Predictors of hepatic flares after nucleos(t)ide analogue cessation – Results of a global cohort study (RETRACT-B study)
Notice bibliographique
Résumé
Background and Aims Flares after nucleos(t)ide analogue (NA) cessation are common and potentially harmful. Predictors of flares are required for risk stratification and to guide off-treatment follow-up. Method This multicenter cohort study included virally suppressed patients with chronic hepatitis B (CHB) who were hepatitis B e antigen negative at NA cessation. Hepatic flares were defined based on an ALT-levels of ≥5-, 10- or 20 x upper limit of normal (ULN). Multivariable Cox regression analyses were performed censoring at retreatment, HBsAg-loss and loss-to-follow-up. A sub-analysis was performed including HBV DNA levels Results Of the 1552 included patients, 350 developed a flare (ALT≥5xULN), of whom 70% within the first year. One-year cumulative incidences for ALT flares ≥5x, ≥10x, ≥20xULN were 18.6%, 10.2% and 3.4%, respectively. Severity of flares decreased over time, but severe flares still occurred after one year. Thirteen patients decompensated after a flare, of whom 3 died. Flares seemed not associated with increased rates of HBsAg loss (adjusted Hazard Ratio [aHR] 1.42, P=0.28). Multivariable-analyses showed that older age (aHR:1.02,P=0.001), male sex (aHR:1.57,P=0.003), HBsAg levels at NA withdrawal (100-1,000 IU/mL; aHR:1.99,P<0.001; >1,000 IU/mL; aHR:2.65,P<0.001) and Tenofovir (TDF) vs. Entecavir therapy (aHR:2.99,P<0.001) were predictive for flares (≥5xULN). Early HBV DNA levels >5log 10 IU/mL were associated with the highest risk of flares (aHR:2.36,P<0.001). Conclusion Flares are common after NA withdrawal, especially within the first year and can result in hepatic decompensation and death. Older age, male sex, higher HBsAg levels at end of treatment and TDF therapy were associated with a higher risk of flares. Close monitoring and retreatment should be considered if HBV DNA levels exceed >5log 10 IU/ml within the first 12 weeks. Lay summary Hepatic flares are common after NA cessation, even after 1 year. More caution is warranted in older patients, HBsAg levels >100 IU/mL, males and after TDF therapy. Furthermore, intensified follow up and retreatment is needed if HBV DNA levels exceeded 5log 10 IU/mL during the first 12 weeks. Impact and implications This is the first large global multi-centered cohort study which provides detailed data about flares after NA cessation in patients with chronic hepatitis B. These results could guide follow-up after withdrawal, helping clinicians identify high risk patients and deciding when to restart anti-viral therapy. Clinical trial number Not applicable.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».