title: Efficacy of combination therapy of interferon-alpha with ursodeoxycholic acid in chronic hepatitis C: a randomized controlled clinical trial.
abstract: The efficacy of interferon-alpha therapy in the treatment of chronic hepatitis C is still limited. A combination therapy of interferon-alpha with ursodeoxycholic acid (UDCA) was tested for its efficacy in the treatment of chronic hepatitis C by a randomized controlled study. Eighty consecutive Japanese patients with chronic hepatitis C were randomly divided into two groups: one group was treated with interferon-alpha (group A, n = 40) and the other with a combination of interferon-alpha and UDCA (group B, n = 40). In both groups, human interferon-alpha (6 million units per day) was intramuscularly injected daily for 2 weeks and then three times a week for 22 weeks: this 24-week period was followed by 24 weeks of observation. In group B, UDCA was also administered, daily at a dose of 600 mg orally, from the beginning of the interferon therapy and administration was continued for 48 weeks. The rates for ALT normalization and clearance of hepatitis C virus (HCV) viremia at the end of the 24-week interferon therapy were similar for groups A and B (58% vs 60% and 55% vs 48%, respectively). At the end of the 24-week follow-up, the sustained normalization rates for ALT levels for the two groups were not different (35% vs 43%), while the rate of clearance was higher in group B (40%) than in group A (23%), but the difference was not significant (P = 0.14). The sustained complete response, i.e., HCV RNA negativity at the end of the follow-up, as well as the maintenance of ALT normalization during the follow-up period, was more frequent in group B (38%) than in group A (18%) although the difference was not significant (P = 0.08). The rate of HCV reactivation after interferon was discontinued was significantly lower in group B (16%) than in group A (59%) (P < 0.01). Although this combination therapy did not lead to a sufficiently sustained complete response, it could serve as adjuvant antiviral therapy when a suitable dosage and administration period are determined.
authors.affiliation: Second Department of Internal Medicine, Osaka University Medical School, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Kiso
authors.forename: S
authors.initials: S
authors.lastname: Kawata
authors.forename: S
authors.initials: S
authors.lastname: Tamura
authors.forename: Y
authors.initials: Y
authors.lastname: Imai
authors.forename: Y
authors.initials: Y
authors.lastname: Inui
authors.forename: T
authors.initials: T
authors.lastname: Nagase
authors.forename: Y
authors.initials: Y
authors.lastname: Maeda
authors.forename: E
authors.initials: E
authors.lastname: Yamasaki
authors.forename: H
authors.initials: H
authors.lastname: Tsushima
authors.forename: T
authors.initials: T
authors.lastname: Igura
authors.forename: S
authors.initials: S
authors.lastname: Himeno
authors.forename: K
authors.initials: K
authors.lastname: Seki
authors.forename: Y
authors.initials: Y
authors.lastname: Matsuzawa
mesh_terms: D000284:Administration, Oral; D000410:Alanine Transaminase / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000628:therapy* / Q000821:virology; D006521:Hepatitis, Chronic / Q000628:therapy; D006801:Humans; D007273:Injections, Intramuscular; D016898:Interferon-alpha / Q000008:administration & dosage*; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D012333:RNA, Messenger / Q000097:blood; D014580:Ursodeoxycholic Acid / Q000008:administration & dosage*
chemical_list: D016898:Interferon-alpha; D012333:RNA, Messenger; D014580:Ursodeoxycholic Acid; D000410:Alanine Transaminase