Clinical Scorecard: Utilizing Point-of-Care Testing for Hepatitis B Core Antigen in Risk Assessment for Treatment Eligibility: Insights from Kenya

At a Glance

Key Highlights

• HBcrAg POCT identified all individuals with HBV viral load >200,000 IU/mL and HBeAg positivity.
• Positive HBcrAg POCT correlated with higher ALT, elevated APRI scores, and increased liver stiffness by elastography.
• HBcrAg POCT is easy to perform with ∼40 minutes turnaround time and requires no specific training.

Guideline-Based Recommendations

Diagnosis

• Use ALT measurement or APRI calculation alongside HBV viral load to determine treatment eligibility per 2024 WHO HBV guidelines.
• HBV viral load >2000 IU/mL combined with elevated ALT or HIV coinfection indicates treatment eligibility.
• Elastography score >7.0 kPa or APRI >0.5 indicates significant fibrosis and treatment eligibility.

Management

• Initiate antiviral treatment in patients meeting WHO criteria based on liver fibrosis, viral load, and ALT levels.
• Consider HBcrAg POCT as a surrogate for HBV viral load in low-resource settings to guide treatment decisions.

Monitoring & Follow-up

• Monitor ALT, APRI, and liver stiffness to assess liver health and treatment response.
• Use HBcrAg POCT for real-time feedback to improve retention in care and viral suppression.

Risks

• Limited access to HBV viral load and HBeAg testing impedes treatment initiation in WHO African Region.
• Current POCTs for HBeAg have poor sensitivity; HBcrAg POCT offers improved diagnostic performance.

Patient & Prescribing Data

102 adults with chronic hepatitis B in Kilifi, Kenya; 75 untreated at cohort entry

HBcrAg POCT positivity was 14%, higher in men and younger patients; it identified all with high viral load and HBeAg positivity, supporting its use in treatment eligibility assessment.

Clinical Best Practices

• Incorporate HBcrAg POCT in routine assessment to identify patients with high HBV viral load and active replication.
• Use ALT and APRI scores alongside HBcrAg POCT to stratify liver disease severity and treatment need.
• Employ HBcrAg POCT to overcome barriers of laboratory-based viral load testing in resource-limited settings.
• Ensure testing is performed by trained clinical or laboratory staff with blinded interpretation to reduce bias.

References

• 2024 Global Hepatitis Report
• 2024 WHO HBV Management Guidelines
• HBcrAg POCT evaluation in The Gambia