title: Pegylated interferon α-2a plus ribavirin for decompensated hepatitis C virus-related cirrhosis: relationship between efficacy and cumulative dose.
abstract: OBJECTIVE
  A combination of pegylated interferon alpha-2a (Peg-IFNα-2a) and ribavirin (RBV) achieves a sustained virological response (SVR) in 40-50% of patients infected with genotype 1 hepatitis C virus (HCV), but efficacy rates are significantly lower in patients with decompensated HCV-induced cirrhosis. The efficacy and tolerability of Peg-IFNα-2a and RBV, the cumulative dose effect, time to achieve planned cumulative dose and role of HCV phenotype on treatment response were determined in patients with decompensated HCV-induced cirrhosis.
  
  
  METHODS
  In this case-controlled study, 257 patients with decompensated HCV-induced cirrhosis were enrolled, including patients treated with partial splenic embolization for leukopaenia. Of patients with sufficient blood cell counts, 130 patients opted for antiviral therapy (treatment group) consisting of 180 μg/kg Peg-IFNα-2a for 48 weeks with 800-1200 mg/day RBV; the remaining 127 were considered the control group. Primary endpoints were SVR and absence of relapse; the secondary end point was assessment of disease progression.
  
  
  RESULTS
  Sustained virological response was highest and relapse rates were lowest when cumulative doses of Peg-IFNα-2a and RBV were both ≥80% of the prescribed dose. Patients achieving ≥80% of the planned cumulative doses in 48 weeks had a significantly higher SVR compared with patients achieving this in 72 weeks. Patients with HCV genotype 1 had significantly lower SVR compared with patients with HCV genotype 2 (19.7% vs. 42.9%, respectively; P = 0.008). Treatment group patients had a significantly lower rate of SVR-independent liver disease-related mortality.
  
  
  CONCLUSIONS
  Our findings provide additional evidence to support the use of Peg-IFNα-2a and RBV therapy for decompensated HCV-induced cirrhosis.
authors.forename: Yan
authors.initials: Y
authors.lastname: Xu
authors.forename: Wenqian
authors.initials: W
authors.lastname: Qi
authors.forename: Xu
authors.initials: X
authors.lastname: Wang
authors.forename: Ping
authors.initials: P
authors.lastname: Zhao
authors.forename: Yonggui
authors.initials: Y
authors.lastname: Zhang
authors.forename: Qian
authors.initials: Q
authors.lastname: Zhang
authors.forename: Shaoyou
authors.initials: S
authors.lastname: Qin
authors.forename: Jiangbin
authors.initials: J
authors.lastname: Wang
mesh_terms: D000328:Adult; D016022:Case-Control Studies; D002681:China; D004305:Dose-Response Relationship, Drug; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D006526:Hepatitis C / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000209:etiology / Q000821:virology; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use*; D013997:Time Factors
chemical_list: D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a