Table 1.
Patient demographics and background disease characteristics
| IL28B rs12979860 genotype | ||||
|---|---|---|---|---|
| CC (n = 978) | CT (n = 1518) | TT (n = 420) | P valuee | |
| Mean age, years ± SD | 46.8 ± 13.6 | 47.3 ± 13.2 | 46.8 ± 12.6 | 0.6973e |
| G1 (n = 1702) | 47.9 ± 13.3 | 48.5 ± 13.2 | 48.1 ± 12.2 | 0.6602e |
| G2 (n = 323) | 54.7 ± 13.1 | 55.1 ± 12.6 | 51.1 ± 15.9 | 0.5182e |
| G3 (n = 574) | 39.2 ± 9.8 | 39.6 ± 10.3 | 39.0 ± 9.4 | 0.6864e |
| G4 (n = 260) | 45.5 ± 13.2 | 44.3 ± 10.2 | 46.0 ± 10.4 | 0.7789e |
| Male, n (%) | 582 (59.5) | 802 (52.8) | 224 (53.3) | 0.0049f |
| Ethnic origin, n (%) | <0.0001g | |||
| Asian | 89 (9.1) | 83 (5.5) | 9 (2.1) | |
| Black | 5 (0.5) | 24 (1.6) | 19 (4.5) | |
| Caucasian | 860 (87.9) | 1349 (88.9) | 373 (88.8) | |
| Othera | 24 (2.5) | 62 (4.1) | 19 (4.5) | |
| Region, n (%) | <0.0001g | |||
| Asia | 78 (8.0) | 66 (4.3) | 8 (1.9) | |
| Europe | 721 (73.7) | 1095 (72.1) | 303 (72.1) | |
| Middle East | 138 (14.1) | 272 (17.9) | 75 (17.9) | |
| Latin America | 41 (4.2) | 85 (5.6) | 34 (8.1) | |
| BMI, kg/m2, mean ± SD | 25.8 ± 4.4 | 26.0 ± 4.5 | 26.0 ± 4.7 | 0.2617e |
| HCV genotype, n (%) | <0.0001g | |||
| Known genotype | 957 (97.9) | 1501 (98.9) | 414 (98.6) | |
| G1b | 500 (52.2) | 930 (62.0) | 272 (65.7) | |
| G2b | 126 (13.2) | 160 (10.7) | 37 (8.9) | |
| G3b | 232 (24.2) | 277 (18.5) | 65 (15.7) | |
| G4b | 92 (9.6) | 129 (8.6) | 39 (9.4) | |
| G5/6b | 7 (0.7) | 5 (0.3) | 1 (0.2) | |
| Unknown/missing | 21 (2.1) | 17 (1.1) | 6 (1.4) | |
| Duration of HCV infection, mean years ± SD | 14.0 ± 12.3 | 14.0 ± 12.6 | 13.0 ± 12.4 | 0.1860e |
| G1 (n = 1615) | 14.8 ± 13.1 | 14.5 ± 13.0 | 12.7 ± 12.5 | 0.0536e |
| G2 (n = 303) | 16.6 ± 12.9 | 15.9 ± 13.5 | 16.6 ± 15.8 | 0.5129e |
| G3 (n = 552) | 10.9 ± 9.6 | 11.8 ± 10.7 | 11.3 ± 8.5 | 0.4443e |
| G4 (n = 249) | 13.7 ± 10.6 | 13.1 ± 10.4 | 14.8 ± 13.8 | 0.9733e |
| HIV–HCV co-infection, n (%) | 38 (3.9) | 49 (3.2) | 15 (3.6) | 0.6000f |
| Autoimmune disease, n (%) | 23 (2.4) | 46 (3.0) | 6 (1.4) | 0.6433f |
| Liver disease other than CHC, n (%) | 34 (3.5) | 35 (2.3) | 13 (3.1) | 0.3728f |
| Glucose intolerance/diabetes, n (%) | 73 (7.5) | 125 (8.2) | 33 (7.9) | 0.6614f |
| Alcohol consumption, mean units/week ± SD | 1.83 ± 8.7 | 1.10 ± 5.2 | 0.87 ± 3.5 | 0.1423e |
| Previous/current drug use/methadone or substitute therapy, n (%) | 289 (29.6) | 361 (23.8) | 96 (22.9) | 0.0013f |
| Smoking, n (%)b | 0.0070g | |||
| Never | 496 (50.9) | 887 (58.5) | 230 (54.9) | |
| Previous | 141 (14.5) | 192 (12.7) | 56 (13.4) | |
| Current | 338 (34.7) | 438 (28.9) | 133 (31.7) | |
| ITPA rs1127354, CC, n (%) | 818 (83.6) | 1338 (88.1) | 372 (88.6) | 0.0020f |
| ITPA rs7270101, AA, n (%) | 793 (81.1) | 1254 (82.6) | 342 (81.4) | 0.6563f |
| Mean ALT, IU/L ± SD | 104.1 ± 103.5 | 83.4 ± 79.2 | 72.9 ± 63.8 | <0.0001e |
| Mean ALT ratio ± SDc | 2.28 ± 2.07 | 1.88 ± 1.55 | 1.65 ± 1.31 | <0.0001e |
| G1 (n = 1671) | 2.09 ± 1.94 | 1.77 ± 1.38 | 1.63 ± 1.30 | 0.0007e |
| G2 (n = 312) | 2.42 ± 2.58 | 1.96 ± 1.96 | 1.21 ± 0.829 | 0.0061e |
| G3 (n = 565) | 2.80 ± 2.15 | 2.32 ± 1.91 | 2.05 ± 1.62 | <0.0001e |
| G4 (n = 247) | 2.00 ± 1.75 | 1.66 ± 1.11 | 1.65 ± 1.09 | 0.3885e |
| Mean HCV RNA, log10 IU/mL ± SD | 5.94 ± 0.99 | 5.83 ± 0.81 | 5.68 ± 0.83 | <0.0001e |
| HCV RNA > 800,000 IU/mL, n (%)bd | 607/959 (63.3) | 764/1498 (51.0) | 179/416 (43.0) | <0.0001f |
| G1 | 320/495 (64.6) | 493/921 (53.5) | 116/268 (43.3) | <0.0001f |
| G2 | 81/124 (65.3) | 80/157 (51.0) | 23/37 (62.2) | 0.1853 |
| G3 | 152/231 (65.8) | 131/276 (47.5) | 22/65 (33.8) | <0.0001 |
| G4 | 44/92 (47.8) | 53/128 (41.4) | 14/39 (35.9) | 0.1792 |
| Assessment of cirrhosis, n (%) | 0.0723g | |||
| Biopsy | 295 (30.2) | 419 (27.6) | 114 (27.1) | |
| Noninvasive | 646 (66.0) | 1046 (68.9) | 289 (68.8) | |
| Both | 37 (3.8) | 46 (3.0) | 12 (2.9) | |
| None | 1 (0.1) | 7 (0.5) | 5 (1.2) | |
| Fibrosis stage (biopsy or noninvasive), n (%) | ||||
| Assessment made | 976 (99.8) | 1511 (99.5) | 415 (98.8) | |
| Cirrhosis/transition to cirrhosisb | 248 (25.4) | 390 (25.8) | 119 (28.7) | 0.2702f |
| No cirrhosisb | 728 (74.6) | 1121 (74.2) | 296 (71.3) | |
| Missing | 2 (0.2) | 7 (0.5) | 5 (1.2) | |
ALT alanine transaminase, IL28B interleukin-28B, ITPA inosine triphosphate pyrophosphatase
aEthnic origin was selected from a drop-down menu in the CSR; “Other” may include patients who are Hispanic, Latino, or identified themselves as Mixed Race
bPercentages calculated for patients with available data only
cALT ratio is ALT divided by upper limit of normal range
dIncludes HCV RNA categories reported as ≤800,000 or >800,000 IU/mL
eJonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories
fCochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories
gPearson Chi square test