TY - JOUR
TI - Off-Therapy Response After Nucleos(t)ide Analogue Withdrawal in Patients With Chronic Hepatitis B: An International, Multicenter, Multiethnic Cohort (RETRACT-B Study)
AU - Hirode, G.
AU - Choi, H.S.J.
AU - Chen, C.-H.
AU - Su, T.-H.
AU - Seto, W.-K.
AU - Van Hees, S.
AU - Papatheodoridi, M.
AU - Lens, S.
AU - Wong, G.
AU - Brakenhoff, S.M.
AU - Chien, R.-N.
AU - Feld, J.
AU - Sonneveld, M.J.
AU - Chan, H.L.Y.
AU - Forns, X.
AU - Papatheodoridis, G.V.
AU - Vanwolleghem, T.
AU - Yuen, M.-F.
AU - Hsu, Y.-C.
AU - Kao, J.-H.
AU - Cornberg, M.
AU - Hansen, B.E.
AU - Jeng, W.-J.
AU - Janssen, H.L.A.
AU - RETRACT-B Study Group
JO - BMJ Open Gastroenterology
PY - 2022
VL - 162
TODO - 3
SP - 757-771.e4
PB - W.B. Saunders
SN - null
TODO - 10.1053/j.gastro.2021.11.002
TODO - 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
TODO - 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
ER -