Clinical outcome of interferon and ribavirin combination treatment in hepatitis C virus infected patients with congenital bleeding disorders in Iran

Summary.  Hepatitis C virus (HCV) infection is a major cause of morbidity and mortality in patients with inherited bleeding disorders. The results of interferon and ribavirin combination therapy have been reported in a limited number of clinical trials on these patients. Peginterferon is a costly treatment. Conventional interferon and ribavirin therapy is still the main available and affordable antiviral therapy in some countries. The goal of this study was to assess the effectiveness and safety of interferon alfa-2b plus ribavirin in HIV seronegative, non-alcoholic, non-cirrhotic, naïve subjects with congenital coagulopathy. Between May 2003 and August 2007, 103 haemophiliacs were treated consecutively with standard inclusion and exclusion criteria, with interferon alfa-2b (PDferon B^®) 3MIU three times a week subcutaneously plus ribavirin, for 24–48 weeks, with appropriate dose adjustments. They were all scheduled to have serial visits and laboratory tests. Among 7(6.8%) female and 96(93.2%) male haemophiliacs, 11(10.68%) cases did not complete the study because of psychological side effects. With intent-to-treat analysis, end-of-treatment response was 63.1%, and sustained virological response (SVR) was 56.3%. There was a significant correlation between SVR and genotype, baseline HCV viral load, rapid virological response, early virological response and BMI. A decrease in the haemoglobin level of two patients required ribavirin dose reduction. One developed thrombocytopenia at the end of treatment, but none had neutropenia. Hypothyroidism was observed in two patients. Interferon plus ribavirin combination therapy in HCV-infected haemophilic patients is well tolerated and treatment outcomes appear to be similar to those seen in the general population.