title: High efficacy of combined therapy with pegylated interferon plus ribavirin in patients with hemophilia and chronic hepatitis C.
abstract: OBJECTIVE
  Eradication of hepatitis C virus (HCV) is particularly difficult in patients with hemophilia. In this open, prospective, multicenter trial, the efficacy and tolerability of the combination therapy with pegylated interferon alpha2b (Peg-IFNalpha2b) plus ribavirin was evaluated in 64 human immunodeficiency virus (HIV) seronegative adult hemophiliacs with chronic hepatitis C naive to previous antiviral therapy.
  
  
  METHODS
  Peg-IFNalpha2b was administered at a dose of 1.5 microg/kg subcutaneously once weekly plus oral ribavirin 800-1200 mg/day, for 24 weeks to patients with HCV genotypes 2 and 3 (n=22, 34%) or for 48 weeks to those with genotypes 1 and 4 (n=42, 66%).
  
  
  RESULTS
  Nine patients (14%) did not complete the study because of non-compliance (n=6) or side-effects such as decompensated diabetes, alanine aminotransferase flares and severe vomiting (n=3). Twenty-eight patients (44%) required dose reduction of either drug. Six months after stopping treatment a sustained virological response was achieved in 40 patients (63%), 19 with genotype 2 or 3 (86%) and 21 with genotype 1 or 4 (50%). A sustained virological response was significantly associated with an early virological response (p<0.0001), HCV genotypes 2 or 3 (p=0.008), no clinical evidence of cirrhosis (p=0.02) and higher pre-treatment serum alanine aminotransferase (p=0.016).
  
  
  CONCLUSIONS
  These results show that combination therapy with Peg-IFNalpha2b plus ribavirin is highly efficacious in hemophiliacs with chronic hepatitis C.
authors.affiliation: Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Department of Medicine and Medical Specialities, University of Milan and IRCCS Maggiore Hospital, Mangiagalli, Italy.
authors.forename: Maria Elisa
authors.initials: ME
authors.lastname: Mancuso
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Rumi
authors.forename: Elena
authors.initials: E
authors.lastname: Santagostino
authors.forename: Silvia
authors.initials: S
authors.lastname: Linari
authors.forename: Antonio
authors.initials: A
authors.lastname: Coppola
authors.forename: Pier Mannuccio
authors.initials: PM
authors.lastname: Mannucci
authors.forename: Massimo
authors.initials: M
authors.lastname: Colombo
mesh_terms: D000328:Adult; D004359:Drug Therapy, Combination; D005260:Female; D006467:Hemophilia A / Q000150:complications / Q000188:drug therapy*; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011446:Prospective Studies; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage*
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a