title: Efficacy of telbivudine in Taiwanese chronic hepatitis B patients compared with GLOBE extension study and predicting treatment outcome by HBV DNA kinetics at week 24.
abstract: BACKGROUND
  The aims of this study were to compare results from a Taiwanese sub-study of the GLOBE 2303 telbivudine study and evaluate the HBV DNA kinetics.
  
  
  METHODS
  Forty-one Taiwanese patients were treated for an additional 2 years with telbivudine. Efficacy endpoints were the same as the GLOBE study. The correlations of reductions in HBV DNA levels at Week 24 were evaluated.
  
  
  RESULTS
  All 7 HBeAg-positive patients with undetectable HBV DNA levels at Week 24 sustained this response at Year 4 with rates of ALT normalization 71%, HBeAg seroconversion 57%, and cumulative resistance 0%. Out of 16 HBeAg-negative patients with undetectable HBV DNA levels at Week 24, 11 (78%) sustained this response at Year 4 with rates of ALT normalization 83% and cumulative resistance 8.7%. There were significant correlations between reductions of DNA of ≥5 log10 copies/mL at Week 24 with maintained PCR negativity at Years 2-4 and a lack of resistance at Year 2.
  
  
  CONCLUSIONS
  Long-term telbivudine efficacy in Taiwanese patients was comparable to the GLOBE 2303 study. A reduction in HBV DNA levels by ≥5 log10 copies/mL at Week 24 represented the optimal cut-off point, which may predict favourable outcomes in patients with high baseline HBV DNA levels.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT00142298 (http://clinicaltrials.gov/).
authors.affiliation: Liver Research Unit, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, 199 Tung Hwa North Road, Taipei 105, Taiwan. hsu2406@adm.cgmh.org.tw
authors.forename: Chao Wei
authors.initials: CW
authors.lastname: Hsu
authors.forename: You Chen
authors.initials: YC
authors.lastname: Chao
authors.forename: Chuan Mo
authors.initials: CM
authors.lastname: Lee
authors.forename: Ting Tsung
authors.initials: TT
authors.lastname: Chang
authors.forename: Yi Cheng
authors.initials: YC
authors.lastname: Chen
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood*; D024882:Drug Resistance, Viral; D005260:Female; D006513:Hepatitis B e Antigens / Q000276:immunology; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013624:Taiwan; D000077712:Telbivudine; D013936:Thymidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D000077712:Telbivudine; D000410:Alanine Transaminase; D013936:Thymidine