EFFECTS OF 2 DIFFERENT ALPHA-INTERFERON REGIMENS ON CLINICAL AND VIROLOGICAL FINDINGS IN MIXED CRYOGLOBULINEMIA

Objective. As previous studies have shown a good response of mixed cry oglobulinemia (MC) to alpha-interferon (IFN) therapy, we investigated the efficacy and tolerability of two IFN regimens in a group of 36 pat ients affected by MC. Methods. The patients, diagnosed on the basis of standard clinical and laboratory criteria, were randomly divided into 2 groups: group A (18 cases) received alpha2b-IFN 3 M.U. thrice a wee k for six months, while group B (18 cases) received alpha2b-IFN thrice a week for 1 year. The patients were followed for six months after th e end of therapy. Liver function tests, cryoglobulin determinations an d a clinical examination were performed each month. HCV serology and H CV-RNA detection by PCR were performed before therapy and at the end o f the follow-up period. Results. The two study groups were comparable in age, male/female ratio, purpura score, cryoglobulin level, mean ALT serum activity and liver histology. 32 patients (89%) were positive f or anti-HCV antibodies and 29 (81%) for HCV-RNA. During therapy all pa tients showed a significant (p < 0.001) decrease in their cryoglobulin level as well as improvement (p < 0.05) in their purpura score. In gr oup A, five patients (28%) showed normalized ALT, but three later rela psed. In group B seven patients (39%) responded to treatment but three relapsed after suspension of the drug. Two patients from group B deve loped severe side effects (hypothyroidism and depression) and therapy was discontinued after 9 and 11 months, respectively. ln all the non-r esponders and relapsed patients, purpura, ALT, and cryoglobulins rose to pretreatment levels within a few months. At the end of follow-up, t wo patients from group A (11%) and four in group B (22%) had achieved complete remission. Conclusion. This study indicates that IFN is usefu l in MC and that viral replication can be considered the target of the therapy. Despite the absence of a statistical difference in the respo nse rate between the two regimens (due to the low number of subjects), the one-year therapy course seemed to show a better efficacy, althoug h associated with higher toxicity.