The aims of this prospective, multicenter, randomized, open-label trial were to compare the efficacy and safety of a steroid-free regimen with basiliximab (BSX) plus cyclosporine microemulsion (CsA-ME) with those of CsA-ME plus steroids in HCV positive liver transplantation (LT). Methods: Adult, HCV-positive recipients of first cadaver LT were randomized to receive BSX (20mg e.v. on Day1 and 4) or steroids for 3 months, both in combination with CsA-ME and MMF. The primary endpoint was the 12-month patient survival with functioning graft. Secondary endpoints were 6-month biopsy-proven acute rejection rate (BPAR) and adverse events (AE) rate. HCV-RNA levels (log genome eq/mL) were compared at 1, 3 and 12-month. Results: 195 patients (95 BSX; 95 ST) were randomized. At 12-month 79 (83.2%) and 80 (84.2%) patients were alive with functioning graft in the BSX and ST groups respectively (p=NS); 7 patients died (7.4%) and 7 were retransplanted (7.4%) in the BSX vs. 8 (8.4%) and 2 (2.1%) in the ST group (p=NS). The 6-month probability of BPAR was 17.9% in BSX and 22.1% in ST group (p=NS). Mean HCV RNA genome log changes from baseline were 0.14±1.51 vs. 0.06±1.22 at month 1, 0.43±1.54 vs. 0.74±1.10 at month 3 and 0.04±1.42 vs. 0.58±1.18 at month-12 in BSX and ST groups respectively (p=ns). Overall there were no differences between the two groups about the incidence of AEs, but steroid-dependent AEs, such as diabetes (12.4 vs. 22.7%) hypercholesterolemia (1 vs. 4.1%) and hypertension (26.8 vs. 39.2%) were less frequent in the BSX group. Conclusions: Steroid-free immunosuppression with BSX is safe and effective in HCV patients with no negative effect on BPAR rate and HCV kinetics; the use of BSX with ST avoidance may reduce ST-related AEs.

Results of a multicenter, randomized, open-label, controlled clinical trial comparing basiliximab versus steroids in hepatitis C positive liver transplant recipients

De Simone P;Filipponi F;
2007

Abstract

The aims of this prospective, multicenter, randomized, open-label trial were to compare the efficacy and safety of a steroid-free regimen with basiliximab (BSX) plus cyclosporine microemulsion (CsA-ME) with those of CsA-ME plus steroids in HCV positive liver transplantation (LT). Methods: Adult, HCV-positive recipients of first cadaver LT were randomized to receive BSX (20mg e.v. on Day1 and 4) or steroids for 3 months, both in combination with CsA-ME and MMF. The primary endpoint was the 12-month patient survival with functioning graft. Secondary endpoints were 6-month biopsy-proven acute rejection rate (BPAR) and adverse events (AE) rate. HCV-RNA levels (log genome eq/mL) were compared at 1, 3 and 12-month. Results: 195 patients (95 BSX; 95 ST) were randomized. At 12-month 79 (83.2%) and 80 (84.2%) patients were alive with functioning graft in the BSX and ST groups respectively (p=NS); 7 patients died (7.4%) and 7 were retransplanted (7.4%) in the BSX vs. 8 (8.4%) and 2 (2.1%) in the ST group (p=NS). The 6-month probability of BPAR was 17.9% in BSX and 22.1% in ST group (p=NS). Mean HCV RNA genome log changes from baseline were 0.14±1.51 vs. 0.06±1.22 at month 1, 0.43±1.54 vs. 0.74±1.10 at month 3 and 0.04±1.42 vs. 0.58±1.18 at month-12 in BSX and ST groups respectively (p=ns). Overall there were no differences between the two groups about the incidence of AEs, but steroid-dependent AEs, such as diabetes (12.4 vs. 22.7%) hypercholesterolemia (1 vs. 4.1%) and hypertension (26.8 vs. 39.2%) were less frequent in the BSX group. Conclusions: Steroid-free immunosuppression with BSX is safe and effective in HCV patients with no negative effect on BPAR rate and HCV kinetics; the use of BSX with ST avoidance may reduce ST-related AEs.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11568/893684
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