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Article Abstract
Background/objective: Chronic hepatitis B (CHB) patients who do not meet any immunostaging criteria are categorized as the "grey zone" (GZ). However, there are discrepancies in the definition of the GZ in different areas.
Aim: To investigate the prevalence and clinical characteristics of Chinese GZ patients and to validate the application value of three international guidelines.
Methods: Data from 807 naïve CHB patients with liver biopsies from seven Chinese centres were retrospectively collected. GZ patients were defined and compared across four guidelines: the Chinese guidelines, the American Association for the Study of Liver Diseases (AASLD) guidelines, the European Association for the Study of the Liver (EASL) guidelines, and the Asian Pacific Association for the Study of the Liver (APASL) guidelines.
Results: When the Chinese guidelines were used, 38.79% of patients were categorized into the GZ, 78.91% of whom were indicated for antiviral therapy. The EASL guidelines yielded a greater proportion of GZ patients (50.56%) than did the APSAL (36.68%) and AASLD guidelines (33.21%). The APASL guidelines yielded a lower proportion of GZ patients who were indicated for antiviral therapy (42.57%) than did the AASLD (47.76%) and EASL guidelines (60.54%). According to the AASLD, EASL, APASL and Chinese guidelines, if liver biopsy was not performed, 13.06%, 31.86%, 0% and 64.54% of GZ patients were indicated for antiviral therapy, respectively.
Conclusions: GZ patients account for a significant proportion of CHB patients, with approximately half of them requiring antiviral therapy.
Clinical Trial Registration: NCT06041022.
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