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Incremental value of HBcrAg to classify 1582 HBeAg-negative individuals in chronic infection without liver disease or hepatitis
Maurizia R Brunetto 1 , Ivana Carey 2 , Benjamin Maasoumy 3 , Cristina Marcos-Fosch 4 , André Boonstra 5 , Gian Paolo Caviglia 6 , Alessandro Loglio 7 , Daniela Cavallone 1 , Caroline Scholtes 8 , Gabriele Ricco 1 , Antonina Smedile 6 , Mar Riveiro-Barciela 4 , Florian van Bömmel 9 , Annemiek van der Eijk 5 , Fabien Zoulim 8 , Thomas Berg 9 , Markus Cornberg 3 , Pietro Lampertico 7 , Kosh Agarwal 2 , Maria Buti 4
Affiliations
Affiliations
1
Pisa, Italy.
2
London, UK.
3
Hannover, Germany.
4
Barcelona, Spain.
5
Rotterdam, the Netherlands.
6
Turin, Italy.
7
Milan, Italy.
8
Lyon, France.
9
Leipzig, Germany.
PMID: 33465257 DOI: 10.1111/apt.16258
Abstract
Background: An accurate, single-point differential diagnosis between HBeAg-negative infection (ENI) and chronic hepatitis B (CHB) is an unmet need.
Aims: To assess the diagnostic value of the new hepatitis B core-related antigen (HBcrAg) assay.
Methods: A retrospective anonymised data analysis was performed in a multicentre European (nine centres and six countries) cohort of 1582 consecutive HBsAg-positive/HBeAg-negative subjects classified according to EASL guidelines as: 550-CHB, 710-ENI and 322-GZ (grey-zone, HBV-DNA <20 000 IU/mL).
Results: Mean age was 44 (±13.2 y), 59% were men; HBV genotypes were 15% A, 2% B, 2% C, 45% D, 9% E, 1% F and 26% unknown. Median HBV-DNA serum levels were 2.2 (1.5-2.7), 3.5 (3.2-3.8) and 5.6 (4.8-6.6) logIU/mL in ENI, GZ and CHB, P < 0.0001. HBsAg serum levels (HBsAgsl) were comparable in CHB and GZ, but lower in ENI (2.9 [2.1-3.6] logIU/mL), P < 0.0001. HBcrAg serum levels (HBcrAgsl) were <3 logU/mL in 90.7% (644/710) ENI, 75.2% (242/322) GZ and 4.7% (26/550) CHB (P < 0.0001). Median HBcrAgsl were 4.8 (3.9-5.7), 2.5 (2.0-2.9) and 2.0 (2.0-2.5) logU/mL in CHB, GZ and ENI, (P < 0.0001). ROC-AUCs for HBcrAg and HBsAg were 0.968 (95% CI, 0.958-0.977) and 0.732 (95% CI, 0.704-0.760) respectively. The optimal HBcrAgsl cut-off to distinguish CHB from ENI was 3.14 logU/mL (95% CI, 3.02-3.25, 91% SE, 93% SP and 92.4% DA). HBcrAgsl were associated with HBV genotypes (P < 0.001, one-way ANOVA) but using genotype-specific cut-offs, HBcrAg DA remained unchanged with overlapping 95% CI.
Conclusion: The HBcrAg assay showed high diagnostic performance in the accurate single-point identification of patients with HBeAg-negative CHB, independently of HBV genotype. This should prompt future prospective studies to confirm its diagnostic role in clinical practice.
© 2021 John Wiley & Sons Ltd. |
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