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Journal Articles Clinical Infectious Diseases Year : 2019

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

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Gibril Ndow
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  • PersonId : 1014238
Kazuaki Takahashi
  • Function : Author
  • PersonId : 1047484
Damien Cohen
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  • PersonId : 1047485
Masayasu Imaizumi
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  • PersonId : 1047486
Kazushige Moriyama
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  • PersonId : 1047487
Katsumi Aoyagi
  • Function : Author
  • PersonId : 1047488
Shunji Mishiro
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  • PersonId : 1047489
Isabelle Chemin
Maud Lemoine
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  • PersonId : 982266

Abstract

Background To 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. Methods Using 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), alanine transaminase (ALT), liver histopathology and/or FibroScan). Results A 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%. Conclusions HBcrAg 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.
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Dates and versions

pasteur-02132081 , version 1 (16-05-2019)

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Yusuke Shimakawa, Gibril Ndow, Ramou Njie, Harr Freeya Njai, Kazuaki Takahashi, et al.. Hepatitis B core-related antigen (HBcrAg): an alternative to HBV DNA to assess treatment eligibility in Africa. Clinical Infectious Diseases, 2019, pp.ciz412. ⟨10.1093/cid/ciz412⟩. ⟨pasteur-02132081⟩
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