Recombinant human α-interferon: A promissory note in non-A, non-B chronic hepatitis

Abstract

Therapy capable of ameliorating the clinical, laboratory, and histologic features of chronic hepatitis due to the non-A, non-B hepatitis viruses is not available. In the present experience, 10 patients with chronic fatigue, elevations of Serum aminotransferase levels for at least 1 yr, and liver biopsy results consistent with chronic non-A, non-B hepatitis were selected to be participants in this drug protocol. Nine of the 10 patients had a history of recognized percutaneous exposure to blood or parenteral drugs. Serum direct bilirubin was normal in all, and serum albumin and prothrombin time were normal in 9 of the 10. Nine of the 10 had chronic active hepatitis on initial liver biopsy and 3 of the 9 had accompanying cirrhosis. The 10th patient had chronic persistent hepatitis. All 10 were treated with self-administered, subcutaneous injections of recombinant huinan a-interferon [initially daily, then on alternate days or three times weekly) in daily doses varying between 5 and 1 million uaits. Subsequent reductions in doses were based on aminotransferase levels and side effects. Neither a placebo control group nor a cross-over schedule was utilized and no measures of compliance were described. In 8 of the 10 patients serum aminotransferase levels fell during treattnent, and in 6 of these patients the aminotransferase levels fell into the normal range. Treatment periods varied between 2 and 12 mo. In contrast, in 2 patients no beneficial effect of recombinant human ainterferon was observed. Of the 6 patients in whom aminotransferase levels returned to normal, 2 experienced a recurrence of elevated serum aminotransferase levels after discontinuation of the drug. Retreatment was associated with a decline into the normal range. Only 3 patients, in whom treatment was continued for 12 mo, underwent repeat biopsy. In each, evidence of histologic improvement was found. Side effect’s of treatment appeared to include fatigue, achiness, headaches, irritability, and fever but apparently in no case was treatment discontinued because of adverse effects. Whether or not the chronic fatigue or other symptoms seen in these patients were altered by treatment is uncertain as clinical improvement is not mentioned.