Please use this identifier to cite or link to this item: http://dx.doi.org/10.25673/108980
Title: A multicenter randomized-controlled trial of nucleos(t)ide analogue cessation in HBeAg-negative chronic hepatitis B
Author(s): Bömmel, FlorianLook up in the Integrated Authority File of the German National Library
Zipprich, AlexanderLook up in the Integrated Authority File of the German National Library
[und viele weitere]
Issue Date: 2023
Type: Article
Language: English
Abstract: Background & Aims: Nucleos(t)ide analogues (NUCs) are the standard and mostly lifelong treatment for chronic HBeAg-negative hepatitis B, as functional cure (loss of HBsAg) is rarely achieved. Discontinuation of NUC treatment may lead to functional cure; however, to date, the evidence for this has been based on small or non-randomized clinical trials. The STOP-NUC trial was designed with the aim of increasing the HBsAg loss rate using a NUC treatment interruption approach. Methods: In this multicenter, randomized-controlled trial, 166 HBeAg-negative patients with chronic hepatitis B on continuous long-term NUC treatment, with HBV DNA <172 IU/ml (1,000 copies/ml) for >− 4 years, were randomized to either stop (Arm A) or continue NUC treatment (Arm B) for a 96-week observation period. In total, 158 patients were available for final analysis, 79 per arm. The primary endpoint was sustained HBsAg loss up to week 96. Results: Our study met its primary objective by demonstrating HBsAg loss in eight patients (10.1%, 95% CI 4.8%–19.5%) in Arm A and in no patient in Arm B (p = 0.006). Among patients with baseline HBsAg levels <1,000 IU/ml, seven (28%) achieved HBsAg loss. In Arm A, re-therapy was initiated in 11 (13.9%) patients, whereas 32 (40.5%) patients achieved sustained remission. A decrease of HBsAg >1 log IU/ml was observed in 16 patients (20.3%) in Arm A and in one patient (1.3%) in Arm B. No serious adverse events related to treatment cessation occurred. Conclusions: Cessation of NUC treatment was associated with a significantly higher rate of HBsAg loss than continued NUC treatment, which was largely restricted to patients with end of treatment HBsAg levels <1,000 IU/ml.
URI: https://opendata.uni-halle.de//handle/1981185920/110935
http://dx.doi.org/10.25673/108980
Open Access: Open access publication
License: (CC BY-NC-ND 4.0) Creative Commons Attribution NonCommercial NoDerivatives 4.0(CC BY-NC-ND 4.0) Creative Commons Attribution NonCommercial NoDerivatives 4.0
Journal Title: Journal of hepatology
Publisher: Elsevier Science
Publisher Place: Amsterdam [u.a.]
Volume: 78
Issue: 5
Original Publication: 10.1016/j.jhep.2022.12.018
Page Start: 926
Page End: 936
Appears in Collections:Open Access Publikationen der MLU

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