title: Clinical Relapse After Cessation of Tenofovir Therapy in Hepatitis B e Antigen-Negative Patients.
abstract: Of the hepatitis B e antigen-negative chronic hepatitis B patients with more than 1 year of 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.
  
  
  
  A retrospective-prospective study was conducted in 85 hepatitis B e antigen-negative chronic hepatitis B patients with sustained HBV suppression who had stopped tenofovir therapy and were monitored every 1 to 3 months for a median duration of 39 weeks (range, 4-133 wk).
  
  
  
  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 an alanine aminotransferase level greater than 5 and 10 times the upper limit of normal, respectively, 23.7% showed a bilirubin level of 2 mg/dL or greater, and 2 developed hepatic decompensation. Relapsers had significantly higher pretherapy baseline hepatitis B surface antigen level, more prior anti-HBV therapy experience, later alanine aminotransferase level normalization, and a shorter duration of treatment and consolidation therapy. Cox regression analyses showed that treatment for more than 3 years combined with consolidation therapy for more than 2 years was an independent significant manageable factor of clinical relapse (adjusted hazard ratio, 0.387; P = .008). With this combination, the clinical relapse rate was reduced to 30%.
  
  
  
  Clinical relapses occurred mostly within 6 months, with high alanine aminotransferase and serum bilirubin levels. Closer monitoring, monthly in the first 3 to 6 months, with timely re-treatment is mandatory for a safe cessation of tenofovir therapy.
authors.affiliation: Liver Research Unit, Chang Gung Memorial Hospital, Linkou, Taiwan; Division of Hepatology, Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Linkou, Taiwan; Chang Gung University College of Medicine, Taiwan.
authors.forename: Wen-Juei
authors.initials: WJ
authors.lastname: Jeng
authors.affiliation: Liver Research Unit, Chang Gung Memorial Hospital, Linkou, Taiwan; Division of Hepatology, Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Linkou, Taiwan; Chang Gung University College of Medicine, Taiwan.
authors.forename: Yi-Cheng
authors.initials: YC
authors.lastname: Chen
authors.affiliation: Liver Research Unit, Chang Gung Memorial Hospital, Linkou, Taiwan; Division of Hepatology, Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Linkou, Taiwan; Chang Gung University College of Medicine, Taiwan.
authors.forename: I-Shyan
authors.initials: IS
authors.lastname: Sheen
authors.affiliation: Chang Gung University College of Medicine, Taiwan; Liver Research Unit, Chang Gung Memorial Hospital, Keelung, Taiwan.
authors.forename: Chih-Lang
authors.initials: CL
authors.lastname: Lin
authors.affiliation: Chang Gung University College of Medicine, Taiwan; Liver Research Unit, Chang Gung Memorial Hospital, Kaohsiung, Taiwan; Division of Hepatogastroenterology, Department of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung, Taiwan.
authors.forename: Tsung-Hui
authors.initials: TH
authors.lastname: Hu
authors.affiliation: Chang Gung University College of Medicine, Taiwan; Liver Research Unit, Chang Gung Memorial Hospital, Keelung, Taiwan.
authors.forename: Rong-Nan
authors.initials: RN
authors.lastname: Chien
authors.affiliation: Liver Research Unit, Chang Gung Memorial Hospital, Linkou, Taiwan; Chang Gung University College of Medicine, Taiwan. Electronic address: liveryfl@gmail.com.
authors.forename: Yun-Fan
authors.initials: YF
authors.lastname: Liaw
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D012189:Retrospective Studies; D000072230:Sustained Virologic Response; D000068698:Tenofovir / Q000008:administration & dosage*; D028761:Withholding Treatment
chemical_list: D000998:Antiviral Agents; D006513:Hepatitis B e Antigens; D000068698:Tenofovir
keywords: Chronic Hepatitis B; Cirrhosis; Consolidation Therapy; Hepatic Decompensation; Hepatitis B Surface Antigen