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

Tomoaki Kato, Jeffrey J. Gaynor, Hideo Yoshida, Marzia Montalvano, Hidenori Takahashi, Nikolaos Pyrsopoulos, Seigo Nishida, Jang Moon, Gennaro Selvaggi, David Levi, Phillip Ruiz, Eugene Schiff, Andreas Tzakis

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70 Scopus citations


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 languageEnglish (US)
Pages (from-to)829-835
Number of pages7
Issue number7
StatePublished - Oct 1 2007



  • Daclizumab induction
  • Hepatitis C virus
  • Mycophenolate mofetil
  • Orthotopic liver transplantation
  • Steroid-free maintenance

ASJC Scopus subject areas

  • Transplantation
  • Immunology

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