title: Long term response to therapy of chronic anti-HBe-positive hepatitis B is poor independent of type and schedule of interferon.
abstract: OBJECTIVE
  The response rate to alpha interferon (IFN) of chronic anti-HBe-positive hepatitis B is variable. We studied whether type, dose, and schedule of IFN, and type and frequency of posttreatment monitoring, influence the response rate.
  
  
  METHODS
  Seventy-two consecutive anti-HBe-positive chronic hepatitis B patients (59 male and 13 female, median age 41 yr) stratified by sex and histology were randomly allocated to three treatment arms. Twenty-seven patients (A) received 10 million units alpha-N1 IFN i.m. t.w. for 24 wk (total dose: 720 million units); 21 (B) received 9 million units alpha-2a IFN i.m. t.w. for 4 wk, followed by 18 million units for 12 wk and 9 million units for 8 wk (972 million units); 24 (C) received 2 alpha-2a IFN courses (9 million units i.m. t.w. for 16 and 12 wk separated by a 6-month interval [756 million units]). Primary response was defined by normal ALT and serum HBV-DNA levels below 10 pg/ml at the end of therapy and sustained response by normal ALT (tested monthly), undetectable HBV-DNA and IgM anti-HBc (<7 I.U. Paul Ehrlich Institute) (tested every 3 months) during the posttreatment follow-up.
  
  
  RESULTS
  At the end of treatment, 12, 8, and 13 patients from groups A, B, and C, respectively, were responders. At the 18-month follow-up, two patients in group A and only one in groups B and C maintained the response. Overall, after 34 months (median posttreatment follow-up), three patients were long term responders, whereas three showed a sustained remission after relapse.
  
  
  CONCLUSIONS
  The rate of long term response to interferon of anti-HBe-positive chronic hepatitis B is poor, independent of IFN type, dose, or schedule; the more stringent the monitoring, the higher the relapse rate.
authors.affiliation: Gastroenterology Department, Azienda Ospedaliera San Giovanni Battista, Torino, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Oliveri
authors.forename: T
authors.initials: T
authors.lastname: Santantonio
authors.forename: G
authors.initials: G
authors.lastname: Bellati
authors.forename: P
authors.initials: P
authors.lastname: Colombatto
authors.forename: G C
authors.initials: GC
authors.lastname: Mels
authors.forename: L
authors.initials: L
authors.lastname: Carriero
authors.forename: G
authors.initials: G
authors.lastname: Dastoli
authors.forename: G
authors.initials: G
authors.lastname: Pastore
authors.forename: G
authors.initials: G
authors.lastname: Ideo
authors.forename: F
authors.initials: F
authors.lastname: Bonino
authors.forename: M R
authors.initials: MR
authors.lastname: Brunetto
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D005260:Female; D006510:Hepatitis B Antibodies / Q000032:analysis*; D006513:Hepatitis B e Antigens / Q000276:immunology*; D019694:Hepatitis B, Chronic / Q000175:diagnosis / Q000276:immunology / Q000628:therapy*; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage; D007372:Interferons / Q000008:administration & dosage*; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D006510:Hepatitis B Antibodies; D006513:Hepatitis B e Antigens; D007370:Interferon Type I; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D007372:Interferons; D000410:Alanine Transaminase