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).
1
Not 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.