Incidence of Hepatic Decompensation After Nucleos(t)ide Analog Withdrawal: Results From a Large, International, Multiethnic Cohort of Patients With Chronic Hepatitis B (RETRACT-B Study) - PubMed (original) (raw)

Multicenter Study

. 2023 Sep 1;118(9):1601-1608.

doi: 10.14309/ajg.0000000000002203. Epub 2023 Jan 30.

Bettina E Hansen 3, Chien-Hung Chen 4, Tung-Hung Su 5, Grace Wong 6, Wai-Kay Seto 7, Stijn Van Hees 8, Margarita Papatheodoridi 9, Sylvia M Brakenhoff 10, Sabela Lens 11, Hannah S J Choi 1, Rong-Nan Chien 12, Jordan J Feld 1 2, Xavier Forns 11, Milan J Sonneveld 10, George V Papatheodoridis 9, Thomas Vanwolleghem 8, Man-Fung Yuen 7, Henry L Y Chan 13, Jia-Horng Kao 5, Yao-Chun Hsu 14, Markus Cornberg 15, Wen-Juei Jeng 12, Harry L A Janssen 10; RETRACT-B study group

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Multicenter Study

Incidence of Hepatic Decompensation After Nucleos(t)ide Analog Withdrawal: Results From a Large, International, Multiethnic Cohort of Patients With Chronic Hepatitis B (RETRACT-B Study)

Grishma Hirode et al. Am J Gastroenterol. 2023.

Abstract

Introduction: Despite improvements in the management of chronic hepatitis B (CHB), risk of cirrhosis and hepatocellular carcinoma remains. While hepatitis B surface antigen loss is the optimal end point, safe discontinuation of nucleos(t)ide analog (NA) therapy is controversial because of the possibility of severe or fatal reactivation flares.

Methods: This is a multicenter cohort study of virally suppressed, end-of-therapy (EOT) hepatitis B e antigen (HBeAg)-negative CHB patients who stopped NA therapy (n = 1,557). Survival analysis techniques were used to analyze off-therapy rates of hepatic decompensation and differences by patient characteristics. We also examined a subgroup of noncirrhotic patients with consolidation therapy of ≥12 months before cessation (n = 1,289). Hepatic decompensation was considered related to therapy cessation if diagnosed off therapy or within 6 months of starting retreatment.

Results: Among the total cohort (11.8% diagnosed with cirrhosis, 84.2% start-of-therapy HBeAg-negative), 20 developed hepatic decompensation after NA cessation; 10 events were among the subgroup. The cumulative incidence of hepatic decompensation at 60 months off therapy among the total cohort and subgroup was 1.8% and 1.1%, respectively. The hepatic decompensation rate was higher among patients with cirrhosis (hazard ratio [HR] 5.08, P < 0.001) and start-of-therapy HBeAg-positive patients (HR 5.23, P < 0.001). This association between start-of-therapy HBeAg status and hepatic decompensation remained significant even among the subgroup (HR 10.5, P < 0.001).

Discussion: Patients with cirrhosis and start-of-therapy HBeAg-positive patients should be carefully assessed before stopping NAs to prevent hepatic decompensation. Frequent monitoring of viral and host kinetics after cessation is crucial to determine patient outcome.

Copyright © 2023 by The American College of Gastroenterology.

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References

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