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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 : On-going

Project Summary

  • Hep B e antigen+ greater infection rate. Is a marker for the active form.

  • Transmission prevention efforts fail in 8-32% of cases

  • Lacking PK data in pregnant women

  • TDF in pregnant women commonly used for HIV, but are inconclusive due to their administration in combination

  • Important to also establish infant drug exposure, the exposure to antiretrovirals is not well established.

  • Aims : Measure PK parameters in 2nd 3rd and post-partum time points. 

  • 24 HBsAg positive women 12 in each 2nd and 3rd trimester, then followed for 2 months post birth

  • 2nd Aim: check the infant exposure through breastmilk

Hepatitis B Virus (HBV) exacts a heavy toll. Worldwide there are 240 million people who carry HBV infection. This is one of the major causes of chronic liver disease and in some cases can lead to the development and progression of hepatocellular carcinoma. In lower- and middle-income countries the most common route of transmission is perinatally.  While a vaccine has be available since the 1980’s many countries have struggled to implement these policies in the more endemic often rural communities. As such the diseases remains a heavy burden on the local government and healthcare systems. One of the major gaps in prevention efforts is the lack of available Pharmacokinetic data on antiretrovirals, like Tenofovir Disoproxil Fumarate (TDF), in late stage pregnancy.  As such correct dosing becomes difficult. Due to the lack to suitable alternatives to breastfeeding, the infant exposure through breastmilk must also be considered. Currently there is no information of this. The McGready lab are currently attempting to fill these knowledge gaps that would allow treatment of the HBV+ pregnant women with TDF to attempt to prevent mother to child transmission.