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Clin Gastroenterol Hepatol. 2016 Jul 9. pii: S1542-3565(16)30378-0. doi: 10.1016/j.cgh.2016.07.002. [Epub ahead of print]
Clinical relapse after cessation of tenofovir therapy in HBeAg-negative patients.Jeng WJ1, Chen YC1, Sheen IS1, Lin CL2, Hu TH3, Chien RN4, Liaw YF5.
Author information
- 1Liver Research Unit, Chang Gung Memorial Hospital, Linkou; Division of Hepatology, Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Linkou; Chang Gung University College of Medicine, Taiwan.
- 2Liver Research Unit, Chang Gung Memorial Hospital, Keelung; Chang Gung University College of Medicine, Taiwan.
- 3Liver Research Unit, Chang Gung Memorial Hospital, Kaohsiung; Division of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital; Chang Gung University College of Medicine, Taiwan.
- 4Liver Research Unit, Chang Gung Memorial Hospital, Keelung; Division of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital; Chang Gung University College of Medicine, Taiwan.
- 5Liver Research Unit, Chang Gung Memorial Hospital, Linkou; Chang Gung University College of Medicine, Taiwan. Electronic address: [email protected].
AbstractBACKGROUND & AIMS: Of the hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) patients with >1 year sustained hepatitis B virus (HBV) suppression during therapy, the 1-year clinical relapse rate after cessation of entecavir therapy was 45%, of which 25.6% occurred within 6 months. The events after cessation of another preferred drug tenofovir were investigated.
METHODS: A retrospective-prospective study was conducted in 85 HBeAg-negative CHB patients with sustained HBV suppression who had stopped tenofovir therapy and were monitored every 1-3 months for a median duration of 39 (4-133) weeks.
RESULTS: Clinical relapse occurred in 38 patients, 57.9% and 86.8% within 3 and 6 months, respectively, with an estimated 1-year cumulative incidence of 52%. The optimal duration of therapy and consolidation therapy were calculated to be 3 and 2 years, respectively. Of the relapsers, 81.6% and 57.9% showed ALT>5X and 10X upper limit of normal, respectively, 23.7% showed bilirubin ≥2mg/dl and 2 developed hepatic decompensation. Relapsers had significantly higher phetherapy baseline hepatitis B surface antigen level, more prior anti-HBV therapy experience, later alanine aminotransferase (ALT) normalization, shorter duration of treatment and consolidation therapy. Cox regression analyses revealed that treatment >3 years combined with consolidation therapy >2 years was an independent significant manageable factor of clinical relapse (adjusted HR: 0.387, P=0.008). With this combination, clinical relapse rate was reduced to 30%.
CONCLUSIONS: Clinical relapses occurred mostly within 6 months with high ALT and serum bilirubin. Closer monitoring, monthly in the first 3-6 month, with timely retreatment is mandatory for a safe cessation of tenofovir therapy.
Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.
KEYWORDS: chronic hepatitis B; consolidation therapy; hepatic decompensation; hepatitis B surface antigen; liver cirrhosis
PMID:27404969DOI:10.1016/j.cgh.2016.07.002
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