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Unreliable Estimation of Fibrosis Regression During Treatment by Liver Stiffness Measurement in Patients With Chronic Hepatitis B
Dong Ji 1 , Yan Chen, Qinghua Shang, Huabao Liu, Lin Tan, Jing Wang, Yongping Chen, Qin Li, Qinghua Long, Laicheng Song, Li Jiang, Guangming Xiao, Zujiang Yu, Liang Chen, Xiaoyu Hu, Xiaodong Wang, Da Chen, Zhiqin Li, Zheng Dong, Guofeng Chen, Yongping Yang
Affiliations
Affiliation
1
Department of Liver Diseases, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China; Department of Liver Diseases, the 960th Hospital of Chinese PLA Joint Logistics Support Force, Taian, Shandong Province, China; Traditional Chinese Medicine Hospital of Chongqing, Chongqing, China; Liver Disease Department, Fuyang 2nd People's Hospital, Fuyang, Anhui Province, China; Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou, Sichuan Province, China; Department of Infectious and Liver Diseases, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China; Fuzhou Infectious Diseases Hospital, Fuzhou, Fujian Province, China; Department of Infection and Liver Disease, Yichun People's Hospital, Yichun, Jiangxi Province, China; Traditional Chinese Medicine Hospital of Taihe, Taihe, Anhui Province, China; Department of Infectious Diseases, the First Affiliated Hospital (the Southwest Hospital) of the Third Military Medical University, Chongqing, China; Guangzhou 8th People's Hospital, Guangzhou, Guangdong Province, China; Department of Infectious Disease, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China; Department of Hepatic Diseases, Shanghai Public Health Clinical Center, Shanghai, China; Department of Infectious Diseases, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, China.
PMID: 33840727 DOI: 10.14309/ajg.0000000000001239
Abstract
Introduction: Little reliable evidence has been reported regarding usefulness of liver stiffness measurement (LSM) for monitoring the hepatic fibrosis changes during treatment. We aimed to assess the association between changes in LSM and histological outcomes in patients with chronic hepatitis B.
Methods: In this prospective multicenter study, 727 treatment-naive patients receiving entecavir-based therapy, who underwent paired biopsies at treatment baseline and week 72, were analyzed. Changes in LSM were defined as ≥30% decrease, minor change, and ≥30% increase. Multivariate logistic regression was used to estimate odds ratios (ORs) of changes in LSM on clinical outcomes accounting for regression to the mean. A new on-treatment LSM threshold was established by receiver operating curve.
Results: Overall regression of fibrosis, improvement of inflammation, significant histological response, virologic response, alanine aminotransferase normalization, and hepatitis B e antigen seroconversion were 51.2%, 74.4%, 22.0%, 86.0%, 83.5%, and 13.3%, respectively. The association between changes in LSM and improvement of inflammation was nonlinear (P = 0.012). LSM decrease ≥30% was associated with regression of fibrosis (OR 1.501, 95% confidence interval [CI] 1.073-2.099, P = 0.018), significant histological response (OR 1.726, 95% CI 1.124-2.652, P = 0.013), and alanine aminotransferase normalization (OR 2.149, 95% CI 1.229-3.757, P = 0.007). After adjusting for regression to the mean, LSM increase ≥30% became negatively associated with the above 3 outcomes. A new on-treatment LSM cutoff value of 5.4 kPa was established for indicating the significant histological response.
Discussion: Changes in LSM are unreliable to estimate regression of fibrosis during treatment; the established cutoff value of on-treatment LSM can optimize monitoring strategy for histological outcomes in patients with chronic hepatitis B.
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