Table 3 HBsAg and HBV DNA at baseline and day 29 in patients with CHB (full analysis 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)

Baseline HBsAg (log10 IU ml−1)

 n

6

12

6

5

2

Mean (s.d.)

3.57 (1.244)

3.89 (1.056)

3.21 (1.304)

2.78 (0.363)

3.77 (1.018)

Day 29 HBsAg (log10 IU ml−1), LOCF

 n

6

12

6

5

2

 Mean (s.d.)

3.06 (1.580)

2.34 (2.232)

3.21 (1.237)

0.79 (2.118)

3.76 (0.979)

Change from baseline to day 29 in HBsAg (log10 IU ml−1), LOCF

 n

6

12

6

5

2

 Mean (s.d.)

–0.50 (0.566)

–1.56 (1.379)

0.00 (0.112)

–1.99 (1.799)

–0.01 (0.039)

 P value (versus placebo)

0.245

0.001

 

0.762

 

Baseline HBV DNA (log10 IU ml−1)

n

6

12

6

5

2

Mean (s.d.)

7.41 (1.396)

6.77 (1.892)

5.57 (2.121)

<1.30 (0.000)

<1.30 (0.000)

Day 29 HBV DNA (log10 IU ml−1), LOCF

n

6

12

6

5

2

Mean (s.d.)

7.03 (1.451)

5.12 (3.073)

5.57 (2.429)

1.37 (0.167)

<1.30 (0.000)

Change from baseline to day 29 in HBV DNA (log10 IU ml−1), LOCF

n

6

12

6

5

2

Mean (s.d.)

–0.38 (0.420)

–1.66 (1.479)

0.00 (0.471)

0.08 (0.167

0.00 (0.000)

P value (versus placebo)

0.116

<0.001

 

NA

 
  1. Baseline was the last nonmissing measurement before the first dose of the study drug. The last observation carried forward (LOCF) method was used to impute missing values. Comparison between bepirovirsen and pooled placebo was performed for each dose level separately using an analysis of covariance model with baseline as a covariate and treatment group as a factor. All comparisons were prespecified with no adjustment for multiple comparisons. Two-sided P values are presented.
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