Telbivudine or lamivudine use in late pregnancy safely reduces perinatal transmission of hepatitis B virus in real-life practice

Authors

  • Hua Zhang,

    1. Department of Obstetrics and Gynecology, Beijing Youan Hospital, Capital Medical University, Beijing, China
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  • Calvin Q. Pan,

    Corresponding author
    1. Division of Gastroenterology, Department of Medicine, New York University Langone Medical Center, New York University School of Medicine, New York, NY
    • Address reprint requests to: Calvin Q. Pan, M.D., Division of Gastroenterology, Department of Medicine, NYU Langone Medical Center, NYU School of Medicine, 132-21 Forty First Avenue, Flushing, NY 11355. E-mail: cpan11355@yahoo.com; fax: 718-353-6901.

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  • Qiumei Pang,

    1. Department of Obstetrics and Gynecology, Beijing Youan Hospital, Capital Medical University, Beijing, China
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  • Ruihua Tian,

    1. Department of Obstetrics and Gynecology, Beijing Youan Hospital, Capital Medical University, Beijing, China
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  • Miaoe Yan,

    1. Department of Obstetrics and Gynecology, Beijing Youan Hospital, Capital Medical University, Beijing, China
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  • Xin Liu

    1. Department of Obstetrics and Gynecology, Beijing Youan Hospital, Capital Medical University, Beijing, China
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  • Potential conflict of interest: Dr. Pan has received research grants from Gilead, Bristol-Myers Squibb, Vertex, and Roche. He also serves as a consultant, advisor, or is on the speakers' bureau for Gilead, Bristol-Myers Squibb, Novartis, Vertex, Salix, Onyx, and Bayer.

  • See Editorial on Page 448

Abstract

Little observational data exist describing telbivudine (LdT) or lamivudine (LAM) use in late pregnancy for preventing hepatitis B mother-to-child transmission (MTCT) in real-world settings. During the period of January 2009 to March 2011, we enrolled hepatitis B e antigen–positive mothers with HBV DNA >6 log10 copies/mL in China. At gestation week 28, the mothers received LdT or LAM until postpartum week 4 or no treatment (NTx). The study endpoints were the safety of LdT/LAM use and MTCT rates. Of the 700 mothers enrolled, 648 (LdT/LAM/NTx = 252/51/345) completed the 52-week study with 661 infants (LdT/LAM/NTx = 257/52/352). On treatment, viral rebound occurred in 1.6% of mothers, all resulting from medication noncompliance. There was no genotypic mutation detected. At delivery, significantly lower HBV DNA levels were noted in mothers who received LdT or LAM versus NTx. Alanine aminotransferase flares were observed in 17.1% of treated mothers versus 6.3% of untreated mothers (P < 0.001). At birth, hepatitis B surface antigen (HBsAg) was detected in 20% and 24% of newborns in the treated and NTx groups, respectively. At week 52, an intention-to-treat analysis indicated 2.2% (95% confidence [CI]: 0.6-3.8) of HBsAg+ infants from the treated group versus 7.6% (95% CI: 4.9-10.3) in the NTx group (P = 0.001) and no difference of HBsAg+ rate between infants in the LdT and LAM groups (1.9% vs. 3.7%; P = 0.758). On-treatment analysis indicated 0% of HBsAg+ infants in the treated group versus 2.84% in the NTx group (P = 0.002). There were no differences for gestational age or infants' height, weight, Apgar scores, or birth defect rates between infants from the treated and untreated groups. Conclusions: LdT and LAM use in late pregnancy for highly viremic mothers was equally effective in reducing MTCT. The treatment was well tolerated with no safety concerns identified. (Hepatology 2014;60:468–476)

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