Long-term clinical outcome after beta-interferon therapy in cirrhotic patients with chronic hepatitis C

BACKGROUND/AIMS: Few data are available concerning the short and long-term effects of beta-IFN in patients with chronic hepatitis C. METHODOLOGY: We randomized 61 consecutive patients with HCV-related cirrhos is to receive: a) natural beta-IFN with a 6 MU/tiw for 6 months followed by 3 MU/tiw for 6 months schedule or b) no treatment. Biochemical and virolog ical response was defined by normalization of ALT and negativization of ser um HCV-RNA. Patients were followed-up for 5 years. RESULTS: A biochemical end-of-therapy response (ETR) was observed in 5/38 p atients (13%) who received beta-IFN compared to 2/23 (9%) of untreated case s, but a virological ETR appeared only in 4/38 (11%) treated cases. At long -term follow-up, 6 cases (16%) who received beta-IFN and 4 untreated (17%) developed a persistent normalization of alanine aminotransferase (ALT) but only 2 (5%) and 1 (4%), respectively, were also HCV-RNA negative. The cumul ative probability of liver decompensation (variceal bleeding ascites or hep atic encephalopathy) at 60 months was 24% in treated and 35% in untreated c ases. Hepatocellular carcinoma developed in 2 treated and in 1 untreated pa tients. CONCLUSIONS: beta-IFN therapy was not associated with a significant improve ment either in biochemical or virological response in cirrhotic patients wi th chronic hepatitis C. No significant reduction of cirrhosis related clini cal events was linked to treatment.