Abstract
BACKGROUND. Due to the known high recurrence rate of hepatitis C virus (HCV) among orthotopic liver transplant (OLT) recipients who receive tacrolimus+corticosteroid maintenance, use of steroid-free induction was considered. METHODS. OLT recipients with HCV were randomized to receive tacrolimus+daclizumab (steroid-free) vs. tacrolimus+corticosteroids during 1999-2001 and then tacrolimus+mycophenolate mofetil (MMF)+daclizumab (steroid-free) vs. tacrolimus+MMF+corticosteroids during 2002-2005. Patients in the steroid-free arm of both periods received no steroids except for treating biopsy-proven rejection. Primary objective was to compare mean fibrosis stage at the 1-year protocol biopsy, between the steroid-free and corticosteroid arms, stratifying by period. RESULTS. No noticeable differences in mean fibrosis stage between the two treatment arms, either averaging across periods (P=0.99) or during either period (P>0.35) were found. Occurrence of acute rejection during the first year was the only factor associated with a significantly increased fibrosis stage at 1 year (P=0.0003); stage ≥2 was seen in 63% (17 of 27) vs. 19% (8 of 43) of those with vs. without rejection. In addition, MMF use was associated with significantly fewer patients experiencing acute rejection during the first 6 and 12 months posttransplant (P=0.006 and 0.046). Regarding steroid-related side effects, posttransplant diabetes mellitus occurred in 10% vs. 45%, and wound infection in 6% vs. 31% of steroid-free vs. corticosteroid patients (P=0.003 and 0.01). CONCLUSIONS. OLT recipients with HCV tolerated the steroid-free protocol with fewer side effects; however, its use had no apparent impact on hepatic fibrosis progression. Occurrence of acute rejection was strongly associated with increased hepatic fibrosis at 1 year, and MMF use appears to have significantly reduced the rejection rate.
| Original language | English |
|---|---|
| Pages (from-to) | 829-835 |
| Number of pages | 7 |
| Journal | Transplantation |
| Volume | 84 |
| Issue number | 7 |
| DOIs | |
| State | Published - Oct 1 2007 |
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Keywords
- Daclizumab induction
- Hepatitis C virus
- Mycophenolate mofetil
- Orthotopic liver transplantation
- Steroid-free maintenance
ASJC Scopus subject areas
- Transplantation
- Immunology
Cite this
Randomized trial of steroid-free induction versus corticosteroid maintenance among orthotopic liver transplant recipients with hepatitis C virus : Impact on hepatic fibrosis progression at one year. / Kato, Tomoaki; Gaynor, Jeffrey; Yoshida, Hideo; Montalvano, Marzia; Takahashi, Hidenori; Pyrsopoulos, Nikolaos; Nishida, Seigo; Moon, Jang; Selvaggi, Gennaro; Levi, David; Ruiz, Phillip; Schiff, Eugene R; Tzakis, Andreas.
In: Transplantation, Vol. 84, No. 7, 01.10.2007, p. 829-835.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Randomized trial of steroid-free induction versus corticosteroid maintenance among orthotopic liver transplant recipients with hepatitis C virus
T2 - Impact on hepatic fibrosis progression at one year
AU - Kato, Tomoaki
AU - Gaynor, Jeffrey
AU - Yoshida, Hideo
AU - Montalvano, Marzia
AU - Takahashi, Hidenori
AU - Pyrsopoulos, Nikolaos
AU - Nishida, Seigo
AU - Moon, Jang
AU - Selvaggi, Gennaro
AU - Levi, David
AU - Ruiz, Phillip
AU - Schiff, Eugene R
AU - Tzakis, Andreas
PY - 2007/10/1
Y1 - 2007/10/1
N2 - BACKGROUND. Due to the known high recurrence rate of hepatitis C virus (HCV) among orthotopic liver transplant (OLT) recipients who receive tacrolimus+corticosteroid maintenance, use of steroid-free induction was considered. METHODS. OLT recipients with HCV were randomized to receive tacrolimus+daclizumab (steroid-free) vs. tacrolimus+corticosteroids during 1999-2001 and then tacrolimus+mycophenolate mofetil (MMF)+daclizumab (steroid-free) vs. tacrolimus+MMF+corticosteroids during 2002-2005. Patients in the steroid-free arm of both periods received no steroids except for treating biopsy-proven rejection. Primary objective was to compare mean fibrosis stage at the 1-year protocol biopsy, between the steroid-free and corticosteroid arms, stratifying by period. RESULTS. No noticeable differences in mean fibrosis stage between the two treatment arms, either averaging across periods (P=0.99) or during either period (P>0.35) were found. Occurrence of acute rejection during the first year was the only factor associated with a significantly increased fibrosis stage at 1 year (P=0.0003); stage ≥2 was seen in 63% (17 of 27) vs. 19% (8 of 43) of those with vs. without rejection. In addition, MMF use was associated with significantly fewer patients experiencing acute rejection during the first 6 and 12 months posttransplant (P=0.006 and 0.046). Regarding steroid-related side effects, posttransplant diabetes mellitus occurred in 10% vs. 45%, and wound infection in 6% vs. 31% of steroid-free vs. corticosteroid patients (P=0.003 and 0.01). CONCLUSIONS. OLT recipients with HCV tolerated the steroid-free protocol with fewer side effects; however, its use had no apparent impact on hepatic fibrosis progression. Occurrence of acute rejection was strongly associated with increased hepatic fibrosis at 1 year, and MMF use appears to have significantly reduced the rejection rate.
AB - BACKGROUND. Due to the known high recurrence rate of hepatitis C virus (HCV) among orthotopic liver transplant (OLT) recipients who receive tacrolimus+corticosteroid maintenance, use of steroid-free induction was considered. METHODS. OLT recipients with HCV were randomized to receive tacrolimus+daclizumab (steroid-free) vs. tacrolimus+corticosteroids during 1999-2001 and then tacrolimus+mycophenolate mofetil (MMF)+daclizumab (steroid-free) vs. tacrolimus+MMF+corticosteroids during 2002-2005. Patients in the steroid-free arm of both periods received no steroids except for treating biopsy-proven rejection. Primary objective was to compare mean fibrosis stage at the 1-year protocol biopsy, between the steroid-free and corticosteroid arms, stratifying by period. RESULTS. No noticeable differences in mean fibrosis stage between the two treatment arms, either averaging across periods (P=0.99) or during either period (P>0.35) were found. Occurrence of acute rejection during the first year was the only factor associated with a significantly increased fibrosis stage at 1 year (P=0.0003); stage ≥2 was seen in 63% (17 of 27) vs. 19% (8 of 43) of those with vs. without rejection. In addition, MMF use was associated with significantly fewer patients experiencing acute rejection during the first 6 and 12 months posttransplant (P=0.006 and 0.046). Regarding steroid-related side effects, posttransplant diabetes mellitus occurred in 10% vs. 45%, and wound infection in 6% vs. 31% of steroid-free vs. corticosteroid patients (P=0.003 and 0.01). CONCLUSIONS. OLT recipients with HCV tolerated the steroid-free protocol with fewer side effects; however, its use had no apparent impact on hepatic fibrosis progression. Occurrence of acute rejection was strongly associated with increased hepatic fibrosis at 1 year, and MMF use appears to have significantly reduced the rejection rate.
KW - Daclizumab induction
KW - Hepatitis C virus
KW - Mycophenolate mofetil
KW - Orthotopic liver transplantation
KW - Steroid-free maintenance
UR - http://www.scopus.com/inward/record.url?scp=38449112478&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=38449112478&partnerID=8YFLogxK
U2 - 10.1097/01.tp.0000282914.20578.7b
DO - 10.1097/01.tp.0000282914.20578.7b
M3 - Article
C2 - 17984834
AN - SCOPUS:38449112478
VL - 84
SP - 829
EP - 835
JO - Transplantation
JF - Transplantation
SN - 0041-1337
IS - 7
ER -