Journal of Hepatology 1996; 24: 539-546 Printed in Denmark All rights reserved Uunksgaard Copenhagen Copyright 0 European Association for the Study of the Liver 1996 Journal of Hepatology ISSN 0168-8278 zyxwvutsrqponmlk Transfusion-associated chronic hepatitis C: alpha-n, interferon for 6 vs. 12 months Antonio Craxi, Vito Di Marco, Oreste Lo Iacono, Pier0 Almasio, Renato Bruno, Calogero Camma, Riccardo Volpes and Luigi Pagliaro Institute di Medicina Generale e Pneumologia, University of Palermo, Palermo, Iialy Aims: To compare the long-term effects of brief and prolonged therapy with alpha-n, interferon for transfusion-associated chronic hepatitis C. Methods: One hundred and sixteen subjects (male/ female 48/68, mean age 46.9 years) were studied. Sixty patients were randomised to brief treatment (group 1: interferon 5 Mu/msq. t.i.w. for 2 months, then 3 Mu/msq. t.i.w. for 4 months), and 56 to pro- longed treatment (group 2: interferon 5 Mu/msq. t.i.w. for 2 months, then 3 Mu/msq. t.i.w. for 10 months). All were followed for 12 months after stopping interferon. Results: The early response rate was 47.4% (Group 1[45%],Group 2 [50%]). No “breakthrough” reac- tivations were observed. The early response rate was 19 % in patients with and 63 % in patients with- out cirrhosis. Twenty-three (19.8%) subjects stopped therapy. Among 54 evaluable early responders, 21 had a sustained response. The rate zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA S INCE ALPHA interferon (Im) was reported effective in chronic non-A, non-B hepatitis (l), many tri- als (2-11) in chronic liver disease due to hepatitis C virus (HCV) have been performed worldwide. Metaanalysis of randomised studies (12) shows that 50 to 60% of all patients with chronic hepatitis C re- ceiving IFN at a dosage of 23 MU t.i.w. for 6 to 12 months normalise alanine aminotransferases (ALT) while on therapy. At least half of the responders re- lapse to abnormal ALT within 3 to 6 months after stopping IPN. The sustained response rate is 20- Received 8 May; revised 26 September; accepted 29 September 1995 Correspondence: Prof. Antonio Craxi, Divisione di Me- dicina Intema Ospedale Vincenzo Cervello, Via Trabucco 180, 90146 Palermo, Italy. of sustained response was comparable in group 1 (18.3%) and group 2 (18.2%). All sustained response subjects and some non-responders were HCV-RNA negative at the end of follow-up. Histo- logical improvement was seen only after sustained response. Cirrhosis developed in 20% of non- responders. Overall, interferon induced a long-last- ing remission of chronic hepatitis C in about one every five patients. Conclusions: In a population predominantly in- fected by hepatitis C virus type 1, 12 months of therapy with high doses of interferon does not con- fer any additional benefit on the early response or sustained response rates as compared to a 6-month course. Key words: Chronic hepatitis; Hepatitis C virus; Interferon; Liver histology. 25%. Alternative approaches, such as escalating dos- ages (13), weekly administration (14) or prolonged treatment (15, 16), do not alter the likelihood of ini- tial response. The best schedule of treatment is still unclear (17, 18). IFN was given in the earlier trials at doses 23 MU t.i.w. for 6 months. Treatment efficacy was suboptimal with the low dose (1 MU t.i.w.). Some studies, evaluating longer periods of therapy (6, 11, 15, 16, 19), showed an increased rate of sus- tained response when IPN was administered for more than 6 months. An uncontrolled study from Japan (8) suggests that the duration of response might be re- lated to the amount of IPN received rather than to the length of treatment. A recent report suggests however that increasing the dose of IFN does not change the response rate (20). Successful treatment of subjects without cirrhosis 539