title: Telbivudine prevents vertical transmission of hepatitis B virus from women with high viral loads: a prospective long-term study.
abstract: OBJECTIVE
  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).
authors.affiliation: Department of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chongqing, China; The Chongqing Key Laboratory for Research of Infectious Diseases, China.
authors.forename: Quanxin
authors.initials: Q
authors.lastname: Wu
authors.affiliation: Department of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chongqing, China; The Chongqing Key Laboratory for Research of Infectious Diseases, China.
authors.forename: Hongfei
authors.initials: H
authors.lastname: Huang
authors.affiliation: Department of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chongqing, China; The Chongqing Key Laboratory for Research of Infectious Diseases, China.
authors.forename: Xiaowen
authors.initials: X
authors.lastname: Sun
authors.affiliation: Department of Infectious Diseases, The First Hospital of Changsha, Hunan, China.
authors.forename: Meimin
authors.initials: M
authors.lastname: Pan
authors.affiliation: The 309th Hospital of Chinese People's Liberation Army, Beijing, China.
authors.forename: Yun
authors.initials: Y
authors.lastname: He
authors.affiliation: Department of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chongqing, China; The Chongqing Key Laboratory for Research of Infectious Diseases, China.
authors.forename: Shun
authors.initials: S
authors.lastname: Tan
authors.affiliation: Department of Gynecology and Obstetrics, the First People's Hospital, Zigong, Sichuan, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Zeng
authors.affiliation: Department of Gynecology and Obstetrics, Southwest Hospital, Third Military Medical University, China.
authors.forename: Li
authors.initials: L
authors.lastname: Li
authors.affiliation: Department of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chongqing, China; The Chongqing Key Laboratory for Research of Infectious Diseases, China.
authors.forename: Guohong
authors.initials: G
authors.lastname: Deng
authors.affiliation: Department of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chongqing, China; The Chongqing Key Laboratory for Research of Infectious Diseases, China.
authors.forename: Zehui
authors.initials: Z
authors.lastname: Yan
authors.affiliation: 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.
authors.forename: Dengming
authors.initials: D
authors.lastname: He
authors.affiliation: Department of Gynecology and Obstetrics, Southwest Hospital, Third Military Medical University, China. Electronic address: summerbolo@gmail.com.
authors.forename: Junnan
authors.initials: J
authors.lastname: Li
authors.affiliation: 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.
authors.forename: Yuming
authors.initials: Y
authors.lastname: Wang
mesh_terms: D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006509:Hepatitis B / Q000188:drug therapy* / Q000635:transmission*; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008137:Longitudinal Studies; D008297:Male; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy* / Q000821:virology; D011446:Prospective Studies; D000077712:Telbivudine; D013936:Thymidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D000077712:Telbivudine; D013936:Thymidine
keywords: Antiviral Drug; Neonate; Nucleoside Analogue; Perinatal