Hepatitis B surface antigen, core-related antigen and HBV RNA: Predicting clinical relapse after NA therapy discontinuatio
- Conditions
- To evaluate the HBV off-therapy relapse rate after discontinuation of NA. To determine the correlation of the new seromarkers to predict the HBV off-therapy relapse of non-cirrhotic chronic hepatitichronic hepatitis B, CHB, antiviral discontinuation, relapse, qHBsAg, HBcrAg, HBV RNA
- Registration Number
- TCTR20180316007
- Lead Sponsor
- Faculty of Medicine, Prince of Songkla University
- Brief Summary
The combined hepatitis B core-related antigen and hepatitis B virus RNA assays at end of treatment were highly predictive of subsequent clinical relapse. These novel biomarkers could potentially be used to identify patients who could safely discontinue nucleos(t)ide analogue therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 92
Patients 18 years of age and older
- Receiving treatment with nucleos(t)ide analogue
- Meet the standard stopping criteria of of the 2015 update of APASL clinical practice guideline
The sample did not include patients with advanced fibrosis or cirrhosis, defined as liver stiffness measured by transient elastography as 11 kPa or more or as Meta-analysis of Histological Data in Viral Hepatitis (METAVIR) stage 3 or higher on liver biopsy, or in whom imaging showed evidence of cirrhosis within the previous 6 months and at baseline before NA initiation. The sample also did not include patients with active hepatocellular carcinoma or other malignancies, those with co-infection with hepatitis C virus or human immunodeficiency virus, those undergoing concomitant treatment with immunosuppressive agents, those with other chronic liver disease, pregnancy or lactating women and patients who refused to participate in the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The HBV off-therapy relapse rate within 1 year after discontinuation NA according to the APASL2015 1 year after discontinuation of NA. Viral relapse is defined as serum HBV DNA greater than 2000 IU/ml after stopping treatment
- Secondary Outcome Measures
Name Time Method The correlation of seromarkers 1 year after discontinuation of NA qHBsAg, HBcrAg, HBV RNA