HBV DNA and HBsAg Levels at 24 Weeks Off-Treatment Predict Clinical Relapse and HBsAg Loss in HBeAg-Negative Patients Who Discontinued Antiviral Therapy - PubMed (original) (raw)

Multicenter Study

. 2024 Jan;166(1):168-177.e8.

doi: 10.1053/j.gastro.2023.09.033. Epub 2023 Sep 26.

Shao-Ming Chiu 2, Jun Yong Park 3, Sylvia M Brakenhoff 4, Apichat Kaewdech 5, Wai-Kay Seto 6, Yasuhito Tanaka 7, Ivana Carey 8, Margarita Papatheodoridi [ 9](#full-view-affiliation-9 "Department of Gastroenterology, "Laiko" General Hospital of Athens, National and Kapodistrian University of Athens, Athens, Greece."), Piero Colombatto 10, Florian van Bömmel 11, Harry L Janssen 4, Thomas Berg 4, Fabien Zoulim 12, Sang Hoon Ahn 3, George N Dalekos 13, Nicole S Erler 14, Maurizia Brunetto 10, Heiner Wedemeyer 15, Markus Cornberg 15, Man-Fung Yuen 6, Kosh Agarwal 8, Andre Boonstra 4, Maria Buti 16, Teerha Piratvisuth 5, George Papatheodoridis [ 9](#full-view-affiliation-9 "Department of Gastroenterology, "Laiko" General Hospital of Athens, National and Kapodistrian University of Athens, Athens, Greece."), Chien-Hung Chen 2, Benjamin Maasoumy 15; CREATE Study Group

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Multicenter Study

HBV DNA and HBsAg Levels at 24 Weeks Off-Treatment Predict Clinical Relapse and HBsAg Loss in HBeAg-Negative Patients Who Discontinued Antiviral Therapy

Milan J Sonneveld et al. Gastroenterology. 2024 Jan.

Free article

Abstract

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.

Keywords: Clinical Relapse; HBV DNA; HBsAg; HBsAg Loss.

Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.

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