To evaluate the possible usefulness of simultaneous administration of
levamisole and interferon, we randomly allocated 38 children with chro
nic hepatitis B to receive either 10 MU/m2 interferon-alpha-2a, three
times a week for 6 mo (group 1, n = 20) or 90 mg/m2 of levamisole for
45 days, together with 10 MU/M2 of interferon-alpha-2a, three times a
week for 6 mo (group 2, n = 18). At the end of the follow-up period (1
5 mo), no significant differences were observed between the groups wit
h respect to loss of hepatitis B virus DNA and HBeAg from serum and no
rmalization of serum ALT levels. During therapy, a significant increas
e in the serum levels of ALT and soluble interleukin-2 receptor was ob
served in both groups but was higher in patients from group 2. The com
bination of levamisole with interferon was associated with severe side
effects. In summary, the combination of levamisole with interferon in
children with chronic hepatitis B does not improve the results obtain
ed with interferon alone.