Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients
Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients
A total of 2000 chronic hepatitis B (CHB) patients with liver biopsy performed after 1 to 3
 years of antiviral therapy are enrolled. All the patients will receive original antiviral
 treatment for the following 3 years. Patients will be assessed at baseline and at every six
 months for 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. HBV-related endpoint events, including cirrhosis decompensations
 (ascites, esophageal variceal bleeding and hepatic encephalopathy), hepatocellular carcinoma
 (HCC), liver transplantation and liver-related death, will be collected during follow-up.
No.
Group 1: Patients with history of HBV-related clinical endpoint events

 Inclusion Criteria:

 -  No age limit;

 -  Male or female;

 -  Patients with liver biopsy performed after 1 to 3 years of antiviral therapy; patients
 with history of clinical endpoint events (decompensated cirrhosis, hepatocellular
 carcinoma, liver transplantation or liver-related death) after liver biopsy;

 -  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.

 Group 2: Patients without history of clinical endpoint events

 Inclusion Criteria:

 -  No age limit;

 -  Male or female;

 -  Patients with liver biopsy performed after 1 to 3 years of antiviral therapy; or
 Chronic hepatitis B (CHB) patients with antiviral therapy for 1 to 3 years content to
 be performed liver biopsy at enrollment;

 -  Patients with liver biopsy or liver stiffness or APRI before antiviral treatment;

 -  Agree to be followed up regularly;

 -  Signature of informed consent.

 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;

 -  Patients with HCV or 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, exclude who were cured;

 -  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.