gave top priority to large andomized studies, including placebo-controlled trials, testing single drug and combination therapiesí effects on liver failure, cancer, and death. The panel also proposed representative prospective cohort studies to define the natural history of the disease to optimize management across diverse patient subgroups. This would also help decide which patients are most in need of immediate therapy and which could be carefully followed without drug therapy.
The panel is encouraged by the National Institute of Diabetes and Digestive and Kidney Disordersí plans to launch the Hepatitis B Clinical Research Network to promote translational research on this challenging condition. It is anticipated that the recommendations in the consensus statement will inform the consortiumís research agenda.
The panel identified elevated hepatitis B DNA blood levels and elevated levels of ALT (alanine aminotransferase, a liver enzyme) as the most important indicators for progression to cirrhosis and liver cancer (hepatocellular carcinoma). Older age, male sex, family history of liver cancer, coinfection with hepatitis C or HIV, and elevated blood levels of hepatitis B DNA were also found to be key predictors.
The panel recommends routine hepatitis B screening for newly arrived immigrants from countries where hepatitis B prevalence is greater than two percent. These practices are intended to facilitate access to care for infected individuals and their families and to provide valuable data on disease prevalence, not to exclude immigrants in any way.
The panel recommends therapy for certain patients, including those with acute liver failure and complications from cirrhosis. However, immediate therapy is not indicated for patients with inactive forms of the disease.
The panelís complete consensus statement will be available later today at http://consensus.nih.gov. The conference was sponsored by the NIH Office of Medical Applications of Research (OMAR) and the National Institute of Diabetes and Digestive and Kidney Diseases, along with other NIH and Department of Health and Human Services components. This conference was conducted under the NIH Consensus Development Program, which convenes conferences to assess the available scientific evidence and develop objective statements on controversial medical issues.
The 12-member conference panel included experts in the fields of hepatology and liver transplantation, gastroenterology, public health and epidemiology, infectious diseases, pathology, oncology, family practice, internal medicine, biostatistics, and a public representative. A complete listing of the panel members and their institutional affiliations is included in the draft conference statement. Interviews with panel members can be arranged by contacting Lisa Ahramjian at 301-496-4999 or AhramjianL@od.nih.gov.
In addition to the material presented at the conference by speakers and the input from conference participants provided during discussion periods, the panel considered pertinent research from the published literature and the results of a systematic review of the literature. The systematic review was prepared through the Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Centers (EPC) program, by the Minnesota Evidence-based Practice Center. The EPCs develop evidence reports and technology assessments based on rigorous, comprehensive syntheses and analyses of the scientific literature, emphasizing explicit and detailed documentation of methods, rationale, and assumptions. The evidence report on management of hepatitis B is available at http://www.ahrq.gov/clinic/tp/hepbtp.htm.
The panel's statement is an independent report and is not a policy statement of the NIH or the federal government. The NIH Consensus Development Program was established in 1977 as a mechanism to judge controversial topics in medicine and public health in an unbiased, impartial manner. NIH has conducted 119 consensus development conferences, and 29 state-of-the-science (formerly "technology assessment") conferences, addressing a wide range of issues. A backgrounder on the NIH Consensus Development Program process is available at http://consensus.nih.gov/forthemedia.htm.
The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at http://www.nih.gov/icd/od.
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and
Human Services. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research,
and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and
its programs, visit www.nih.gov.