Hepatitis B assessment without hepatitis B virus DNA quantification: a prospective cohort study in Uganda

BACKGROUND: Chronic hepatitis B infection affects 240 million people, with the highest prevalence in Africa and Asia, and results in 700 000 deaths annually. Access to diagnostics, particularly for hepatitis B virus viral load quantification (HBV DNA), is a major barrier to treatment. We aimed to test World Health Organization guidelines for hepatitis B management in resource-limited settings. METHODS: We compared treatment allocation with and without the use of HBV DNA in a cohort in Uganda. Hepatitis B surface antigen test–positive, human immunodeficiency virus–negative, treatment-naïve adults were recruited prospectively. Following liver ultrasound and routine haematological and biochemical tests, preliminary allocations into treatment and observation groups were made. HBV DNA was performed for each participant and final treatment decisions were made and compared with preliminary allocations. RESULTS: Full assessment was completed for 100 participants; treatment was indicated in 20. Assessment without HBV DNA identified patients for treatment with a positive predictive value of 88.2% and a negative predictive value of 94% compared with assessment using HBV DNA. CONCLUSIONS: Where HBV DNA is unavailable, patients with hepatitis B can be assessed by liver ultrasound and routine laboratory tests. These findings will enable physicians in resource-limited settings to initiate treatment more readily and inform policy with regards to viral hepatitis elimination.