A US-Based Multi-Site Pilot to Screen Hepatitis B Surface Antigen-Positive Patients for Hepatitis D

Area of Science:

• Hepatology
• Infectious Diseases
• Public Health Epidemiology

Background:

• Hepatitis D virus (HDV) is a severe, neglected, and underdiagnosed infection with significant clinical impact.
• The epidemiology of HDV remains poorly characterized globally and within the United States.
• Effective screening strategies are crucial for understanding and managing HDV prevalence.

Purpose of the Study:

• To determine the prevalence of HDV in US healthcare institutions with high Hepatitis B virus (HBV) seropositivity.
• To describe the characteristics of patients who tested positive for HDV.
• To evaluate the diagnostic and laboratory processes involved in HDV screening.

Main Methods:

• A pilot project conducted across eight healthcare institutions from August 2022 to April 2024.
• Tested 106,693 patients for Hepatitis B surface antigen (HBsAg); 1112 (1.04%) were HBsAg-positive.
• Performed Hepatitis D virus antibody (HDV Ab) testing on 645 HBsAg-positive samples, with confirmatory HDV RNA testing on positive cases.

Main Results:

• An overall HBsAg positivity rate of 1.04% was observed.
• HDV Ab positivity was 0.81% (9/1112) among HBsAg-positive individuals.
• HDV RNA positivity was confirmed in 2 cases (0.18%), indicating active HDV infection.

Conclusions:

• The study identified low rates of HDV positivity among HBsAg-positive patients in the pilot sites.
• Incomplete testing and screening processes present challenges for accurate HDV diagnosis.
• Further research is essential to understand the true burden of HDV in the US and inform implementation strategies.