@article{3118513,
    title = "Off-Therapy Response After Nucleos(t)ide Analogue Withdrawal in Patients With Chronic Hepatitis B: An International, Multicenter, Multiethnic Cohort (RETRACT-B Study)",
    author = "Hirode, G. and Choi, H.S.J. and Chen, C.-H. and Su, T.-H. and Seto, W.-K. and Van Hees, S. and Papatheodoridi, M. and Lens, S. and Wong, G. and Brakenhoff, S.M. and Chien, R.-N. and Feld, J. and Sonneveld, M.J. and Chan, H.L.Y. and Forns, X. and Papatheodoridis, G.V. and Vanwolleghem, T. and Yuen, M.-F. and Hsu, Y.-C. and Kao, J.-H. and Cornberg, M. and Hansen, B.E. and Jeng, W.-J. and Janssen, H.L.A. and RETRACT-B Study Group",
    journal = "BMJ Open Gastroenterology",
    year = "2022",
    volume = "162",
    number = "3",
    pages = "757-771.e4",
    publisher = "W.B. Saunders",
    doi = "10.1053/j.gastro.2021.11.002",
    keywords = "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",
    abstract = "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"
}