Triple therapy of interferon and ribavirin with zinc supplementation for patients with chronic hepatitis C: A randomized controlled clinical trial

Table 1 Comparison of clinical data of patients with chronic hepatitis C who received dual or triple therapy

	Triple therapygroup	Dual therapygroup	P value
Demography
Male/Female	24/26	38/14	0.0151
Agea (yr)	57±23 (27-69 )	53.8±9.8 (23-70)	NS2
Body weighta (kg)	60.5±9.8 (35-93)	63.5±12.4 (35-93)	NS2
BMIa (kg/m2)	23.5±3.1	23.4±2.1	NS2
Naïve/Retreatment	34/15	40/11	NS1
Biochemistry
HCV RNA (kcopy/mL)	700 (100-1490)	720 (110-2310)	NS2
ALTa (U/L)	95.6±61.1	97.4±59.8	NS2
Ferritina	216.8±244.4	214±139.6	NS2
Serum zinca (μg/dL)	73.3±20.3	69.8±17.2	NS2
Histopathology
F 0/1/2/3/4	3/12/23/10/1	1/20/15/13/1	NS1
A 1/2/3	26/20/2	20/24/5	NS1

^aData are mean ± SE and (range).

¹ Fisher’s exact test.

² Wilcoxon NS, not significant.

Table 2 Virological response rates for dual and triple therapy groups at different weeks (w) after commencement of each treatment

HCV RNA(kcopy/mL)	Triple therapy group				Dual therapy group
	1wk	4wk	24wk	48wk	1wk	4wk	24wk	48wk
>500	1/17	13/21	21/26	5/26	1/20	10/20	25/26	7/26
	5.9%	61.9%	69.2%	19.2%	5.0%	50.0%	96.2%	26.9%
					NS	NS	NS	NS
100-499	4/8	10/12	13/13	8/13	2/9	6/8	13/13	6/13
	50.0%	83.3%	100%	61.5%	22.2%	75.0%	100%	46.2%
					NS	NS	NS	NS
All patients	5/25	23/33	34/39	13/39	3/29	16/28	38/39	13/39
	20.0%	69.7%	87.2%	33.3%	10.3%	57.1%	97.4%	33.3%
					NS	NS	NS	NS

Fisher’s exact test. NS, not significant.

Table 3 The logistic multiple regression model

Variable	Odds ratio	95%CI	P-value
HCV RNA (kcopy/mL)
<500	1.000	0.014-0.690	0.0197
≥500	0.097
Body weight (kg)
<64	1.000	0.931-63.301	0.0583
≥64	7.677
Pre-treatment platelet count (×104/μL)
<16	1.000	0.032-1.909	0.1798
≥16	0.246

CI: confidence interval

Table 4 Summary of adverse events n (%)

	Triple therapy group	Dual therapy group
Fever	35 (89.7)	38 (97.4)	NS
Anorexia	26 (66.7)	25 (64.1)	NS
Fatigue	24 (61.5)	22 (59.0)	NS
Arthralgia	20 (51.3)	18 (46.1)	NS
Eczema	16 (41.0)	13 (33.3)	NS
Nausea	14 (35.9)	13 (33.3)	NS
Abdominal discomfort	8 (20.5 )	18 (46.2)	P < 0.019
Stomatitis	13 (33.3)	12 (30.8)	NS
Headache	11 (28.2)	14 (35.9)	NS
Hair loss	12 (30.8)	7 (17.9)	NS
Psychosomatic	3 (7.7)	1 (2.6)	NS

Fisher’s exact test. NS, not significant.

Table 5 Laboratory abnormalities

	Triple therapy group	Dual therapy group
Decrease in WBC (<2 000 μL)	5	5	NS
(<1 500 μL)	1	0	NS
Decrease in hemoglobin (> 10 g/dL)	13	14	NS
(>8.5 g/dL)	3	4	NS
Decrease in platelet count (<50 000 μL)	1	3	NS
IFN dose reduction	9	10	NS
Ribavirin dose reduction	15	17	NS

Fisher’s exact test. NS, not significant.

Table 6 Reasons for withdrawal from the study

Causes	Triple therapy group	Dual group therapy Causes Triple therapy group
Anemia	2	3	NS
Psychosomatic	3	4	NS
Anorexia & Fatigue	2	3	NS
HCC1	1	0	NS
Dizziness	0	1	NS
Lost to follow-up	3	2	NS
Total	11	13	NS

Fisher’s exact test. NS, not significant.

¹Hepatocellular carcinoma was detected during the treatment.