Clinical course and perinatal transmission of chronic hepatitis B during pregnancy: A real-world prospective cohort study.

OBJECTIVE: To determine the clinical course and perinatal transmission of chronic hepatitis B during pregnancy in a real life setting.

METHODS: A total of 221 singleton pregnant women with detectable HBV-DNA levels (≥103 copies/mL) were enrolled during January 2011 to June 2015. Forty-three high viraemic patients (≥106 copies/mL) received telbivudine in the 2nd or 3rd trimester according to their intention, while 89 high viraemic and 79 low viraemic (≥103 and <106 copies/mL) patients were the control cohorts. Primary endpoint was the pregnancy outcomes and secondary endpoint the perinatal transmission including intrauterine infection, immunoprophylaxis failure and occult infection.

RESULTS: In all, 209 patients completed pregnancy with 209 infants, while 2 in telbivudine-treated cohort had unexplained late stillbirths. Twenty-nine (70.7%) of telbivudine-treated patients and 3 (3.4%) of untreated high viraemic controls achieved undetectable HBV-DNA levels prior delivery. At 7 months postpartum, immunoprophylaxis failure was significantly lower (2.4%) in telbivudine-treated cohort, compared with 16.9% and 10.1% in untreated high and low viraemic cohorts, respectively.

CONCLUSIONS: Low viraemic patients may also need antiviral therapy since they bear moderate risk for perinatal transmission of HBV. However, more multicenter, large-scale studies are required before antepartum antiviral therapy is routinely recommended in patients with detectable viral loads.