title: Interferon alfa therapy for chronic hepatitis B in children: a multinational randomized controlled trial.
abstract: OBJECTIVE
  Treatment of chronic hepatitis B with interferon alfa is not approved in children. The aim of this study was to evaluate the safety and efficacy of interferon alfa (IFN-alpha) in children with chronic hepatitis B and increased transaminase levels.
  
  
  METHODS
  Children were given either IFN-alpha2b (6 megaunits/m2 thrice weekly for 24 weeks) or no treatment. Clearance of markers of viral replication was evaluated 24 weeks after therapy and after 48 weeks of observation in controls.
  
  
  RESULTS
  Of 149 children enrolled, 144 were evaluable (70 treated and 74 controls). Serum hepatitis B e antigen and viral DNA became negative in 26% of treated children and 11% of controls (P < 0.05). Serum aminotransferase levels normalized and liver histology improved among responders. Hepatitis B surface antigen became undetectable in 10% of treated patients and 1% of controls. Female gender and interferon treatment were the only significant predictors of response. Ethnic origin, baseline aminotransferase level, initial DNA levels, and histology did not correlate with response. Most adverse reactions were mild or moderate, and dose was reduced in 24% of children.
  
  
  CONCLUSIONS
  In children with chronic hepatitis B, INF-alpha promotes loss of viral replication markers and surface antigen and improves aminotransferases and histology.
authors.affiliation: Cliniques St. Luc, Pediatric Hepatology, Université Catholique de Louvain, Brussels, Belgium. sokal@pedilucl.ac.be
authors.forename: E M
authors.initials: EM
authors.lastname: Sokal
authors.forename: H S
authors.initials: HS
authors.lastname: Conjeevaram
authors.forename: E A
authors.initials: EA
authors.lastname: Roberts
authors.forename: F
authors.initials: F
authors.lastname: Alvarez
authors.forename: E M
authors.initials: EM
authors.lastname: Bern
authors.forename: P
authors.initials: P
authors.lastname: Goyens
authors.forename: P
authors.initials: P
authors.lastname: Rosenthal
authors.forename: A
authors.initials: A
authors.lastname: Lachaux
authors.forename: M
authors.initials: M
authors.lastname: Shelton
authors.forename: J
authors.initials: J
authors.lastname: Sarles
authors.forename: J
authors.initials: J
authors.lastname: Hoofnagle
mesh_terms: D000293:Adolescent; D000410:Alanine Transaminase / Q000097:blood; D002648:Child; D002675:Child, Preschool; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D005500:Follow-Up Studies; D006513:Hepatitis B e Antigens / Q000032:analysis; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000276:immunology / Q000378:metabolism / Q000628:therapy*; D006801:Humans; D007223:Infant; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D007391:International Cooperation; D008297:Male; D016896:Treatment Outcome
chemical_list: D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha; D000410:Alanine Transaminase