TREATMENT OF CHRONIC HEPATITIS-B IN CHILDREN WITH PREDNISONE FOLLOWEDBY ALFA-INTERFERON - A CONTROLLED RANDOMIZED STUDY

The efficacy and safety of sequential treatment with prednisone and in terferon was evaluated in a randomized, controlled study on 43 childre n with biopsy proven HBsAg/HbeAg/hepatitis B virus-DNA positive, anti- delta negative, chronic hepatitis (34 chronic persistent hepatitis, 9 chronic active hepatitis). Patients received either a 1-month course o f prednisone (0.6 to 0.3 mg/kg per day) followed by interferon alfa-2a (3 MU/m(2), thrice weekly, for 12 months; 22 patients) or no treatmen t (21 patients). At the end of the study (20 months), clearance of hep atitis B virus-DNA and HBeAg seroconversion were observed in nine (41% ) of the patients treated with prednisone and interferon and in two (9 .5%) of the untreated controls (p=0.020). Two of the treated patients who lost HBeAg, also cleared HBsAg. In the treated group, 13 (59%) pat ients had stable normal levels of alanine aminotransferase on their la st examination. The baseline serum level of hepatitis B virus-DNA was an important predictor of response. In fact, HBeAg clearance was obser ved in 75% of patients with a baseline hepatitis B virus-DNA level low er than 100 pg/ml and in none with a level above 100 pg/ml. We suggest that combined treatment with prednisone followed by alfa-interferon m ay be safe and effective in inducing a stable clearance of HBeAg and, in some cases, of HBsAg in children with chronic hepatitis B and with a low level of viral replication. For children with high levels of vir al replication, this regimen seems to be ineffective. (C) Journal of H epatology.