Multicenter randomized hepatitis C (HCV) three trial post liver transplantation (OLT): A preliminary report

O372 Aims: To assess the efficacy and safety of mycophenolate mofetil (MMF) and steroid (Pred)-free immunosuppression (IS) in an effort to minimize HCV recurrence (HCVR), acute rejection (ACR) and adverse events (AE) post OLT. Methods: The trial was designed as an open label, prospective, randomized multicenter study involving adult HCV-OLT recipients (Pt) allocated into 3 IS regimens. Arm 1: tacrolimus (TAC) + Pred; arm 2: TAC + Pred + MMF and, arm 3: TAC + MMF + 3 dose – daclizumab (2 mg/kg), but no steroids. HCV-OLT Pt (n=312) from 18 different institutions were allocated at a 1:1: 2 ratio, respectively. Laboratory data and liver histology (LBx) were evaluated when clinically indicated and, by protocol, at 90, 365 and 730 days (d). HCVR was staged according to Batts and Ludwig. ACR was graded according to Banff criteria. Primary endpoints were clinically significant HCVR (fibrosis stage (Sg) ≥ 2 at d. 90 or 365 and/or ≥ 3 at 730 d.) and/or clinically significant ACR (Banff grade (Gr) 2 + RAI 4). Results: Report is based on the Data Safety Monitoring Board assessment from November 2003, in order to maintain the validity of the trial. Out of 228 patients enrolled, 182 patients had a median follow up of 89 days. The table summarizes the average patient characteristics. Day 90 Lbx were done in 82% Pt. Preliminary information on 98 Pt showed: HCVR (Sg ≥ 2) in 8 Pt (8.2%) who were placed on antivirals (endpoint). ACR were found on 10 Pt (10.2%, Gr 2 (6); Gr 3 (4)) at a median of 13 d. post OLT. Five patients died due to: lung failure + cancer; CVA; idiopathic lung disease; HA thrombosis; sepsis. Study withdrawal: 3 Pt.Figure*HBVSag and cAB donors were excluded; C.I.T.: cold ischemia time (hours). Conclusions: This 90-d preliminary report suggests the safety of the Pred-free IS (TAC+MMF+daclizumab) used in the trial. The initial low HCVR rate found is encouraging and needs further follow up. The very low ACR rate is of significance, since most of ACR occur early post OLT. Enrollment was completed on 4/1/04 (312 Pt) and a first interim analysis of the treatment groups will be available at presentation.