title: Interferon plus ursodeoxycholic acid versus interferon in the treatment of chronic C viral hepatitis.
abstract: BACKGROUND
  The aim of as study was to ascertain whether the association of interferon alpha-2a and ursodeoxycholic acid (IFN+UDCA) was more efficacious in ameliorating liver parameters than interferon (IFN) alone in patients with chronic hepatitis C.
  
  
  METHODS
  Forty-one chronic hepatitis C patients, who had at least twice the normal value of one transaminase, were randomly assigned to treatment with IFN + UDCA (n = 21) or IFN alone (n = 20). IFN was administered subcutaneously at a dose of 3 MU thrice weekly, UDCA orally at 10 mg/kg bw/day. IFN therapy was terminated 6 months later and the responders (normalized transaminases) of both groups were treated with UDCA alone for a further 12 months.
  
  
  RESULTS
  In the IFN + UDCA group there were 2 drop-outs from therapy and 11 responders, while in the IFN group they were, respectively, 3 and 10. Transaminases normalized after the first month of treatment in 7/11 responders with IFN + UDCA compared with 3/10 in the IFN responders group. The trend to normalization was more rapid with IFN + UDCA than with IFN alone (chi 2t = 3.95; p < 0.05). Disease relapse (defined as at least one transaminase > x 1.5 the normal value) was 3/11 in the IFN + UDCA group and 4/10 in the IFN group. 2/11 responders in the IFN + UDCA and 1/10 in the IFN group were HCV RNA negative by PCR. The total Knodell histological score decreased more in the IFN+UDCA than in the IFN group (-2.67 +/- 3.44. vs -1.67 +/- 2.16, mean +/- SD).
  
  
  CONCLUSIONS
  The administration of UDCA determine an earlier normalization-time of transaminases in the patients responders to IFN therapy and could be useful to reduce the relapse into disease after the IFN therapy.
authors.affiliation: Clinica di Gastroenterologia ed Endoscopia Digestiva, Università degli Studi, Perugia.
authors.forename: C
authors.initials: C
authors.lastname: Clerici
authors.forename: E
authors.initials: E
authors.lastname: Distrutti
authors.forename: G
authors.initials: G
authors.lastname: Gentili
authors.forename: A
authors.initials: A
authors.lastname: Solinas
authors.forename: M
authors.initials: M
authors.lastname: Miglietti
authors.forename: S
authors.initials: S
authors.lastname: Balò
authors.forename: M
authors.initials: M
authors.lastname: Giansanti
authors.forename: A G
authors.initials: AG
authors.lastname: Rusticali
authors.forename: A M
authors.initials: AM
authors.lastname: Morselli-Labate
authors.forename: A
authors.initials: A
authors.lastname: Morelli
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D002756:Cholagogues and Choleretics / Q000627:therapeutic use*; D002908:Chronic Disease; D004359:Drug Therapy, Combination; D005260:Female; D006526:Hepatitis C / Q000097:blood / Q000473:pathology / Q000628:therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D012008:Recurrence; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*
chemical_list: D000998:Antiviral Agents; D002756:Cholagogues and Choleretics; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D014580:Ursodeoxycholic Acid