Patients who have completed 2 years follow-up of the past National 12th Five-Year Major Project on Infectious Diseases will receive another 8 years treatment with entecavir (10 years in total). Collect serology, imaging, and other clinical data to evaluate the incidence and mortality of decompensated cirrhosis and hepatocellular carcinoma. Understand the effects of long-term antiviral therapy on HBV-induced liver fibrosis/cirrhosis.
Patients who have completed 2-years entecavir-based treatment in Regress Study will receive another 8 years of entecavir extension therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBV-DNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan; A third liver biopsy will be performed at the 5th year of treatment in patients who have significant fibrosis at second biopsy. CT /MRI and endoscopy will be performed at baseline and the 5th and 10th year of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
800
oral entecavir 0.5mg daily for 8 years
Peking University First Hospital
Beijing, Beijing Municipality, China
Fibrosis regression rate
Ishak fibrosis score decrease after long-term treatment
Time frame: year 3
Cumulative incidence of liver decompensation
Cumulative incidence of liver decompensation (including ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) and death after long-term treatment
Time frame: year 8
Virological response
Percentage of patients achieving hepatitis B virus (HBV) DNA \< 20IU/mL at year 3, 5, 7 and 10
Time frame: year 3, 5, 7 and 10
Aminotransferase response
The percentage of patients with alanine aminotransferase (ALT) normalization at year 3, 5, 7 and 10
Time frame: year 3, 5, 7 and 10
HBeAg loss or HBeAg seroconversion
Percentage of patients with HBeAg loss or HBeAg seroconversion at year 2, 5, 7 and 10
Time frame: year 2, 5, 7 and 10
HBsAg loss or HBsAg seroconversion rate
Percentage of patients with HBsAg loss or HBsAg seroconversion at year 2, 5, 7 and 10
Time frame: year 2, 5, 7 and 10
Dynamic changes of Child-Pugh score
Dynamic changes of Child-Pugh score after 3, 5, 7 and 10 years of treatment
Time frame: year 3, 5, 7 and 10
Dynamic changes of MELD score
Dynamic changes of MELD score after 3, 5, 7 and 10 years of treatment
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Tongji Hospital, Tongji Medical College , Huazhong University of Science and Technology
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...and 10 more locations
Time frame: year 3, 5, 7 and 10
Dynamic changes of liver stiffness values measured by Transient Elastography
Dynamic changes of liver stiffness values after 3, 5, 7 and 10 years of treatment
Time frame: year 3, 5, 7 and 10
Improvement of life quality (SF36 and EQ-5D)
Improvement of life quality after 3, 5, 7 and 10 years of treatment
Time frame: year 3, 5, 7 and 10