Journal article

Baseline serum HBV RNA is associated with the risk of hepatitis flare after stopping nucleoside analog therapy in HBeAg-negative participants

AJ Thompson, K Jackson, S Bonanzinga, SAL Hall, S Hume, GS Burns, V Sundararajan, D Ratnam, MT Levy, J Lubel, AJ Nicoll, SI Strasser, W Sievert, PV Desmond, MC Ngu, M Sinclair, C Meredith, G Matthews, PA Revill, M Littlejohn Show all

Hepatology Communications | Published : 2023

Abstract

Background and Aims: HBV RNA in peripheral blood reflects HBV cccDNA transcriptional activity and may predict clinical outcomes. The prospective Melbourne HBV-STOP trial studied nucleot(s)ide analog discontinuation in HBeAg-negative non-cirrhotic participants with long-term virological suppression. Ninety-six weeks after stopping treatment, the proportion of participants with virological relapse (HBV DNA > 2000 IU/mL), biochemical relapse (ALT > 2 × ULN and HBV DNA > 2000 IU/mL), or hepatitis flare (ALT > 5 × ULN and HBV DNA > 2000 IU/mL) was 89%, 58%, and 38%, respectively. We evaluated the ability of serum HBV RNA levels to predict these outcomes. Approach & Results: HBV RNA levels were me..

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Grants

Awarded by AbbVie


Funding Acknowledgements

<STRONG>& nbsp;</STRONG>The clinical study was supported by the National Health and Medical Research Council of Australia Project Grant 1066536. Additional support for data extraction was provided by Roche Molecular Systems, Inc. Alexander Thompson received funding from the National Health and Medical Research Council of Australia (MRFF Practitioner Fellowship 1142976). cobas (R) 6800/8800 HBV RNA Investigational Assay reagents were provided by Roche Molecular Systems, Inc.