iTAP program: Eliminating mother-to-child transmission of hepatitis B virus (2012-2022)

Hepatitis B virus infects the liver and causes liver damage with a risk of fibrosis, cirrhosis and liver cancer in adulthood. Perinatal transmission is the number one source of new infections worldwide. Stopping this transmission is needed to eliminate hepatitis B infections, and this is therefore a priority for the Thailand-France research collaboration at Faculty of Associated Medical Sciences, Chiang Mai University

In a first clinical trial, iTAP-1, women with HBV infection took tenofovir disoproxil fumarate (TDF) once a day from 28 weeks’ pregnancy until 2 months postpartum. None of their infants were infected. The tolerance of TDF was excellent for the mothers and for the infants. In this clinical trial, all infants received both hepatitis B vaccine and immune globulin. However, the price of immunoglobulin is high and it is very difficult to maintain stocks outside of important health centers.

A second trial, iTAP-2, aims at determining whether immune globulin is needed when mothers receive TDF as in iTAP-1. 

More details:

iTAP-1 results: https://www.nejm.org/doi/full/10.1056/NEJMoa1708131

iTAP-2 study: https://clinicaltrials.gov/ct2/show/NCT03343431