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

Research output: Contribution to journalArticle

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 2007

Fingerprint

Immunosuppression
Tacrolimus
Adrenal Cortex Hormones
Mycophenolic Acid
Liver
Recurrence
Graft Survival
Treatment Failure
Hepacivirus
Liver Transplantation
Multicenter Studies
Multivariate Analysis
Genotype
Demography
daclizumab
Transplant Recipients
Tissue Donors
Therapeutics

ASJC Scopus subject areas

  • Surgery
  • Transplantation

Cite this

Klintmalm, G. B. G., Washburn, W. K., Rudich, S. M., Heffron, T. G., Teperman, L. W., Fasola, C., ... 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

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

In: Liver Transplantation, Vol. 13, No. 11, 11.2007, p. 1521-1531.

Research output: Contribution to journalArticle

Klintmalm, GBG, Washburn, WK, Rudich, SM, Heffron, TG, Teperman, LW, Fasola, C, Eckhoff, DE, Netto, GJ & Katz, E 2007, 'Corticosteroid-free immunosuppression with daclizumab in HCV+ liver transplant recipients: 1-year interim results of the HCV-3 study', Liver Transplantation, vol. 13, no. 11, pp. 1521-1531. https://doi.org/10.1002/lt.21182
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. / Corticosteroid-free immunosuppression with daclizumab in HCV+ liver transplant recipients : 1-year interim results of the HCV-3 study. In: Liver Transplantation. 2007 ; Vol. 13, No. 11. pp. 1521-1531.
@article{fc534f28e08043f088563f76d01d7c78,
title = "Corticosteroid-free immunosuppression with daclizumab in HCV+ liver transplant recipients: 1-year interim results of the HCV-3 study",
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.",
author = "Klintmalm, {Goran B G} and Washburn, {W. Kenneth} and Rudich, {Steven M.} and Heffron, {Thomas G.} and Teperman, {Lewis W.} and Carlos Fasola and Eckhoff, {Devin E.} and Netto, {George J.} and Eliezer Katz",
year = "2007",
month = "11",
doi = "10.1002/lt.21182",
language = "English (US)",
volume = "13",
pages = "1521--1531",
journal = "Liver Transplantation",
issn = "1527-6465",
publisher = "John Wiley and Sons Ltd",
number = "11",

}

TY - JOUR

T1 - Corticosteroid-free immunosuppression with daclizumab in HCV+ liver transplant recipients

T2 - 1-year interim results of the HCV-3 study

AU - Klintmalm, Goran B G

AU - Washburn, W. Kenneth

AU - Rudich, Steven M.

AU - Heffron, Thomas G.

AU - Teperman, Lewis W.

AU - Fasola, Carlos

AU - Eckhoff, Devin E.

AU - Netto, George J.

AU - Katz, Eliezer

PY - 2007/11

Y1 - 2007/11

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=36448976921&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=36448976921&partnerID=8YFLogxK

U2 - 10.1002/lt.21182

DO - 10.1002/lt.21182

M3 - Article

C2 - 17969201

AN - SCOPUS:36448976921

VL - 13

SP - 1521

EP - 1531

JO - Liver Transplantation

JF - Liver Transplantation

SN - 1527-6465

IS - 11

ER -