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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