Impact of immunosuppression minimization and withdrawal in long-term hepatitis C virus liver transplant recipients

Table 1 Baseline characteristics of the three groups n (%)

Variable	Tol group	CNI group	MMF group	P-value
Patients (n)	10	21	15	NS
Age (yr) al TX	52.4 ± 5.5	54.7 ± 10.3	50.4 ± 5.7	NS
Gender (M/F)	8/2	17/4	11/4	NS
BMI	26 ± 3.9	27 ± 3.4	27 ± 2.9	NS
Donor age (yr)	35 ± 13	44 ± 17.9	33 ± 18	NS
Follow-up from LT (mean)	83 ± 30.5	83 ± 29.1	89 ± 40	NS
HCV genotype 1-4	2 (20)	6 (28.5)	6 (40)	NS
HCV genotype 2-3	1 (10)	3 (14.2)	2 (13.3)	NS
HCV-RNA > 500000 IU/mL	70	42.8	46.6	NS
Anti-HBc positive recipients	None	4 (19)	1 (6.6)	NS
Cholestatic hepatitis	None	None	None	NS
HIV positive	None	None	None	NS
Azathioprine treated	1 (10)	7 (33.3)	9 (60)	NS
Mean ALT (IU/L)	71.1 ± 54.2	53.9 ± 33.7	59.4 ± 45.6	NS
ACE-inhibitors treated	3 (30)	None	1 (6.6)	NS
IDDM	3 (30)	7 (33.3)	4 (26.6)	NS
Baseline Fibrosis score (Ishak)	2.7 ± 0.7	2.2 ± 1.7	2.5 ± 1.5	NS
Baseline grading score (Ishak)	4.1 ± 1.8	3 ± 2.2	3.2 ± 1.6	NS
Treated with ribavirin	8 (80)	9 (42.8)	7 (46.6)	NS
Patients who achieved SVR	2	8	5	NS
Rejection episode	None	None	None	NS
Boluses of steorids after LT	None	None	None	NS
Antibodies after LT	None	None	None	NS
CMV infection after LT	1 (10)	2 (9.5)	1 (6.7)	NS
Total ishemica times (min)	502 ± 133.8	456 ± 86.5	411 ± 127.6	NS
Liver donor's steatosis	None 0 (20) Mild 2 (10) Severe 0 (0)	None 17 (81) Mild 3 (14.3) Severe 1 (4.8)	None 14 (93.3) Mild 1 (6.7) Severe 0 (0)

HIV: Human immunodeficiency virus; HCV: Hepatitis C virus; CNI: Calcineurin inhibitors; MMF: Mycophenolate; BMI: Body mass index; CMV: Cytomegalovirus; LT: Liver transplantation; SVR: Sustained virologic response; IDDM: Insulin dependent diabetes mellitus; NS: Not significant.

Table 2 Three groups data at baseline and after 6 years of follow up

Variables	Tol group			CNI group			MMF group
	Baseline	6 yr	P-value	Baseline	6 yr	P-value	Baseline	6 yr	P-value
Grading	4.1 ± 1.8	3.1 ± 1.45	NS	3 ± 2.2	2.8 ± 1.9	NS	3.2 ± 1.6	3.25 ± 1.54	NS
Staging	2.7 ± 0.7	2.5 ± 1.2	NS	2.2 ± 1.7	3.9 ± 1.6	0.008	2.5 ± 1.5	2.9 ± 1.73	NS

CNI: Calcineurin inhibitors; MMF: Mycophenolate; NS: Not significant.

Table 3 Main clinical findings after 6 years of follow up

Variables	Tol group	CNI group	MMF group	P value
	6 yr	6 yr	6 yr	Tol vs CNII	Tol vs MMFF
Patients (n)	10	21	15
Death (n)	0	1	0
ALT (IU/L)	71.1 ± 54.2	53.9 ± 33.7	59.4 ± 45.6	NS	NS
Creatinina	1.3 ± 0.5	1.28 ± 0.5	1.7 ± 1.6	NS	NS
Cholesterol	153.6 ± 55.2	161.9 ± 43.2	155.9 ± 30	NS	NS
Triglycerides	130.6 ± 64.1	125.4 ± 45.6	121.8 ± 39.8	NS	NS
HCV-RNA > 500000 IU/mL	70	42.8	46.6	NS	NS
Recurrent infections1	0	42.8	40	0.029	0.019
Cardiovascular diseases	50	23	6.6	NS	NS
Diabetes	30	33	27	NS	NS
Dyslipidemia	50	19	13	NS	NS
FPR	-0.019	0.32	0.02	0.02	NS

¹Urinary and bronchopulmonary infections. FPR: Fibrosis progression rate; ALT: Alanine aminotransferase; HCV: Hepatitis C virus; CNI: Calcineurin inhibitors; MMF: Mycophenolate; NS: Not significant.