title: A randomized, multicenter study comparing steroid-free immunosuppression and standard immunosuppression for liver transplant recipients with chronic hepatitis C.
abstract: This randomized, prospective, multicenter trial compared the safety and efficacy of steroid-free immunosuppression (IS) to the safety and efficacy of 2 standard IS regimens in patients undergoing transplantation for hepatitis C virus (HCV) infection. The outcome measures were acute cellular rejection (ACR), severe HCV recurrence, and survival. The patients were randomized (1:1:2) to tacrolimus (TAC) and corticosteroids (arm 1; n = 77), mycophenolate mofetil (MMF), TAC, and corticosteroids (arm 2; n = 72), or MMF, TAC, and daclizumab induction with no corticosteroids (arm 3; n = 146). In all, 295 HCV RNA-positive subjects were enrolled. At 2 years, there were no differences in ACR, HCV recurrence (biochemical evidence), patient survival, or graft survival rates. The side effects of IS did not differ, although there was a trend toward less diabetes in the steroid-free group. Liver biopsy samples revealed no significant differences in the proportions of patients in arms 1, 2, and 3 with advanced HCV recurrence (ie, an inflammation grade ≥ 3 and/or a fibrosis stage ≥ 2) in years 1 (48.2%, 50.4%, and 43.0%, respectively) and 2 (69.5%, 75.9%, and 68.1%, respectively). Although we have found that steroid-free IS is safe and effective for liver transplant recipients with chronic HCV, steroid sparing has no clear advantage in comparison with traditional IS.
authors.affiliation: Baylor University Medical Center at Dallas, Dallas, TX 75246, USA. gorank@baylorhealth.edu
authors.forename: Göran B
authors.initials: GB
authors.lastname: Klintmalm
authors.forename: Gary L
authors.initials: GL
authors.lastname: Davis
authors.forename: Lewis
authors.initials: L
authors.lastname: Teperman
authors.forename: George J
authors.initials: GJ
authors.lastname: Netto
authors.forename: Kenneth
authors.initials: K
authors.lastname: Washburn
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Rudich
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Pomfret
authors.forename: Hugo E
authors.initials: HE
authors.lastname: Vargas
authors.forename: Robert
authors.initials: R
authors.lastname: Brown
authors.forename: Devin
authors.initials: D
authors.lastname: Eckhoff
authors.forename: Timothy L
authors.initials: TL
authors.lastname: Pruett
authors.forename: John
authors.initials: J
authors.lastname: Roberts
authors.forename: David C
authors.initials: DC
authors.lastname: Mulligan
authors.forename: Michael R
authors.initials: MR
authors.lastname: Charlton
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Heffron
authors.forename: John M
authors.initials: JM
authors.lastname: Ham
authors.forename: David D
authors.initials: DD
authors.lastname: Douglas
authors.forename: Linda
authors.initials: L
authors.lastname: Sher
authors.forename: Prabhakar K
authors.initials: PK
authors.lastname: Baliga
authors.forename: Milan
authors.initials: M
authors.lastname: Kinkhabwala
authors.forename: Baburao
authors.initials: B
authors.lastname: Koneru
authors.forename: Michael
authors.initials: M
authors.lastname: Abecassis
authors.forename: Michael
authors.initials: M
authors.lastname: Millis
authors.forename: Linda W
authors.initials: LW
authors.lastname: Jennings
authors.forename: Carlos G
authors.initials: CG
authors.lastname: Fasola
mesh_terms: D000305:Adrenal Cortex Hormones / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000627:therapeutic use; D001706:Biopsy; D016009:Chi-Square Distribution; D000077561:Daclizumab; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D017093:Liver Failure / Q000175:diagnosis / Q000401:mortality / Q000601:surgery* / Q000821:virology; D016031:Liver Transplantation / Q000276:immunology* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D012008:Recurrence; D018570:Risk Assessment; D012307:Risk Factors; D015996:Survival Rate; D016559:Tacrolimus / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D000305:Adrenal Cortex Hormones; D061067:Antibodies, Monoclonal, Humanized; D000998:Antiviral Agents; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D012367:RNA, Viral; D000077561:Daclizumab; D009173:Mycophenolic Acid; D016559:Tacrolimus