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A randomized, multicenter study comparing steroid-free immunosuppression and standard immunosuppression for liver transplant recipients with chronic hepatitis C.

Abstract
This randomized, prospective, multicenter trial compared the safety and efficacy of steroid-free immunosuppression (IS) to the safety and efficacy of 2 standard IS regimens in patients undergoing transplantation for hepatitis C virus (HCV) infection. The outcome measures were acute cellular rejection (ACR), severe HCV recurrence, and survival. The patients were randomized (1:1:2) to tacrolimus (TAC) and corticosteroids (arm 1; n = 77), mycophenolate mofetil (MMF), TAC, and corticosteroids (arm 2; n = 72), or MMF, TAC, and daclizumab induction with no corticosteroids (arm 3; n = 146). In all, 295 HCV RNA-positive subjects were enrolled. At 2 years, there were no differences in ACR, HCV recurrence (biochemical evidence), patient survival, or graft survival rates. The side effects of IS did not differ, although there was a trend toward less diabetes in the steroid-free group. Liver biopsy samples revealed no significant differences in the proportions of patients in arms 1, 2, and 3 with advanced HCV recurrence (ie, an inflammation grade ≥ 3 and/or a fibrosis stage ≥ 2) in years 1 (48.2%, 50.4%, and 43.0%, respectively) and 2 (69.5%, 75.9%, and 68.1%, respectively). Although we have found that steroid-free IS is safe and effective for liver transplant recipients with chronic HCV, steroid sparing has no clear advantage in comparison with traditional IS.
AuthorsGöran B Klintmalm, Gary L Davis, Lewis Teperman, George J Netto, Kenneth Washburn, Stephen M Rudich, Elizabeth A Pomfret, Hugo E Vargas, Robert Brown, Devin Eckhoff, Timothy L Pruett, John Roberts, David C Mulligan, Michael R Charlton, Thomas G Heffron, John M Ham, David D Douglas, Linda Sher, Prabhakar K Baliga, Milan Kinkhabwala, Baburao Koneru, Michael Abecassis, Michael Millis, Linda W Jennings, Carlos G Fasola
JournalLiver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society (Liver Transpl) Vol. 17 Issue 12 Pg. 1394-403 (Dec 2011) ISSN: 1527-6473 [Electronic] United States
PMID21850690 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
CopyrightCopyright © 2011 American Association for the Study of Liver Diseases.
Chemical References
  • Adrenal Cortex Hormones
  • Antibodies, Monoclonal, Humanized
  • Antiviral Agents
  • Immunoglobulin G
  • Immunosuppressive Agents
  • RNA, Viral
  • Daclizumab
  • Mycophenolic Acid
  • Tacrolimus
Topics
  • Adrenal Cortex Hormones (adverse effects, therapeutic use)
  • Antibodies, Monoclonal, Humanized (adverse effects, therapeutic use)
  • Antiviral Agents (therapeutic use)
  • Biopsy
  • Chi-Square Distribution
  • Daclizumab
  • Drug Therapy, Combination
  • Female
  • Graft Rejection (immunology, prevention & control)
  • Hepacivirus (genetics)
  • Hepatitis C, Chronic (complications, diagnosis, drug therapy, mortality)
  • Humans
  • Immunoglobulin G (adverse effects, therapeutic use)
  • Immunosuppressive Agents (adverse effects, therapeutic use)
  • Kaplan-Meier Estimate
  • Liver Failure (diagnosis, mortality, surgery, virology)
  • Liver Transplantation (immunology, mortality)
  • Male
  • Middle Aged
  • Mycophenolic Acid (adverse effects, analogs & derivatives, therapeutic use)
  • Proportional Hazards Models
  • Prospective Studies
  • RNA, Viral (blood)
  • Recurrence
  • Risk Assessment
  • Risk Factors
  • Survival Rate
  • Tacrolimus (adverse effects, therapeutic use)
  • Time Factors
  • Treatment Outcome
  • United States

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