title: Randomized, multicenter trial comparing tacrolimus plus mycophenolate mofetil to tacrolimus plus steroids in hepatitis C virus-positive recipients of living donor liver transplantation.
abstract: The purpose of this prospective, randomized, multicenter trial was to evaluate the effects of a steroid-avoiding immunosuppression protocol on hepatitis C virus (HCV)-positive recipients of living donor liver transplantation (LDLT). Seventy-five HCV-positive LDLT recipients were included in this study, and they were randomized to receive tacrolimus (TAC) plus a corticosteroid (ST; n = 35) or TAC plus mycophenolate mofetil (MMF; n = 40). Biopsy-proven acute rejection (BPAR) was treated with steroid pulse therapy in both groups. Protocol biopsy was performed 3, 6, and 12 months after LDLT and annually thereafter. Histological recurrence of HCV (fibrosis stage ≥ F1 according to the METAVIR score), BPAR resistant to 2 sets of steroid pulse therapy, hepatocellular carcinoma (HCC) recurrence, retransplantation, and patient death were defined as events, and the primary endpoint was event-free survival. The median follow-up was 55 months. The event-free survival rates at 1, 3, and 5 years were 38.2%, 11.8%, and 5.9%, respectively, for the ST group and 25.0%, 17.5%, and 14.6%, respectively, for the MMF group (P = 0.45). The overall 5-year patient survival rates were similar for the ST group (82.7%) and the MMF group (81.0%, P = 0.28). Steroid-resistant BPAR occurred in only 1 patient from the MMF group. HCC recurrence occurred for 1 patient from the ST group and 2 patients from the MMF group. HCV recurrence rates with a fibrosis stage ≥ F1 1 and 3 years after LDLT were 59.4% and 85.9%, respectively, for the ST group and 74.2% and 81.9%, respectively, for the MMF group (P = 0.57). In conclusion, our steroid-avoidance regimen had no apparent impact on LDLT outcomes for HCV-positive recipients.
authors.affiliation: Department of Hepatopancreatobiliary and Transplant Surgery, Ehime University, Toon, Japan.
authors.forename: Yasutsugu
authors.initials: Y
authors.lastname: Takada
authors.forename: Toshimi
authors.initials: T
authors.lastname: Kaido
authors.forename: Katsuhiro
authors.initials: K
authors.lastname: Asonuma
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Sakurai
authors.forename: Shoji
authors.initials: S
authors.lastname: Kubo
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Kiuchi
authors.forename: Yukihiro
authors.initials: Y
authors.lastname: Inomata
authors.forename: Shuji
authors.initials: S
authors.lastname: Isaji
authors.forename: Hayami
authors.initials: H
authors.lastname: Tsumura
authors.forename: Satoshi
authors.initials: S
authors.lastname: Teramukai
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Matsubara
authors.forename: Satomi
authors.initials: S
authors.lastname: Sakabayashi
authors.forename: Shinji
authors.initials: S
authors.lastname: Uemoto
mesh_terms: D000328:Adult; D000368:Aged; D001706:Biopsy; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D016174:Hepacivirus; D006526:Hepatitis C / Q000150:complications / Q000628:therapy*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008103:Liver Cirrhosis / Q000473:pathology; D017093:Liver Failure / Q000150:complications / Q000628:therapy*; D016031:Liver Transplantation / Q000379:methods*; D019520:Living Donors; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D011446:Prospective Studies; D012008:Recurrence; D013256:Steroids / Q000008:administration & dosage*; D016559:Tacrolimus / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D013256:Steroids; D009173:Mycophenolic Acid; D016559:Tacrolimus