Table 1 Demographics and baseline characteristics in patients with CHB (safety population)

From: Safety, tolerability and antiviral activity of the antisense oligonucleotide bepirovirsen in patients with chronic hepatitis B: a phase 2 randomized controlled trial

 

Treatment-naïve

On-NA

Bepirovirsen 150 mg (n = 6)

Bepirovirsen 300 mg (n = 12)

Placebo (n = 6)

Bepirovirsen 300 mg (n = 5)

Placebo (n = 2)

Age (years)

 Mean (s.d.)

42.5 (11.22)

42.6 (14.12)

49.3 (12.66)

48.4 (7.40)

37.0 (2.83)

 Range

23, 52

18, 61

34, 69

40, 59

35, 39

Sex, n (%)

 Male

3 (50.0)

4 (33.3)

4 (66.7)

4 (80.0)

1 (50.0)

 Female

3 (50.0)

8 (66.7)

2 (33.3)

1 (20.0)

1 (50.0)

 Height (cm), mean (s.d.)

166.12 (4.673)

165.97 (8.796)

163.52 (4.436)

166.60 (10.188)

166.50 (6.364)

 Weight (kg), mean (s.d.)

66.00 (13.838)

62.25 (9.321)

60.00 (8.199)

66.68 (16.066)

68.60 (4.525)

Race, n (%)

 Asian

6 (100.0)

12 (100.0)

6 (100.0)

5 (100.0)

2 (100.0)

HBsAg (log10 IU ml−1)

 Mean (s.d.)

3.57 (1.244)

3.89 (1.056)

3.21 (1.304)

2.78 (0.363)

3.77 (1.018)

 Median

3.85

4.34

3.08

2.80

3.77

 Min, max

1.75, 4.78

2.03, 5.04

1.82, 5.25

2.24, 3.20

3.05, 4.49

HBeAg status, n (%)

 Positive

5 (83.3)

6 (50.0)

2 (33.3)

0 (0)

0 (0)

 Negative

1 (16.7)

6 (50.0)

4 (67.7)

5 (100.0)

2 (100.0)

HBV DNA (log10 IU ml−1)

 Mean (s.d.)

7.41 (1.396)

6.77 (1.892)

5.57 (2.121)

<1.30 (0.000)a

<1.30 (0.000)a

 Median

7.29

7.20

5.14

<1.30

<1.30

 Min, max

5.98, 9.11

3.93, 8.74

3.67, 9.29

NA

NA

HBsAg genotype, n (%)

 Type B

2 (33.3)

4 (33.3)

2 (33.3)

0

0

 Type C

4 (66.7)

8 (66.7)

4 (66.7)

0

0

 Indeterminate

0

0

0

5 (100.0)b

2 (100.0)b

 Anti-HBs antibody presence, n (%)

1 (16.7)

0

1 (16.7)

0

0

 Anti-HBe antibody presence, n (%)

1 (16.7)

6 (50.0)

4 (66.7)

4 (80.0)

2 (100.0)

ALT (U l−1)

 Mean (s.d.)

53.2 (35.52)

42.9 (31.77)

35.8 (13.29)

20.8 (9.31)

15.0 (7.07)

 Min, max

24, 107

11, 103

22, 51

12, 34

10, 20

AST (U l−1)

 Mean (s.d.)

35.5 (19.56)

33.3 (16.42)

29.8 (13.06)

21.4 (5.64)

17.0 (8.49)

 Min, max

17, 64

15, 65

18, 55

16, 28

11, 23

  1. aBecause all participants in cohort 4 were stably maintained on NA, they had undetectable HBV DNA levels at baseline. This table presents log10 values of either <20 IU ml−1 or ‘target not detected’.
  2. bHistorical data not available and HBV DNA levels were below the LLOQ to establish genotyping.
  3. Anti-HBe antibody, antibody to HBV e antigen; anti-HBs, antibody to HBV surface antigen.
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