Treatment of hepatitis c virus-related cirrhosis: A randomized, controlledtrial 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 o f IFN therapy versus observation. Eight centers included a total of 99 pati ents with biopsy-proven cirrhosis. IFN-alpha 2b, 3 million units three time s per week, or no antiviral therapy was given for 48 weeks. Twenty-three pa tients 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 pa tients. Controls and treated patients did not significantly differ with reg ard to the changes in serum level of albumin, bilirubin, alpha-fetoprotein, in plasma prothrombin, in histological activity, or liver collagen content . During trial or follow-up (160 +/- 57 weeks), hepatocellular carcinoma de veloped in 9 controls and 5 treated patients (NS); decompensation of cirrho sis occurred in 5 controls and 7 treated patients. Seven controls and 10 tr eated patients died. In conclusion, in patients with compensated HCV-relate d 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 patien ts. However, a 48-week course of IFN therapy usually fails to achieve susta ined response and, within the limit of this study, did not significantly im prove the 3-year outcome. Therefore, a longer course of IFN therapy err com bination therapy with ribavirin should be evaluated in patients with HCV-re lated cirrhosis.