Treatment with daily consensus interferon (CIFN) plus ribavirin in non-responder patients with chronic hepatitis C: A randomized open-label pilot study

Background/Aims: Therapeutic options for hepatitis C non-responder patients are limited. Methods: We initiated an open-label pilot study to investigate the efficacy of CIFN plus ribavirin on viral kinetics, sustained virological response (SVR), and histological response in hepatitis C non-responder patients. Seventy-seven patients were enrolled to receive CIFN given daily in combination with 1000/1200 mg ribavirin. An 8-week induction-dosing regimen of 18 mu g CIFN, followed by 9 mu g for 40 weeks was compared to 9 mu g CIFN for 48 weeks. 90% of patients were infected with HCV-genotype 1. Results: Overall, 82% of the patients demonstrated an early virological response, 65% had an end-of-treatment response, and the SVR was 30%. Interferon/ribavirin non-responders demonstrated a SVR of 22%. Induction-dosing resulted in a greater first-phase HCV-RNA decay that, however, did not translate to better SVRs, presumably due to more dose modifications. High ALT, younger age, and second-phase viral kinetics were associated with SVR. Only sustained responders and relapse patients showed an improved liver histology. Conclusions: Daily dosing of CIFN plus ribavirin may be a promising concept for selected non-responder patients before considering therapies which are anti-viral but not curative. However, motivation and compliance are requisites and a CIFN induction is not required. (C) 2005 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.