title: Biochemical and virological response of chronic hepatitis C after treatment with interferon-alpha for 6 or 12 months: predictors of sustained remission.
abstract: OBJECTIVE
  To evaluate the biochemical and virological response in chronic hepatitis C patients treated with interferon-alpha at the usual dosage of 3 MU thrice weekly for 6 or 12 months, and to analyse the significance of clearance of serum HCV RNA and of HCV genotype in the prediction of sustained biochemical remission.
  
  
  METHODS
  Liver Unit, Western Attica General Hospital, Athens, Greece.
  
  
  METHODS
  Sixty consecutive patients with histologically confirmed chronic hepatitis C.
  
  
  METHODS
  All patients received interferon-alpha-2b in a dose of 3 MU thrice weekly for 6 (n = 26) or 12 (n = 34) months. Serial serum samples were retrospectively tested for the presence of HCV RNA by a polymerase chain reaction assay and pretreatment serum samples for the determination of HCV genotype.
  
  
  RESULTS
  Sustained biochemical response rate was significantly higher in the 12-month group (62% vs. 35%, P = 0.037). Clearance of serum HCV RNA at the end of treatment was achieved in 33 (58.9%) of the 56 patients with detectable pretreatment HCV RNA. HCV RNA reappeared in serum significantly more often in patients treated for 6 than for 12 months (35.7% vs. 5.3%, P = 0.037). Serum HCV RNA after 6 months of therapy was a prognostic factor of sustained biochemical response, which was observed in 75% of the HCV RNA-negative and in only 16.7% of the HCV RNA-positive patients (OR 0.067, P < 0.001). Moreover, in patients negative for HCV RNA after 6 months of therapy, 12 months' treatment resulted in a higher sustained response rate than did 6 months' (89% vs. 57%, P = 0.05). HCV genotype 1 was associated with a significantly lower sustained response rate (30% vs. 60.7%, P = 0.035), whereas 12 months' treatment induced sustained remission significantly more often only in patients with genotype 1 (6/12 vs. 0/8, P = 0.024).
  
  
  CONCLUSIONS
  In chronic hepatitis C treatment HCV genotype and serum HCV RNA after 6 months of therapy are strong predictive factors of a sustained response, and a 12-month rather than a 6-month interferon regimen may induce a more persistent clearance of HCV RNA in total and a higher sustained response rate in patients with HCV genotype 1 and in those who clear HCV RNA after 6 months of therapy.
authors.affiliation: First Department of Medicine, Western Attica General Hospital, Athens, Greece.
authors.forename: G V
authors.initials: GV
authors.lastname: Papatheodoridis
authors.forename: A
authors.initials: A
authors.lastname: Katsoulidou
authors.forename: G
authors.initials: G
authors.lastname: Touloumi
authors.forename: J K
authors.initials: JK
authors.lastname: Delladetsima
authors.forename: A
authors.initials: A
authors.lastname: Hatzakis
authors.forename: N C
authors.initials: NC
authors.lastname: Tassopoulos
mesh_terms: D000328:Adult; D002908:Chronic Disease; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000628:therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012367:RNA, Viral / Q000032:analysis; D011994:Recombinant Proteins; D013997:Time Factors
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins