Azathioprine versus prednisone in chronic active hepatitis and non-alcoholic cirrhosis. Effect on survival and activity.

A prospective unblinded, randomized trial of treatment for chronic aggressive hepatitis and non-alcoholic cirrhosis involving 154 patients chosen by predefined histological criteria showed no difference with regard to survival between patients receiving 100 mg of azathioprine and those receiving 10-15 mg of prednisone daily. Survival was unrelated to initial biochemical activity. In the initially most active cases biochemical activity was significantly reduced (p = 0.02), more often by prednisone than by azathioprine. The reduced activity was not reflected in subjective complaints or in the working capacity of the patients. Side effects were more frequent in the azathioprine group. Hematological side effects were exclusively found among azathioprine-treated patients. Prognosis was worst in patients who initially had high values of serum bilirubin and alkaline phosphatases and low values of serum albumin and prothrombin. The follow-up study is being carried out to obtain long-term observations.