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Corticosteroid‐free immunosuppression with daclizumab in HCV + liver transplant recipients: 1‐year interim results of the HCV‐3 study
Author(s) -
Klintmalm Goran B.G.,
Washburn W. Kenneth,
Rudich Steven M.,
Heffron Thomas G.,
Teperman Lewis W.,
Fasola Carlos,
Eckhoff Devin E.,
Netto George J.,
Katz Eliezer
Publication year - 2007
Publication title -
liver transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.814
H-Index - 150
eISSN - 1527-6473
pISSN - 1527-6465
DOI - 10.1002/lt.21182
Subject(s) - medicine , daclizumab , immunosuppression , tacrolimus , liver transplantation , hazard ratio , gastroenterology , regimen , hepatitis c virus , corticosteroid , hepatitis c , interim analysis , transplantation , surgery , randomized controlled trial , immunology , confidence interval , virus
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. Liver Transpl 13:1521–1531, 2007. © 2007 AASLD.