Efficacy of MK615 for the treatment of patients with liver disorders

Table 1 Background of patients with liver disorders

	Chronic hepatitis C	NAFLD	Autoimmune liver disease
Number	40	15	3
Gender (M/F)	25/15	14/1	1/2
Age (yr)	64.4 ± 11.3	52.5 ± 13.7	65.7 ± 4.0
HCV viral load(10n/mL)	6.2 ± 0.8
≥ 5log/< 5log/ND	35/3/2
WBC count (/μL)	4153 ± 994	6800 ± 1578	3967 ± 723
RBC count (104/μL)	415 ± 59	490 ± 51	448 ± 48
Hemoglobin (g/dL)	13.1 ± 1.8	15.5 ± 1.1	12.5 ± 1.7
Platelet count (104/μL)	13.8 ± 5.7	20.3 ± 8.4	17.2 ± 5.1
AST (IU/L)	94.2 ± 55.5	84.5 ± 50.0	129.3 ± 90.5
ALT (IU/L)	93.4 ± 51.1	131.9 ± 72.5	96.7 ± 50.1
γ-GTP (IU/L)	72.9 ± 60.5	181.9 ± 197.5	120.3 ± 74.2
LDH (IU/L)	237.8 ± 54.8	228.9 ± 44.4	270 ± 44.3
ALP (IU/L)	318.1 ± 116.8	303.4 ± 106.8	391 ± 293.1
Total bilirubin (mg/dL)	0.84 ± 0.29	0.8 ± 0.44	0.67 ± 0.15
Total cholesterol (mg/dL)	162 ± 35.2	188.5 ± 49.1	174.7 ± 40.1
Total protein (g/dL)	7.5 ± 0.6	7.7 ± 0.3	7.9 ± 0.9
Albumin (g/dL)	3.9 ± 0.4	4.4 ± 0.3	3.9 ± 0.9
BUN (mg/dL)	16.2 ± 4.0	13.6 ± 3.2	15.3 ± 3.1
Creatinine (mg/dL)	0.76 ± 0.16	0.75 ± 0.1	0.62 ± 0.06

Data are expressed as the mean ± standard deviation. NAFLD: Non-alcoholic fatty liver disease; ND: Not done; M: Male; F: Female; HCV: Hepatitis C virus; WBC: White blood cell; RBC: Red blood cell; AST: Aspartate aminotransferase; ALT: Alanine aminotransferase; γ-GTP: γ guanosine triphosphate; LDH: Lactate dehydrogenase; ALP: Alkaline phosphatase; BUN: Blood urea nitrogen.

Table 2 Response rate of MK615 therapy in patients with liver disorder (%)

	ALT	AST
Chronic hepatitis C	20/40 (50)	16/40 (40)
NAFLD	5/15 (33)	6/15 (40)
Autoimmune liver disease	1/3 (33)	3/3 (100)
Total	26/58 (45)	25/58 (43)

NAFLD: Non-alcoholic fatty liver disease; AST: Aspartate aminotransferase; ALT: Alanine aminotransferase.

Table 3 Changes of serum level during MK615 therapy in patients with liver disorders

	Before therapy	During therapy 12 wk	P value1
WBC count (/μL)	4828 ± 1640	4977 ± 1855	NS
RBC count (104/μL)	436 ± 65	435 ± 65	NS
Hemoglobin (g/dL)	13.7 ± 2.0	13.8 ± 1.9	NS
Platelet count (104/μL)	15.7 ± 7.0	15.6 ± 6.6	NS
AST (IU/L)	94 ± 56	66 ± 35	< 0.05
ALT (IU/L)	104 ± 59	72 ± 39	< 0.05
γ-GTP (IU/L)	104 ± 121	74 ± 93	< 0.05
LDH (IU/L)	237 ± 52	227 ± 52	< 0.05
ALP (IU/L)	318 ± 124	298 ± 126	< 0.05
Total bilirubin (mg/dL)	0.8 ± 0.3	0.8 ± 0.3	NS
Total cholesterol (mg/dL)	170 ± 40	171 ± 43	NS
Total protein (g/dL)	7.6 ± 0.6	7.6 ± 0.5	NS
Albumin (g/dL)	4.0 ± 0.5	4.1 ± 0.4	NS
BUN (mg/dL)	15.5 ± 3.9	14.7 ± 3.5	NS
Creatinine (mg/dL)	0.75 ± 0.15	0.74 ± 0.15	NS

Data are expressed as the mean ± standard deviation.

¹Dunnett’s test. NS: Not significant; WBC: White blood cell; RBC: Red blood cell; AST: Aspartate aminotransferase; ALT: Alanine aminotransferase; γ-GTP: γ-guanosine triphosphate; LDH: Lactate dehydrogenase; ALP: Alkaline phosphatase; BUN: Blood urea nitrogen; NS: Not significant.