Interferon and ursodeoxycholic acid combined therapy in chronic viral C hepatitis: controlled randomized trial in 203 patients

Aims. This prospective randomized trial was carried out in order to determi ne whether the long-term administration of ursodeoxycholic acid after disco ntinuation of interferon had any beneficial effect on the clinical course o f hepatitis C virus infection. Methods. Enrolled in the study were 203 patients with chronic active hepati tis C. They were all given: interferon alpha-2a (3 MU subcutaneously thrice a week) and ursodeoxycholic acid (10 mg/kg/day) for 9 months. At month 9, biochemical responders only were randomized into ursodeoxycholic acid treat ment or placebo for 12 additional months (double blind study). Results. At the end of interferon therapy, 71 patients (37%) were virologic al responders and 107 [56%) patients were biochemical responders and were r andomized: 54 into the ursodeoxycholic acid group and 53 into the placebo g roup. Sustained response was evaluated 12 months after withdrawal of interf eron. Sustained biochemical and virological responses were, respectively, 3 0% and 22% in the ursodeoxycholic acid group and 46% and 32% in the placebo group, which did not significantly differ. Histological evolution of fibro sis and necrotic inflammatory activity were similar in the two groups. Conclusion. Continuation of ursodeoxycholic acid therapy after withdrawal o f interferon in patients with end-of-treatment response did not result in a ny significant improvement either in the maintenance of response to interfe ron or in liver histology.