SHIELD
Saudi Hepatitis B Investigation, Evaluation, and Longitudinal Database
A national, multicenter, prospective registry tracking the epidemiology, treatment patterns, and clinical outcomes of chronic hepatitis B across Saudi Arabia, modeled on international studies BRIDGE and REVEAL-HBV, governed by the SGA.
Registry Objectives
- Establish a comprehensive national database for chronic hepatitis B patients, addressing the 1.7% HBsAg seroprevalence in Saudi Arabia
- Characterize HBV genotype distribution, treatment response patterns, and HCC risk profiles in the Saudi population
- Track functional cure (HBsAg loss) rates under nucleos(t)ide analogue and pegylated interferon therapy per 2025 AASLD/EASL guidelines
- Monitor HCC surveillance adherence and outcomes using validated PAGE-B and REACH-B risk scores
- Build a biobank for HBV translational research including host genomics and viral sequencing
- Enable benchmarking against BRIDGE, REVEAL-HBV, and international HBV cohort studies
About SHIELD
SHIELD aims to establish the first comprehensive national CHB database in Saudi Arabia. With ~1.7% HBsAg seroprevalence and >500,000 estimated carriers, Saudi Arabia faces a significant hepatitis B burden requiring systematic data collection.
Regulatory Compliance
SHIELD complies with Saudi PDPL and is HIPAA-aligned. All data encrypted with full audit logging. Includes biobank component compliant with SFDA standards. HBV notification data integrated with MOH surveillance where applicable.