Format

Send to

Choose Destination
Clin Gastroenterol Hepatol. 2015 Jun;13(6):1170-6. doi: 10.1016/j.cgh.2014.08.043. Epub 2014 Sep 22.

Telbivudine prevents vertical transmission of hepatitis B virus from women with high viral loads: a prospective long-term study.

Author information

1
Department of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chongqing, China; The Chongqing Key Laboratory for Research of Infectious Diseases, China.
2
Department of Infectious Diseases, The First Hospital of Changsha, Hunan, China.
3
The 309th Hospital of Chinese People's Liberation Army, Beijing, China.
4
Department of Gynecology and Obstetrics, the First People's Hospital, Zigong, Sichuan, China.
5
Department of Gynecology and Obstetrics, Southwest Hospital, Third Military Medical University, China.
6
Department of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chongqing, China; Liver Disease Diagnoses and Treatment Center, the 88th Hospital of Chinese People's Liberation Army, Taian, Shandong, China.
7
Department of Gynecology and Obstetrics, Southwest Hospital, Third Military Medical University, China. Electronic address: summerbolo@gmail.com.
8
Department of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chongqing, China; The Chongqing Key Laboratory for Research of Infectious Diseases, China. Electronic address: wym417@163.com.

Abstract

BACKGROUND & AIMS:

Hepatitis B virus (HBV) infection is a leading cause of liver diseases. We investigated the efficacy and safety of telbivudine in preventing transmission of HBV from hepatitis B e antigen-positive pregnant women with high viral loads to their infants in an open-label study.

METHODS:

We performed a prospective study of 450 hepatitis B e antigen-positive pregnant women with HBV DNA levels greater than 10(6) IU/mL; 279 women received telbivudine (600 mg/d) during weeks 24 to 32 of gestation, and 171 women who were unwilling to take antiviral drugs participated as controls. All newborns were vaccinated with a recombinant HBV vaccine and hepatitis B immune globulin, according to a standard immunoprophylaxis procedure. Mother-to-child transmission of HBV was determined by detection of hepatitis B surface antigen and HBV DNA in the infant 6 months after birth.

RESULTS:

None of the infants whose mothers were given telbivudine tested positive for of hepatitis B surface antigen at 6 months, compared with 14.7% of infants in the control group (P = 5.317 × 10(-8)). Levels of HBV DNA also decreased among women given telbivudine; 40 of 172 (23.2%) women given telbivudine had undetectable HBV DNA levels before delivery, compared with none of the controls. A significantly higher proportion of women given telbivudine had undetectable levels of HBV DNA in cord blood (99.1%) than controls (61.5%; P = 1.195 × 10(-22)). No severe adverse events or complications were observed in women or infants.

CONCLUSIONS:

Telbivudine significantly reduces vertical transmission of HBV from pregnant women to their infants; it is safe and well tolerated by women and infants. Antiretroviral Pregnancy Registry Health Care Providers ID: 26592; Government number: Natural Science Foundation of China (NSFC) 30830090, 30972598; and Third Military Medical University Key Project for Clinical Research: 2012XLC05).

KEYWORDS:

Antiviral Drug; Neonate; Nucleoside Analogue; Perinatal

PMID:
25251571
DOI:
10.1016/j.cgh.2014.08.043
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center