PROSPECTIVE COMPARISON OF 4 LYMPHOBLASTOID INTERFERON-ALPHA SCHEDULESFOR CHRONIC HEPATITIS-C - A MULTIVARIATE-ANALYSIS OF FACTORS PREDICTIVE OF SUSTAINED RESPONSE TO TREATMENT

Objective: Interferon alpha (IFN-alpha) provides effective treatment i n some patients with chronic hepatitis C. Since this drug is costly an d causes potentially severe side effects, there is a need for clarific ation of the optimal dose regimen and treatment duration and of the pr edictive factors of long-term response to this therapy. Design: Prospe ctive, randomized study in patients with chronic hepatitis C. Setting: `Crespi' Division of Medicine and Centre for Liver Diseases, Niguarda Hospital, Milan, Italy. Patients and methods: One hundred and forty-t wo patients with chronic hepatitis C were randomized to receive IFN-al pha at a dosage of 2-4 mega units/square metre of body surface area th rice weekly for 6-12 months. Eleven baseline variables that might pred ict sustained response to IFN-alpha were evaluated in this series. Sus tained response was defined as normalization of transaminase levels ob served by the fourth month of therapy and lasting for at least 6 month s after treatment withdrawal. Results: According to univariate analysi s, variables significantly associated with sustained response to treat ment were: hepatitis C virus (HCV) genotype, treatment duration, serum HCV-RNA level and duration of hepatitis. On multivariate analysis onl y two of these variables were found to be independently associated wit h sustained response to IFN-alpha: HCV genotype ( and treatment durati on (P = 0.0015). In P<0.0001) the patients infected with genotype 1b, IFN-alpha was effective only when administered at the higher dosage an d for the longer period. Conclusion: Viral genotype and treatment dura tion are independently related to sustained response to IFN-alpha in p atients with chronic hepatitis C. The patients infected with HCV genot ype 1b should receive IFN-alpha at the higher dosage and for the longe r period.