Transfusion-associated chronic hepatitis C: Alpha-n(1) interferon for 6 vs 12 months

Aims: To compare the long-term effects of brief and prolonged therapy with alpha-n(1) 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 prolonged 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'' reactivations were observed, The early response rate was 19% in patients with and 63% in patients without cirrhosis, Twenty-three (19.8%) subjects stopped therapy, Among 54 evaluable early responders, 21 had a sustained response, The rate 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, Histological improvement was seen only after sustained response, Cirrhosis developed in 20% of non-responders, Overall, interferon induced a long-lasting remission of chronic hepatitis C in about one every five patients. Conclusions: In a population predominantly infected by hepatitis C virus type 1, 12 months of therapy with high doses of interferon does not confer any additional benefit on the early response or sustained response rates as compared to a 6-month course.