title: Antiviral therapy in advanced chronic liver disease due to hepatitis C virus infection: pilot study.
abstract: BACKGROUND
  Antiviral therapy has not been adequately evaluated in patients with hepatitis C virus (HCV)-related advanced liver disease due to apprehensions of adverse events and intolerance. The titrable dose of interferon (IFN)-alpha and ribavirin was evaluated in a flexible regimen in a pilot study.
  
  
  METHODS
  Twenty-five patients with HCV-related advanced chronic liver disease received IFN-alpha 1-3 MIU daily with ribavirin 200-600 mg daily for 9 months-3 years. Careful assessment of safety, tolerability and efficacy was made.
  
  
  RESULTS
  Improvement in Child-Pugh score (8.4 +/- 1.2 to 7.4 +/- 2.0; P = 0.010) and serum albumin (3.0 +/- 0.5 g/dL to 3.6 +/- 0.5 g/dL; P = 0.007) occurred at follow up after antiviral therapy (median dose and duration: IFN-alpha 1.5 MIU/day for 12 months and ribavirin 400 mg/day for 7.5 months) as compared to baseline. Ascites regressed in 53% of patients (11/21). Thirteen patients (52%) lost HCV-RNA on therapy and eight (32%) achieved sustained virological response (SVR). Death occurred in three patients (12%) while on therapy, in two due to infection. No patient died in the responder group compared to five deaths (29%) in the non-responder group. However, there was no difference in the cumulative probability of survival in the sustained virological responder versus non-responder (P = 0.09). Adverse events were common (92%), but permanent withdrawal was required in only five patients (20%).
  
  
  CONCLUSIONS
  Low and titrable dose IFN-alpha and ribavirin therapy in patients with HCV-related advanced chronic liver disease achieves improvement in hepatic synthetic function, Child-Pugh score and ascites. However, close monitoring for serious adverse events is warranted.
authors.affiliation: Department of Gastroenterolgy, GB Pant Hospital, New Delhi, India.
authors.forename: Rakesh
authors.initials: R
authors.lastname: Kumar
authors.forename: Sudheer
authors.initials: S
authors.lastname: Kumar
authors.forename: Barjesh Chander
authors.initials: BC
authors.lastname: Sharma
authors.forename: Jagdeep
authors.initials: J
authors.lastname: Singh
authors.forename: Shiv K
authors.initials: SK
authors.lastname: Sarin
mesh_terms: D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D018709:Statistics, Nonparametric; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D012254:Ribavirin