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 (≥10^{3} copies/mL) were enrolled during January 2011 to June 2015. Forty-three high viraemic patients (≥10^{6} copies/mL) received telbivudine in the 2^{nd} or 3^{rd} trimester according to their intention, while 89 high viraemic and 79 low viraemic (≥10^{3} and <10^{6} 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.