title: Lymphoblastoid interferon alfa with or without steroid pretreatment in children with chronic hepatitis B: a multicenter controlled trial.
abstract: The comparative efficacy of prednisolone followed by interferon alfa (IFN-alpha) versus IFN-alpha alone in enhancing the rate of antibody to hepatitis B e antigen (anti-HBe) seroconversion has not been evaluated in a large cohort of white children. To determine this, a multicenter-controlled trial was conducted in 95 hepatitis B virus (HBV)-DNA/hepatitis B e antigen (HBeAg)-positive children (median age, 9 years [range, 2-16 years]; 56 boys; 84 [89 percent] white), all having inflammatory changes on liver biopsy. Patients were randomized to receive either prednisolone followed by IFN-alpha (n = 34); placebo followed by IFN-alpha (n = 30); or no treatment (n = 31). The prednisolone/placebo was given on a double-blind basis. Lymphoblastoid IFN-alpha was given at 5 MU/m(2) three times a week for 12 weeks. Baseline clinical, biochemical, and histological features were similar for the three groups. The majority (85 percent) had a baseline aspartate aminotransferase (AST) level < or = 100 IU/L. On follow-up between 12 and 18 months (median, 15 months) after treatment, the loss of HBeAg with anti-HBe seroconversion was more common in patients pretreated with steroids (12 of 34 [35 percent]) or placebo [12 of 30 (40 percent)] as against controls (4 of 31 [13 percent], P< .05). Factors predictive of anti-HBe seroconversion were baseline HBV-DNA concentration of < or = 1,000 pg/mL and a greater degree of portal tract inflammation on pretrial biopsy. Our results show that in white children treatment with IFN-alpha, at the dose and duration used in this study, improves the rate of anti-HBe seroconversion. Steroid priming does not potentiate the effect of IFN-alpha.
authors.affiliation: Department of Child Health, King's College School of Medicine and Dentistry, London, England.
authors.forename: G V
authors.initials: GV
authors.lastname: Gregorio
authors.forename: P
authors.initials: P
authors.lastname: Jara
authors.forename: L
authors.initials: L
authors.lastname: Hierro
authors.forename: C
authors.initials: C
authors.lastname: Diaz
authors.forename: A
authors.initials: A
authors.lastname: de la Vega
authors.forename: A
authors.initials: A
authors.lastname: Vegnente
authors.forename: R
authors.initials: R
authors.lastname: Iorio
authors.forename: F
authors.initials: F
authors.lastname: Bortolotti
authors.forename: C
authors.initials: C
authors.lastname: Crivellaro
authors.forename: L
authors.initials: L
authors.lastname: Zancan
authors.forename: H
authors.initials: H
authors.lastname: Daniels
authors.forename: B
authors.initials: B
authors.lastname: Portmann
authors.forename: G
authors.initials: G
authors.lastname: Mieli-Vergani
mesh_terms: D000293:Adolescent; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D006509:Hepatitis B / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D006510:Hepatitis B Antibodies / Q000097:blood; D006513:Hepatitis B e Antigens / Q000276:immunology; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology; D008297:Male
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006510:Hepatitis B Antibodies; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha; D000410:Alanine Transaminase