title: Efficacy of hepatitis B vaccination and interferon-alpha-2b combination therapy versus interferon-alpha-2b monotherapy in children with chronic hepatitis B.
abstract: BACKGROUND
  Although interferon (IFN) has been approved in the treatment of chronic hepatitis B in children, it is effective only in 30-40% of patients. In some studies it has been suggested that therapeutic use of anti-hepatitis B virus (HBV) vaccine may be beneficial in patients with chronic hepatitis B. The aim of the present study was to compare the efficacy of hepatitis B vaccination and IFN-alpha-2b in combination and IFN-alpha-2b monotherapy in children with chronic hepatitis B.
  
  
  METHODS
  Fifty treatment-naive children with chronic hepatitis B infection were randomly assigned to receive either 5 million units/m(2) recombinant IFN-alpha-2b subcutaneously three times per week for 9 months, and pre-S2/S vaccine at the beginning and 4 and 24 weeks after initiation of IFN therapy (n = 25) or recombinant IFN-alpha-2b (5 million units/m(2) subcutaneously thrice weekly) alone for 9 months (n = 25). Children were followed for at least 6 months after the end of therapy.
  
  
  RESULTS
  There was no statistically significant difference in the mean alanine aminotransferase levels, histologic activity index and fibrosis scores between combination and IFN monotherapy groups at the end of the therapy and end of the follow-up period. When combination and monotherapy groups were compared, the mean HBV-DNA values were significantly reduced in combination group at the end of the therapy (P = 0.004), but no statistically significant difference was found at the end of the follow up. Sustained HBeAg seroconversion with clearance of HBV-DNA was obtained in 13 of 25 children (52%) treated with combination therapy, and in eight of 25 patients (32%) treated with IFN monotherapy (P = 0.251).
  
  
  CONCLUSIONS
  Although the difference was statistically insignificant, the sustained response rates were better in the combination therapy group than in the monotherapy group. The potential benefit of combining IFN and hepatitis B vaccine should be investigated in further studies with different regimens of combination therapy.
authors.affiliation: Department of Pediatrics, Social Security Tepecik Teaching Hospital, Izmir, Turkey.
authors.forename: Mehmet
authors.initials: M
authors.lastname: Helvaci
authors.forename: Asli
authors.initials: A
authors.lastname: Kizilgunesler
authors.forename: Erhun
authors.initials: E
authors.lastname: Kasirga
authors.forename: Ebru
authors.initials: E
authors.lastname: Ozbal
authors.forename: Muge
authors.initials: M
authors.lastname: Kuzu
authors.forename: Gulben
authors.initials: G
authors.lastname: Sozen
mesh_terms: D000293:Adolescent; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D005260:Female; D017325:Hepatitis B Vaccines / Q000627:therapeutic use*; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D011994:Recombinant Proteins; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D017325:Hepatitis B Vaccines; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D000410:Alanine Transaminase