Table 1 Baseline characteristics and SVR12 rates in patients started on treatment through the EAP and patients started on treatment outside the EAP
Variable | All patients (n = 105) | Treated through the EAP (n = 53) | Treated outside the EAP (n = 52) | P value |
|---|---|---|---|---|
Gender, female (n, %) | 31 (29.5) | 15 (28.3) | 16 (30.8) | 0.782 |
Age, years (median, IQR) | 52 (10) | 53 (9) | 50 (7) | 0.010 |
Age, <52 years (n, %) | 46 (43.8) | 18 (34.0) | 28 (53.8) | 0.04 |
Ethnicity | ||||
White/Caucasian (n, %) | 86 (81.9) | 45 (84.9) | 41 (78.8) | 0.298 |
Black (n, %) | 6 (5.7) | 3 (90.6) | 3 (5.8) | 0.981 |
Other (n, %) | 13 (12.3) | 5 (9.5) | 8 (15.4) | 0.355 |
Liver fibrosis | ||||
Non-advanced, i.e. METAVIR F0-F2 (n, %) | 55 (52.4) | 24 (45.3) | 31 (59.6) | 0.141 |
Advanced, i.e. METAVIR F3 or F4 (n, %) | 50 (47.6) | 29 (54.7) | 21 (40.4) | |
Previous HCV treatment | ||||
Naïve | 29 (27.6) | 6 (11.3) | 23 (44.2) | 0.001 |
Interruption due to side effects | 5 (4.8) | 2 (3.8) | 3 (5.8) | 0.631 |
Viral breakthrough | 7 (6.7) | 6 (11.3) | 1 (1.9) | 0.113 |
Relapser | 33 (31.4) | 18 (34.0) | 15 (28.8) | 0.572 |
Partial responder | 8 (7.6) | 5 (9.4) | 3 (5.8) | 0.479 |
Null responder | 23 (21.9) | 16 (30.2) | 7 (13.5) | 0.038 |
HCV protease inhibitor | ||||
Boceprevir (n, %) | 17 (16.2) | 11 (20.7) | 6 (11.6) | 0.200 |
Telaprevir (n, %) | 88 (83.8) | 42 (79.3) | 46 (88.4) | |
HCV genotype | ||||
1a | 45 (42.9) | 24 (45.3) | 21 (40.4) | 0.281 |
1b | 43 (40.9) | 18 (34.0) | 25 (48.1) | |
1 non-subtyped | 17 (16.2) | 11 (20.7) | 6 (11.5) | 0.290 |
HCV viral load, IU/mL (median, IQR) | 1,833,451 (3,459,687) | 1,893,740 (3,480,802) | 1,588,705 (3,024,102) | 0.423 |
HCV viral load, <800,000 IU/mL (n, %) | 30 (28.5) | 14 (26.4) | 16 (30.8) | 0.621 |
IL28B rs12979860 genotype | ||||
CC (n, %) | 23 (21.9) | 8 (15.1) | 15 (28.8) | 0.088 |
CT (n, %) | 67 (63.8) | 37 (69.8) | 30 (57.7) | 0.196 |
TT (n, %) | 15 (14.3) | 8 (15.1) | 7 (13.5) | 0.811 |
IL28B rs8099917 genotype | ||||
TT (n, %) | 45 (42.8) | 22 (41.5) | 23 (44.2) | 0.778 |
GT (n, %) | 51 (48.6) | 28 (52.8) | 23 (44.2) | 0.378 |
GG (n, %) | 9 (8.6) | 3 (5.7) | 6 (11.6) | 0.319 |
SVR12 to triple therapy | 69 (65.7) | 32 (60.4) | 37 (71.2) | 0.245 |