title: Telbivudine prevents vertical transmission from HBeAg-positive women with chronic hepatitis B.
abstract: OBJECTIVE
  Telbivudine reduces hepatitis B virus (HBV) DNA and normalizes levels of alanine aminotransferase (ALT) in patients with chronic hepatitis B (CHB). We investigated its use in preventing vertical transmission.
  
  
  METHODS
  We performed an open-label, prospective study of 88 hepatitis B (HB) e antigen (HBeAg)-positive pregnant women with CHB, levels of HBV DNA >6 log(10) copies/mL, and increased levels of ALT. Women were given telbivudine (n = 53) starting in the 2nd or 3rd trimester, or no treatment (controls, n = 35) and followed until postpartum week (PPW) 28. All infants received standard immunoprophylaxis after birth.
  
  
  RESULTS
  At 28 weeks, none of the infants whose mothers received telbivudine had immunoprophylaxis failure, whereas 8.6% of the infants of control mothers did (P = .029). There were no differences between groups in mothers' adverse events or infants' congenital deformities, gestational age, height, and weight, or Apgar scores. At postpartum week 28, significantly more telbivudine-treated mothers had levels of HBV DNA <500 copies/mL, normalized levels of ALT, and hepatitis B e antigen seroconversion compared with controls (58% vs none, P < .001; 92% vs 71%; P = .008; and 15% vs none; P < .001, respectively) but none had loss of hepatitis B surface antigen. Telbivudine-treated mothers had no virologic breakthrough (HBV DNA >1 log(10) increase from <500 copies/mL) or discontinuations from adverse events. After delivery, 13/52 patients discontinued telbivudine due to preference. There were no episodes of severe hepatitis (levels of ALT >10 times the upper limit of normal) in either group during 28 weeks of postpartum observation.
  
  
  CONCLUSIONS
  Women with CHB given telbivudine during the second or third trimester of pregnancy have reduced rates of perinatal transmission. Telbivudine produced no adverse events in mothers or infants by 28 weeks.
authors.affiliation: Department of Medicine, Division of Liver Diseases, Mount Sinai Medical Center, Mount Sinai School of Medicine, New York, New York, USA.
authors.forename: Calvin Q
authors.initials: CQ
authors.lastname: Pan
authors.forename: Guo-Rong
authors.initials: GR
authors.lastname: Han
authors.forename: Hong-Xiu
authors.initials: HX
authors.lastname: Jiang
authors.forename: Wei
authors.initials: W
authors.lastname: Zhao
authors.forename: Min-Kai
authors.initials: MK
authors.lastname: Cao
authors.forename: Cui-Min
authors.initials: CM
authors.lastname: Wang
authors.forename: Xin
authors.initials: X
authors.lastname: Yue
authors.forename: Gen-Ju
authors.initials: GJ
authors.lastname: Wang
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D016022:Case-Control Studies; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood*; D019694:Hepatitis B, Chronic / Q000188:drug therapy / Q000517:prevention & control* / Q000635:transmission*; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008297:Male; D009705:Nucleosides / Q000008:administration & dosage*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011446:Prospective Studies; D011744:Pyrimidinones / Q000008:administration & dosage*; D000077712:Telbivudine; D013936:Thymidine / Q000031:analogs & derivatives
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D009705:Nucleosides; D011744:Pyrimidinones; D000077712:Telbivudine; D013936:Thymidine