ALPHA-INTERFERON TREATMENT OF CHRONIC HEPATITIS-C - A CONTROLLED, MULTICENTER, PROSPECTIVE-STUDY

This prospective, controlled study was designed in order to evaluate t he response rate to a-interferon (IFN) versus no treatment in 63 patie nts affected by chronic hepatitis C. Fifty-two patients were randomly chosen to receive no treatment of IFN alfa-2b (6 MU 3 times weekly for the first month and 3 MU for the next 11 months). Eleven additional p atients were crossed to active treatment after a 1-year control period without any change of serum pattern and were therefore enrolled both as controls and cases. Four patients had to be withdrawn from the acti ve treatment for adverse effects. Sixteen out of the remaining 23 had normal alanine aminotransferase (ALT) values at the end of the treatme nt, and 14 were still normal 12 months later. A liver biopsy, taken 6 months after the end of the treatment, showed improvement in 12 patien ts and normalization in 1. Only 1 out of the 25 controls had transamin ase normalization and 5 a decrease. One of them showed also a histolog ical improvement. Eight of the 11 case/control patients showed ALT nor malization after IFN administration, 5 of them histological improvemen t and 2 liver normalization. Hepatitis C virus (HCV) RNA became negati ve in 13 of 17 cases in whom the assay was carried out. Therefore this study confirms that the longterm administration of alpha-IFN induced a prolonged remission of disease activity in over 50% of the patients and the clearance of HCV RNA in the majority of the responders.