Infection of hepatitis B virus (HBV) occurs in ~10% of infants of HBV-infected mothers with positive hepatitis B e antigen (HBeAg) after immunoprophylaxis. We aimed to evaluate the safety and efficacy of telbivudine used during late pregnancy for preventing mother-to-child transmission of HBV. We conducted a multicenter prospective cohort study in 5 hospitals from 2012 to 2014, which enrolled HBV-infected singleton pregnant women with positive HBeAg. By their choice, women were divided into therapy (telbivudine 600 mg/day, from gestation 28-32 weeks to 3-4 weeks postpartum) and control (no antiviral agent) groups. Infants received passive-active immunoprophylaxis and follow-up at the age of 7-14 months. Totally, 328 pregnant women were included: 149 in the telbivudine group and 179 in the control group. Baseline HBV DNA levels were similar in the 2 groups (7.43 vs 7.37 log IU/mL, P = .711). At delivery, HBV DNA levels in the telbivudine and control groups were 3.80 and 7.26 log IU/mL, respectively (P < .0001). Of the infants, 128 (85.9%) in the telbivudine group and 156 (87.2%) in the control group were followed up. No infant in the telbivudine group had chronic infection, while 2 (1.28%) infants in the control group did (P = .503). Three (2.34%) infants in the telbivudine group, but none in the control group, had severe congenital or developmental abnormalities (P = .090). The data indicate that telbivudine may block perinatal HBV transmission. However, larger studies are required to clarify whether anti-HBV therapy in pregnancy is associated with severe adverse effects in the foetuses and infants.

Abstract Background Passive-active immunoprophylaxis against mother-to-child transmission (MTCT) of hepatitis B virus (HBV) recommends administer hepatitis B immunoglobulin (HBIG) and birth dose hepatitis B vaccine in infants within 12 or 24 hours after birth. With this protocol, MTCT of HBV still occurs in 5–10% infants of HBV-infected mothers with positive hepatitis B e antigen (HBeAg). Methods The present study aimed to investigate whether earlier administration of HBIG and hepatitis B vaccine after birth can further increase the protection efficacy. Results Totally, 1140 HBV-infected pregnant women were enrolled, and 982 infants (9 twins) of 973 mothers were finally followed up at 9.6 ± 1.9 months age. HBIG and birth dose vaccine were administered in newborn infants with a median 0.17 hour (0.02–1.0) after birth. The overall rate of MTCT was 0.9% (9/982), with none (0%) of 607 infants of HBeAg-negative mothers and 9 (2.4%) of 375 infants of HBeAg-positive mothers. All nine HBV-infected infants were born to mothers with HBV DNA &gt;2.75×106 IU/ml. Maternal HBV DNA levels &gt;1×106 IU/ml was an independent risk factor (OR = 10.627, 95% CI: 2.135–+∞) for immunoprophylaxis failure. Conslusions Earlier use (within one hour after birth) of HBIG and hepatitis B vaccine can provide better protection efficacy against MTCT of HBV.

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