Safety and efficacy of lamivudine or telbivudine started in early pregnancy for mothers with active chronic hepatitis B
Few data exist regarding use of nucleos(t)ide analogs started in early pregnancy for mothers with active chronic hepatitis B (CHB). We assessed the safety and efficacy of lamivudine/telbivudine initiated in the first trimester versus no treatment in mothers with active CHB.
We retrospectively enrolled 94 mothers newly diagnosed with active CHB in the first trimester of pregnancy. Patients with or without antiviral therapy were followed until postpartum week 28. All newborns received immunoprophylaxis. The primary endpoint was the safety of mothers and infants. The secondary endpoints were hepatitis B virus (HBV) DNA suppression and mother-to-child transmission (MTCT) rate.
Fifty-nine of the 94 mothers initiated lamivudine/telbivudine (27/32) in the first trimester of pregnancy; 35 received no treatment. At delivery, the viral load reduction was similar between lamivudine and telbivudine. Early initiation of lamivudine/telbivudine significantly increased the proportion of mothers achieving HBV DNA <106 copies/ml compared with those with no treatment (100 versus 42.42 %, p < 0.001). At postpartum week 28, the MTCT rate was significant lower in the treated group than in the control group (0/61 or 0 versus 4/34 or 11.76 %, p = 0.028). Lamivudine and telbivudine were well tolerated in the mothers except mild creatine kinase (CK) elevation. There existed no differences in gestational age, infant length and weight, Apgar score, adverse events, or birth defect rates between infants from treated and untreated mothers.
Treatment with lamivudine or telbivudine for active CHB in early pregnancy appears to be safe and effective for controlling maternal disease as well as interrupting MTCT.
KeywordsChronic hepatitis B Lamivudine Telbivudine Early Mother-to-child transmission
Chronic hepatitis B
Food and drug administration
Gestational diabetes mellitus
Hepatitis B immunoglobulin
Hepatitis B e antigen
Hepatitis B surface antigen
Hepatitis B virus
Hemolysis disease of newborn
Human immunodeficiency virus
Low birth weight
Lower limit of quantitation
Polymerase chain reaction
Upper limit of normal
The authors thank Dr. Yameng Sun and Dr. Yiwen Shi (Beijing Friendship Hospital, Capital Medical University, China) for statistical advice and assistance. This study was funded by Beijing Municipal Science and Technology Commission for the category of “Capital clinical characteristics applied research” (no. Z141107002514131).
Drs. He TY, Ou XJ, Cai HD, and Jia JD contributed fully to the study conception and design. Drs. Yi W, Liu M, and Cai HD contributed fully to the data collection and project supervision. Drs. He TY, Bai YQ, and Jia JD contributed fully to the manuscript writing.
This study was funded by a grant from Beijing Municipal Science and Technology Commission for the category of “Capital clinical characteristics applied research” (no. Z141107002514131).
Compliance with ethical standards
Conflict of interest
Jidong Jia received lecture fee and consultation fee from BMS, MSD, and Novartis pharmaceutical companies in the last 2 years. Tianyu He, Yuqing Bai, Haodong Cai, Xiaojuan Ou, Min Liu, and Wei Yi declare that they have no conflicts of interest.
The study protocol was approved by the medical ethics committee of Beijing Ditan Hospital, and informed consent was waived (no. BJDTEC-37). The current study complied with the Helsinki Declaration.
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