Hepatitis B core-related antigen (HBcrAg): an alternative to HBV DNA to assess treatment eligibility in Africa

• Published in: Clinical infectious diseases
• Main Authors: Shimakawa, Yusuke, Ndow, Gibril, Njie, Ramou, Freeya Njai, Harr, Takahashi, Kazuaki, Akbar, Mohammad Fazle, Cohen, Damien, Nayagam, Shevanthi, Jeng, Adam, Ceesay, Amie, Sanneh, Bakary, Baldeh, Ignatius, Imaizumi, Masayasu, Moriyama, Kazushige, Aoyagi, Katsumi, d'Alessandro, Umberto, Mishiro, Shunji, Chemin, Isabelle, Mendy, Maimuna, Thursz, Mark R., Lemoine, Maud
• Format: Journal Article
• Language: English
• Published: Oxford University Press (OUP) 17.05.2019
• Subjects: Human health and pathology; Infectious diseases; Life Sciences; Microbiology and Parasitology; Virology; Hepatitis B core-related antigen; Africa; validation studies; diagnostic test; sensitivity and specificity
• ISSN: 1058-4838; 1537-6591
• DOI: 10.1093/cid/ciz412

BackgroundTo eliminate hepatitis B virus (HBV) infection, it is essential to scale up testing and treatment. However, conventional tools to assess treatment eligibility, particularly nucleic acid testing (NAT) to quantify HBV DNA, are hardly available and affordable in resource-limited countries. We therefore assessed the performance of novel immunoassay, hepatitis B core-related antigen(HBcrAg), as an inexpensive (US$ <10-15/assay) alternative to NAT to diagnose clinically important HBV DNA thresholds (≥2,000; ≥20,000; and ≥200,000 IU/ml), and select patients for antiviral therapy in Africa.MethodsUsing well-characterized cohort of treatment-naïve patients with chronic HBV infection in The Gambia, we evaluated the accuracy of serum HBcrAg to diagnose HBV DNA levels, and to indicate treatment eligibility determined by the American Association for the Study of Liver Diseases, based on the reference tests (HBV DNA, HBV e antigen (HBeAg), alaninetransaminase (ALT), liver histopathology and/or FibroScan).ResultsA total of 284 treatment-naïve patients were included in the analysis. The area under the receiver operating characteristic curve (AUROC), sensitivity and specificity of serum HBcrAg were: 0.88 (95% CI: 0.82-0.93), 83.3% and 83.9% to diagnose HBV DNA ≥2,000 IU/ml; and 0.94 (0.88-0.99), 91.4% and 93.2% for ≥200,000 IU/ml. A simplified treatment algorithm using HBcrAg without HBV DNA showed high AUROC (0.91 (95% CI: 0.88-0.95)) with a sensitivity of 96.6%and specificity of 85.8%.ConclusionsHBcrAg might be an accurate alternative to HBV DNA quantification as a simple and inexpensive tool to identify HBV-infected patients in need of antiviral therapy in low-and middle-income countries.