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

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 KinkhabwalaBaburao Koneru, Michael Abecassis, Michael Millis, Linda W. Jennings, Carlos G. Fasola

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79 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1394-1403
Number of pages10
JournalLiver Transplantation
Volume17
Issue number12
DOIs
StatePublished - Dec 2011

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