None listed
Conditions
Brief summary
Recent WHO guidance for prevention of mother-to-child transmission (MTCT) of hepatitis B virus (HBV) recommends tenofovir prophylaxis during pregnancy for pregnant women with a high HBV DNA viral load, however there is limited access to laboratory testing in Pacific Island Countries (PIC). The objective of this study is to assess if providing all HBV-infected pregnant women with tenofovir prophylaxis is more effective in PIC than restricting tenofovir to those that can access laboratory testing. We hypothesize that providing all HBV-infected pregnant women with tenofovir prophylaxis will reduce the incidence of hepatitis B among infants born to HBV-infected mothers compared to only proving tenofovir prophylaxis to those with laboratory evidence of high hepatitis B DNA viral load. This study is a two-arm parallel, block randomized field trial that compares the “treat-all” approach to “guideline-based care”. The study population includes HBV-infected pregnant women and their infant/s. The primary outcome measure is the proportion of HBV-infected infants at 6-12 months after birth.
Interventions
The intervention is a variation of the World Health Organization (WHO) 2020 Guidelines on Antiviral Prophylaxis in Pregnancy. All hepatitis B surface antigen (HBsAg)-positive pregnant women allocated to the treat-all arm will be provided with tenofovir prophylaxis (without treatment eligibility based on HBV DNA level, as per the 2020 WHO Guidelines) .
Therapeutic: Tenofovir disoproxil fumarate (TDF). Tenofovir disoproxil fumarate was added to the Vanuatu Essential Medicines List in 2020 and is
The intervention is a variation of the World Health Organization (WHO) 2020 Guidelines on Antiviral Prophylaxis in Pregnancy. All hepatitis B surface antigen (HBsAg)-positive pregnant women allocated to the treat-all arm will be provided with tenofovir prophylaxis (without treatment eligibility based on HBV DNA level, as per the 2020 WHO Guidelines) . Therapeutic: Tenofovir disoproxil fumarate (TDF). Tenofovir disoproxil fumarate was added to the Vanuatu Essential Medicines List in 2020 and is the only antiviral therapy for hepatitis B infection available in Vanuatu. Route of administration: Oral Dosage: 300 mg tablet to be ingested orally once daily. Duration: Week 28 of pregnancy until at least 6 weeks after delivery.
Sponsors
Burnet Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible participants include pregnant women aged 18 years and older, 14-28 weeks gestation at their first ANC appointment, that have a positive HBsAg test result during routine antenatal care, and able and willing to provide written informed consent prior to study-related procedures being performed. Infants born to eligible HBsAg-positive pregnant women are also considered participants.
Exclusion criteria
Exclusion criteria includes women coinfected with either HIV or hepatitis C, evidence of cirrhosis or if already receiving hepatitis B antiviral therapy prior to pregnancy. Women not planning on delivering or living in Vanuatu in the 12 months after delivery (and therefore not available for follow-up) will also be excluded. Pregnant women with evidence of cirrhosis (indicated through calculation of the APRI score ([aspartate aminotransferase ratio index], which is calculated based on AST and platelet counts, as per the Vanuatu Hepatitis B Guidelines)) will be referred to separate clinics for hepatitis B treatment assessment but will not be eligible for inclusion in the study.
Outcome results
None listed