Efficacy and safety of treatment of hepatitis C virus infection in renal transplant recipients

Table 1 Mean ± SD of parameters measured at different stages of therapy (n = 19)

Parameters	Baseline	12 wk	24 wk	48 wk	P value (baseline vs 48 wk)
AST (U/L)	43.7 (30.4)	32.4 (29.6)	36.8 (35.4)	32.9 (34.3)	0.18
ALT (U/L)	65.4 (56.3)	34.0 (33.7)	34.9 (25.9)	30.8 (21.3)	0.01
HCV-RNA (log10 IU/mL)	6.3 (0.69)	3.0 (2.9)	2.6 (3.0)	1.1 (2.1)	0.0001
WBC (109/L)	5.5 (2.7)	4.5 (2.7)	5.1 (4.8)	6.6 (1.0)	0.698
Hemoglobin (G/L)	116.7 (43.6)	100.1 (33.8)	101.2 (24.7)	107.7 (25.8)	0.238
Platelets (109/L)	195 (101)	154 (76)	175 (83)	188 (98)	0.752
Creatinine (Umol/L)	122 (41)	122 (41)	138 (75)	130 (52)	0.183
GFR (mL/min)	70.4 (24.5)	69.0 (22.7)	68.2 (27.2)	69.7 (25.2)	0.772

AST: Aspartate aminotransferase; ALT: Abnormal alanine aminotransferase; HCV: Hepatitis C virus; WBC: White cell count; GFR: Glomerular filtration rate.

Table 2 Hepatitis C virus-RNA, alanine aminotransferase, and aspartate aminotransferase at different times of treatment and follow up

	0 (before treatment)	24 wk	48 wk	24 wk post treatment
No. of patients with 2 log drop in HCV-RNA	0	1 (0.05%)	2 (0.1%)	NA
No. of patients with undetected HCV-RNA	0	9 (47.4%)	9 (47.4%)	8 (42.1%)
Normal ALT	10	14 (73.6%)	Out of all patients 15/19 (78.9%)	Out of all patients15/19 (78.9%)
			Out of responders 9/9 (100%)	Out of responders 8/8 (100%)
Normal AST	10	13 (68.4%)	Out of all patients13/19 (68.4%)	Out of all patients13/19 (68.4%)
			Out of responders 9/9 (100%)	Out of responders 9/9 (100%)

AST: Aspartate aminotransferase; ALT: Abnormal alanine aminotransferase; HCV: Hepatitis C virus; NA: Not applicable.

Table 3 Impact of patient gender on the parameters at the end of therapy

Parameters	Males (n = 13)	Females (n = 6)	P value
AST (U/L)	33.69	27.67	0.56
ALT (U/L)	32.23	28.33	0.62
HCV-RNA (log10 IU/mL)	2.3	3.27	0.54
WBC (109/L)	4.08	7.05	0.43
Hemoglobin (G/L)	99.77	102.33	0.88
Creatinine (Umol/L)	145.62	123.33	0.53
GFR (mL/min)	66.15	72.67	0.71

AST: Aspartate aminotransferase; ALT: Abnormal alanine aminotransferase; HCV: Hepatitis C virus; WBC: White cell count; GFR: Glomerular filtration rate.

Table 4 Impact of duration post transplant on the parameters at the end of therapy

Parameters	Duration post transplant		P value
	> 49 mo(n = 10)	< 49 mo(n = 9)
AST (U/L)	27.6	36.44	0.63
ALT (U/L)	33.4	28.33	0.59
HCV-RNA (log10 IU/mL)	2.38	2.94	0.72
WBC (109/L)	4.38	5.73	0.59
Hemoglobin (G/L)	107	93.44	0.28
Creatinine (Umol/L)	161.80	112.78	0.15
GFR (mL/min)	61.90	75.22	0.37

AST: Aspartate aminotransferase; ALT: Abnormal alanine aminotransferase; HCV: Hepatitis C virus; WBC: White cell count; GFR: Glomerular filtration rate.

Table 5 Impact of age on the parameters at the end of therapy

Parameters	Age > 39 yr(n=11)	Age < 39 yr(n=8)	P value
AST (U/L)	32.91	30.25	0.82
ALT (U/L)	30.09	32.25	0.81
HCV-RNA (log10 IU/mL)	2.92	2.33	0.7
WBC (109/L)	4.28	6.04	0.53
Hemoglobin (G/L)	109.18	88.75	0.11
Creatinine (Umol/L)	148.73	124.63	0.46
GFR (mL/min)	67.73	68.88	0.92

AST: Aspartate aminotransferase; ALT: Abnormal alanine aminotransferase; HCV: Hepatitis C virus; WBC: White cell count; GFR: Glomerular filtration rate.

Table 6 Summary of some reports on the efficacy and rejection rate following the use of interferon alone or in combination with ribavirin in post renal transplant hepatitis C virus infection

Ref.	Yr	No. of patientstreated	Anti HCV therapy used(No. of patients)	Immunosuppression used(% of patients)	ETR (%)	SVR (%)	Rate of allograftrejection/failure (%)
Ozgur et al[32]	1995	5	CI alone (5)	CNI (100)	NR	NR	40
				Aza (100)
				S (100)
Rosting et al[31]	19951	14	CI alone (14)	CNI (85.7)	28.60	0	35.70
				Aza (50)
				S (85.7)
Hanafusa et al[14]	1998	10	CI alone (10)	CNI (NS)	10	0	40
				Aza (100)
				S (100)
Baid et al[27]	20032	12	CI + R (11)	CNI (100)	NS	33	17
			CI alone (1)	Aza (17)
				C (67)
				S (100)
Sharma et al[26]	20063	6	CI + R (5)	CNI (100)	66.60	33.30	66.60
			PEG-INF + R (1)	Aza (50)
				C (14)
				S (100)
Pageaux et al[67]	2009	8	PEG-INF + R (4)	CNI (75)	75	50	0
			PEG-INF alone (4)	Aza (37.5)
				C (25)
				S (100)
Aljumah et al	Current study	19	PEG-INF + R (19)	CNI (89.5)	47.40	42.10	5.30
				C (78.9)
				S (100)

HCV: Hepatitis C virus; CI: Conventional interferon; PEG-IFN: Pegylated interferon; R: Ribavirin; CNI: Calcineurin inhibitors; C: Cellcept; S: Steroids; Aza:azathioprine; ETR: End of treatment response; SVR: Sustained virological response; NR: Not reported; NS: Not specified.

¹Five patients developed acute renal failure, but biopsy did not confirm rejection.

²CI changed to PEG-IFN in 3 patients but study did not specify these patients.

³In this study 8 patients received ribavirin alone without interferon, so they were not included. ³Four patients developed severe renal dysfunction, only one patient biopsied and showed chronic allograft nephropathy.