About
Project presentation
To achieve global elimination of hepatitis B virus (HBV), it is imperative to eliminate HBV mother-to-child transmission (MTCT) by ensuring high coverage of HBV birth dose vaccine and expanding the adoption of peripartum tenofovir prophylaxis. Current international guidelines require hepatitis B surface antigen (HBsAg)-positive pregnant women to undergo HBV DNA quantification to identify those at high risk (viral load ≥200,000 IU/mL) who should receive tenofovir. However, HBV DNA testing remains inaccessible in many resource-limited settings, particularly in remote rural areas. Consequently, the World Health Organization (WHO), recently developed a conditional recommendation for administering tenofovir prophylaxis to all HBsAg-positive women lacking access to HBV DNA or hepatitis B e antigen (HBeAg) testing. Although this universal strategy may appear promising for simplifying the diagnostic process, it may result in overtreating the majority of HBsAg-positive pregnant women, estimated at 85% in sub-Saharan Africa and 70% in Asia, for whom the birth dose vaccine is likely sufficient. Moreover, the real-world applicability of this strategy in resource-limited settings has never been formally tested, and its effectiveness, feasibility, and impact on costs, logistics, and implementation remain unknown.
As an innovative alternative, we propose the adoption of a point-of-care test called the rapid test for hepatitis B core-related antigen (HBcrAg-RDT) to identify women eligible for tenofovir prophylaxis. This test requires only a drop of capillary blood, eliminating the need for electricity or centrifugation, and can provide a reliable result within 45 minutes. Compared to the universal strategy, the HBcrAg-RDT strategy is expected to be less expensive and could prevent unnecessary tenofovir exposure for both women and their fetuses.
Our aim is to establish the non-inferiority of the HBcrAg-RDT strategy, in comparison to the universal strategy, in terms of effectiveness, defined as the reduction in maternal HBV DNA levels at the time of childbirth, a main driver of the risk of perinatal HBV transmission. We will conduct a two-arm cluster-randomized non-inferiority trial through a multidisciplinary framework integrating health economics, implementation science, and health policy analysis.
This project is coordinated by Yusuke SHIMAKAWA (Institut Pasteur, France) alongside Didier EKOUEVI (University of Lomé, Togo) and Olivier SEGERAL (Geneva University Hospital, Switzerland).
Fundings
- ANRS / MIE
- AMED
Project partners
- Geneva University Hospital
- Université d’Aix-Marseille
- Observatoire Regional de la Santé – PACA
- University of Lomé, Togo
- Centre Médical des Capucines, Cameroun
- PAC-CI, Côte d’Ivoire
- Hai Phong University of Medicine and Pharmacy, Vietnam
- Institut Pasteur du Cambodge, Cambodge
- Japan Institute of Health Security, Japan
