Unreliable Estimation of Fibrosis Regression During Treatment by Liver Stiffness Measurement in Patients With Chronic Hepatitis B.

"CONFLICTS OF INTEREST Guarantor of the article: Yongping Yang, MD. Specific author contributions: Dong Ji, MD, PhD, Yan Chen, MD, and Qinghua Shang, MD, contributed equally. Y.Y. and G.C. were responsible for the study design, study supervision, and critical revision of the manuscript. D.J., Y.C., and Q.S. were responsible for statistical analyses, drafting of the manuscript, and interpretation of the data. H.L., L.T., J.W., Y.C., Q. L., Q. L., L.S., L.J., G.X., Z.Y., L.C., X.H., X.W., D.C., Z.L., and Z.D. were responsible for management of patients and data collection. All authors approved the final submission. Financial support: This study was supported by National Major Science and Technology Special Project of China (2018ZX10725-506) and Beijing Municipal Science and Technology Commission (Z181100001718034). The funding sources had no role in study design, data collection, data analysis and interpretation, preparation of the manuscript, or decision to publish. Potential competing interests: None to report. The name of RCT: A Clinical Evaluation on Traditional Chinese Medicine Diagnosis and Treatment Program Blocking and Reversing Hepatitis B-related Liver Fibrosis—a Randomized, Controlled, Double-blind, Multi-center Clinical Trial. RCT No.: NCT01965418.Study HighlightsWHAT IS KNOWN✓ Accurate assessment of liver fibrosis is important for patients with chronic hepatitis B.✓ Liver stiffness measurement (LSM) has been recommended as the most accurate noninvasive method assessing liver fibrosis for treatment-naive chronic hepatitis B patients.✓ The usefulness of LSM for indicating histological outcomes during antiviral treatment has not been determined.WHAT IS NEW HERE✓ A decrease in LSM after initiating of antiviral treatment can be caused by regression of fibrosis, improvement of inflammation, alanine aminotransferase normalization, and random measurement error.✓ Decreases in LSM might lead to unreliable or even over estimation of regression of fibrosis, which should be interpreted cautiously.✓ An on-treatment LSM cutoff value of 5.4 kPa was established to identify the significant histological response."

"Financial support: This study was supported by National Major Science and Technology Special Project of China (2018ZX10725-506) and Beijing Municipal Science and Technology Commission (Z181100001718034). The funding sources had no role in study design, data collection, data analysis and interpretation, preparation of the manuscript, or decision to publish."