TY - JOUR
T1 - A pilot study of interferon alfa and ribavirin combination in liver transplant recipients with recurrent hepatitis C
AU - Shakil, A. Obaid
AU - McGuire, Brendon
AU - Crippin, Jeff
AU - Teperman, Lewis
AU - Demetris, A. Jake
AU - Conjeevaram, Hari
AU - Gish, Robert
AU - Kwo, Paul
AU - Balan, Vijayan
AU - Wright, Teresa L.
AU - Brass, Clifford
AU - Rakela, Jorge
N1 - Funding Information:
Abbreviations: HCV, hepatitis C virus; IFN, interferon; ALT, alanine aminotransferase. From the 1Department of Medicine, Divisions of Gastroenterology, Hepatology, and Nutrition and 5Department of Pathology, Transplantation Pathology, University of Pittsburgh School of Medicine, Pittsburgh, PA; 2Department of Medicine, University of Alabama, Birmingham, AL; 3Department of Medicine, Baylor University, Dallas, TX; 4Department of Surgery, New York University Medical Center, New York, NY; 6Department of Medicine, University of Chicago, Chicago, IL; 7Department of Medicine, California Pacific Medical Center, San Francisco, CA; 8Department of Medicine, Indiana University, Indianapolis, IN; 9Department of Medicine, University of San Francisco, San Francisco, CA; and 10Integrated Therapeutics Group, Kenilworth, NJ. Received January 28, 2002; accepted July 24, 2002. Supported by Integrated Therapeutics Group (Kenilworth, NJ). Current affiliations are as follows: Jeff Crippin: Washington University School of Medicine, St. Louis, MO; Hari Conjeevaram: University of Michigan Medical Center, Ann Arbor, MI; Vijayan Balan and Jorge Rakela: Mayo Clinic, Scottsdale, AZ. Address reprint requests to: A. Obaid Shakil, M.D., M.R.C.P., UPMC Center for Liver Diseases, Falk Medical Building, 3rd Floor, 3601 Fifth Avenue, Pittsburgh, PA 15213. E-mail: obaid@med.pitt.edu; fax: 412-647-9268. Copyright © 2002 by the American Association for the Study of Liver Diseases. 0270-9139/02/3605-0030$35.00/0 doi:10.1053/jhep.2002.36162
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2002/11/1
Y1 - 2002/11/1
N2 - Although interferon alfa (IFN-α) and ribavirin are widely used in the treatment of hepatitis C, their role in the transplant recipient is unclear. We conducted a pilot study to determine the efficacy and safety of this therapy in transplant recipients with recurrent hepatitis C. Patients at least 6 months posttransplantation were treated with IFN-α 3 million units 3 times a week subcutaneously and ribavirin 800 mg daily by mouth for 48 weeks followed by ribavirin monotherapy for 24 weeks. The primary end point was sustained virologic response, and secondary end points included biochemical, virologic, and histologic responses at the end of combination treatment. Thirty-eight patients initiated therapy but 16 withdrew due to adverse effects, including 2 with myocardial infarction. Median age was 50 years; 74% were men, and 91% had genotype 1. The median interval between transplantation and enrollment was 23 months. On an intention-to-treat basis, 7 patients (18%) had a biochemical and 5 (13%) had a virologic response at the end of combination treatment. Inflammatory activity did not change, but fibrosis worsened in virologic nonresponders. Ribavirin maintenance caused a further decrease in serum alanine aminotransferase levels, but hepatitis C virus (HCV) RNA levels increased. Only 2 of the 38 patients (5%) had a sustained virologic response. Several patients required treatment with erythropoietin for anemia. In conclusion, IFN-α and ribavirin are effective in a small proportion of liver allograft recipients with recurrent hepatitis C. Adverse effects occur commonly, requiring dose reductions and treatment withdrawal.
AB - Although interferon alfa (IFN-α) and ribavirin are widely used in the treatment of hepatitis C, their role in the transplant recipient is unclear. We conducted a pilot study to determine the efficacy and safety of this therapy in transplant recipients with recurrent hepatitis C. Patients at least 6 months posttransplantation were treated with IFN-α 3 million units 3 times a week subcutaneously and ribavirin 800 mg daily by mouth for 48 weeks followed by ribavirin monotherapy for 24 weeks. The primary end point was sustained virologic response, and secondary end points included biochemical, virologic, and histologic responses at the end of combination treatment. Thirty-eight patients initiated therapy but 16 withdrew due to adverse effects, including 2 with myocardial infarction. Median age was 50 years; 74% were men, and 91% had genotype 1. The median interval between transplantation and enrollment was 23 months. On an intention-to-treat basis, 7 patients (18%) had a biochemical and 5 (13%) had a virologic response at the end of combination treatment. Inflammatory activity did not change, but fibrosis worsened in virologic nonresponders. Ribavirin maintenance caused a further decrease in serum alanine aminotransferase levels, but hepatitis C virus (HCV) RNA levels increased. Only 2 of the 38 patients (5%) had a sustained virologic response. Several patients required treatment with erythropoietin for anemia. In conclusion, IFN-α and ribavirin are effective in a small proportion of liver allograft recipients with recurrent hepatitis C. Adverse effects occur commonly, requiring dose reductions and treatment withdrawal.
UR - http://www.scopus.com/inward/record.url?scp=0036829821&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0036829821&partnerID=8YFLogxK
U2 - 10.1053/jhep.2002.36162
DO - 10.1053/jhep.2002.36162
M3 - Article
C2 - 12395337
AN - SCOPUS:0036829821
SN - 0270-9139
VL - 36
SP - 1253
EP - 1258
JO - Hepatology
JF - Hepatology
IS - 5
ER -