Trial reportJHEP reports : innovation in hepatology2026
Hepatic flares, their immune signatures, and ALT variability after nucleos(t)ide analogue cessation in HBeAg-negative hepatitis B.
Trial report in JHEP reports : innovation in hepatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03681132 (The Norwegian Nucleoside Analogue Stop Study), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Norwegian Nucleoside Analogue Stop Study: a Randomized Open-label Trial in HBeAg Negative Chronic Hepatitis B, Aiming at Achieving a Functional Cure.
Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND &
aimsHepatic flares frequently occur after nucleos(t)ide analogue (NA) cessation in patients with chronic hepatitis B (CHB) and can be beneficial ('good flares') or harmful ('bad flares'). We characterised flares after NA cessation aiming to identify predictors and immunological correlates of good and bad flares.
methodsThis study was nested in the prospective Nuc-Stop study, in which 127 patients with e-antigen negative CHB discontinued NA treatment with a 36-month follow-up. Flares were defined as an alanine aminotransferase (ALT) increase >2 × the upper limit of normal or >2 × baseline. Predictors of flares were identified by logistic regression. In 32 patients with flares without treatment restart, we compared clinical characteristics and soluble immune marker profiles of good flares (HBsAg loss or >1 log
resultsFlares occurred in 58.3% of patients. Age (per 1-year increment; adjusted odds ratio [aOR], 1.07; 95% confidence intervals [CI] 1.02-1.12) and end-of-treatment HBsAg level (per 1 log
conclusionsFlares occurred in over half the patients after NA cessation and were associated with age and end-of-treatment HBsAg levels. ALT variability following the initial flare and soluble marker profiles might serve as prognostic factors and distinguish good from bad flares. IMPACT AND IMPLICATIONS: NA cessation in HBeAg-negative CHB may facilitate functional cure, but hepatic flares are common and potentially detrimental, making careful patient selection essential. In this prospective, multicentre trial, flares occurred in over half of the patients, with severe flares in 12.6%. Increasing age and higher end-of-treatment HBsAg levels were predictors of flares and should be considered when deciding on treatment discontinuation. Close monitoring, particularly during the first 6 months, is critical for safe patient management, whereas ALT variability following the initial flare and soluble immune markers may help differentiate good from bad flares and guide retreatment decisions. CLINICAL TRIALS REGISTRATION (FOR THE NUC-STOP STUDY): NCT03681132.
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