Consensus interferon for chronic hepatitis C patients with genotype 1 who failed to respond to, or relapsed after, interferon alpha-2b and ribavirin in combination: an Italian pilot study

OBJECTIVE: To evaluate the long-term efficacy of consensus interferon in the treatment of chronic hepatitis C patients with genotype 1 who failed to respond to, or relapsed after, combination therapy with interferon alpha-2b and ribavirin. DESIGN: Open label pilot study. METHODS: Twenty-four chronic hepatitis C outpatient non-responders to (12 cases), or relapsers after (12 cases), standard combination therapy were treated with consensus interferon (9 microg five times per week) for 36 weeks. The patients were followed up for a further 24 weeks. The primary end-point of the study was the rate of sustained virological response. RESULTS: Sustained virological response was observed in 33% of previous non-responders and in 42% of previous relapsers. Improvement of the histological score was documented in 80% of previous non-responders and in all previous relapsers who showed undetectable levels of hepatitis C virus RNA at the end of treatment. Logistic regression analysis showed that sustained virological response was associated with a hepatitis C viral load of 2 x 106 copies/ml or less, with an inflammation score of 7 or less and with an estimated duration of disease of 10 years or less. The treatment was well tolerated with an 83% compliance. CONCLUSIONS: Consensus interferon given at a dose of 9 microg five times per week for 36 weeks may offer a good chance of sustained virological response in a subset of patients who failed to respond to, or relapsed after, standard combination therapy. However, a larger randomized trial is required to assess the efficacy of consensus interferon before its use can be advocated for the treatment of such patients.