Pre-treatment with prednisolone does not improve the efficacy of subsequent alpha interferon therapy in chronic hepatitis C

Background/Aims: Alpha interferon administration is quite disappointing as a single therapy in chronic hepatitis C, A brief course of corticosteroid t herapy might increase the effectiveness of subsequent alpha interferon admi nistration, but data on this issue are controversial, Methods: One hundred and fifty-six consecutive patients with chronic hepati tis C were randomly assigned to be treated blind with tapering doses of ora l prednisolone or placebo for 4 weeks, Two weeks after cessation of therapy , patients received alpha interferon (3 MU t.i.w.) for 48 weeks and were fo llowed for 24 additional weeks, Response was defined by the presence of nor mal alanine aminotransferase (ALT) and negative HCV-RNA in serum, Results: ALT activity decreased during prednisolone administration and rebo unded upon withdrawal in 38% of the patients treated with this drug. Signif icant changes in serum bilirubin were not observed. HCV-RNA serum concentra tion tended to increase during prednisolone administration and to decrease upon withdrawal. ALT and HCV-RNA did not change during administration of pl acebo, At the end of interferon administration, 33% of patients treated wit h prednisolone and 25% of those treated with placebo presented biochemical and virological response, At the end of post-treatment follow-up, response was maintained in 12% and 13% of patients treated with prednisolone or plac ebo, respectively. Response was not related to ALT or HCV-RNA changes obser ved during the pre-interferon phase of the study, No adverse events related to prednisolone administration were observed. Conclusions: Prednisolone administration and withdrawal induced a rebound i n ALT activity and a decrease in HCV-RNA serum concentration in about one t hird of the patients with chronic hepatitis C. However, these changes did n ot enhance the effectiveness of subsequent alpha interferon therapy.