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

June 11, 2015 at 8:50 am

Clin Gastroenterol Hepatol. 2015 June V.13 N.6 P.1170-6.

Wu Q1, Huang H1, Sun X1, Pan M2, He Y3, Tan S1, Zeng Y4, Li L5, Deng G1, Yan Z1, He D6, Li J7, Wang Y8.

Author information

1Department of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chongqing, China; The Chongqing Key Laboratory for Research of Infectious Diseases, China.

2Department of Infectious Diseases, The First Hospital of Changsha, Hunan, China.

3The 309th Hospital of Chinese People’s Liberation Army, Beijing, China.

4Department of Gynecology and Obstetrics, the First People’s Hospital, Zigong, Sichuan, China.

5Department of Gynecology and Obstetrics, Southwest Hospital, Third Military Medical University, China.

6Department 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.

7Department of Gynecology and Obstetrics, Southwest Hospital, Third Military Medical University, China. Electronic address: summerbolo@gmail.com.

8Department 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).

abstract

http://www.cghjournal.org/article/S1542-3565(14)01356-1/abstract

PDF

http://www.cghjournal.org/article/S1542-3565(14)01356-1/pdf

 

Entry filed under: Antivirales no HIV, Biología Molecular, Epidemiología, Hepatitis B, Infecciones en embarzadas, Infecciones virales, Inmunizaciones, Metodos diagnosticos, REPORTS, Update. Tags: .

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