HBV markers in patients stopping antiviral therapy for chronic HBV
Research type
Research Study
Full title
Novel HBV markers in patients stopping antiviral therapy for chronic HBV
IRAS ID
271780
Contact name
Bo Wang
Contact email
Sponsor organisation
Kings College London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Chronic hepatitis B virus (HBV) infection is a major cause of liver disease and liver cancer. There is no cure, but long-term viral suppression can be achieved with oral antiviral medication. Antivirals, namely nucleoside or nucleotide analogues (NUC), are conventionally life-long, which is not ideal due to pill burden, potential adverse effects and significant cost to the healthcare provider. Recently, evidence has emerged that stopping NUC treatment in a carefully selected group of patients may be safe and that maintenance of remission off-treatment may be achievable. There is also some evidence to suggest that stopping treatment may even be beneficial in terms of expediting HBV cure. The risk is severe HBV flares which may cause hepatitis and jaundice. At present, there are no validated ways of predicting which patients might stop successfully and which may have a severe flare. Novel serum markers of HBV replication, namely HBV core-related antigen (HBcrAg) and HBV pre-genomic RNA (pgRNA), have shown promise in many areas of HBV research of being clinically useful in predicting outcomes and end-points. The aim of this study is to investigate these markers in a cohort of patients who are stopping long-term antiviral therapy, potentially establishing predictors of outcomes after stopping.
REC name
North West - Preston Research Ethics Committee
REC reference
19/NW/0729
Date of REC Opinion
5 Jun 2020
REC opinion
Further Information Favourable Opinion