title: Relapse of hepatitis B in HBeAg-negative chronic hepatitis B patients who discontinued successful entecavir treatment: the case for continuous antiviral therapy.
abstract: OBJECTIVE
  To evaluate the off-treatment durability of response in HBeAg-negative chronic hepatitis B patients who achieved a protocol-defined 'Response' (HBV-DNA<0.7MEq/mL and ALT<1.25xULN) with entecavir at 48 weeks and the efficacy of entecavir in patients treated beyond one year.
  
  
  METHODS
  Entecavir-treated and lamivudine-treated patients who achieved a protocol-defined 'Response' were evaluated off-treatment for HBV-DNA<300copies/mL and ALT normalisation. Entecavir- and lamivudine-treated patients who achieved a protocol-defined 'Virological Response' (HBV-DNA<0.7MEq/mL but ALT1.25xULN) at 48 weeks, continued blinded treatment until they achieved Response or 96 weeks, whichever came first.
  
  
  RESULTS
  Among 'Responders' who discontinued treatment after 48 weeks, 7/257 (3%) entecavir-treated and 10/201 (5%) lamivudine-treated patients sustained HBV-DNA below 300copies/mL at 24-weeks off-treatment. Among the 54 patients who continued blinded treatment in the second year, 7/26 (27%) entecavir-treated and 6/28 (21%) lamivudine-treated patients normalised ALT and 22/26 (85%) entecavir-treated and 16/28 (57%) lamivudine-treated patients maintained HBV-DNA<300copies/mL at end-of-dosing. The safety profiles of both drugs remained comparable through a second year of treatment.
  
  
  CONCLUSIONS
  The majority of protocol-defined Responders relapsed after 1 year when treatment was discontinued. Treatment with entecavir beyond 1 year provided continued virological and biochemical benefit.
authors.affiliation: Liver Unit, Hadassah - Hebrew University Hospital, Ein-Kerem, Jerusalem 91120, Israel. shouval@cc.huji.ac.il
authors.forename: Daniel
authors.initials: D
authors.lastname: Shouval
authors.forename: Ching-Lung
authors.initials: CL
authors.lastname: Lai
authors.forename: Ting-Tsung
authors.initials: TT
authors.lastname: Chang
authors.forename: Hugo
authors.initials: H
authors.lastname: Cheinquer
authors.forename: Paul
authors.initials: P
authors.lastname: Martin
authors.forename: Giampiero
authors.initials: G
authors.lastname: Carosi
authors.forename: Steven
authors.initials: S
authors.lastname: Han
authors.forename: Sabahattin
authors.initials: S
authors.lastname: Kaymakoglu
authors.forename: Ricardo
authors.initials: R
authors.lastname: Tamez
authors.forename: Joanna
authors.initials: J
authors.lastname: Yang
authors.forename: Daniel
authors.initials: D
authors.lastname: Tenney
authors.forename: Helena
authors.initials: H
authors.lastname: Brett-Smith
mesh_terms: D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D004311:Double-Blind Method; D024882:Drug Resistance, Viral; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006513:Hepatitis B e Antigens / Q000097:blood*; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use; D012008:Recurrence; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D019259:Lamivudine; C413685:entecavir; D006147:Guanine; D000410:Alanine Transaminase