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Title: Stopping nucleot(s)ide analogues in non-cirrhotic HBeAg-negative chronic hepatitis B patients: HBsAg loss at 96 weeks is associated with low baseline HBsAg levels.
Austin Authors: Hall, Samuel A L;Burns, Gareth S;Anagnostou, Despina;Vogrin, Sara;Sundararajan, Vijaya;Ratnam, Dilip;Levy, Miriam T;Lubel, John S;Nicoll, Amanda J;Strasser, Simone I;Sievert, William;Desmond, Paul V;Ngu, Meng C;Angus, Peter W ;Sinclair, Marie ;Meredith, Christopher;Matthews, Gail;Revill, Peter A;Jackson, Kathy;Littlejohn, Margaret;Bowden, D Scott;Locarnini, Stephen A;Visvanathan, Kumar;Thompson, Alexander J
Affiliation: Central Clinical School, Monash University, The Alfred Centre, Melbourne, Australia
University of Sydney, Sydney, Australia
Gastroenterology Department of Concord Repatriation General Hospital, Sydney, Australia
Gastroenterology and Hepatology
University of Melbourne, Melbourne, Australia
Department of Gastroenterology, Alfred Health, Melbourne, Australia
Gastroenterology Department of St Vincent's Hospital Melbourne, Melbourne, Australia
Department of Infectious Disease and Immunology Research Centre, St Vincent's Hospital, Melbourne, Australia
The Department of Public Health, La Trobe University, Melbourne, Australia
Gastroenterology & Hepatology Unit, Monash Health, Melbourne, Australia
Monash University, Melbourne, Australia
Gastroenterology Department of Liverpool Hospital, Sydney, Australia
Gastroenterology Department of Bankstown-Lidcombe Hospital, Sydney, Australia
Department of infectious Disease, St Vincent's Hospital Sydney, Sydney, Australia
Victorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital, The Doherty Institute, Melbourne, Australia
Gastroenterology Department of Eastern Health, Melbourne, Australia
AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, Sydney, Australia
Issue Date: 6-May-2022
Date: 2022
Publication information: Alimentary Pharmacology & Therapeutics 2022; 56(2): 310-320
Abstract: Current guidelines recommend long-term nucleot(s)ide analogue (NA) therapy for patients with HBeAg-negative chronic hepatitis B (CHB). However, disease remission has been described after stopping NA therapy, as well as HBsAg loss. We performed a prospective multi-centre cohort study of stopping NA therapy. Inclusion criteria were HBeAg-negative CHB, the absence of cirrhosis and HBVDNA<lower limit of quantification for ≥18 months. We assessed virological and biochemical outcomes including HBsAg loss, as well as NA restart rates, over 96 weeks. In total, 110 patients [62% entecavir (ETV); 28% tenofovir (TDF), 10% other] were enrolled. Median age was 56 years, 57% were male, 85% were Asian, median baseline HBsAg level was 705 (214-2325) IU/ml. Virological reactivation occurred in 109/110 patients, median time to detection was 8 (4-12) weeks, and occurred earlier after stopping TDF versus ETV (median 4 vs. 12 weeks p < 0.001). At week 96, 77 (70%) remained off-treatment, 65 (59%) had ALT <2× ULN, 31 (28%) patients were in disease remission with HBVDNA <2000 IU/ml plus ALT <2× ULN and 7 (6%) patients had lost HBsAg. Baseline HBsAg ≤10 IU/ml was associated with HBsAg loss (6/9 vs. 1/101 p < 0.001). ALT >5× ULN occurred in 35 (32%); ALT flares were not associated with HBsAg loss. There were no unexpected safety issues. Virological reactivation was very common after stopping NA therapy and occurred earlier after stopping TDF versus ETV. The majority of patients had ALT <2× ULN at week 96, but only one-third achieved disease remission and HBsAg loss was rare. Very low HBsAg levels at baseline were uncommon but predicted for HBsAg loss and disease remission.
DOI: 10.1111/apt.16968
ORCID: 0000-0001-7158-585X
Journal: Alimentary Pharmacology & Therapeutics
PubMed URL: 35521992
Type: Journal Article
Appears in Collections:Journal articles

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