title: Treatment of chronic hepatitis B in children with prednisone followed by alfa-interferon: a controlled randomized study.
abstract: The efficacy and safety of sequential treatment with prednisone and interferon was evaluated in a randomized, controlled study on 43 children 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 of prednisone (0.6 to 0.3 mg/kg per day) followed by interferon alfa-2a (3 MU/m2, thrice weekly, for 12 months; 22 patients) or no treatment (21 patients). At the end of the study (20 months), clearance of hepatitis 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%) patients had stable normal levels of alanine aminotransferase on their last examination. The baseline serum level of hepatitis B virus-DNA was an important predictor of response. In fact, HBeAg clearance was observed in 75% of patients with a baseline hepatitis B virus-DNA level lower 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 may 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 viral replication, this regimen seems to be ineffective.
authors.affiliation: Institute of Medical Therapy, University of Naples, 2nd Medical School, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Utili
authors.forename: E
authors.initials: E
authors.lastname: Sagnelli
authors.forename: G B
authors.initials: GB
authors.lastname: Gaeta
authors.forename: B
authors.initials: B
authors.lastname: Galanti
authors.forename: S
authors.initials: S
authors.lastname: Nardiello
authors.forename: F M
authors.initials: FM
authors.lastname: Felaco
authors.forename: G
authors.initials: G
authors.lastname: Pasquale
authors.forename: A
authors.initials: A
authors.lastname: Marrone
authors.forename: L
authors.initials: L
authors.lastname: Aprea
authors.forename: T
authors.initials: T
authors.lastname: Pizzella
mesh_terms: D000293:Adolescent; D002648:Child; D002908:Chronic Disease; D004279:DNA, Viral / Q000032:analysis; D004359:Drug Therapy, Combination; D005260:Female; D006509:Hepatitis B / Q000628:therapy*; D006515:Hepatitis B virus / Q000235:genetics; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D011241:Prednisone / Q000008:administration & dosage*
chemical_list: D004279:DNA, Viral; D016898:Interferon-alpha; D011241:Prednisone