(b)
| Patient survival rate (%) | Graft rejection rate (%) | Acute rejection rate (%) | BPAR (%) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 6 months | 1 year | Other time points | 6 months | 1 year | 3 years | 6 months | 1 year | Other time points | ||
| De novo/maintenance dosing | ||||||||||
| De Simone et al. Am J Transplant. 2012; 12: 3008–20 [87] | 96.3 versus 97.5 (EVR + TAC-RD versus TAC-SD, P = NS) | 2.4 versus 1.2 (EVR + TAC-RD versus TAC-SD, P = NS) | 4.1 versus 10.7 (EVR + TAC-RD versus TAC-SD, P = 0.005) | |||||||
| Grazi et al. Presented at ILTS; 2011 (Abstract P-256) [88] | ||||||||||
| Levy et al. Liver Transpl. 2006; 12: 1640–8 [52] (Low) + CNI | 82.1, 96.7, 87.1 for EVR 1, 2 and 4 mg/day∗† | 0, 13.3 and 3.2 for EVR 1, 2 and 4 mg/day∗† | 39.3, 30.0 and 29.0 for EVR 1, 2 and 4 mg/day∗† | 32.1, 26.7, and 25.8 for EVR 1, 2 and, 4 mg/day∗† | 39.3, 30.0, and 29.0 for EVR 1, 2, and 4 mg/day∗† at 3 years | |||||
|
| ||||||||||
| Early conversion (≤3 months after transplantation) | ||||||||||
| Fischer et al. Am J Transplant. 2012; 12: 1855–1865 [50] | 95.8 versus 95.9 (EVR versus CNI control at 11 months, P = NS) | 2.1 versus 2.0 (EVR versus CNI control at 11 months) | 17.7 versus 15.3 (EVR versus CNI control at 11 months) | |||||||
| Schlitt et al. AASLD 2012 [91] | 95.7 versus 90.0 (EVR versus CNI control at 35 months, P = NS) |
24.4 versus 15.8 (EVR versus CNI control at 35 months, P = NS) |
||||||||
| Masetti et al. Am J Transplant. 2010; 10: 2252–62 [89] | 92.3 versus 92.3 (EVR versus CsA, P = NS) | 90.4 versus 88.5 (EVR versus CsA, P = NS) | 5.7 at 40–87 days after transplant versus 7.7 at days 41–240 after transplant CsA (P = NS) | |||||||
| De Simone et al. Am J Transplant. 2012; 12: 3008–3020 [87] | 96.5 versus 96.3 versus 97.5 (TAC elim versus EVR + TAC-RD versus TAC-SD) | 2.2 versus 2.4 versus 1.2 (TAC elim versus EVR + TAC-RD versus TAC-SD) | 19.9 versus 4.1 versus 10.7 (TAC elim versus EVR + TAC-RD versus TAC-SD) | |||||||
| Saliba et al. AASLD 2012 [90] | 6.1 versus 13.3; delta risk: −7.2% (95% CI: −13.5%, −0.9%; P = 0.010. EVR+TAC-RD versus TAC-SD at 24 months) | |||||||||
|
| ||||||||||
| Late conversion (>3 months after transplantation) | ||||||||||
| Casanovas et al. Transplant Proc. 2011; 43: 2216–9 [93] | 94.3 | |||||||||
| Castroagudín et al. Liver Transpl. 2009; 15: 1792–7 [94] | 0 | |||||||||
| De Simone et al. Transpl Int. 2009; 22: 279–86 [95] | 100 | 0 | 15 | |||||||
| De Simone et al. Liver Transpl. 2009; 15: 1262–9 [96] | 98.6 versus 100 (EVR versus CNI) | 95.8 versus 95.9 (EVR versus CNI) | 0 versus 0 (EVR versus CNI) | 1.4 versus 1.4 (EVR versus CNI) | 4.2 versus 4.1 (EVR versus CNI) | |||||
| Saliba et al. Liver Transpl. 2011; 17: 905–13 [98] | 1.6 | |||||||||
| Vallin et al. Clin Transplant. 2011; 25: 660–9 [99] | 9 | |||||||||
P values are included where available; *P: not significant for all efficacy-related events versus placebo; otherwise, where not stated.
†Timepoint refers to time after immunosuppression was initiated.
AASLD: The Liver Meeting 62nd Annual Meeting of the American Association for the Study of Liver Diseases; BPAR: biopsy-proven acute rejection; CsA: cyclosporin A; CNI: calcineurin inhibitor; EVR: everolimus; NS: nonsignificant; TAC elim; tacrolimus elimination; TAC-RD: reduced dose tacrolimus (C0: 3–5 ng/mL); TAC-SD: standard-dose tacrolimus (C0: 6–10 ng/mL).