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Table 2 Antiviral responses after 48 and 96 weeks of treatment (FAS)

From: Switching from entecavir to tenofovir disoproxil fumarate for HBeAg-positive chronic hepatitis B patients: a phase 4, prospective study

Key efficacy endpoints Baseline Week 48 Week 96
Positive HBsAg at baseline (N = 74)
 Participants achieving 0.25 log10 HBsAg reduction from baseline
  HBsAg ≤ −0.25 log10, n (%), [95% CI] 3 (4), [0.8, 11.4] 9 (12), [5.7, 21.8]
 Participants achieving HBsAg seroclearance   0 0
 Participants achieving HBsAg/anti-HBs seroconversiona   0 0
 Change from baseline in HBsAg (log10 IU/mL)    
  Mean (SD), [95% CI] 3.52 (0.46), [3.41, 3.62]b −0.11 (0.08), [−0.13, −0.10]c −0.14 (0.12), [−0.17, −0.11]a
Positive HBeAg at baseline (N = 69)
 Participants achieving HBeAg seroclearance, n (%)   8 (12) 17 (25)
 Participants achieving HBeAg/anti-HBe seroconversion,d n (%)   7 (13) 13 (25)
Change from baseline in HBcrAg (N = 74), (log10 U/mL)
 Mean (SD), [95% CI] 5.53 (0.54), [5.40, 5.65]b −0.17 (0.29), [−0.23, −0.10]c −0.30 (0.36), [−0.38, −0.22]a
Change from baseline in HBV-DNA (N = 74), (log10 IU/mL)
 Mean (SD), [95% CI] 0.92 (0.12), [0.89, 0.95]b −0.02 (0.10), [−0.04, 0.01]c −0.02 (± 0.12), [−0.05, 0.01]a
  1. Anti-HBe anti-hepatitis B e-antibody, FAS full analysis set, Anti-HBs hepatitis B surface antibody, CI confidence interval, HBeAg hepatitis B e-antigen, HBcrAg hepatitis B core-related antigen, HBsAg hepatitis B surface antigen, HBV hepatitis B virus, SD standard deviation, TDF tenofovir disoproxil fumarate
  2. aThe mean and SD baseline values are absolute values
  3. bN = 74
  4. cN = 73
  5. dHBeAg/Ab seroconversion was analyzed in the 53 participants who were HBeAg-positive and anti-HBe-negative at baseline