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
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...
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e038123.full |
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| author | François Nosten Rose McGready Verena Carrara Stephan Ehrhardt Chaisiri Angkurawaranon Nan Guo Yuanxi Jia Marieke Bierhoff Kenrad E Nelson Podjanee Jittamala Wanitda Watthanaworawit Clare Ling Fuanglada Tongprasert Michele van Vugt Marcus Rijken Chloe Lynne Thio |
| author_facet | François Nosten Rose McGready Verena Carrara Stephan Ehrhardt Chaisiri Angkurawaranon Nan Guo Yuanxi Jia Marieke Bierhoff Kenrad E Nelson Podjanee Jittamala Wanitda Watthanaworawit Clare Ling Fuanglada Tongprasert Michele van Vugt Marcus Rijken Chloe Lynne Thio |
| author_sort | François Nosten |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-b2edb2c97d634be98c3350faaf132004 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-b2edb2c97d634be98c3350faaf1320042025-01-06T14:40:10ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-038123Prevention 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 pregnancyFrançois Nosten0Rose McGready1Verena Carrara2Stephan Ehrhardt3Chaisiri Angkurawaranon4Nan Guo5Yuanxi Jia6Marieke Bierhoff7Kenrad E Nelson8Podjanee Jittamala9Wanitda Watthanaworawit10Clare Ling11Fuanglada Tongprasert12Michele van Vugt13Marcus Rijken14Chloe Lynne Thio15Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UKShoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Mae Sot, Thailand1Infectious Diseases Data Observatory (IDDO), University of Oxford, UKDepartment of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USADepartment of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, ThailandDepartment of Cardiology, Hebei Medical University, Cangzhou Central Hospital, Cangzhou, Hebei, ChinaDepartment of Medicine, School of Medicine, Johns Hopkins University, 1830 East Monument Street, Suite 8068, Baltimore, MD 21287, USADepartment of Maternal and Child health, Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, ThailandDepartment of Epidemiology, Johns Hopkins University, Baltimore, Maryland, USADepartment of Maternal and Child health, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandDepartment of Microbiology, Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, ThailandCentre for Tropical Medicine and Global Health, Oxford University, Oxford, Oxfordshire, UKDepartment of Obstetrics and Gynecology, Chiang Mai University, Suthep, Chiang Mai, ThailandInternal Medicine, Amsterdam UMC Location AMC, Amsterdam, The NetherlandsDepartment of Obstetrics and Gynecology, Utrecht University, Utrecht, The NetherlandsDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USAIntroduction 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.https://bmjopen.bmj.com/content/10/9/e038123.full |
| spellingShingle | François Nosten Rose McGready Verena Carrara Stephan Ehrhardt Chaisiri Angkurawaranon Nan Guo Yuanxi Jia Marieke Bierhoff Kenrad E Nelson Podjanee Jittamala Wanitda Watthanaworawit Clare Ling Fuanglada Tongprasert Michele van Vugt Marcus Rijken Chloe Lynne Thio 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/9/e038123.full |
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