title: Efficacy and resistance to telbivudine treatment in chronic hepatitis B patients with favorable predictors: a multicenter study in Taiwan.
abstract: OBJECTIVE
  A subgroup analysis of a GLOBE study identified subgroups of chronic hepatitis B (CHB) patients with excellent outcomes to telbivudine (LdT) treatment. The aim of this study was to validate this concept using a real-world clinical population.
  
  
  METHODS
  This prospective, retrospective, and multicenter study examined both HBeAg-positive and HBeAg-negative CHB patients treated with LdT for 2 years.
  
  
  RESULTS
  A total of 116 CHB patients were recruited. Of the 64 HBeAg-positive patients, 35 had favorable baseline characteristics [hepatitis B virus (HBV) DNA ≤ 9 log(10) copies/mL and alanine aminotransferase ≥ 2× the upper limit of normal (ULN)], but only 40% (14/35) achieved polymerase chain reaction (PCR) negativity at week 24. Among the 14 patients with favorable baseline characteristics and on-treatment response, the rates of virologic, biochemical, and serologic response and genotypic resistance were 78.6% (11/14), 64.3% (9/14), 50% (7/14), and 7.1% (1/14), respectively, at week 104 of therapy. Of the 52 HBeAg-negative patients, 34 met the criteria of a baseline serum HBV-DNA level less than 7 log(10) copies/mL, and 29 (85.3%) achieved PCR negativity at week 24. Among the 29 patients with favorable baseline characteristics and on-treatment response, the rates of virologic and biochemical response and genotypic resistance were 96.6% (28/29), 72.4% (21/29), and 6.9% (2/29), respectively. In addition, the PCR negativity at week 24 was the only factor associated with the virologic response and genotypic resistance to LdT treatment.
  
  
  CONCLUSIONS
  The efficacy and resistance to LdT treatment in CHB patients with favorable predictors were comparable between a real-world clinical population and the GLOBE study. In addition, PCR negativity at week 24 could predict virologic response and genotypic resistance to LdT treatment.
authors.affiliation: Department of Gastroenterology, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and School of Medicine, Tzu Chi University, Hualien, Taiwan. uld888@yahoo.com.tw.
authors.forename: Chia-Chi
authors.initials: CC
authors.lastname: Wang
authors.affiliation: Department of Gastroenterology, Taipei City Hospital, Ren-Ai Branch, Taipei, Taiwan. DAB53@tpech.gov.tw.
authors.forename: Chih-Lin
authors.initials: CL
authors.lastname: Lin
authors.affiliation: Department of Gastroenterology, Tri-service General Hospital, Taipei, Taiwan. tyh1216@ms46.hinet.net.
authors.forename: Tsai-Yuan
authors.initials: TY
authors.lastname: Hsieh
authors.affiliation: Department of Hepatology, Da-Lin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and School of Medicine, Tzu Chi University, Hualien, Taiwan. tsengkuochih@gmail.com.
authors.forename: Kuo-Chih
authors.initials: KC
authors.lastname: Tseng
authors.affiliation: Department of Gastroenterology, China Medical University Hospital, Shenyang, China. cypeng@mail.cmuh.org.tw.
authors.forename: Cheng-Yuan
authors.initials: CY
authors.lastname: Peng
authors.affiliation: Graduate Institute of Clinical Medicine and Hepatitis Research Center, College of Medicine and Hospital, National Taiwan University, Taipei, Taiwan. tunghungsu@gmail.com.
authors.forename: Tung-Hung
authors.initials: TH
authors.lastname: Su
authors.affiliation: Division of Gastroenterology & Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan. yansh@vghtc.gov.tw.
authors.forename: Sheng-Shun
authors.initials: SS
authors.lastname: Yang
authors.affiliation: Department of Gastroenterology, Changhua Christian Hospital, Changhua, Taiwan. 77149@cch.org.tw.
authors.forename: Yu-Chun
authors.initials: YC
authors.lastname: Hsu
authors.affiliation: Department of Gastroenterology and Hepatology, Tungs' Taichung MetroHarbor Hospital, Taichung, Taiwan. reilybabybaby@yahoo.com.tw.
authors.forename: Tsung-Ming
authors.initials: TM
authors.lastname: Chen
authors.affiliation: Graduate Institute of Clinical Medicine and Hepatitis Research Center, College of Medicine and Hospital, National Taiwan University, Taipei, Taiwan. kaojh@ntu.edu.tw.|Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, 1 Chang-Te Street, Taipei, 100, Taiwan. kaojh@ntu.edu.tw.
authors.forename: Jia-Horng
authors.initials: JH
authors.lastname: Kao
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D004279:DNA, Viral / Q000097:blood; D024882:Drug Resistance, Viral; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012189:Retrospective Studies; D013624:Taiwan; D000077712:Telbivudine; D013936:Thymidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D000077712:Telbivudine; D013936:Thymidine
keywords: Hepatitis B virus; Roadmap concept; Super-responder; Telbivudine