Randomized controlled trial of consensus interferon with or without zinc for chronic hepatitis C patients with genotype 2

Table 1 Characteristics of participating patients

	RegimenAIFN+zinc)	RegimenB (CIFN)	P
Number of entry	41	42
Male/Female	28/13	21/21	NS
Age (yr)	60±8.5	55±21	NS
Body mass index	23±2.4	24±3.7	NS
Pre-treatment zinc concentration (μg/dl)	77.8±13.6	82.5±16.4	NS
Pre-treatment ALT (IU/l)	113±75	101±96	NS
Pre-treatment leukocyte counts (x103mm-3)	5.1±1.3	5.0±1.4	NS
Pre-treatment platelet counts (x103mm-3)	19±5	17±5	NS
Pre-treatment HCV-RNA genotype (2A/2B)	31/10	31/11	NS
Pre-treatment HCV-RNA titer (KIU/mL)	484±1075	304±318	NS
0<pretreatment HCV-RNA<100	11	16	NS
100 ≤pretreatment HCV-RNA<400	15	14	NS
400 ≤pretreatment HCV-RNA<700	6	2	NS
700 ≤pretreatment HCV-RNA	9	9	NS
Histological findings (staging)	1.8±1	1.3±0.8	NS
Histological findings (grading)	1.6±0.7	1.3±0.9	NS

Mean±SD; NS: not significant

Table 2 Effect on viremia and serum transaminases

	Regimen A(CIFN+zinc)	RegimenB (CIFN)	P
ALT (U/l):
Wk 0	113±75	101±96	NS
Wk 24	46±51	40±30	NS
Wk 48	26±17	22±12	NS
Biochemical response (by intention to treat):
Wk 24 (EBR)	46%	50%	NS
Wk 48 (SBR)	68%	69%	NS
Virological response (by intention to treat):
Wk 24 (EVR)	68%	76%	NS
Wk 48 (SVR)	54%	67%	NS

Mean±SD; EBR: End-of treatment biochemical response; SBR: Sustained biochemical response; EVR: End-of treatment virological response; SVR: Sustained virological response; NS: not significant

Table 3 Logistic regression model of predictors of response to CIFN treatment

Variables	Odds ratio (95%Confidence Interval)
Zinc supplementation (regimen B vs. A)	0.254 (0.033-1.948)	0.1873
BMI (<23.4 vs. ≥23.4)	1.245 (0.162-9.579)	0.8330
Staging (0-1 vs. 2-3)	0.213 (0.024-1.877)	0.1635
pretreatment HCV-RNA (<400 vs. ≥400)	0.104 (0.011-0.951)	0.0450
Week of HCV-RNA clearance (<8 vs. ≥8)	0.106(0.005-2.399)	0.1584
pretreatment ALT (<107 vs. ≥107)	13.709 (0.960-195.749)	0.1873

Table 4 Incidence of selected adverse events (>10% frequency)

Adverse event	RegimenA(CIFN+zinc)	Regimen B(CIFN)
n	41	42
Fever	41 (100%)	42 (100%)
Headache	17 (41.5%)	16 (38.1%)
Malaise	15 (36.6%)	12 (28.6%)
Anorexia	14 (34.1%)	19 (45.2%)
Arthralgia	14 (34.1%)	13 (31.0%)
Insomnia	11 (26.8%)	11 (26.2%)
Stomach discomfort	7 (17.1%)	5 (11.9%)
Alopecia	6 (14.6%)	6 (14.3%)
depression	6 (14.6%)	5 (11.9%)
Nausea	6 (14.6%)	5 (11.9%)
Myalgia	5 (12.2%)	6 ( 14.3%)
Rash	5 (12.2%)	4 (9.5%)

Table 5 Incidence of selected laboratory abnormalities (>10% frequency)

Laboratory abnormality	Regimen A(CIFN+zinc)	Regimen B(CIFN)
n	41	42
Thrombocytopenia	31 (78%)	29 (69%)
Leucopenia	24 (59%)	30(71%)
Increase in AST	20 (49%)	18 (43%)
Increase in ALT	18 (44%)	16 (38%)
Increase in γ-GTP	12 (29%)	12 (29%)
Decrease in hemoglobin	7 (17%)	9 (21%)
Increase in ZTT	7 (17%)	7 (17%)