High efficacy of combined therapy with pegylated interferon plus ribavirin in patients with hemophilia and chronic hepatitis C.
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.
Mancuso
Maria Elisa
ME
Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Department of Medicine and Medical Specialities, University of Milan and IRCCS Maggiore Hospital, Mangiagalli, Italy.
Rumi
Maria Grazia
MG
Santagostino
Elena
E
Linari
Silvia
S
Coppola
Antonio
A
Mannucci
Pier Mannuccio
PM
Colombo
Massimo
M
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*
D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a