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Table 1 Patient demographics and background disease characteristics

From: IL28B genotype is associated with cirrhosis or transition to cirrhosis in treatment-naive patients with chronic HCV genotype 1 infection: the international observational Gen-C study

  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)  
  1. ALT alanine transaminase, IL28B interleukin-28B, ITPA inosine triphosphate pyrophosphatase
  2. 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
  3. bPercentages calculated for patients with available data only
  4. cALT ratio is ALT divided by upper limit of normal range
  5. dIncludes HCV RNA categories reported as ≤800,000 or >800,000 IU/mL
  6. eJonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories
  7. fCochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories
  8. gPearson Chi square test