Efficacy and safety of triple therapy with recombinant interleukin-1β, recombinant interferon-α and ribavirin in patients with chronic hepatitis C, genotype 1 infection, the non-responders to previous treatment with interferon and ribavirin

Abstract

To assess the efficacy and safety of an experimental course of antiviral therapy with recombinant IL-1β in combination with recombinant interferon-α2b and ribavirin in patients with chronic hepatitis C infected with genotype 1 hepatitis C virus in lacking the virologic response to previous dual therapy pegIFN-α or standard IFN-α and ribavirin has been formed by a group of 50 patients. All patients were treated with recombinant IL-1β – 10 subcutaneous injection at a dose of 0.005 mg/kg every other day, the course of 3 weeks, with 5 courses, recombinant IFN-α2b – subcutaneous injections of 3 million IU every other day for 48 weeks. Ribavirin 1000–1200 mg per day (depending on body weight) for 48 weeks. The duration of follow-up after the end of therapy was 24 weeks. Estimated sustained virologic response (SVR). Comparison of SVR according to the version of virologic response in primary treatment showed that the use of the pilot treatment scheme is most effective at relapse (63%) than in the «null-responders» (33%) and partial (23%) responses to the preceding treatment. In the present study did not reveal a single case of serious adverse events or unexpected adverse events. Thus, the inclusion of proven safety of recombinant IL-1β in the scheme of antiviral therapy in combination with standard interferon-α and ribavirin in patients with chronic hepatitis C, and demonstrated the effectiveness of using recombinant IL-1β (in combination with standard interferon-α and ribavirin), especially in patients with recurrent HCV-infection.

Keywords

• chronic viral hepatitis c
• antiviral therapy
• efficacy
• safety
• interferon
• il-1β