Limited Sustained Remission After Nucleos(t)ide Analog Withdrawal: Results From a Large, Global, Multiethnic Cohort of Patients With Chronic Hepatitis B (RETRACT-B Study).

Autor:	Hirode G; Toronto Centre for Liver Disease, University Health Network, Toronto, Ontario, Canada.; The Toronto Viral Hepatitis Care Network (VIRCAN), Toronto, Ontario, Canada.; Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada., Hansen BE; Toronto Centre for Liver Disease, University Health Network, Toronto, Ontario, Canada.; Department of Epidemiology, Biostatistics, Erasmus Medical Center, Rotterdam, Netherlands.; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada., Chen CH; Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan., Su TH; Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan., Wong GLH; Medical Data Analytics Centre (MDAC), The Chinese University of Hong Kong, Hong Kong, China., Seto WK; Department of Medicine and State Key Laboratory of Liver Research, School of Clinical Medicine, The University of Hong Kong, Hong Kong, China., d'Almeida AF; Viral Hepatitis Research Group, Laboratory of Experimental Medicine and Pediatrics, University of Antwerp, Antwerp, Belgium., Papatheodoridi M; Medical School of National and Kapodistrian University of Athens, Athens, Greece., Brakenhoff SM; Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, the Netherlands., Lens S; Hospital Clinic Barcelona, IDIBAPS and CIBEREHD, University of Barcelona, Barcelona, Spain., Choi HSJ; Toronto Centre for Liver Disease, University Health Network, Toronto, Ontario, Canada., Chien RN; Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital Linkou Medical Center, Chang Gung University, Linkou, Taiwan., Feld JJ; Toronto Centre for Liver Disease, University Health Network, Toronto, Ontario, Canada.; The Toronto Viral Hepatitis Care Network (VIRCAN), Toronto, Ontario, Canada.; Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada., Forns X; Hospital Clinic Barcelona, IDIBAPS and CIBEREHD, University of Barcelona, Barcelona, Spain., Sonneveld MJ; Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, the Netherlands., Papatheodoridis GV; Medical School of National and Kapodistrian University of Athens, Athens, Greece., Vanwolleghem T; Viral Hepatitis Research Group, Laboratory of Experimental Medicine and Pediatrics, University of Antwerp, Antwerp, Belgium.; Department of Gastroenterology and Hepatology, Antwerp University Hospital, Antwerp, Belgium., Yuen MF; Department of Medicine and State Key Laboratory of Liver Research, School of Clinical Medicine, The University of Hong Kong, Hong Kong, China., Chan HLY; Medical Data Analytics Centre (MDAC), The Chinese University of Hong Kong, Hong Kong, China., Kao JH; Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan., Hsu YC; Center for Liver Diseases, E-Da Hospital/I-Shou University, Kaohsiung, Taiwan., Cornberg M; Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.; Centre for Individualized Infection Medicine (CiiM), Hannover, Germany., Jeng WJ; Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital Linkou Medical Center, Chang Gung University, Linkou, Taiwan., Janssen HLA; Toronto Centre for Liver Disease, University Health Network, Toronto, Ontario, Canada.; Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, the Netherlands.
Jazyk:	angličtina
Zdroj:	The American journal of gastroenterology [Am J Gastroenterol] 2024 Sep 01; Vol. 119 (9), pp. 1849-1856. Date of Electronic Publication: 2024 May 14.
DOI:	10.14309/ajg.0000000000002759
Abstrakt:	Introduction: Complete viral suppression with nucleos(t)ide analogs (NAs) has led to a profound reduction in hepatocellular carcinoma and mortality among patients with chronic hepatitis B. Finite therapy yields higher rates of functional cure; however, initial hepatitis B virus (HBV) DNA and alanine aminotransferase (ALT) elevations are almost certain after treatment interruption. We aimed to analyze off-treatment outcomes beyond 12 months after NA cessation. Methods: Patients with well-suppressed chronic hepatitis B who were hepatitis B e antigen-negative at NA cessation and remained off treatment without hepatitis B surface antigen (HBsAg) loss at 12 months were included (n = 945). HBV DNA and ALT fluctuations were allowed within the first 12 months. We used Kaplan-Meier methods to analyze outcomes beyond 12 months. Sustained remission was defined as HBV DNA <2,000 IU/mL and ALT <2× upper limit of normal (ULN) and an ALT flare as ALT ≥5× ULN. Results: Cumulative probability of sustained remission was 29.7%, virological relapse was 65.2% with a mean peak HBV DNA of 5.0 ± 1.5 log 10 IU/mL, an ALT flare was 15.6% with a median peak ALT × ULN of 8.3 (5.7-11.3), HBsAg loss was 9.9% and retreatment was 34.9% at 48 months after NA cessation. A single occurrence of virological relapse or an ALT flare within the first 12 months off-treatment were associated with significantly lower rates of sustained remission beyond 12 months. Discussion: Despite allowing for HBV DNA and ALT fluctuations within the first 12 months off-treatment, most patients without HBsAg loss did not maintain a sustained response thereafter. The best candidates for NA withdrawal are patients with low HBsAg levels at NA cessation, and those without profound or recurrent virological and biochemical relapses in the first off-treatment year. (Copyright © 2024 by The American College of Gastroenterology.)
Databáze:	MEDLINE
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