Prevention of mother-to-child transmission of hepatitis B virus: a phase III, placebo-controlled, double-blind, randomized clinical trial to assess the efficacy and safety of a short course of tenofovir disoproxil fumarate in women with hepatitis B virus e-antigen

Details

• Alternative Title:
  BMC Infect Dis
• Personal Author:
  Jourdain, Gonzague ; Ngo-Giang-Huong, Nicole ; Cressey, Tim R. ; Hua, Lei ; Harrison, Linda ; Tierney, Camlin ; Salvadori, Nicolas ; Decker, Luc ; Traisathit, Patrinee ; Sirirungsi, Wasna ; Khamduang, Woottichai ; Bowonwatanuwong, Chureeratana ; Puthanakit, Thanyawee ; Siberry, George K. ; Watts, Diane Heather ; Murphy, Trudy V. ; Achalapong, Jullapong ; Hongsiriwon, Suchat ; Klinbuayaem, Virat ; Thongsawat, Satawat ; Chung, Raymond T. ; Pol, Stanislas ; Chotivanich, Nantasak
• Description:
  Background
  
  Chronic hepatitis B virus (HBV) infection is complicated by cirrhosis and liver cancer. In Thailand, 6-7 % of adults are chronically infected with HBV. The risk of mother-to-child transmission (MTCT) of HBV has been estimated to be about 12 % when mothers have a high hepatitis B viral load, even if infants receive passive-active prophylaxis with HBV immunoglobulin (HBIg) and initiate the hepatitis B vaccine series at birth. We designed a study to assess the efficacy and safety of a short course of maternal tenofovir disoproxil fumarate (TDF) among women with a marker of high viral load for the prevention of MTCT of HBV.
  
  Methods
  
  The study is a phase III, multicenter (17 sites in Thailand), placebo-controlled, double-blind, randomized 1:1, two-arm clinical trial of TDF 300 mg once daily versus placebo among pregnant women from 28 weeks’ gestation through 2-month post-partum. All infants receive HBIg at birth, and a hepatitis B (HB) vaccination series according to Thai guidelines: birth, and age 1, 2, 4 and 6 months. Participant women at study entry must be age ≥18 years, hepatitis B surface antigen (HBsAg) and e-antigen (HBeAg) positive, have alanine aminotransferase (ALT) level < 30 IU/L at screening (confirmed < 60 IU/L pre-entry), negative hepatitis C serology, creatinine clearance >50 mL/min, and no history of anti-HBV antiviral treatment.
  
  Discussion
  
  The results of this randomized trial will clarify the efficacy and safety of a short course of antiviral treatment to prevent mother-to-child transmission of HBV and inform international guidelines.
  
  Trial registration
  
  ClinicalTrials.gov Identifier NCT01745822.
  
  
• Subjects:
  Adult Alanine Transaminase Antibiotic Prophylaxis Antiviral Agents Biomarkers Double-Blind Method Female Gestational Age Hepatitis B Hepatitis B E Antigens Hepatitis B Surface Antigens Hepatitis B Vaccines Humans Immunoglobulins Infant Infectious Disease Transmission, Vertical Mothers Pregnancy Pregnancy Complications, Infectious Tenofovir Viral Load

  More +
• Source:
  BMC Infect Dis. 16.
• Pubmed ID:
  27506549
• Pubmed Central ID:
  PMC4977630
• Document Type:
  Journal Article
• Place as Subject:
  Thailand
• Volume:
  16
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:ada18e5f1dbba77f5255f01b1e916bf93c3ac24d6b9399b8ebf0c9f506af32b3
• Download URL:
  https://stacks.cdc.gov/view/cdc/41142/cdc_41142_DS1.pdf
• File Type:
  [PDF - 599.76 KB ]