Combination thymosin α1 and lymphoblastoid interferon treatment in chronic hepatitis C

Abstract

Background - Monotherapy for chronic hepatitis C using interferon (IFN) results in a very small proportion of patients exhibiting a sustained response. Clinical trials assessing the benefit of combination drug therapy may provide evidence of improved treatment response over that seen with single drug treatment. Aim - To assess the response in patients with chronic hepatitis C to one year of combination treatment: thymosin α1 (Tα1), 1 mg twice weekly, and lymphoblastoid (L)-IFN, 3 MU thrice weekly. Patients and Methods - Fifteen patients with serum HCV RNA positive chronic hepatitis C were studied. Eleven patients were treatment naive and four had failed previous standard IFN therapy. Thirteen patients were HCV RNA serotype 1b. All patients were given combination Tα1 and L-IFN therapy for one year with a six month follow up period. Results - Six months after initiation of treatment seven patients (47%) were sera HCV RNA negative and at completion of the one year treatment 11 (73%), including two who had failed previous standard IFN treatment, had negative serum HCV RNA. Six months after treatment, six patients (40%), including five with HCV type 1b, showed a sustained response characterised by a negative serum HCV RNA. Conclusions - The results of this open label trial suggest that there may be a potential benefit to combining an immune modulator (Tα1) with an antiviral (IFN) in the treatment of chronic hepatitis C. Verification of the observations in this study require completion of a randomised controlled study.