BACKGROUND AND OBJECTIVES: 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. DESIGN AND 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). INTERPRETATION AND CONCLUSIONS: These results show that combination therapy with Peg-IFNalpha2b plus ribavirin is highly efficacious in hemophiliacs with chronic hepatitis C.
BACKGROUND AND OBJECTIVES: 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. DESIGN AND 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). INTERPRETATION AND CONCLUSIONS: These results show that combination therapy with Peg-IFNalpha2b plus ribavirin is highly efficacious in hemophiliacs with chronic hepatitis C.