A multicenter study to evaluate the safety and efficacy of Heberon (interferon alfa-2b) in combination with ribavirin for the treatment of chronic hepatitis C in Iran

Abstract

Background: Combination therapy with interferon and ribavirin is the most effective treatment for chronic hepatitis C today. The aim of this study was to evaluate the efficacy and safety of thrice-weekly Heberon (interferon alfa-2b) in combination with ribavirin as first-line treatment of chronic hepatitis C. Methods: A total of 97 treatment-naive patients received Heberon three million units thrice-weekly subcutaneously in combination with ribavirin for 12 months. Serum HCV RNA levels were measured before and during therapy and 6 months after the end of therapy. End-of-treatment and sustained virological responses was defined as an undetectable HCV-RNA level at the end of treatment, and 6 months after treatment was completed (end of follow-up), respectively. Results: In an intent-to-treat analysis, HCV-RNA was undetectable at the end of treatment in 49.5% of patients. At the end of follow-up, sustained virological response was 36.1%. Combination treatment was generally well tolerated. Six patients stopped therapy because of side effects: severe cytopenia (n=4), depression (n=1), and hyperthyroidism (n=1). Common side effects of therapy include: Flu-like syndrome (85.6%), generalized alopecia (41.2%), injection site inflammation (37.1%), mood changes (36%), anorexia (34%) and weight loss (32%). Conclusion: Heberon as an IFN product in combination with ribavirin for treatment of patients with chronic hepatitis C is relatively safe, feasible, and potentially efficacious. It has comparable results in achieving end-of-treatment and sustained virological responses in chronic hepatitis C.