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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