Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/33325
Title: Baseline serum HBV RNA is associated with the risk of hepatitis flare after stopping nucleoside analog therapy in HBeAg-negative participants.
Austin Authors: Thompson, Alexander J;Jackson, Kathy;Bonanzinga, Sara;Hall, Sam A L;Hume, Simon;Burns, Gareth S;Sundararajan, Vijaya;Ratnam, Dilip;Levy, Miriam T;Lubel, John;Nicoll, Amanda J;Strasser, Simone I;Sievert, William;Desmond, Paul V;Ngu, Meng C;Sinclair, Marie ;Meredith, Christopher;Matthews, Gail;Revill, Peter A;Littlejohn, Margaret;Bowden, D Scott;Canchola, Jesse A;Torres, Jason;Siew, Philip;Lau, Jasmin;La Brot, Benjamin;Kuchta, Alison;Visvanathan, Kumar
Affiliation: Department of Gastroenterology, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.;Immunology Research Centre, Department of Medicine (St Vincent's Hospital), The University of Melbourne, Melbourne, Victoria, Australia.
Victorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital, Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
mmunology Research Centre, Department of Medicine (St Vincent's Hospital), The University of Melbourne, Melbourne, Victoria, Australia.
Department of Gastroenterology, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.;Immunology Research Centre, Department of Medicine (St Vincent's Hospital), The University of Melbourne, Melbourne, Victoria, Australia.
Immunology Research Centre, Department of Medicine (St Vincent's Hospital), The University of Melbourne, Melbourne, Victoria, Australia.;Department of Public Health, La Trobe University, Melbourne, Victoria, Australia.
Gastroenterology & Hepatology Unit, Monash Health, Melbourne, Victoria, Australia.;Monash University, Melbourne, Victoria, Australia.
Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney, Australia.
Department of Gastroenterology, Alfred Health, Melbourne, Victoria, Australia.;Central Clinical School, Monash University, The Alfred Centre, Melbourne, Victoria, Australia.
Gastroenterology Department of Eastern Health, Melbourne, Victoria, Australia.
AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, Sydney, Australia.;University of Sydney, Sydney, Australia.
Gastroenterology & Hepatology Unit, Monash Health, Melbourne, Victoria, Australia.;Monash University, Melbourne, Victoria, Australia.
Department of Gastroenterology, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.
Department of Gastroenterology, Concord Repatriation General Hospital, Sydney, Australia.
Department of Gastroenterology and Hepatology, Austin Health, Melbourne, Victoria, Australia.
Department of Gastroenterology, Bankstown-Lidcombe Hospital, Sydney, Australia.
Department of Infectious Disease, St Vincent's Hospital Sydney, Sydney, Australia.
Victorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital, Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
Roche Molecular Systems, Inc., Pleasanton, California, USA.
Roche Diagnostics, Pty Ltd, North Ryde, Australia.
Victorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital, Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
Gastroenterology and Hepatology
Issue Date: 1-Aug-2023
Date: 2023
Publication information: Hepatology Communications 2023-08-01; 7(8)
Abstract: 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. HBV RNA levels were measured using the Roche cobas 6800/8800 HBV RNA Investigational Assay. Sixty-five participants had baseline and longitudinal off-treatment specimens available for RNA testing. HBV RNA was detectable at baseline in 25% of participants and was associated with a higher risk of biochemical relapse (81% vs. 51%, p value 0.04) and hepatitis flare (63% vs. 31%, p value 0.04). Participants who had undetectable serum HBV RNA as well as HBsAg ≤ 100 IU/mL at baseline were less likely to experience virological relapse (4 of 9, 44%) than participants with detectable HBV RNA and HBsAg level > 100 IU/mL (15/15, 100%; p value 0.0009). Off-treatment levels of HBV RNA were correlated with HBV DNA and were associated with the risk of hepatitis flare. Serum HBV RNA may be a useful biomarker for guiding clinical decision-making before stopping nucleot(s)ide analog therapy. Baseline HBV RNA and HBsAg levels are associated with the risk of clinical relapse, hepatitis flare, and disease remission off-treatment.
URI: https://ahro.austin.org.au/austinjspui/handle/1/33325
DOI: 10.1097/HC9.0000000000000188
ORCID: 
Journal: Hepatology Communications
PubMed URL: 37459199
ISSN: 2471-254X
Type: Journal Article
Appears in Collections:Journal articles

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