Off-Therapy Response After Nucleos(t)ide Analogue Withdrawal in Patients With Chronic Hepatitis B: An International, Multicenter, Multiethnic Cohort (RETRACT-B Study) - PubMed (original) (raw)

Multicenter Study

. 2022 Mar;162(3):757-771.e4.

doi: 10.1053/j.gastro.2021.11.002. Epub 2021 Nov 9.

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

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Multicenter Study

Off-Therapy Response After Nucleos(t)ide Analogue Withdrawal in Patients With Chronic Hepatitis B: An International, Multicenter, Multiethnic Cohort (RETRACT-B Study)

Grishma Hirode et al. Gastroenterology. 2022 Mar.

Erratum in

Abstract

Background & aims: Functional cure, defined based on hepatitis B surface antigen (HBsAg) loss, is rare during nucleos(t)ide analogue (NA) therapy and guidelines on finite NA therapy have not been well established. We aim to analyze off-therapy outcomes after NA cessation in a large, international, multicenter, multiethnic cohort of patients with chronic hepatitis B (CHB).

Methods: This cohort study included patients with virally suppressed CHB who were hepatitis B e antigen (HBeAg)-negative and stopped NA therapy. Primary outcome was HBsAg loss after NA cessation, and secondary outcomes included virologic, biochemical, and clinical relapse, alanine aminotransferase flare, retreatment, and liver-related events after NA cessation.

Results: Among 1552 patients with CHB, cumulative probability of HBsAg loss was 3.2% at 12 months and 13.0% at 48 months of follow-up. HBsAg loss was higher among Whites (vs Asians: subdistribution hazard ratio, 6.8; 95% confidence interval, 2.7-16.8; P < .001) and among patients with HBsAg levels <100 IU/mL at end of therapy (vs ≥100 IU/mL: subdistribution hazard ratio, 22.5; 95% confidence interval, 13.1-38.7; P < .001). At 48 months of follow-up, Whites with HBsAg levels <1000 IU/mL and Asians with HBsAg levels <100 IU/mL at end of therapy had a high predicted probability of HBsAg loss (>30%). Incidence rate of hepatic decompensation and hepatocellular carcinoma was 0.48 per 1000 person-years and 0.29 per 1000 person-years, respectively. Death occurred in 7/19 decompensated patients and 2/14 patients with hepatocellular carcinoma.

Conclusions: The best candidates for NA withdrawal are virally suppressed, HBeAg- negative, noncirrhotic patients with CHB with low HBsAg levels, particularly Whites with <1000 IU/mL and Asians with <100 IU/mL. However, strict surveillance is recommended to prevent deterioration.

Keywords: Antiviral; Discontinuation; HBV; HBsAg seroconversion.

Copyright © 2022 AGA Institute. Published by Elsevier Inc. All rights reserved.

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