title: Long-term clinical outcome after beta-interferon therapy in cirrhotic patients with chronic hepatitis C. TVVH Study Group.
abstract: OBJECTIVE
  Few data are available concerning the short and long-term effects of beta-IFN in patients with chronic hepatitis C.
  
  
  METHODS
  We randomized 61 consecutive patients with HCV-related cirrhosis to receive: a) natural beta-IFN with a 6 MU/tiw for 6 months followed by 3 MU/tiw for 6 months schedule or b) no treatment. Biochemical and virological response was defined by normalization of ALT and negativization of serum HCV-RNA. Patients were followed-up for 5 years.
  
  
  RESULTS
  A biochemical end-of-therapy response (ETR) was observed in 5/38 patients (13%) who received beta-IFN compared to 2/23 (9%) of untreated cases, but a virological ETR appeared only in 4/38 (11%) treated cases. At long-term follow-up, 6 cases (16%) who received beta-IFN and 4 untreated (17%) developed a persistent normalization of alanine aminotransferase (ALT) but only 2 (5%) and 1 (4%), respectively, were also HCV-RNA negative. The cumulative probability of liver decompensation (variceal bleeding ascites or hepatic encephalopathy) at 60 months was 24% in treated and 35% in untreated cases. Hepatocellular carcinoma developed in 2 treated and in 1 untreated patients.
  
  
  CONCLUSIONS
  beta-IFN therapy was not associated with a significant improvement either in biochemical or virological response in cirrhotic patients with chronic hepatitis C. No significant reduction of cirrhosis related clinical events was linked to treatment.
authors.affiliation: Department of Clinical and Experimental Medicine, University of Padova, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Bernardinello
authors.forename: L
authors.initials: L
authors.lastname: Cavalletto
authors.forename: L
authors.initials: L
authors.lastname: Chemello
authors.forename: I
authors.initials: I
authors.lastname: Mezzocolli
authors.forename: C
authors.initials: C
authors.lastname: Donada
authors.forename: L
authors.initials: L
authors.lastname: Benvegnú
authors.forename: C
authors.initials: C
authors.lastname: Merkel
authors.forename: A
authors.initials: A
authors.lastname: Gatta
authors.forename: A
authors.initials: A
authors.lastname: Alberti
mesh_terms: D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D016174:Hepacivirus / Q000235:genetics / Q000276:immunology; D018937:Hepatitis C Antibodies / Q000032:analysis; D019698:Hepatitis C, Chronic / Q000097:blood / Q000150:complications / Q000628:therapy* / Q000821:virology; D006801:Humans; D016899:Interferon-beta / Q000627:therapeutic use*; D008103:Liver Cirrhosis / Q000097:blood / Q000150:complications* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000032:analysis; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D018937:Hepatitis C Antibodies; D012367:RNA, Viral; D016899:Interferon-beta; D000410:Alanine Transaminase