Corticosteroid-free immunosuppression with daclizumab in HCV+ liver transplant recipients: 1-year interim results of the HCV-3 study

Goran B.G. Klintmalm, W. Kenneth Washburn, Steven M. Rudich, Thomas G. Heffron, Lewis W. Teperman, Carlos Fasola, Devin E. Eckhoff, George J. Netto, Eliezer Katz

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108 Scopus citations

Abstract

This work is a 1-yr interim analysis of a prospective, randomized, multicenter trial evaluating the effect of corticosteroid-free immunosuppression on hepatitis C virus-positive (HCV+) liver transplant recipients following liver transplantation (LT). Patients received tacrolimus and corticosteroids (Arm 1; n = 80); tacrolimus, corticosteroids, and mycophenolate mofetil (MMF) (Arm 2; n = 79); or daclizumab induction, tacrolimus, and MMF (Arm 3; n = 153). At 1 yr, 64.1%, 63.4%, and 69.4% of patients achieved the composite primary endpoint of freedom from rejection, freedom from HCV recurrence, and freedom from treatment failure, respectively. Excellent patient and graft survival did not differ significantly among treatment arms. Freedom from HCV recurrence at 1 yr was 61.8 ± 6.2%, 60.1 ± 6.1%, and 67.0 ± 4.3% in Arms 1, 2, and 3, respectively (P = not significant). Freedom from rejection was significantly higher in Arm 3 compared to Arm 1 (93.0 ± 2.2% vs. 81.9 ± 4.4%; P = 0.011). Multivariate analysis identified acute rejection (hazard ratio = 2.692; P = 0.001) and donor age (hazard ratio = 1.015; P = 0.001) as significant risk factors for HCV recurrence. HCV recurrence was not influenced by recipient demographics, HCV genotype, or immunosuppression. In conclusion, these results suggest that a corticosteroid-free regimen of tacrolimus and MMF following daclizumab induction is safe and effective in HCV+ liver transplant recipients.

Original languageEnglish (US)
Pages (from-to)1521-1531
Number of pages11
JournalLiver Transplantation
Volume13
Issue number11
DOIs
StatePublished - Nov 1 2007

ASJC Scopus subject areas

  • Surgery
  • Hepatology
  • Transplantation

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    Klintmalm, G. B. G., Washburn, W. K., Rudich, S. M., Heffron, T. G., Teperman, L. W., Fasola, C., Eckhoff, D. E., Netto, G. J., & Katz, E. (2007). Corticosteroid-free immunosuppression with daclizumab in HCV+ liver transplant recipients: 1-year interim results of the HCV-3 study. Liver Transplantation, 13(11), 1521-1531. https://doi.org/10.1002/lt.21182