Interferon alpha is effective in the treatment of chronic hepatitis B in adults and is approved for this indication in the United States and several other countries. Its safety and efficacy has not been as carefully evaluated in children. This trial at several centers in Canada, Europe and the United States examined the use of interferon alpha in children between the ages of 1 and 17 years with chronic hepatitis B. Subjects were randomized to either 24 weeks of treatment with interferon alpha-2b (6 million units per square meter three times a week) or to observation (there was no placebo control). All subjects had detectable serum hepatitis Be antigen (HBeAg) and viral DNA which are indicative or virus replication. No children had cirrhosis and only a few had significant fibrosis on liver biopsy. Treated subjects were evaluated 24 weeks after stopping interferon alpha and control subjects after 48 weeks of observation. Of 149 patients enrolled, 144 were ultimately available for evaluation (70 treated and 74 observed). Serum HBeAg and viral DNA became negative in 26% of treated and 11% of observed children (P < 0.05). Loss of HBeAg has been associated with a significantly improved prognosis in adults.
Hepatitis B surface antigen became negative (most likely indicative of viral clearance and cure) in 10% of treated children and 1% of controls. Pretreatment and posttreatment liver biopsies were only available from 10 subjects and suggested improvement in histology. Most adverse events were described as mild or moderate and dose reductions were required in 24% of the treated children. These results show that interferon alpha treatment of children promotes clearance of markers of virus replication and hepatitis B surface antigen.
Copyright, 1998, Columbia University Division of GastroenterologyHepatitis B
By Howard J. Worman, M. D. Sokal, E. M., Conjeevaram, H. S., Roberts, E. A., Alvarez, F., Bern, E. M., Goyens, P., Rosenthal, P., Lachaux, A., Shelton, M., Sarles, J., and Hoofnagle, J. 1998