Severe hepatitis B flares with hepatic decompensation after withdrawal of nucleos(t)ide analogues: A population‐based cohort study

Abstract

Background: Finite nucleos(t)ide analogue (NUC) therapy has been proposed as an alternative treatment strategy for chronic hepatitis B (CHB). Aim:To quantify the incidence of severe hepatitis flares following NUC cessation in everyday clinical practice.Methods: This population-based cohort study enrolled 10,192 patients (male 71.7%, median age 50.9 years, cirrhosis 10.7%) who had received first-line NUCs for at least 1 year before discontinuing treatment. The primary outcome was severe flare with hepatic decompensation. We used competing risk analyses to assess event incidences and associated risk factors.Results: During a median follow-up of 2.2 years, 132 patients developed severe flares with hepatic decompensation, yielding a 4-year cumulative incidence of 1.8% (95% confidence interval [CI], 1.5%-2.2%). Significant risk factors were cirrhosis (adjusted sub-distributional hazard ratio [aSHR], 2.74; 95% CI, 1.82-4.12), manifestations of

Editorial: Mitigating the risk of severe hepatitis flare following nucleoside analogue discontinuation—Insights from a real‐world study

“…Hsu et al reported the real‐world safety data of nucleoside analogue discontinuation in a heterogeneous population involving 10,192 patients with CHB of whom 10.7% had cirrhosis and 4.6% had a prior history of liver failure 6 . These patients were given a nucleoside analogue, which was subsequently stopped according to local reimbursement policies.…”

“…5 Hsu et al reported the real-world safety data of nucleoside analogue discontinuation in a heterogeneous population involving 10,192 patients with CHB of whom 10.7% had cirrhosis and 4.6% had a prior history of liver failure. 6 These patients were given a nucleoside analogue, which was subsequently stopped according to local reimbursement policies. The primary outcome was severe flare with hepatic decompensation, defined as serum alanine aminotransferase >5 times upper limit of normal plus hyperbilirubinaemia plus coagulopathy;…”

Letter: Safety after cessation of nucleos(t)ide analogue therapy in patients with chronic hepatitis B infection

“…We read with great concern of the study by Hsu et al 1 on severe hepatitis flare with decompensation after cessation of nucleos(t)ide analogue (NUC) based on a large database of patients with chronic hepatitis B (CHB) infection in Taiwan. The study showed 4-year cumulative incidence of off-therapy hepatic decompensation and mortality/ liver transplantation 1.8% and 0.7%, respectively; the 4-year incidence of hepatic decompensation decreased to 1.3% in patients without evidence of cirrhosis and 1.1% in those adhering to a standardised stopping rule.…”

Letter: Safety after cessation of nucleos(t)ide analogue therapy in patients with chronic hepatitis B infection—Authors' reply

“…This article is linked to Hsu et al papers. To view these articles, visit https://doi.org/10.1111/apt.17614 and https://doi.org/10.1111/ apt.17657 Yao-Chun Hsu 1,2,3 Mindie H. Nguyen 4,5 Chun-Ying Wu 3,6 AP&T correspondence columns are restricted to invited editorials and letters discussing papers that have been published in the journal. An invited editorial or letter must have a maximum of 500 words, may contain one table or figure, and should have no more than 10 references.…”

“…1 However, we did not find an association between the antiviral regimen and hepatic decompensation from withdrawal flares in our study. 2 If Liu et al had reviewed LETTER TO THE EDITOR…”