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

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A Correction to this article was published on 01 May 2018

This article has been updated

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.

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Change history

  • 11 June 2018

    The aim of this erratum is to clearly state the individual author’s contribution which was erroneously mentioned as “Tianyu He, Yuqing Bai, Wei Yi, and Jidong Jia contributed equally to this work.”

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

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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).

Funding

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).

Author information

Author notes

  1. Tianyu He, Yuqing Bai, Wei Yi, and Jidong Jia contributed equally to this work.

Authors and Affiliations

  1. Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center of Digestive Diseases, Liver Research Center, Beijing Friendship Hospital, Capital Medical University, No. 95 Yong-an Road, Xicheng District, Beijing, 100050, China

    Tianyu He, Xiaojuan Ou & Jidong Jia

  2. Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Beijing, China

    Haodong Cai

  3. Department of Obstetrics and Gynecology, Beijing Ditan Hospital, Capital Medical University, No. 8 Jing-shun East Street, Chaoyang District, Beijing, 100015, China

    Yuqing Bai, Min Liu & Wei Yi

Authors
  1. Tianyu He
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  2. Yuqing Bai
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  3. Haodong Cai
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  4. Xiaojuan Ou
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  5. Min Liu
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  6. Wei Yi
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  7. Jidong Jia
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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.

Corresponding authors

Correspondence to Wei Yi or Jidong Jia.

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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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He, T., Bai, Y., Cai, H. et al. Safety and efficacy of lamivudine or telbivudine started in early pregnancy for mothers with active chronic hepatitis B. Hepatol Int 12, 118–125 (2018). https://doi.org/10.1007/s12072-017-9839-5

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  • DOI: https://doi.org/10.1007/s12072-017-9839-5

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