Table 3.
Clinical characteristics of operationally tolerant patients and non-tolerant patients
| Operationally tolerant (n = 8) | Non-toleranta (n = 15) | P-value | |
|---|---|---|---|
| Age (years) | 56 ± 19 | 55 ± 16 | 0.93 |
| Sex (% males) | 63 | 60 | 0.99 |
| Diagnosis (number of patients) | |||
| HCV cirrhosis | 3 | 5 | 0.99 |
| Alcoholic cirrhosis | 0 | 2 | 0.53 |
| Autoimmune | 0 | 2 | 0.53 |
| FHF | 1 | 1 | 0.99 |
| NASH | 1 | 3 | 0.99 |
| Other | 3 | 2 | 0.29 |
| Time from transplant to trial enrolment (months) | 158 ± 83 | 91 ± 51 | 0.03 |
| Free of rejection prior to enrolment (%) | 75 | 68 | 0.99 |
| IS regimen prior to withdrawal (%) | |||
| Tacrolimus | 50 | 73 | 0.37 |
| Cyclosporine | 50 | 27 | 0.37 |
| MMF | 13 | 20 | 0.99 |
| CNI drug levels prior to IS withdrawal (ng/ml) | |||
| Tacrolimus (trough level) | 5.8 ± 0.5 | 5.9 ± 1.5 | 0.68 |
| Cyclosporine (C2 level) | 354 ± 245 | 278 ± 133 | 0.89 |
| Donor age (years) | 48 ± 7 | 46 ± 9 | 0.82 |
| Type of transplantation (%) | 0.99 | ||
| Deceased donor | 88 | 80 | |
| Living donor | 12 | 20 | |
| Laboratory values at enrolment | |||
| Creatinine | 107 ± 36 | 94 ± 18 | 0.27 |
| AST | 22 ± 4 | 29 ± 10 | 0.07 |
| ALT | 19 ± 6 | 33 ± 17 | 0.05 |
| ALP | 99 ± 33 | 110 ± 53 | 0.61 |
| Bilirubin | 12.6 ± 5 | 10.6 ± 10.6 | 0.33 |
| INR | 1 ± 0 | 1 ± 0.1 | 0.43 |
Data are expressed at mean ± SD. CNI, calcineurin inhibitor; FHF, fulminant hepatic failure; HCV, hepatitis C virus; INR, international normalized ratio; NASH, non-alcoholic steatohepatitis.
Patients with either unsuccessful IS withdrawal (n = 6) or abnormal baseline liver biopsy (n = 9).