The National Institute of Health (NIH) convened a panel last week to examine and discuss issues relating to the management of hepatitis B. Because this disease is not completely understood as to its course and treatment, as well as a lack of encompassing studies, the NIH took steps to gain more insight into health management evidence through the independent, impartial panel.

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.

Note that 95 percent of U.S. children are routinely vaccinated for hepatitis B, yet 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 body's 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. Top priority was given to large randomized studies, including placebo-controlled trials, testing single drug and combination therapies' 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. Such studies could indicate which patients are most in need of immediate therapy and which could be carefully followed without drug therapy.

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. 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 not for the purpose of excluding immigrants.

The panel recommends therapy for certain patients, including those with acute liver failure and complications from cirrhosis. However, immediate therapy was not recommended for patients with inactive forms of the disease.

The panel's complete consensus statement is available at http://consensus.nih.gov.

Adapted from a press release by the National Institute of Health

More Industry Headlines