Project Details

Expanding use of tenofovir to prevent mother-to-child transmission of hepatitis B in Vanuatu

Caroline van Gemert, PhD, MAppEpi, MPH

Summary

BACKGROUND: Hepatitis B is a leading cause of liver cancer and cirrhosis, and Pacific Island countries have among the highest prevalence of hepatitis B globally. Mother-to-child transmission (MTCT) accounts for 40% of new infections. Tenofovir prophylaxis during pregnancy is a safe and effective way to prevent MTCT of hepatitis B. WHO recommends providing antiviral prophylaxis to pregnant women with laboratory evidence of a high hepatitis B DNA viral load, but there is limited access to laboratory testing in Vanuatu and other Pacific Island countries to measure viral load, especially in geographically isolated islands. GAP: In Pacific Island countries, it may be more effective to provide all hepatitis B-infected pregnant women with tenofovir prophylaxis to prevent MTCT rather than determining eligibility through laboratory testing, but the effectiveness of this has not been demonstrated. HYPOTHESIS: We hypothesize that providing all hepatitis B-infected pregnant women with tenofovir prophylaxis will reduce the incidence of hepatitis B among infants born to hepatitis B- infected mothers, compared to only proving tenofovir prophylaxis to those with laboratory evidence of high hepatitis B DNA viral load. METHODS: This is a two-arm parallel, block randomized field trial in Vanuatu, comparing an intervention group (“treat-all” arm) to a control group (“guideline-based care”. The study population includes HBsAg-positive pregnant women attending antenatal clinics and their infant/s. RESULTS: Pending. IMPACT: The treat-all approach is highly novel and will facilitate a major paradigm shift in prevention of mother-to-child transmission of hepatitis B in low and low-middle income countries including Pacific Island countries. The results of this trial will be used to inform Pacific guidelines for the prevention of MTCT of hepatitis B. Website Link: www.burnet.edu.au