Impact of immunosuppression without steroids on rejection and hepatitis C virus evolution after liver transplantation: results of a prospective randomized study

Liver Transpl. 2008 Dec;14(12):1752-60. doi: 10.1002/lt.21629.

Abstract

The purpose of this study was to evaluate the influence of a steroid-free immunosuppression on hepatitis C virus (HCV) recurrence. A total of 198 liver transplantation (LT) patients were randomized to receive immunosuppression with basiliximab and cyclosporine, either with prednisone (steroid [St] group) or without prednisone (no steroids [NoSt] group). The group of 89 HCV-infected patients was followed up with protocol biopsies for 2 years after LT. This group of HCV patients are the patients evaluated in the present study. The rejection rate was 19% (St: 21% versus NoSt: 17%; P = 0.67). Patients in the St group had a slightly higher rate of bacterial infections (59% versus 38%; P = 0.05). Almost all patients had histological HCV-recurrence (St: 39/40 (97%) versus NoSt: 40/41 (97%); P = 1). The percentage of accumulated biopsies with grade 4 portal inflammation at 6 months, 1 year, and 2 years were, 23%, 49%, and 49% in the NoSt group, compared to 33%, 55%, and 69% in the St group, respectively (P = 0.04 at 2 years). The percentage of accumulated biopsies with grade 3 or 4 fibrosis at 6 months, 1 year, and 2 years were 0%, 8%, and 22% in the NoSt group, compared to 8%, 19%, and 31% in the St group, respectively. Immunosuppression without steroids in HCV patients is safe, reduces bacterial infections and metabolic complications, and improves histological short-term evolution of HCV recurrence.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / therapeutic use*
  • Basiliximab
  • Cyclosporine / adverse effects
  • Cyclosporine / therapeutic use*
  • Evolution, Molecular
  • Female
  • Glucocorticoids / therapeutic use
  • Graft Rejection / pathology
  • Graft Rejection / prevention & control*
  • Graft Rejection / virology
  • Hepacivirus / drug effects
  • Hepacivirus / isolation & purification
  • Hepatitis C, Chronic / complications
  • Hepatitis C, Chronic / prevention & control*
  • Humans
  • Immunosuppression Therapy / methods*
  • Immunosuppressive Agents / therapeutic use*
  • Liver Cirrhosis / etiology
  • Liver Cirrhosis / surgery
  • Liver Cirrhosis / virology
  • Liver Transplantation*
  • Male
  • Methylprednisolone / therapeutic use
  • Middle Aged
  • Prospective Studies
  • Recombinant Fusion Proteins / adverse effects
  • Recombinant Fusion Proteins / therapeutic use*
  • Secondary Prevention

Substances

  • Antibodies, Monoclonal
  • Glucocorticoids
  • Immunosuppressive Agents
  • Recombinant Fusion Proteins
  • Cyclosporine
  • Basiliximab
  • Methylprednisolone