title: Dual-centre, double-blind, randomised trial of lymphoblastoid interferon alpha with or without steroid pretreatment in children with chronic hepatitis B.
abstract: Thirty-five children with chronic HBV infection, HBV-DNA and eAg serum positivity, and HBcAg in liver tissue were treated with lymphoblastoid human interferon alpha with (16 cases) or without (19 cases) prednisolone pretreatment. The patients were double-blind randomized to receive steroid or placebo for 4 weeks, followed after 2 weeks by 5 or 10 MU/m2 interferon for 12 weeks. The e anti-e seroconversion rate reached 48%, which is much higher than the spontaneous seroconversion rate. The influence of "prednisolone priming" was not statistically significant. HBeAg clearance was similar in both groups (44% after prednisolone/interferon and 53% after interferon alone). The response to either treatment did not correlate with the pretreatment serum transaminase. HBV-DNA or degree of histological activity. Interferon was well tolerated, the side effects being less severe than in adults, and never led to suspension of the treatment.
authors.affiliation: Department of Infectious Diseases, University of Genoa, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Giacchino
authors.forename: J
authors.initials: J
authors.lastname: Main
authors.forename: A
authors.initials: A
authors.lastname: Timitilli
authors.forename: G
authors.initials: G
authors.lastname: Giambartolomei
authors.forename: F
authors.initials: F
authors.lastname: Facco
authors.forename: C
authors.initials: C
authors.lastname: Cirillo
authors.forename: M R
authors.initials: MR
authors.lastname: Jacyna
authors.forename: M G
authors.initials: MG
authors.lastname: Brook
authors.forename: F
authors.initials: F
authors.lastname: Callea
authors.forename: P
authors.initials: P
authors.lastname: Kariayannis
mesh_terms: D000293:Adolescent; D001706:Biopsy; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D004279:DNA, Viral / Q000032:analysis; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006509:Hepatitis B / Q000188:drug therapy* / Q000378:metabolism; D006514:Hepatitis B Surface Antigens / Q000032:analysis; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D011239:Prednisolone / Q000627:therapeutic use*; D000637:Transaminases / Q000378:metabolism
chemical_list: D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D016898:Interferon-alpha; D011239:Prednisolone; D000637:Transaminases