title: Prolonged and high dose recombinant interferon alpha-2b alone or after prednisone priming accelerates termination of active viral replication in children with chronic hepatitis B infection.
abstract: BACKGROUND
  There is no generally accepted treatment for chronic hepatitis B (HB) infection in children.
  
  
  OBJECTIVE
  To evaluate the efficacy of a prolonged course of high dose interferon alone or after prednisone priming in children with chronic HB infection.
  
  
  METHODS
  The outcome of 31 children with HB e antigen (HBeAg)-positive chronic hepatitis who randomly received either no treatment (n = 9) or 10 million units of interferon alpha-2b/m2, alone (n = 13) or after prednisone priming (n = 9), three times weekly for 1 year was studied.
  
  
  RESULTS
  One patient withdrew from treatment. By the end of the first year treatment induced a loss of HB virus DNA and HBeAg from serum in 10 of 21 patients (48%), and a loss of HB surface antigen (HBsAg) in 4 (19%). Alanine aminotransferase values became normal in one patient (4.8%). Response rates in the two groups of treated patients were similar. In controls only one patient lost HBeAg and HBV DNA (11%; P = 0.05), and none lost HBsAg or showed alanine aminotransferase normalization (P = 0.21 and 0.70, respectively). After a posttreatment 2-year follow-up there were still no differences in the response rates of the two treatments; of the 21 pooled treated patients, 61% lost HBeAg and DNA and 67% normalized alanine aminotransferase (vs. 33 and 44% of controls, respectively; P = 0.32 and 0.40). Reversion to HBeAg and HBV DNA negativity in treated patients occurred significantly earlier (P = 0.02 and 0.006, respectively) than in controls. No further patient lost HBsAg, but one reacquired HBsAg. Treated patients had posttreatment histologic scores better than controls (P = 0.03).
  
  
  CONCLUSIONS
  Our medium term follow-up results indicate that a prolonged course of high dose interferon in children with chronic HB infection, regardless of prednisone priming, poorly affects response rates but significantly speeds termination of active viral replication.
authors.affiliation: Department of Pediatrics, Università di Napoli Federico II, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Vajro
authors.forename: M
authors.initials: M
authors.lastname: Tedesco
authors.forename: A
authors.initials: A
authors.lastname: Fontanella
authors.forename: A
authors.initials: A
authors.lastname: De Vincenzo
authors.forename: R
authors.initials: R
authors.lastname: Vecchione
authors.forename: R
authors.initials: R
authors.lastname: Ammendola
authors.forename: L M
authors.initials: LM
authors.lastname: Terracciano
authors.forename: A
authors.initials: A
authors.lastname: Novissimo
authors.forename: A
authors.initials: A
authors.lastname: Vegnente
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006509:Hepatitis B / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology / Q000821:virology; D006515:Hepatitis B virus / Q000187:drug effects* / Q000235:genetics / Q000276:immunology / Q000502:physiology; D006521:Hepatitis, Chronic / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology / Q000821:virology; D006801:Humans; D007370:Interferon Type I / Q000627:therapeutic use*; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008099:Liver / Q000276:immunology / Q000473:pathology / Q000821:virology; D008297:Male; D011237:Predictive Value of Tests; D011241:Prednisone / Q000494:pharmacology*; D011446:Prospective Studies; D011994:Recombinant Proteins; D013997:Time Factors; D014779:Virus Replication
chemical_list: D007370:Interferon Type I; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011241:Prednisone