• Göran 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, and Carlos G Fasola.
• Baylor University Medical Center at Dallas, Dallas, TX 75246, USA. gorank@baylorhealth.edu
• Liver Transpl. 2011 Dec 1; 17 (12): 1394-403.

AbstractThis 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.Copyright © 2011 American Association for the Study of Liver Diseases.

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