Maintenance therapy with gradual reduction of the interferon dose over oneyear 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 im proved by continuing interferon-alpha (IFN) treatment in patients with chro nic hepatitis C (HCV) with a biochemical response and no viral clearance af ter a usual IFN treatment. Methods: Fifty-seven patients with normal alanine aminotransferase (ALAT) l evels and positive HCV RNA at the end of a I year IFN treatment were random ly assigned to either group I (n = 28) where IFN was stopped, or group 2 (n = 29) where IFN was continued for I more year with gradual reduction of th e dose to keep serum ALAT activity below the upper limit of normal. Liver b iopsies were obtained before, and then 6 months after the end of treatment. Results: Knodell's 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 gro up 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 maintai n biochemical response prevents histological progression in the sub-group o f patients without virological response. (C) 2001 European Association for the Study of the Liver. Published by Elsevier Science B.V. All rights reser ved.