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Gut. 2019 Aug 28. pii: gutjnl-2019-318981. doi: 10.1136/gutjnl-2019-318981. [Epub ahead of print]
Limited sustained response after stopping nucleos(t)ide analogues in patients with chronic hepatitis B: results from a randomised controlled trial (Toronto STOP study).
Liem KS1,2, Fung S1, Wong DK1, Yim C1, Noureldin S1, Chen J1, Feld JJ1,3, Hansen BE1,4, Janssen HLA5.
Author information
1
Toronto Centre for Liver Disease, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.
2
Department of Gastroenterology and Hepatology, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands.
3
Sandra Rotman Centre for Global Health, Toronto, Ontario, Canada.
4
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
5
Toronto Centre for Liver Disease, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada [email protected].
Abstract
OBJECTIVE:
Although most patients with chronic hepatitis B (CHB) reach effective virological suppression with long-term nucleos(t)ide analogues (NA) therapy, some might not need to continue treatment for life. In this randomised, controlled, phase IV trial, we evaluated off-therapy outcomes in patients after discontinuing long-term NA therapy.
DESIGN:
Patients who had received NA therapy for ≥1 year and achieved virological suppression (hepatitis B e antigen (HBeAg) seroconversion combined with undetectable hepatitis B virus (HBV) DNA ≥12 months in HBeAg-positive patients or undetectable HBV DNA ≥36 months in HBeAg-negative patients) were randomised 2:1 to stop or continue NA therapy for 72 weeks. Sustained disease remission (HBeAg negative, HBV DNA <2000 IU/mL and normal alanine aminotransferase (ALT)) was evaluated at 72 weeks after stopping NA therapy.
RESULTS:
Among 67 enrolled patients, sustained disease remission was observed in 13/45 (29%) stop versus 18/22 (82%) continue patients. Hepatitis B surface antigen (HBsAg) loss occurred in two patients (one in each group). The median HBsAg decline from randomisation to week 72 was similar in both groups (0.2 (0.0-0.4) vs 0.1 (0.0-0.2) log IU/mL in stop vs continue patients; p=0.04). Among patients who stopped, 15/45 (33%) had virological or biochemical relapse and 17/45 (38%) were retreated according to predefined criteria. A total of 11/18 (61%) pretreatment HBeAg-positive versus 6/27 (22%) HBeAg-negative patients required retreatment (p=0.01). Fourteen (31%) patients developed ALT >10× upper limit of normal (ULN) and another 7 (16%) had ALT >5× ULN. No patients experienced liver decompensation or died.
CONCLUSION:
The findings of this prospective study suggest limited benefit of stopping NA therapy in chronic hepatitis B.
TRIAL REGISTRATION NUMBER:
NCT01911156.
© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.
KEYWORDS:
HBeAg negative; discontinuation; nucleos(t)ide analogue; viral hepatitis
PMID:
31462554
DOI:
10.1136/gutjnl-2019-318981 |
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