Hepatology International

, Volume 12, Issue 2, pp 118–125 | Cite as

Safety and efficacy of lamivudine or telbivudine started in early pregnancy for mothers with active chronic hepatitis B

Original Article
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Abstract

Background

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.

Methods

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.

Results

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.

Conclusions

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.

Keywords

Chronic hepatitis B Lamivudine Telbivudine Early Mother-to-child transmission 

Abbreviations

AE

Adverse event

ALT

Alanine transaminase

CHB

Chronic hepatitis B

CK

Creatine kinase

FDA

Food and drug administration

GDM

Gestational diabetes mellitus

HBIG

Hepatitis B immunoglobulin

HBeAg

Hepatitis B e antigen

HBsAg

Hepatitis B surface antigen

HBV

Hepatitis B virus

HCC

Hepatocellular carcinoma

HDN

Hemolysis disease of newborn

HIV

Human immunodeficiency virus

LAM

Lamivudine

LBW

Low birth weight

LdT

Telbivudine

LLQ

Lower limit of quantitation

MTCT

Mother-to-child transmission

NA

Neocleos(t)ide analogue

P

Serum phosphorus

PTL

Preterm labor

PCR

Polymerase chain reaction

N/n

Number

SD

Standard deviation

TDF

Tenofovir

ULN

Upper limit of normal

Notes

Acknowledgements

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).

Authors’ contributions

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.

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.

Ethics approval

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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Copyright information

© Asian Pacific Association for the Study of the Liver 2018

Authors and Affiliations

  1. 1.Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center of Digestive Diseases, Liver Research Center, Beijing Friendship HospitalCapital Medical UniversityBeijingChina
  2. 2.Department of Hepatology, Beijing Ditan HospitalCapital Medical UniversityBeijingChina
  3. 3.Department of Obstetrics and Gynecology, Beijing Ditan HospitalCapital Medical UniversityBeijingChina

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