Distribution and clinical characteristics of patients with chronic hepatitis B virus infection in the grey zone
Yao, Liu and Wang contributed equally to this work.
Funding information
The study was supported from the National Science and Technology Major Project of China (2018ZX10302205), National Natural Science Foundation of China (81672025 and 81702011), Jiangsu Science and Technology Development Plan (BE2017605), Jiangsu Provincial Medical Innovation Team (CXTDA2017005) and Nanjing Medical Science and Technique Development Foundation (QRX17121).
Abstract
A substantial proportion of patients with chronic hepatitis B (CHB) who do not fit into any of the usual immune states are considered to be in the ‘grey zone (GZ)’. We aimed to investigate the distribution and characteristics of GZ in a large cohort of CHB patients. Four thousand seven hundred and fifty-nine consecutive treatment-naïve CHB patients were enrolled. The immune states were defined based on AASLD 2018 Hepatitis B Guidance. GZ CHB patients were classified into four groups: HBeAg positive, normal ALT levels and serum HBV DNA ≤106 IU/ml (GZ-A); HBeAg positive, elevated ALT levels and serum HBV DNA ≤2 × 104 IU/ml (GZ-B); HBeAg negative, normal ALT levels and serum HBV DNA ≥2 × 103 IU/ml (GZ-C); HBeAg negative, elevated ALT levels and serum HBV DNA ≤2 × 103 IU/ml (GZ-D). The distributions of different immune states were: 233 (4.90%) patients in immune-tolerant phase, 941 (19.77%) patients in HBeAg-positive immune active phase, 1,717 (36.08%) patients in inactive phase and 546 (11.47%) patients in HBeAg-negative immune active phase. Of note, 1,322 (27.78%) patients did not fit into any of above phases and were defined as the GZ. A high proportion of patients in GZ-B had advanced fibrosis (33.3%) or cirrhosis (25.8%). Older age, HBeAg-positive status and higher ALT levels were independently risk factors of advanced disease in GZ CHB patients. Therefore, our results revealed that more than a quarter of CHB patients were classified into the GZ and a high proportion of patients in GZ-B had advanced fibrosis or even cirrhosis.
CONFLICTS OF INTEREST
The authors have declared that no conflicts of interest exist.
Open Research
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available from the corresponding author upon reasonable request.
