Pegylated interferon plus ribavirin for genotype Ib chronic hepatitis C in Japan

Table 1 Clinical characteristics of patients at baseline (mean ± SE)

No. of patients	120
Sex, n (%)
Male	70 (58.3)
Female	50 (41.7)
Age (median, range, yr)	54.8 ± 0.98 (56, 27-75)
Male	54.1 ± 1.39 (55.5, 29-72)
Female	55.8 ± 1.33 (56, 27-75)
Weight	62.1 ± 1.09 (61.4, 35.0-99.8)
Body mass index (median, range, kg)	23.7 ± 0.32 (23.6, 14.6-34.1)
Viral load (kIU kirocopies/mL)	1510 (120->5000)
ALT (median, range, IU/L)	89.4 ± 7.39 (67, 18-636)
WBC (median, range, /μL)	5083 ± 136.6 (4900, 2400-9000)
Hemoglobin (median, range, g/dL)	14.4 ± 0.12 (14.1, 11.8-17.2)
Platelet (median, range, × 103/μL)	163.1 ± 4.71 (162.5, 8.1-33.2)
Interferon treatment history, n (%)
Present	41 (34.2)
Null-responder/relapser/unknown	8/15/18
Absent	77 (64.2)
Unknown	2 (1.6)

ALT: Alanine aminotransferase; WBC: White blood cell.

Table 2 Univariate analysis of association between sustained virological response (SVR) and influential factors (mean ± SE)

Factor	SVR patients (n = 53)	Non-SVR patients (n = 67)	P
Parameters before interferon treatment
Age (yr)	52.5 ± 1.50	56.5 ± 1.26	0.0481
Sex (Male:Female)	35:18	35:32	0.1402
Body mass index	23.6 ± 0.48	23.8 ± 0.44	0.3611
Viral load (kirocopies/mL, median)	1500	1800	0.1963
ALT (IU/L)	108.4 ± 13.8	74.5 ± 7.04	0.0478
WBC (/μL)	5227 ± 201	4967 ± 186	0.2880
Hemoglobin (g/dL)	14.5 ± 0.18	14.3 ± 0.16	0.2352
Platelet (× 103/μL)	173 ± 7.7	155 ± 5.7	0.0630
Parameters associated with treatment
EVR	42/51 (82.4%)	13/59 (22.0%)	< 0.0001
Cumulative exposure to peg-IFN
12 wk (≥ 80%/< 80%)	38/41 (92.7%)	41/69 (68.3%)	0.0034
Overall (≥ 80%/< 80%)	35/41 (85.4%)	29/60 (48.3%)	0.0001
Cumulative exposure to RBV
12 wk (≥ 80%/< 80%)	41/50 (82%)	44/63 (69.8%)	0.1882
Overall (≥ 80%/< 80%)	32/50 (64%)	25/63 (39.7%)	0.0138

ALT: Alanine aminotransferase; WBC: White blood cell; EVR: Early virological response; Peg-IFN: Pegylated interferon; RBV: Ribavirin.

Table 3 Multivariate analysis of association between sustained virological response and influential factors

Factor	Coefficient	χ2	Odds ratio (95% CI)	P
EVR (not achieved)	-2.725	19.325	0.066 (0.019-0.221)	< 0.0001
Cumulative exposure to peg-IFN
Overall (≥ 80%)	2.392	6.600	10.934 (1.763-67.82)	0.0102
Constant	1.294

EVR: Early virological response; Peg-IFN: Pegylated interferon.

Table 4 Univariate analysis of association between sustained virological response (SVR) and influential factors (mean ± SE)

Factor	SVR patients (n = 20)	Non-SVR patients (n = 37)	P
Parameters before interferon treatment
Age (yr)	64.0 ± 0.71	63.8 ± 0.73	0.6637
Sex (male:female)	16:4	18:19	0.0262
Body mass index	23.3 ± 0.56	23.6 ± 0.53	0.3973
Viral load (kirocopies/mL)	1500	1800	0.3616
ALT (IU/L)	94.5 ± 31.1	76.6 ± 11.0	0.3038
WBC (/μL)	5119 ± 313	4832 ± 223	0.3798
Hemoglobin (g/dL)	14.1 ± 0.23	14.1 ± 0.19	0.8473
Platelet (× 103/μL)	173 ± 12.4	151 ± 7.9	0.1434
Parameters associated with treatment
EVR	13/18 (72.2%)	7/32 (21.9%)	0.0008
Cumulative exposure to peg-IFN
12 wk (≥ 80%/< 80%)	16/17 (94.1%)	20/33 (60.6%)	0.0183
Overall (≥ 80%/< 80%)	15/17 (88.2%)	14/33 (42.4%)	0.0023
Cumulative exposure to RBV
12 wk (≥ 80%/< 80%)	14/20 (70%)	20/34 (58.8%)	0.5612
Overall (≥ 80%/< 80%)	8/20 (40%)	13/34 (38.2%)	> 0.9999

ALT: Alanine aminotransferase; WBC: White blood cell; EVR: Early virological response; Peg-IFN: Pegylated interferon; RBV: Ribavirin.