title: [Analysis of a randomized, double-blind, double-dummy, controlled, multicenter study confirmed the similar therapeutic efficacies of entecavir maleate and entecavir for treatment of HBeAg-positive chronic hepatitis B].
abstract: OBJECTIVE
  To evaluate the efficacy and safety of entecavir maleate (ETV) versus ETV in Chinese patients with hepatitis B e antigen(HBeAg)-positive chronic hepatitis B(CHB).
  
  
  METHODS
  The patient population of this previously published randomized, double-blind, double-dummy, controlled, multicenter study was expanded by patients in the 0.5 mg/day ETV maleate group (total n = 110) and patients in the 0.5 mg/day ETV group (total n = 108). At treatment weeks 12, 24 and 48, hepatitis B virus (HBV) DNA levels were measured by the Roche Cobas Ampliprep/Cobas Taqman PCR assay. Adverse events (AE) were recorded.
  
  
  RESULTS
  As in the original analysis, the two treatment groups showed similar characteristics at baseline. In addition, the results for the all therapeutic effects showed identical trends to the results obtained in the original analysis, including the statistically similar effects of ETV and ETV maleate treatment-induced decreases in mean HBV DNA level at weeks 12, 24, and 48 (ETV: by 4.28, 5.00, and 5.53 log10 IU/ml vs. ETV maleate: by 4.46, 4.99, and 5.51 log10 IU/ml, respectively; all vs. baseline P more than 0.05), achievement of undetectable levels of serum HBV DNA ( less than 20 IU/ml) at week 48 (ETV: 38.18% vs. ETV maleate: 35.19%; P more than 0.05), HBeAg loss rates at week 48 (ETV: 10.91% vs. ETV maleate: 12.96%; P more than 0.05), HBeAg seroconversion rates at week 48 (ETV: 7.77% vs. ETV maleate: 10.38%; P more than 0.05), normalization of alanine aminotransferase at week 48 (ETV: 75.47% vs. ETV maleate: 82.86%; P more than 0.05), and overall incidence of AE (ETV: 18.02% vs. ETV maleate: 17.43%; P more than 0.05).
  
  
  CONCLUSIONS
  Performing analysis of the therapeutic efficacies of entecavir maleate versus entecavir with a larger study population confirmed our original findings of similar efficacy and safety profiles for these two drugs in patients with HBeAg-positive CHB.
authors.affiliation: Department of Infectious Diseases, Peking University First Hospital, Beijing 100034, China.
authors.forename: Jing-hang
authors.initials: JH
authors.lastname: Xu
authors.forename: Yan-yan
authors.initials: YY
authors.lastname: Yu
authors.forename: Chong-wen
authors.initials: CW
authors.lastname: Si
authors.forename: Zheng
authors.initials: Z
authors.lastname: Zeng
authors.forename: Jun
authors.initials: J
authors.lastname: Li
authors.forename: Qing
authors.initials: Q
authors.lastname: Mao
authors.forename: Da-zhi
authors.initials: DZ
authors.lastname: Zhang
authors.forename: Hong
authors.initials: H
authors.lastname: Tang
authors.forename: Ji-fang
authors.initials: JF
authors.lastname: Sheng
authors.forename: Xin-yue
authors.initials: XY
authors.lastname: Chen
authors.forename: Qin
authors.initials: Q
authors.lastname: Ning
authors.forename: Guang-feng
authors.initials: GF
authors.lastname: Shi
authors.forename: Qing
authors.initials: Q
authors.lastname: Xie
authors.forename: Xi-quan
authors.initials: XQ
authors.lastname: Zhang
authors.forename: Jun
authors.initials: J
authors.lastname: Dai
authors.forename: Zhong-nan
authors.initials: ZN
authors.lastname: Xu
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006147:Guanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006513:Hepatitis B e Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D008297:Male; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D006513:Hepatitis B e Antigens; C413685:entecavir; D006147:Guanine