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dc.contributor.authorMarieke Bierhoffen_US
dc.contributor.authorKenrad E. Nelsonen_US
dc.contributor.authorNan Guoen_US
dc.contributor.authorYuanxi Jiaen_US
dc.contributor.authorChaisiri Angkurawaranonen_US
dc.contributor.authorPodjanee Jittamalaen_US
dc.contributor.authorVerena Carraraen_US
dc.contributor.authorWanitda Watthanaworawiten_US
dc.contributor.authorClare Lingen_US
dc.contributor.authorFuanglada Tongpraserten_US
dc.contributor.authorMichele van Vugten_US
dc.contributor.authorMarcus Rijkenen_US
dc.contributor.authorFrancois Nostenen_US
dc.contributor.authorRose McGreadyen_US
dc.contributor.authorStephan Ehrhardten_US
dc.contributor.authorChloe Lynne Thioen_US
dc.description.abstract© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. INTRODUCTION: 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. METHODS AND ANALYSES: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT02995005, Pre-results.en_US
dc.titlePrevention 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 pregnancyen_US
article.title.sourcetitleBMJ openen_US
article.volume10en_US Malaria Research Uniten_US of Medicine, Ramathibodi Hospital, Mahidol Universityen_US Universityen_US Universityen_US Department of Medicineen_US Universityen_US Hopkins Universityen_US van Amsterdamen_US Hopkins School of Medicineen_US Mai Universityen_US
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