
TDF (Tenofovir Disoproxil Fumarate) for pregnancy to reduce mother to child transmission of HEP B to infants
Principal Investigator : Rose McGready & Marieke Bierhoff, SMRU
Project Status : Completed
Project Summary
Hepatitis B Virus (HBV) Overview: Hepatitis B Virus (HBV) exacts a heavy toll, with 240 million people worldwide carrying the infection. It is a leading cause of chronic liver disease and, in some cases, can progress to hepatocellular carcinoma. In lower- and middle-income countries, perinatal transmission is the most common route of infection. Although a vaccine has been available since the 1980s, many endemic and often rural communities struggle to implement vaccination policies effectively. Consequently, HBV remains a significant burden on local governments and healthcare systems.
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Gaps in HBV Prevention Efforts: Prevention efforts, including vaccination and treatment, fail in 8-32% of cases. One major gap is the lack of pharmacokinetic (PK) data for antiretrovirals, such as Tenofovir Disoproxil Fumarate (TDF), during late-stage pregnancy. TDF is commonly used in pregnant women with HIV; however, its effectiveness in preventing HBV transmission during pregnancy is inconclusive because it is often administered in combination with other drugs. Moreover, the impact of infant drug exposure through breastmilk remains poorly understood.
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Research Goals: The McGready Lab aims to address these critical knowledge gaps. Their primary objective is to measure PK parameters in HBV-positive pregnant women during the second and third trimesters and postpartum. The study will include 24 HBsAg-positive women, with 12 participants in each trimester group, who will be followed for two months after birth. A secondary aim is to evaluate infant exposure to antiretrovirals through breastmilk. By generating this data, the research seeks to optimize TDF dosing for pregnant women and assess the implications for infant health, thereby contributing to efforts to prevent mother-to-child HBV transmission more effectively.
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