Incidence of Hepatic Decompensation After... : American Journal of Gastroenterology (original) (raw)

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 Hirode2
• Bettina E. Hansen3
• Chien-Hung Chen4
• Tung-Hung Su5
• Grace Wong6
• Wai-Kay Seto7
• Stijn Van Hees8
• Margarita Papatheodoridi9
• Sylvia M. Brakenhoff10
• Sabela Lens11
• Hannah S.J. Choi1
• Rong-Nan Chien12
• Jordan J. Feld2
• Xavier Forns11
• Milan J. Sonneveld10
• George V. Papatheodoridis9
• Thomas Vanwolleghem8
• Man-Fung Yuen7
• Henry L.Y. Chan13
• Jia-Horng Kao5
• Yao-Chun Hsu14
• Markus Cornberg15
• Wen-Juei Jeng12
• Harry L.A. Janssen10
• on behalf of the RETRACT-B study group

American Journal of Gastroenterology

118

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9

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:p

1601

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1608

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September 2023

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| DOI: 10.14309/ajg.0000000000002203

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.