title: Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial.
abstract: BACKGROUND
  The efficacy of nucleoside and nucleotide analogues for hepatitis B has been linked to the magnitude and durability of hepatitis B virus (HBV) suppression.
  
  
  OBJECTIVE
  To compare the antiviral efficacy of telbivudine and adefovir dipivoxil, and the effects of switching from adefovir to telbivudine, in hepatitis B e antigen (HBeAg)-positive patients with chronic hepatitis B.
  
  
  METHODS
  Randomized, controlled, open-label trial.
  
  
  METHODS
  16 outpatient clinics.
  
  
  METHODS
  135 treatment-naive, HBeAg-positive adults with chronic hepatitis B.
  
  
  METHODS
  Patients were randomly assigned in a 1:1:1 ratio to 52 weeks of telbivudine (group A) or adefovir (group B), or 24 weeks of adefovir and then telbivudine for the remaining 28 weeks (group C). One hundred thirty-one patients completed 52 weeks of treatment.
  
  
  METHODS
  The primary efficacy comparison was serum HBV DNA reduction at week 24, with a secondary comparison at week 52.
  
  
  RESULTS
  At week 24, mean HBV DNA reduction was greater in group A than in pooled groups B and C (-6.30 vs. -4.97 log10 copies/mL; difference, -1.33 log10 copies/mL [95% CI, -1.99 to -0.66 log(10) copies/mL]; P < 0.001), and more patients in group A were polymerase chain reaction-negative (39% vs. 12%; odds ratio, 4.46 [CI, 1.86 to 10.72]; P = 0.001). At week 52, the mean residual HBV DNA level was lower in group A and group C than in group B (3.01 log10 copies/mL [group A] and 3.02 log10 copies/mL [group C] vs. 4.00 log10 copies/mL [group B]; difference, -0.99 log10 copies/mL [CI, -1.67 to -0.32 log10 copies/mL] and -0.98 log10 copies/mL [CI, -1.64 to -0.32 log10 copies/mL]; P = 0.004). Adverse events were similar across groups; the most common were upper respiratory symptoms, headache, back pain, and diarrhea.
  
  
  CONCLUSIONS
  The trial was open-label and was not of sufficient size or duration to compare clinical outcomes and long-term efficacy.
  
  
  CONCLUSIONS
  Telbivudine demonstrated greater and more consistent HBV DNA suppression than adefovir after 24 weeks of treatment. After 52 weeks, HBV DNA suppression was greater in patients who had received continuous telbivudine or were switched to telbivudine after 24 weeks than in those who received continuous adefovir.
authors.affiliation: The Chinese University of Hong Kong, Shatin, Hong Kong, China. hlychan@cuhk.edu.hk
authors.forename: Henry L Y
authors.initials: HL
authors.lastname: Chan
authors.forename: E Jenny
authors.initials: EJ
authors.lastname: Heathcote
authors.forename: Patrick
authors.initials: P
authors.lastname: Marcellin
authors.forename: Ching-Lung
authors.initials: CL
authors.lastname: Lai
authors.forename: Mong
authors.initials: M
authors.lastname: Cho
authors.forename: Young M
authors.initials: YM
authors.lastname: Moon
authors.forename: You-Chen
authors.initials: YC
authors.lastname: Chao
authors.forename: Robert P
authors.initials: RP
authors.lastname: Myers
authors.forename: Gerald Y
authors.initials: GY
authors.lastname: Minuk
authors.forename: Lennox
authors.initials: L
authors.lastname: Jeffers
authors.forename: William
authors.initials: W
authors.lastname: Sievert
authors.forename: Natalie
authors.initials: N
authors.lastname: Bzowej
authors.forename: George
authors.initials: G
authors.lastname: Harb
authors.forename: Ralf
authors.initials: R
authors.lastname: Kaiser
authors.forename: Xin-Jian
authors.initials: XJ
authors.lastname: Qiao
authors.forename: Nathaniel A
authors.initials: NA
authors.lastname: Brown
mesh_terms: D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood*; 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; D009705:Nucleosides / Q000009:adverse effects / Q000627:therapeutic use*; D063065:Organophosphonates / Q000009:adverse effects / Q000627:therapeutic use*; D011744:Pyrimidinones / Q000009:adverse effects / Q000627:therapeutic use*; D000077712:Telbivudine; D013936:Thymidine / Q000031:analogs & derivatives; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D009705:Nucleosides; D063065:Organophosphonates; D011744:Pyrimidinones; D000077712:Telbivudine; D000225:Adenine; C106812:adefovir dipivoxil; D013936:Thymidine