HCV-specific immune responses induced by CIGB-230 in combination with IFN-α plus ribavirin

Table 5 CIGB-230 administration induces differential courses of cell-mediated immunity in virological responder and non-responder patients under therapy with interferon-α plus ribavirin

Immune response		HCV RNA (-) on week 48			HCV RNA (+) on week 48			HCV RNA (-) on week 72			HCV RNA (+) on week 72
		Week 0	Week 48	P value	Week 0	Week 48	P value	Week 0	Week 48	P value	Week 0	Week 48	P value
CIGB-230 immunized patients
IgG	Core	32193.3	15486.7	0.0001	22068.7	15130.5	ns	32193.3	15486.7	0.003	22920.0	15130.5	0.0041
	E2	272.3	103.5	0.0061	50	295.3	ns	138.8	103.1	ns	254.3	138.7	ns
	NS3	8277.2	2969.1	< 0.0001	7177.4	5555.5	0.006	8013.1	2900.1	0.002	7263.8	5555.5	0.0002
IFN-γ	Core	69.2	15	ns	88.8	57.5	ns	68.8	18.3	ns	76.3	43.5	0.041
	E2	17.4	5.6	ns	10.8	5.8	ns	22.5	5.2	ns	10.8	5.8	ns
	NS3	14.6	2.5	ns	38.8	16.3	ns	15	0	ns	26.3	15.1	ns
SI	Core	1.3	1	ns	1.4	1	ns	1.3	1	0.04	1.4	1	ns
	E2	1	0.9	0.0061	0.9	1.2	ns	1	0.8	ns	0.9	1.2	ns
	NS3	1.2	1	ns	0.9	0.9	ns	1.2	1.1	ns	1.1	0.9	ns
Control patients
IgG	Core	26820.1	9096.3	0.0010	14778.9	10761.0	0.008	28066.9	12800.0	0.002	14778.9	8873.2	0.0005
	E2	85.7	233.1	ns	339.3	94.5	0.040	85.7	185	ns	339.3	155	ns
	NS3	5150.3	2856.7	0.0010	15003.7	10833.1	ns	5150.3	2856.7	0.003	15003.8	8577.9	ns
IFN-γ	Core	78.7	19.1	0.0410	60.3	15.6	ns	80.4	35	ns	60.3	14	0.0200
	E2	39.5	6.6	ns	5	0	ns	36.2	7.5	ns	32.5	2.5	ns
	NS3	35.9	4.1	0.0310	11.6	ne	-	47.7	13	ns	12.9	4.2	ns
SI	Core	0.9	0.8	ns	1.2	0.8	ns	1	0.7	ns	1.1	1	ns
	E2	0.8a	0.8	ns	1.8a	1.4	ns	0.8c	0.7	ns	1.4c	1.4	ns
	NS3	0.8	0.8	ns	1.5	1.1	ns	0.8	0.7	ns	1.2	1.1	ns

Median values are shown. SI: Stimulation index; ns: Not significant; ne: Not evaluated. Differences were considered statistically significant when P < 0.05 (Wilcoxon signed rank test).

¹Not significant when virological relapsers and non-responders were separately analyzed. ^a,cIndicate differences between virological responders and non responders, on both evaluation time points (week 48 and week 72) (P < 0.05, Unpaired t test). HCV: Hepatitis C virus.