LOW-DOSE ALPHA-INTERFERON THERAPY CAN BE EFFECTIVE IN CHRONIC ACTIVE HEPATITIS-C - RESULTS OF A MULTICENTER, RANDOMIZED TRIAL

Background-There is some controversy concerning the efficacy of low do se a interferon therapy in chronic hepatitis C. Aims-To evaluate the e ffectiveness of treatment with low doses of or interferon in chronic h epatitis C. Patients-One hundred and forty one patients with anti-HCV positive chronic active hepatitis C from six hospitals were enrolled i n the study. Methods-Patients were randomised to treatment with 5 MU ( group A) or 1.5 MU (group B) injections. The dose was reduced in respo nders from group A or increased in non-responders from group B to main tain treatment with the minimal effective dose. Patients were treated for 48 weeks and followed up for 24 additional weeks with no treatment . Normalisation of alanine aminotransferase (ALT) was used to evaluate response. Results-A sustained response was seen in eight patients fro m group A (12%) and in 15 (21%) from group B. This difference was not statistically significant. Increasing the dose of interferon led to su stained response in only five of 58 patients (9%) from group B who did not respond to 1.5 MU injections. In contrast, 15 of 21 patients (71% ) in whom ALT remained normal with 1.5 MU injections developed a susta ined response. By multivariate analysis sustained response seemed asso ciated with young age and was more frequent in patients with genotype 3 HCV infection. Sustained response was preceded by a rapid normalisat ion of ALT and was inversely related to the amount of a interferon nec essary to maintain ALT at low values during treatment. Conclusions-Som e patients with chronic hepatitis C are very sensitive to or interfero n and can be successfully treated with low doses. Treatment with highe r doses may be effective in a minority of patients who do not respond to low doses.