Improvement of Hard Endpoint in Chronic Hepatitis B Patients Treated With Antiviral Therapy

Conditions

Chronic Hepatitis B

Keywords

Liver Cirrhosis

Brief summary

Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be performed at baseline and 7 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.

Detailed description

Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be performed at baseline and 7 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.

Wu X, Zhou J, Sun Y, Ding H, Chen G, Xie W, Piao H, Xu X, Jiang W, Ma H, Ma A, Chen Y, Xu M, Cheng J, Xu Y, Meng T, Wang B, Chen S, Shi Y, Kong Y, Ou X, You H, Jia J.

2021-01-185 citations

10.1007/s12072-020-10114-1

Interventions

DRUGNucleos(t)ide Analogues

Entecavir 0.5mg daily, Lamivudine100mg qd daily, Adefovir Dipivoxil 10mg daily, telbivudine 600mg qd daily, their combination therapy, tenofovir 300mg qd daily.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

* Patients who have participated in the research funded by Beijing science and Technology Commission and have completed 156 weeks follow-up. * Patients comply with the requirements of the trail voluntarily * Written informed consent

Exclusion criteria

* Pregnant woman or patient with severe disease * Patients with poor adherence to the study * Patients not suitable for the study evaluated by the investigator

Design outcomes

Primary

Measure	Time frame	Description
Cumulative rate of liver decompensation and/or hepatic carcinoma and/or liver related death	10 years	Cumulative rate of liver decompensation (including ascites,hepatic encephalopathy,Gastrointestinal hemorrhage)，and/or hepatocellular carcinoma， and/or liver related death after 10 years of antiviral treatment

Secondary

Measure	Time frame	Description
Decrease of transient elastography	10 years	Decrease of transient elastography after 10 years of antiviral treatment
HBeAg seroconversion rate	10 years	HBeAg seroconversion rate after 10 years of antiviral treatment
HBsAg seroconversion rate	10 years	HBsAg seroconversion rate after 10 years of antiviral treatment
HBV-DNA undetectable rate	10 years	HBV-DNA undetectable rate after 10 years of antiviral treatment
Decrease of MELD score	10 years	Decrease of MELD score after 10 years of antiviral treatment
Improvement of life Quality assessed by SF-36	10 years	Improvement of life Quality assessed by SF-36 after 10 years of antiviral treatment
Improvement of life Quality assessed by EQ-5D	10 years	Improvement of life Quality assessed by EQ-5D after 10 years of antiviral treatment
Decrease of Child-Pugh score	10 years	Decrease of Child-Pugh score after 10 years of antiviral treatment

Countries

China

Outcome results

None listed