title: Leukocyte interferon alpha early retreatment for Child A HCV genotype 1b-infected cirrhotics intolerant to pegylated interferons.
abstract: OBJECTIVE
  The pegylated interferon (PEG-IFN)/ribavirin combination has been shown to be effective for hepatitis C virus (HCV)-related compensated cirrhosis, but it frequently causes adverse events, leading to premature termination. In this open study we evaluated the safety and efficacy of early retreatment with leukocyte IFN-alpha in Child A HCV genotype 1b-infected cirrhotics intolerant to PEG-IFNs.
  
  
  METHODS
  61 patients were treated with PEG-IFN (either alpha-2b 1.2-1.5 lg/kg weekly or alpha-2a 180 lg/weekly) plus ribavirin (1,000 mg/day) for 48 weeks. During the first 6 months, patients who discontinued treatment because of side effects were retreated with leukocyte IFN-alpha (6 MU/three times weekly) plus ribavirin (1,000 mg/day) for 48 weeks after a 1-month wash-out. The primary end points were safety and efficacy in terms of sustained virological response (SVR).
  
  
  RESULTS
  At intention-to-treat analysis of the 61 patients receiving PEG-IFNs plus ribavirin revealed that 18 (29.5%) obtained a SVR. 16 patients (26.2%) prematurely discontinued treatment and were retreated with leukocyte IFN-alpha plus ribavirin. The switch was well tolerated, and all but one patient completed the treatment period. As a result of the switch, 4 of these 16 (25%) patients also obtained a SVR. Thus, the overall SVR rate of this study was 22/61 (36.1%).
  
  
  CONCLUSIONS
  These results suggest that an early retreatment with leukocyte IFN-alpha may be a safe and valid therapeutic option among difficult-to-treat HCV cirrhotic patients who cannot tolerate PEG-IFNs.
authors.affiliation: Department of Internal Medicine and Medical Specialties, Institute of Infectious Diseases, University of Catania, Via Passo Gravina 187, 90157, Catania, Italy. cacopardobruno@inwind.it
authors.forename: B
authors.initials: B
authors.lastname: Cacopardo
authors.forename: G
authors.initials: G
authors.lastname: Nunnari
authors.forename: F
authors.initials: F
authors.lastname: Benanti
authors.forename: A
authors.initials: A
authors.lastname: Cappellani
authors.forename: A
authors.initials: A
authors.lastname: Onorante
authors.forename: E
authors.initials: E
authors.lastname: Caltabiano
authors.forename: R
authors.initials: R
authors.lastname: Russo
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000821:virology; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use; D011994:Recombinant Proteins; D012254:Ribavirin / Q000627:therapeutic use; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a