Safety and Efficacy of Antiviral Therapy for Chronic Hepatitis B Throughout Entire Pregnancy

Abstract

Background: The data of antiviral therapy throughout the entire pregnancy are relatively scarce. The aim of the present study was to evaluate the safety and efficacy of antiviral therapy for chronic HBV infection throughout the entire pregnancy.Methods: This was a single-center, prospectively study. Fifty-five women received antiviral therapy (TDF or LDT) from pre-conception to the entire pregnancy. Sixty-four women did not receive antiviral therapy during pre-conception and the entire pregnancy. All infants in the two groups had received immunoprophylaxis on schedule. Mother-infant pairs were followed up at least 7 months postpartum. The outcome was the safety and efficacy of antiviral therapy for mothers and offspring.Findings: All mothers tolerated antiviral therapy (TDF or LDT) well. The mean maternal HBV DNA level in the antiviral therapy group was less than that of the control group before delivery as well as in the three months postpartum (PP=0.010). However, in 3 months postpartum, there was not a statistically significant difference in the maternal serum ALT level between the two groups (P=0.185). There was not a statistically significant difference in the pregnancy complications, the gestational weeks, and the mode of delivery between the two groups, respectively (P>0.05). Furthermore, there was not a statistically significant difference in the birth weight, the birth length, and the congenital diseases of infants between the two groups, respectively (P>0.05). In 7 months postpartum, none of infants who tested HBV status in the two groups was positive for HBsAg.Interpretation: Antiviral therapy (TDF or LDT) from pre-conception to the entire pregnancy could be safe and effective for pregnant women with HBV infection and their fetuses/ infants.Trial Registration: The present study was registered in ClinicalTrials.gov (No. NCT03181607).Funding Statement: The present study was funded by the National Key Research and Development Program of China (2017YFC1001402, 2018YFC1002900), National Natural Science Foundation of China (81401306, 81830045), Clinical Research Project of Guangzhou Medical University (No. 2017[160]) and Sino-German Center for Research Promotion (SGC)'s Rapid Response Funding Call for Bilateral Collaborative Proposals between China and Germany in COVID-19 Related Research (No. C-0032).Declaration of Interests: All authors declare no financial, potential personal or commercial conflict of interest.Ethics Approval Statement: The present study was approved by the Institutional Ethics Committee of the Third Affiliated Hospital of Guangzhou Medical University, and was carried out in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. Informed written consent was obtained from each participant in the present study.