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

Authors
 Milan J Sonneveld  ;  Shao-Ming Chiu  ;  Jun Yong Park  ;  Sylvia M Brakenhoff  ;  Apichat Kaewdech  ;  Wai-Kay Seto  ;  Yasuhito Tanaka  ;  Ivana Carey  ;  Margarita Papatheodoridi  ;  Piero Colombatto  ;  Florian van Bömmel  ;  Harry L Janssen  ;  Thomas Berg  ;  Fabien Zoulim  ;  Sang Hoon Ahn  ;  George N Dalekos  ;  Nicole S Erler  ;  Maurizia Brunetto  ;  Heiner Wedemeyer  ;  Markus Cornberg  ;  Man-Fung Yuen  ;  Kosh Agarwal  ;  Andre Boonstra  ;  Maria Buti  ;  Teerha Piratvisuth  ;  George Papatheodoridis  ;  Chien-Hung Chen  ;  Benjamin Maasoumy  ;  CREATE Study Group 
Citation
 GASTROENTEROLOGY, Vol.166(1) : 168-177, 2024-01 
Journal Title
GASTROENTEROLOGY
ISSN
 0016-5085 
Issue Date
2024-01
MeSH
Antiviral Agents / therapeutic use ; DNA, Viral ; Follow-Up Studies ; Hepatitis B Surface Antigens* ; Hepatitis B e Antigens ; Hepatitis B virus / genetics ; Hepatitis B, Chronic* / diagnosis ; Hepatitis B, Chronic* / drug therapy ; Humans ; Recurrence ; Treatment Outcome
Keywords
Clinical Relapse ; HBV DNA ; HBsAg ; HBsAg Loss
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. © 2024 The Authors
Files in This Item:
T202400612.pdf Download
DOI
10.1053/j.gastro.2023.09.033
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Jun Yong(박준용) ORCID logo https://orcid.org/0000-0001-6324-2224
Ahn, Sang Hoon(안상훈) ORCID logo https://orcid.org/0000-0002-3629-4624
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/198556
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