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Tacrolimus: A Potential New Treatment for Autoimmune Chronic Active Hepatitis: Results of an Open‐Label Preliminary Trial

Van Thiel, DH and Wright, H and Carroll, P and Abu‐Elmagd, K and Rodriguez‐Rilo, H and McMichael, J and Irish, W and Starzl, TE (1995) Tacrolimus: A Potential New Treatment for Autoimmune Chronic Active Hepatitis: Results of an Open‐Label Preliminary Trial. The American Journal of Gastroenterology, 90 (5). 771 - 776. ISSN 0002-9270

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Autoimmune chronic active hepatitis (CAH‐A) is a chronic liver disease of unknown etiology that is believed to have an autoimmune pathogenesis. The disease is slowly progressive until hepatic failure and portal hypertension develop and either death or liver transplantation occur. Currently, the only widely recognized therapy is the administration of glucocorticoids, which have both anti‐inflammatory and immunosuppressive actions. Many patients cannot tolerate such therapy because of the psychiatric, osteoporotic, and weight‐enhancing actions of steroids. Tacrolimus (FK 506) is a new macrolide antibiotic that has an immunosuppressive activity that is estimated to be 10–200 times greater than that of cyclosporine. Because of its greater immunosuppressive activity, we have used it in the treatment of 21 patients with autoimmune chronic active hepatitis. Before each subject was treated, a liver biopsy and a panel of hematological, serological, and biochemical parameters were assessed. The Tacrolimus was administered orally at 12‐h intervals, and the dose was controlled by monitoring plasma FK trough levels. After 3 months of therapy at an oral dose of 3 mg twice a day, having achieved a median blood level of 0.5 ng/ml, the serum ALT level was reduced by 80%, and the AST level was reduced by 70%. Modest change in the white blood cell count and platelet count were noted. The median BUN level increased from a level of 12 to 18 mg/dl, and the serum creatinine increased from 0.9 to 1.3 mg/dl. These preliminary data demonstrate that: 1) Tacrolimus can be used to successfully treat CAH‐A; 2) the response of CAH‐A to Tacrolimus treatment is rapid and sustained; and 3) a minor increase in the serum BUN and creatinine levels occurs as a consequence of Tacrolimus treatment. It is anticipated that with continued treatment for periods of 1–2 yr, the natural history of CAH‐A will be changed such that hepatic failure and the requirement for liver transplantation may be averted. Copyright © 1995, Wiley Blackwell. All rights reserved


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Item Type: Article
Status: Published
CreatorsEmailPitt UsernameORCID
Van Thiel, DH
Wright, H
Carroll, P
Abu‐Elmagd, K
Rodriguez‐Rilo, H
McMichael, J
Irish, W
Starzl, TEtes11@pitt.eduTES11
Centers: Other Centers, Institutes, Offices, or Units > Thomas E. Starzl Transplantation Institute
Date: 1 January 1995
Date Type: Publication
Journal or Publication Title: The American Journal of Gastroenterology
Volume: 90
Number: 5
Page Range: 771 - 776
DOI or Unique Handle: 10.1111/j.1572-0241.1995.tb09317.x
Institution: University of Pittsburgh
Refereed: Yes
ISSN: 0002-9270
Other ID: uls-drl:31735062133339, Starzl CV No. 1869
Date Deposited: 08 Apr 2010 17:31
Last Modified: 02 Aug 2020 10:56


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