title: Efficacy of high dose of recombinant alpha 2b interferon on long term response in chronic hepatitis C and cirrhosis: prospective randomized multicentre study.
abstract: OBJECTIVE
  The long-term response to alpha-Interferon in HCV-related chronic liver diseases is disappointing. A randomized controlled trial was conducted to investigate: 1) if doubling the standard regimen of 3 MU recombinant alpha 2b-interferon thrice weekly for one year could improve the long-term response, and 2) the efficacy of these two schedules in cirrhotic patients.
  
  
  METHODS
  A series of 80 anti-HCV positive patients with biopsy proven liver disease (52 chronic hepatitis and 28 cirrhosis) were randomized to receive either 3 MU or 6 MU alpha 2b-interferon.
  
  
  RESULTS
  Based on "intention-to-treat analysis", 38% in the 3 MU group and 53% in the 6 MU group had end-of-treatment response. After 24 months, 18% had long-term response: 5% in 3 MU group and 30% in 6 MU group (p < 0.008). HCV genotype had no influence on the response rate. Thirty-eight percent of the cirrhotics treated with 6 MU had long-term response, while none of those treated with 3 MU had long-term response (difference 38%; 95% confidence internal 10%-67%; p = 0.03). At the end of treatment, 38% of patients lost HCV-RNA. After 24 months only 19% remained HCV-RNA negative: 12 patients (31%) in the 6 MU group and 2 (6%) in the 3 MU group (p < 0.05).
  
  
  CONCLUSIONS
  6 MU of alpha 2b-interferon thrice weekly for 12 months is significantly better than 3 MU in inducing a long-term response and permanent loss of HCV-RNA. This result is particularly striking in the subgroup of cirrhotics.
authors.affiliation: Liver Pathophysiology Unit, A. Cardarelli Hospital, Napoli, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Ascione
authors.forename: M
authors.initials: M
authors.lastname: De Luca
authors.forename: C
authors.initials: C
authors.lastname: Canestrini
authors.forename: G G
authors.initials: GG
authors.lastname: Di Costanzo
authors.forename: G
authors.initials: G
authors.lastname: Raimondo
authors.forename: G
authors.initials: G
authors.lastname: Longo
authors.forename: M P
authors.initials: MP
authors.lastname: Manns
authors.forename: H L
authors.initials: HL
authors.lastname: Tillmann
authors.forename: G B
authors.initials: GB
authors.lastname: Forte
authors.forename: P
authors.initials: P
authors.lastname: Rocco
authors.forename: O
authors.initials: O
authors.lastname: Biceglia
authors.forename: D
authors.initials: D
authors.lastname: Faleo
authors.forename: F
authors.initials: F
authors.lastname: Vinelli
authors.forename: E M
authors.initials: EM
authors.lastname: Cela
authors.forename: L
authors.initials: L
authors.lastname: Amitrano
authors.forename: L
authors.initials: L
authors.lastname: Addario
authors.forename: T
authors.initials: T
authors.lastname: Gigliotti
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage*; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000201:enzymology / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012367:RNA, Viral / Q000032:analysis; D011994:Recombinant Proteins; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D007370:Interferon Type I; D012367:RNA, Viral; D011994:Recombinant Proteins; D000410:Alanine Transaminase