Τίτλος:
Off-Therapy Response After Nucleos(t)ide Analogue Withdrawal in Patients With Chronic Hepatitis B: An International, Multicenter, Multiethnic Cohort (RETRACT-B Study)
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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. © 2022 AGA Institute
Συγγραφείς:
Hirode, G.
Choi, H.S.J.
Chen, C.-H.
Su, T.-H.
Seto, W.-K.
Van Hees, S.
Papatheodoridi, M.
Lens, S.
Wong, G.
Brakenhoff, S.M.
Chien, R.-N.
Feld, J.
Sonneveld, M.J.
Chan, H.L.Y.
Forns, X.
Papatheodoridis, G.V.
Vanwolleghem, T.
Yuen, M.-F.
Hsu, Y.-C.
Kao, J.-H.
Cornberg, M.
Hansen, B.E.
Jeng, W.-J.
Janssen, H.L.A.
RETRACT-B Study Group
Περιοδικό:
BMJ Open Gastroenterology
Λέξεις-κλειδιά:
antivirus agent; entecavir; guanine; hepatitis B surface antigen; hepatitis B(e) antigen; nucleoside; tenofovir; virus DNA, adult; age; Asian; blood; Caucasian; chronic hepatitis B; clinical trial; cohort analysis; female; follow up; Hepatitis B virus; human; male; middle aged; multicenter study; pathophysiology; recurrent disease; retreatment, Adult; Age Factors; Antiviral Agents; Asians; Cohort Studies; DNA, Viral; Female; Follow-Up Studies; Guanine; Hepatitis B e Antigens; Hepatitis B Surface Antigens; Hepatitis B virus; Hepatitis B, Chronic; Humans; Male; Middle Aged; Nucleosides; Race Factors; Recurrence; Retreatment; Tenofovir; Whites
DOI:
10.1053/j.gastro.2021.11.002
