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

Table 1 Demographic, virological and histological data of patients included in the trial n (%)

		Control group	Group E6	Group E9	Group L6	Group L9
Demographics1 and virological response
		n = 30	n = 16	n = 16	n = 15	n = 15
Age (yr)	mean ± SD	48.5 ± 7.4	47.4 ± 9.1	42.6 ± 7.9	47.3 ± 7.5	45.3 ± 7.3
Sex	Feminine	12 (40)	11 (68.8)	8 (50.0)	11 (73.3)	9 (60)
	Masculine	18 (60)	5 (31.3)	8 (50.0)	4 (26.7)	6 (40)
Body Mass Index	mean ± SD	26.7 ± 2.8	24.8 ± 3.5	28.6 ± 4.6	25.3 ± 5.0	24.9 ± 4.4
Race	White	16 (53.3)	12 (75.0)	11 (68.8)	10 (66.7)	8 (53.3)
	Black	4 (13.3)	3 (18.8)	3 (18.8)	4 (26.7)	3 (20.0)
	Mixed	10 (33.3)	1 (6.3)	2 (12.5)	1 (6.7)	4 (26.7)
Response to treatment2	cEVR	18 (60.0)	10 (62.5)	9 (56.3)	7 (46.7)	4 (26.7)
	SVR	14 (46.7)	8 (50)	8 (50)	7 (46.7)	2 (13.3)
Histology3
Week 0	n	30	16	16	15	15
Necroinflammation	mean ± SD	6.7 ± 3.6	6.4 ± 3.2	6.1 ± 3.3	5.1 ± 3.4	7.0 ± 4.1
Fibrosis		1.6 ± 1.4	1.9 ± 1.3	1.4 ± 1.4	1.6 ± 1.3	2.3 ± 1.8
Week 72	n	19	13	14	9	8
Necroinflammation	mean ± SD	3.3 ± 2.5	3.8 ± 2.2	3.2 ± 2.8	4.9 ± 3.0	5.6 ± 3.2
Fibrosis		1.3 ± 1.5	2.1 ± 1.3	1.1 ± 1.3	2.1 ± 1.6	2.5 ± 1.6

¹Corresponding to baseline;

²By intention to treat;

³According to Ishak score[17]. cEVR: Complete early viral responders; SVR: Sustained viral responders.