Maintenance therapy with gradual reduction of the interferon dose over one year improves histological response in patients with chronic hepatitis C with biochemical response: results of a randomized trial,

Background/Aims: Our aim was to assess whether histological response was improved by continuing interferon-alpha (IFN) treatment in patients with chronic hepatitis C (HCV) with a biochemical response and no viral clearance after a usual IFN treatment. Methods: Fifty-seven patients with normal alanine aminotransferase (ALAT) levels and positive HCV RNA at the end of a 1 year IFN treatment were randomly assigned to either group 1 (n=28) where IFN was stopped, or group 2 (n=29) where IFN was continued for 1 more year with gradual reduction of the dose to keep serum ALAT activity below the upper limit of normal. Liver biopsies were obtained before, and then 6 months after the end of treatment. Results: Knodellʹs index improved between paired biopsies in group 2 (8.2±2.4 vs. 5.5±2.1), but not in group 1 (8±2.3 vs. 6.5±2). In post-treatment biopsies, the METAVIR activity score was significantly lower in group 2 than in group 1 (0.7±0.2 vs. 1.1±0.3, P<0.05). In group 2, an improvement of the METAVIR fibrosis score was observed (1.3±0.4 vs. 1.1±0.2), whereas fibrosis progressed in group 1 (1.3±0.4 vs. 1.6±0.4). Conclusions: Maintenance therapy by the minimal dose of IFN able to maintain biochemical response prevents histological progression in the sub-group of patients without virological response.