title: Efficacy and safety of prolonged 3-year telbivudine treatment in patients with chronic hepatitis B.
abstract: BACKGROUND
  In the GLOBE trial, telbivudine demonstrated superior efficacy to lamivudine at 2 years in patients with chronic hepatitis B (CHB).
  
  
  OBJECTIVE
  To investigate the long-term efficacy and safety of telbivudine in the telbivudine-treated cohort from the GLOBE trial.
  
  
  METHODS
  Virological and biochemical responses were assessed in 213 HBeAg-positive and 186 HBeAg-negative CHB patients who continued telbivudine treatment for 3 years.
  
  
  RESULTS
  Undetectable hepatitis B virus DNA and HBeAg seroconversions were achieved by 77 and 37% of HBeAg-positive patients respectively. Cumulative HBeAg seroconversion rate was 46%. HBeAg seroconversion was sustained at 52 weeks off therapy in 84% of the patients enrolled in the off-treatment follow-up arm of the study. Undetectable viraemia and normal alanine aminotransferase (ALT) levels at 3 years were achieved by 85 and 83% of HBeAg-negative patients respectively. Genotypic resistance rates for the study population who continued therapy during the third year were 11.3 in HBeAg-positive and 6.5% in HBeAg-negative patients. Patients with undetectable viraemia at treatment week 24 had optimal outcomes at 3 years. In the HBeAg-positive population, cumulative HBeAg seroconversion occurred in 58%. Resistance rates for HBeAg-positive and HBeAg-negative patients were 3.6 and 6.2% respectively. The telbivudine safety profile during prolonged therapy was similar to that in the GLOBE trial.
  
  
  CONCLUSIONS
  Three years of telbivudine treatment yielded high rates of viral suppression and ALT normalization with a favourable safety profile. High rates of HBeAg seroconversion were achieved with prolonged telbivudine therapy and were sustained in the majority of patients over 52 weeks off therapy.
authors: New Zealand Liver Unit, Auckland City Hospital, Auckland, New Zealand. edgane@adhb.govt.nz
authors: Edward J
authors: EJ
authors: Gane
authors: Yuming
authors: Y
authors: Wang
authors: Yun-Fan
authors: YF
authors: Liaw
authors: Jinlin
authors: J
authors: Hou
authors: Satawat
authors: S
authors: Thongsawat
authors: MoBin
authors: M
authors: Wan
authors: Young M
authors: YM
authors: Moon
authors: JiDong
authors: J
authors: Jia
authors: You C
authors: YC
authors: Chao
authors: Junqi
authors: J
authors: Niu
authors: Nancy
authors: N
authors: Leung
authors: Didier
authors: D
authors: Samuel
authors: Chao Wei
authors: CW
authors: Hsu
authors: Weibin
authors: W
authors: Bao
authors: Patricia
authors: P
authors: Lopez
authors: Claudio
authors: C
authors: Avila
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015415:Biomarkers / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D004334:Drug Administration Schedule; D024882:Drug Resistance, Viral / Q000235:genetics; D005260:Female; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009705:Nucleosides / Q000008:administration & dosage* / Q000009:adverse effects; D011744:Pyrimidinones / Q000008:administration & dosage* / Q000009:adverse effects; D000077712:Telbivudine; D013936:Thymidine / Q000031:analogs & derivatives; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D009705:Nucleosides; D011744:Pyrimidinones; D000077712:Telbivudine; D000410:Alanine Transaminase; D013936:Thymidine