Panel calls for a conservative approach until more clinical data and therapeutic options are available
DOYLESTOWN, Pa., Oct. 20 /PRNewswire-USNewswire/ -- In a report published on October 1, 2010 in the journal Hepatology (online), an expert panel of nationally recognized pediatric liver specialists convened by the Hepatitis B Foundation established the first national recommendations for the treatment of children with chronic hepatitis B virus (HBV) infections. Following their first meeting at the Hepatitis B Foundation headquartered in Doylestown, PA in November of 2008, the panel's recommendations for screening and monitoring of children chronically infected with HBV were published in Pediatrics. The panel assembled for a second meeting on August 11, 2009 to discuss the special issues and challenges associated with antiviral treatment of children.
"There is an urgent need for specific guidance in the management and treatment of children living with chronic HBV infections," said Joan Block, executive director of the Hepatitis B Foundation. "Currently, there is a significant gap in knowledge among most pediatricians, and even among many pediatric specialists, in the appropriate care and management of these children."
Therapeutic options for children with chronic HBV infection are currently limited. Only four of the seven FDA-approved HBV-antiviral drugs are labeled for use in children, and only two of those may be used in young children under 12 years of age. Most importantly, unnecessary treatment with the nucleos(t)ide analog class of antiviral drugs can lead to the development drug-resistant HBV strains. Viral resistance not only impacts the future treatment options for an individual later in life, but is also an emerging public health threat. The panel's report reviews the currently available therapies for children with chronic HBV infection, and offers recommendations for prudent use.
"Based on our review of the available data, the panel concluded that outside of carefully-designed clinical trials, it is generally not appropriate to treat children in the immune tolerant phase of HBV infection," said lead author, Maureen M. Jonas, MD, of Children's Hospital Boston. "There is no established benefit of treatment with currently available therapies in this phase, and there are very serious concerns about the potential for development of drug-resistant virus." The panel also agreed that there is no indication for treatment of children in the inactive "carrier" state.
While most children with chronic HBV will not require treatment, they are at imminent risk for progression to serious liver disease. Routine monitoring is essential so that a child needing treatment is not missed. Children who are in the immune active or reactivation phases of chronic HBV disease will have laboratory indicators of active disease. However, such children may still appear asymptomatic. In these cases, the decision to treat can be aided by assessing the child's liver histology, in concert with family history of liver disease including liver cancer. The publication includes a flowchart outlining the panel's recommended approach to selection of children for anti-HBV treatment.
"There is still much to be elucidated about the appropriate use of HBV therapy in children," said author Brian McMahon, MD, of the Alaska Native Tribal Health Consortium. "It is important to identify children with chronic HBV infection through screening, monitor them closely, and treat if appropriate, but until more clinical data and therapeutic options are available, a conservative approach is warranted."
To learn more about hepatitis B disease, please visit the Hepatitis B Foundation website at www.hepb.org.
Jonas, M., Block, J., Haber, B., Karpen, S., London, W. T., Murray, K., Narkewicz, M., Rosenthal, P., Schwarz, K. and McMahon, B. Treatment of children with chronic hepatitis B virus infection in the United States: Patient selection and therapeutic options. Hepatology. Published online ahead of print Oct 1, 2010. doi: 10.1002/hep.23934 (http://onlinelibrary.wiley.com/doi/10.1002/hep.23934/abstract)
About the Hepatitis B Foundation
The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure and improving the quality of life for those affected with hepatitis B worldwide through research, education and patient advocacy. Visit www.hepb.org.
SOURCE Hepatitis B Foundation