Prevention of mother-to-child transmission of hepatitis B virus: protocol for a one-arm, open-label intervention study to estimate the optimal timing of tenofovir in pregnancy.
Antiviral Agents
/ therapeutic use
Child
DNA, Viral
Female
Hepatitis B
/ drug therapy
Hepatitis B virus
/ genetics
Hepatitis B, Chronic
/ drug therapy
Humans
Infant
Infant, Newborn
Infectious Disease Transmission, Vertical
/ prevention & control
Myanmar
Pregnancy
Pregnancy Complications, Infectious
/ drug therapy
Tenofovir
/ therapeutic use
Thailand
Viral Load
fetal medicine
maternal medicine
public health
therapeutics
tropical medicine
virology
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
13 09 2020
13 09 2020
Historique:
entrez:
15
9
2020
pubmed:
16
9
2020
medline:
15
5
2021
Statut:
epublish
Résumé
Hepatitis B virus (HBV) remains a public health threat and the main route of transmission is from mother to child (MTCT). Tenofovir disoproxil fumarate (TDF) treatment can reduce MTCT of HBV although the optimal timing to attain undetectable HBV DNA concentrations at delivery is unknown. This protocol describes the procedures following early initiation of maternal TDF prior to 20 weeks gestation to determine efficacy, safety and feasibility of this approach in a limited-resource setting. One hundred and seventy pregnant women from the Thailand-Myanmar border between 12 and <20 weeks gestational age will be enrolled into a one-arm, open-label, TDF treatment study with cessation of TDF 1 month after delivery. Sampling occurs monthly prenatal, at birth and at 1, 2, 4 and 6 months post partum. Measurement of tenofovir concentrations in maternal and cord plasma is anticipated in 10-15 women who have detectable HBV DNA at delivery and matched to 20-30 women with no detectable HBV DNA. Infant HBsAg status will be determined at 2 months of age and HBV DNA confirmed in HBsAg positive cases. Adverse events including risk of flare and adherence, based on pill count and questionnaire, will be monitored. Infants will receive HBV vaccinations at birth, 2, 4 and 6 months and hepatitis B immunoglobulin at birth if the mother is hepatitis B e antigen positive. Infant growth and neurodevelopment at 6 months will be compared with established local norms. This study has ethical approval by the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University (FTM ECF-019-06), Johns Hopkins University (IRB no: 00007432), Chiang Mai University (FAM-2559-04227), Oxford Tropical Research Ethics Committee (OxTREC Reference: 49-16) and by the local Tak Community Advisory Board (TCAB-02/REV/2016). The article will be published as an open-access publication. NCT02995005, Pre-results.
Identifiants
pubmed: 32928858
pii: bmjopen-2020-038123
doi: 10.1136/bmjopen-2020-038123
pmc: PMC7488796
doi:
Substances chimiques
Antiviral Agents
0
DNA, Viral
0
Tenofovir
99YXE507IL
Banques de données
ClinicalTrials.gov
['NCT02995005']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e038123Subventions
Organisme : Wellcome Trust
ID : 106698/Z/14/Z
Pays : United Kingdom
Informations de copyright
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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