Longterm treatment with pegylated interferon-alfa2b reduces hepatocellular carcinoma incidence and prevents clinical complication in hepatitis C liver cirrhosis–an interim analysis of a multicenter trial

Background and aims: Interferons has been shown to inhibit fibrosis progression. This multicenter, randomized, prospective trial investigated the efficacy of low-dose pegylated interferon-alpha 2b (0,35–1µg/kg/wk) given for 3 years to prevent complications of liver cirrhosis. Methods/patients: Patients (N=88) with chronic hepatitis C and histologically proven cirrhosis (Child Pugh Score 5–7) who were non-responsive to prior anti-viral therapy were randomised to treatment with low dose pegylated interferon-alpha 2b (0,35–1µg/kg/wk, group A) or observation only (group B). Gastroscopy and liver function tests were performed every 12 months, sonography, clinical and laboratory controls were carried out every 6 months. Results: Mean follow-up of the patients was 17±11 months. Kaplan-Meier analysis showed a decreased incidence of hepatocellular carcinoma in patients treated with low-dose pegylated interferon compared to untreated controls (p<0.01). There were 6 HCCs in the control arm but none in the treatment arm. Other complications of liver cirrhosis like hepatic encephalopathy, ascites and esophageal variceal bleeding or progression of varices were significantly diminished (p<0.01) in treated compared to untreated patients. ALT and GGT levels at one year worsened in untreated patients but remained stable in IFN treated patients (p<0.005). HCV load dropped from 1.7×10 6 IU/ml to 0.8×10 6 IU/ml in group A (p<0.004). but did not change in group B. Conclusions: The interim analysis suggests that the incidence of HCC and other complications of liver cirrhosis can be reduced in HCV-associated liver cirrhosis by longterm application of pegylated interferon-alpha 2b. However complete follow-up of patients has still to be accomplished. cirrhosis - hepatitis - interferon