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

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...

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Published inClinical 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
LanguageEnglish
Published Oxford University Press (OUP) 17.05.2019
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Abstract 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.
AbstractList 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.
Author Freeya Njai, Harr
Jeng, Adam
Mendy, Maimuna
Imaizumi, Masayasu
Lemoine, Maud
Njie, Ramou
Moriyama, Kazushige
d'Alessandro, Umberto
Aoyagi, Katsumi
Ceesay, Amie
Mishiro, Shunji
Ndow, Gibril
Cohen, Damien
Sanneh, Bakary
Shimakawa, Yusuke
Baldeh, Ignatius
Akbar, Mohammad Fazle
Chemin, Isabelle
Takahashi, Kazuaki
Nayagam, Shevanthi
Thursz, Mark R.
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Keywords Hepatitis B core-related antigen
Africa
validation studies
diagnostic test
sensitivity and specificity
Language English
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Snippet BackgroundTo eliminate hepatitis B virus (HBV) infection, it is essential to scale up testing and treatment. However, conventional tools to assess treatment...
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SubjectTerms Human health and pathology
Infectious diseases
Life Sciences
Microbiology and Parasitology
Virology
Title Hepatitis B core-related antigen (HBcrAg): an alternative to HBV DNA to assess treatment eligibility in Africa
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