Non-Invasive Model for Fibrosis Regression in HBV Patients

Beijing Friendship Hospital1,100 enrolled

Overview

A total of 1000 chronic hepatitis B (CHB) patients with liver biopsy performed at least 1 year after antiviral therapy are retrospectively enrolled. All the patients received NAs treatment. Blood count, liver function test, alpha fetoprotein (AFP), prothrombin time, liver ultrasonography, liver stiffness measurement (LSM), Hepatitis B virus (HBV) DNA and HBV serological markers were collected. HBV-related endpoint events, including cirrhosis decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), hepatocellular carcinoma (HCC), liver transplantation and liver-related death were collected. Fibrosis regression prediction model based on dynamic changes in liver stiffness will be developed based on the retrospective cohort. An independent cohort of CHB patients with liver biopsy performed at least 1 year after antiviral therapy will be retrospectively enrolled for model validation.

Study Type

OBSERVATIONAL

Enrollment

1,100

Conditions

Chronic Hepatitis B Virus (HBV) Infection Liver Fibrosis

Interventions

Nucleos(t)ide Analogs (NA)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with liver biopsy performed at least 1 year after antiviral therapy; * Patients with liver biopsy or liver stiffness or aspartate aminotransferase (AST)-to-platelet (PLT) ratio index (APRI) before antiviral treatment. Exclusion Criteria: * Patients with decompensated cirrhosis (including ascites, hepatic encephalopathy, esophageal varices bleeding, hepatorenal syndrome, spontaneous bacterial peritonitis, or other complications of decompensated cirrhosis), hepatocellular carcinoma, or liver transplantation before liver biopsy; * Patients with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, or other chronic liver diseases; * Patients with malignant lesion on liver image; * Patients with other uncured malignant tumors; * Patients with severe heart, lung, kidney, brain, blood, neuropsychiatric or other organs diseases; * Pregnant or lactating women; * Patients with any other reasons not suitable for the study.

Outcomes

Primary Outcomes

Diagnostic accuracy of non-invasive model for fibrosis regression

Liver fibrosis regression was defined as decrease \>= 1 point by Ishak fibrosis scoring system (range from 0 to 6, higher values represent a worse outcome) or Predominantly Regressive in P-I-R ( predominantly progressive, indeterminate and predominately regressive) score

Time frame: 5 years

Secondary Outcomes

Incidence of HBV-related clinical endpoint events

clinical endpoint event includes: liver decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), HCC, liver transplantation and liver-related death

Time frame: 7 years

Percentage of HBV-induced liver fibrosis regression

Time frame: 5 years

AUROC of non-invasive model for fibrosis regression

Time frame: 5 years

Sensitivity of non-invasive model for fibrosis regression

Time frame: 5 years

Specificity of non-invasive model for fibrosis regression

Time frame: 5 years

Non-Invasive Model for Fibrosis Regression in HBV Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts