Treatment of hepatitis C virus–related cirrhosis: A randomized, controlled trial of interferon alfa‐2b versus no treatment

To examine the effects of interferon (IFN) therapy on clinical, biochemical, and histological features in patients with compensated hepatitis C virus (HCV)‐related cirrhosis, we have conducted a randomized, controlled trial of IFN therapy versus observation. Eight centers included a total of 99 patients with biopsy‐proven cirrhosis. IFN‐α2b, 3 million units three times per week, or no antiviral therapy was given for 48 weeks. Twenty‐three patients dropped out. End‐of‐treatment biochemical response was not observed in any of the 39 controls but was observed in 6 of the 47 treated patients (P < .02); sustained biochemical response was obtained in only 2 treated patients. Controls and treated patients did not significantly differ with regard to the changes in serum level of albumin, bilirubin, α‐fetoprotein, in plasma prothrombin, in histological activity, or liver collagen content. During trial or follow‐up (160 ± 57 weeks), hepatocellular carcinoma developed in 9 controls and 5 treated patients (NS); decompensation of cirrhosis occurred in 5 controls and 7 treated patients. Seven controls and 10 treated patients died. In conclusion, in patients with compensated HCV‐related cirrhosis, a 48‐week course of IFN therapy is safe and is able to induce end‐of‐treatment biochemical response in a significant proportion of patients. However, a 48‐week course of IFN therapy usually fails to achieve sustained response and, within the limit of this study, did not significantly improve the 3‐year outcome. Therefore, a longer course of IFN therapy or combination therapy with ribavirin should be evaluated in patients with HCV‐related cirrhosis.