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Tenofovir Disoproxil Fumarate for Prevention of Vertical Transmission of Hepatitis B Virus Infection by Highly Viremic Pregnant Women: A Case Series

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Abstract

Background

Despite appropriate immunoprophylaxis, up to 10 % of infants born to highly viremic hepatitis B virus (HBV–DNA ≥ 7 log IU/mL) mothers are infected with HBV. Use of TDF to prevent vertical transmission (VT) by such mothers has not been evaluated.

Purpose

To evaluate the efficacy and safety of TDF in preventing VT from highly viremic HBV-infected mothers.

Methods

Data were collected retrospectively from HBV mono-infected, hepatitis B e antigen (HBeAg) positive, pregnant women between 6/2008 and 11/2010. Cases enrolled were HBV mono-infected mothers who received TDF (300 mg orally once a day) in the third trimester. Those with pregnancy complications or an abnormal fetus on sonography were excluded from use of TDF. All infants received hepatitis B immunoglobulin and vaccination at birth and subsequently.

Results

Eleven Asian mothers received TDF at the median gestational age of 29 (28–32) weeks and the median duration of TDF use before delivery was 10 (7–12) weeks. A significant reduction in serum HBV–DNA was achieved at delivery compared with baseline (mean 5.25 ± 1.79 vs. 8.87 ± 0.45 log10 copies/mL, respectively; p < 0.01). Three had serum ALT levels more than 1.5 times the upper limit of normal and two of these normalized before delivery. The 11 infants were born with no obstetric complication or birth defects. Five infants were breastfed. All infants were hepatitis B surface antigen negative 28–36 weeks after birth.

Conclusion

Our preliminary data suggest that TDF use in the third trimester is safe, and effectively prevents VT of HBV from high viremic HBeAg-positive mothers.

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Abbreviations

HBV:

Hepatitis B virus

VT:

Vertical transmission

HBsAg:

Hepatitis B surface antigen

HBeAg:

Hepatitis B e antigen

HBIG:

Hepatitis B immunoglobulin

TDF:

Tenofovir disoproxil fumarate

ALT:

Alanine aminotransferase

ULN:

Upper limit of normal

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Acknowledgments

We thank Dr Szu Yu Chen (Department of Obstetrics and Gynecology, New York Downtown Hospital) for helping us with data collection.

Conflict of interest

Calvin Q. Pan received research grants from Bristol–Myers Squibb Company, Novartis, Idenix, Roche, and Gilead Sciences, Inc. He also serves as a consultant, advisor, and is on the Speakers Bureau of Gilead, Bristol Myers Squibb, Novartis, Idenix, Roche, Genentech, Axcan USA, Schering Plough, Onyx, Three Rivers, Salix, and Pharmasset; Li-Jun Mi received funding from Gilead Sciences for Investigator-initiated clinical studies; Chalermrat Bunchorntavakul no conflict of interest; Jeffrey Karsdon no conflict of interest; William M. Huang paid consultant for Gilead Sciences, Inc. in the past; Gaurav Singhvi no conflict of interest; Marc G. Ghany no conflict of interest; K. Rajender Reddy is an ad hoc advisory board member for Gilead Sciences, Inc.

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Authors and Affiliations

  1. Division of Liver Diseases, Department of Medicine, Mount Sinai Medical Center, Mount Sinai School of Medicine, New York, NY, USA

    Calvin Q. Pan

  2. Department of Internal Medicine, New York Downtown Hospital, New York, NY, USA

    Li-Jun Mi

  3. Division of Gastroenterology and Hepatology, Department of Medicine, University of Pennsylvania, 2 Dulles, 3400 Spruce Street, Philadelphia, PA, 19104, USA

    Chalermrat Bunchorntavakul & K. Rajender Reddy

  4. Division of Gastroenterology and Hepatology, Department of Medicine, Ministry of Public Health, Rajavithi Hospital, Bangkok, Thailand

    Chalermrat Bunchorntavakul

  5. Division of Neonatology, Department of Pediatrics, New York Downtown Hospital, New York, NY, USA

    Jeffrey Karsdon

  6. Division of maternal–fetal Medicine, Department of Obstetrics and Gynecology, New York Downtown Hospital, New York, NY, USA

    William M. Huang

  7. Division of Gastroenterology, Department of Internal Medicine, Mt. Sinai Services, Elmhurst Hospital, New York, NY, USA

    Gaurav Singhvi

  8. Liver Disease Branch, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA

    Marc G. Ghany

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  1. Calvin Q. Pan
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Corresponding author

Correspondence to K. Rajender Reddy.

Additional information

Li-Jun Mi—Co-first author.

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Pan, C.Q., Mi, LJ., Bunchorntavakul, C. et al. Tenofovir Disoproxil Fumarate for Prevention of Vertical Transmission of Hepatitis B Virus Infection by Highly Viremic Pregnant Women: A Case Series. Dig Dis Sci 57, 2423–2429 (2012). https://doi.org/10.1007/s10620-012-2187-3

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  • DOI: https://doi.org/10.1007/s10620-012-2187-3

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