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Table 2 Summary of 2 clinical trials using tenofovir to reduce mother-to-infant transmission on top of standard immunoprophylaxis

From: Elimination of Hepatitis B: Is It a Mission Possible?

Study

Chen et al. [24]

Pan et al. [25]

Study design

Prospective non-randomized control trial

Prospective randomized control trial

No. of mother

TDF (N = 92), Control (N = 56)

TDF (N = 97), Control (N = 100)

Intervention

TDF vs. Control

TDF vs. Control

Time of intervention

30–32 weeks of gestation

30-32 weeks of gestation

Maternal viral load

≥20,000,000 IU/mL

≥200,000 IU/mL

Maternal HBeAg-positive rate

100%

100%

Mother-to-infant transmission rate

TDF (1.54%) vs. Control (10.71%), P = 0.0481*

Intention-to-treat analysis: TDF (5%) vs. Control (18%), P = 0.007**

Per-protocol analysis: TDF (0%) vs. Control (7%), P = 0.01

  1. Note
  2. TDF tenofovir, HBeAg hepatitis B e antigen
  3. * Defined by HBsAg positivity at 6 months postpartum
  4. ** Defined by serum HBV DNA level of more than 20 IU per milliliter (i.e., above the lower limit of detection) or HBsAg positivity at 28 weeks postpartum. Participants who lost to follow-up or who discontinued treatment were counted as having treatment failure