A Randomized Controlled Trial of Recombinant Interferon-α in Chronic Hepatitis C in Hemophiliacs

• Published in: Blood Vol. 78; no. 7; pp. 1672 - 1677
• Main Authors: Makris, M., Preston, F.E., Triger, D.R., Underwood, J.C.E., Westlake, L., Adelman, M.I.
• Format: Journal Article
• Language: English
• Published: Washington, DC Elsevier Inc 01.10.1991; The Americain Society of Hematology
• Subjects: Adult; Alanine Transaminase - blood; Biological and medical sciences; Hematologic and hematopoietic diseases; Hemophilia A - complications; Hepatitis C - etiology; Hepatitis C - pathology; Hepatitis C - therapy; hepatitis C virus; Hepatitis, Chronic - etiology; Hepatitis, Chronic - pathology; Hepatitis, Chronic - therapy; Humans; Interferon alpha-2; Interferon-alpha - adverse effects; Interferon-alpha - therapeutic use; Liver - enzymology; Liver - pathology; Medical sciences; Recombinant Proteins; Infection; Human; Non A non B viral hepatitis; Chronic; Treatment; Alpha interferon; Viral disease; Hemophilia; Clinical trial; Hemopathy; Coagulopathy
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V78.7.1672.1672

Chronic liver disease associated with hepatitis C virus (HCV) is an important cause of morbidity and mortality in hemophilia. We have used recombinant interferon α-2b (IFNα-2b) in a randomized controlled liver biopsy trial to treat hemophiliacs with chronic hepatitis. Eighteen patients entered the study, 16 of whom were subsequently shown to have antibodies to the HCV. All underwent liver biopsy at entry and were randomized to either treatment with self-administered IFNα-2b, 3 million units subcutaneously thrice weekly (n = 10) or no treatment (control group) (n = 8). Nine subjects had chronic active hepatitis, seven had chronic persistent hepatitis, and two had cirrhosis. Twelve months after entry into the study 17 patients underwent a second liver biopsy. All biopsies were coded, assessed, and scored according to the histologic severity of the liver disease. Ten patients were administered IFN for 1 year, and in four patients normalization of alanine aminotransferase (ALT) occurred compared with none in the untreated group. After the second liver biopsy, six of the eight initial no-treatment patients were treated with interferon 3 million units thrice weekly for 6 months, and normalization of ALT was seen in five patients. Biochemical relapse within 4 months of stopping IFN occurred in one of four patients treated for 1 year and in four of five patients treated for 6 months. IFN treatment was well tolerated. Although the histologic scores of the two groups were similar at entry into the study, after 12 months the biopsy appearances in the treated group were significantly improved compared with the controls (P < .01). Histologic improvement was noted in the three interferon-treated human immunodeficiency virus antibody-positive patients and also in other patients who had no biochemical response. We conclude that low-dose recombinant IFNα is effective in normalizing transaminases and improving the histologic appearances in at least 50% of hemophiliacs with chronic hepatitis C.