Sistema de Salut de Catalunya
Institut Català de la Salut
[Sonneveld MJ, Brakenhoff SM] Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, the Netherlands. [Chiu SM] Department of Internal Medicine, Koahsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan. [Park JY] Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea. [Kaewdech A] Faculty of Medicine, Prince of Songkla University, Hatyai, Thailand. [Seto WK] Department of Medicine, State Key Laboratory for Liver Research, School of Clinical Medicine, The University of Hong Kong, Hong Kong. [Buti M] Servei d’Hepatologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Ciberehd del Intituto Carlos III de Barcelona, Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
2024-01-26T11:08:44Z
2024-01-26T11:08:44Z
2024-01
Clinical Relapse; HBsAg Loss
Recaiguda clínica; Pèrdua d'HBsAg
Recaída Clínica; Pérdida de HBsAg
Background & Aims Patients who discontinue nucleo(s)tide analogue therapy are at risk of viral rebound and severe hepatitis flares, necessitating intensive off-treatment follow-up. Methods We studied the association between hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA levels at off-treatment follow-up week 24 (FU W24), with subsequent clinical relapse, and HBsAg loss in a multicenter cohort of hepatitis B e antigen (HBeAg)–negative patients with chronic hepatitis B who discontinued nucleo(s)tide analogue therapy. Results We studied 475 patients, 82% Asian, and 55% treated with entecavir. Patients with higher HBV DNA levels at FU W24 had a higher risk of clinical relapse (hazard ratio [HR], 1.576; P < .001) and a lower chance of HBsAg loss (HR, 0.454; P < .001). Similarly, patients with higher HBsAg levels at FU W24 had a higher risk of clinical relapse (HR, 1.579; P < .001) and a lower chance of HBsAg loss (HR, 0.263; P < .001). A combination of both HBsAg <100 IU/mL and HBV DNA <100 IU/mL at FU W24 identified patients with excellent outcomes (9.9% clinical relapse and 58% HBsAg loss at 216 weeks of follow-up). Conversely, relapse rates were high and HBsAg loss rates negligible among patients with both HBsAg >100 IU/mL and HBV DNA >100 IU/mL (P < .001). Conclusions Among HBeAg-negative patients with chronic hepatitis B who discontinued antiviral therapy and who did not experience clinical relapse before FU W24, serum levels of HBV DNA and HBsAg at FU W24 can be used to predict subsequent clinical relapse and HBsAg clearance. A combination of HBsAg <100 IU/mL with HBV DNA <100 IU/mL identifies patients with a low risk of relapse and excellent chances of HBsAg loss and could potentially be used as an early surrogate end point for studies aiming at finite therapy in HBV.
Article
Published version
English
Hepatitis B - Tractament; Medicaments antivírics - Ús terapèutic; Antígens; CHEMICALS AND DRUGS::Biological Factors::Antigens::Antigens, Viral::Hepatitis Antigens::Hepatitis B Antigens::Hepatitis B Surface Antigens; DISEASES::Digestive System Diseases::Liver Diseases::Hepatitis::Hepatitis, Chronic::Digestive System Diseases::Liver Diseases::Hepatitis::Hepatitis B, Chronic; CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents; COMPUESTOS QUÍMICOS Y DROGAS::factores biológicos::antígenos::antígenos víricos::antígenos de las hepatitis::antígenos de la hepatitis B::antígenos de superficie de la hepatitis B; ENFERMEDADES::enfermedades del sistema digestivo::enfermedades hepáticas::hepatitis::hepatitis crónica::enfermedades del sistema digestivo::enfermedades hepáticas::hepatitis::hepatitis B crónica; COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antivíricos
Elsevier
Gastroenterology;166(1)
https://doi.org/10.1053/j.gastro.2023.09.033
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
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