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

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 cirrhosis 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 virological response was defined by normalization of ALT and negativization of serum HCV-RNA. Patients were followed-up for 5 years. RESULTS: A biochemical end-of-therapy response (ETR) was observed in 5/38 patients (13%) who received beta-IFN compared to 2/23 (9%) of untreated cases, 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 cumulative probability of liver decompensation (variceal bleeding ascites or hepatic encephalopathy) at 60 months was 24% in treated and 35% in untreated cases. Hepatocellular carcinoma developed in 2 treated and in 1 untreated patients. CONCLUSIONS: beta-IFN therapy was not associated with a significant improvement either in biochemical or virological response in cirrhotic patients with chronic hepatitis C. No significant reduction of cirrhosis related clinical events was linked to treatment.