Document Detail


Telbivudine prevents vertical transmission from HBeAg-positive women with chronic hepatitis B.
MedLine Citation:
PMID:  22343511     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND & AIMS: 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:
Calvin Q Pan; Guo-Rong Han; Hong-Xiu Jiang; Wei Zhao; Min-Kai Cao; Cui-Min Wang; Xin Yue; Gen-Ju Wang
Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't     Date:  2012-02-14
Journal Detail:
Title:  Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association     Volume:  10     ISSN:  1542-7714     ISO Abbreviation:  Clin. Gastroenterol. Hepatol.     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-04-23     Completed Date:  2012-08-08     Revised Date:  2013-08-26    
Medline Journal Info:
Nlm Unique ID:  101160775     Medline TA:  Clin Gastroenterol Hepatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  520-6     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 AGA Institute. Published by Elsevier Inc. All rights reserved.
Affiliation:
Department of Medicine, Division of Liver Diseases, Mount Sinai Medical Center, Mount Sinai School of Medicine, New York, New York, USA.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT01337791
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MeSH Terms
Descriptor/Qualifier:
Adult
Antiviral Agents / administration & dosage*
Case-Control Studies
DNA, Viral / blood
Female
Hepatitis B e Antigens / blood*
Hepatitis B, Chronic / drug therapy,  prevention & control*,  transmission*
Humans
Incidence
Infant, Newborn
Infectious Disease Transmission, Vertical / prevention & control*
Male
Nucleosides / administration & dosage*
Pregnancy
Pregnancy Complications, Infectious / drug therapy*
Prospective Studies
Pyrimidinones / administration & dosage*
Chemical
Reg. No./Substance:
0/Antiviral Agents; 0/DNA, Viral; 0/Hepatitis B e Antigens; 0/Nucleosides; 0/Pyrimidinones; 2OC4HKD3SF/telbivudine
Comments/Corrections
Comment In:
Nat Rev Gastroenterol Hepatol. 2012 Apr;9(4):190   [PMID:  22410430 ]

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