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A randomized, multicenter study comparing steroid-free immunosuppression and standard immunosuppression for liver transplant recipients with chronic hepatitis C†
Article first published online: 29 NOV 2011
Copyright © 2011 American Association for the Study of Liver Diseases
Volume 17, Issue 12, pages 1394–1403, December 2011
How to Cite
Klintmalm, G. B., Davis, G. L., Teperman, L., Netto, G. J., Washburn, K., Rudich, S. M., Pomfret, E. A., Vargas, H. E., Brown, R., Eckhoff, D., Pruett, T. L., Roberts, J., Mulligan, D. C., Charlton, M. R., Heffron, T. G., Ham, J. M., Douglas, D. D., Sher, L., Baliga, P. K., Kinkhabwala, M., Koneru, B., Abecassis, M., Millis, M., Jennings, L. W. and Fasola, C. G. (2011), A randomized, multicenter study comparing steroid-free immunosuppression and standard immunosuppression for liver transplant recipients with chronic hepatitis C. Liver Transpl, 17: 1394–1403. doi: 10.1002/lt.22417
This study was supported by a grant from Roche.
- Issue published online: 29 NOV 2011
- Article first published online: 29 NOV 2011
- Accepted manuscript online: 17 AUG 2011 01:44PM EST
- Manuscript Accepted: 5 AUG 2011
- Manuscript Received: 19 APR 2011
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. Liver Transpl, 2011. © 2011 AASLD.