title: [A clinical study of adefovir dipivoxil, made in China, for treatment of hepatitis B e antigen-positive patients with chronic hepatitis B].
abstract: OBJECTIVE
  To evaluate the efficacy and safety of a China made adefovir dipivoxil (ADV) treatment for hepatitis B e antigen-positive patients with chronic hepatitis B.
  
  
  METHODS
  Two hundred and thirty patients with chronic hepatitis B who were positive for hepatitis B e antigen (HBeAg) were randomly put into groups A or B, and 58 patients with lamivudine-resistant chronic hepatitis B were randomly put into groups C or D. During the first 12 weeks of the trial, 112 patients in group A and 115 patients in group B received 10 mg of ADV and a placebo once a day; 28 patients in group C received 100 mg of lamivudine (LMV) and 10 mg of ADV; 29 patients in group D received 100 mg of LMV and a placebo once a day. In the second trial period, all patients received ADV for 36 weeks. The primary checking criterion was the serum HBV DNA change during the treatment. The secondary ones were alanine aminotransferase (ALT) normalization, HBeAg loss, and HBeAg seroconversion.
  
  
  RESULTS
  At week 12, the median serum hepatitis B virus (HBV) DNA level of group A (ADV-ADV) was reduced 2.8 log10 copies/ml, significantly greater than that of group B (placebo-ADV) of 0.3 log10 copies/ml reduction (P = 0.000). At week 48, the median serum HBV DNA level of group A and group B were reduced 3.6 and 3.4 log10 copies/ml respectively. At week 12, the median serum HBV DNA level of group C (LMV+ADV) was reduced 3.0 log10 copies/ml, significantly greater than that of the group D (LMV+placebo) of 0.16 log10 copies/ml reduction (P = 0.000). At week 48, the median serum HBV DNA level of group C and group D were reduced 3.6 and 3.8 log10 copies/ml respectively. Only 5.56% (16/288) patients had adverse events that were mild to moderate. There was no significant difference in the change of serum creatinine compared with their baseline levels.
  
  
  CONCLUSIONS
  In our HBeAg positive lamivudine-resistant chronic hepatitis B patients, 48 weeks of ADV treatment was safe and resulted in significant virological and biochemical improvements.
authors.affiliation: Department of Infectious Diseases, First Hospital of Beijing University, Beijing 100034, China.
authors.forename: Xiao-Hong
authors.initials: XH
authors.lastname: Lin
authors.forename: Chong-Wen
authors.initials: CW
authors.lastname: Si
authors.forename: Yan-Yan
authors.initials: YY
authors.lastname: Yu
authors.forename: Jun
authors.initials: J
authors.lastname: Li
authors.forename: Xin-Yue
authors.initials: XY
authors.lastname: Chen
authors.forename: Xi-Min
authors.initials: XM
authors.lastname: Ren
authors.forename: Pei
authors.initials: P
authors.lastname: Liu
authors.forename: Shu-Lin
authors.initials: SL
authors.lastname: Zhang
authors.forename: Xiao-Ping
authors.initials: XP
authors.lastname: Kang
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D024882:Drug Resistance, Viral; D006513:Hepatitis B e Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D008875:Middle Aged; D009154:Mutation; D063065:Organophosphonates / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D006513:Hepatitis B e Antigens; D063065:Organophosphonates; D000225:Adenine; C106812:adefovir dipivoxil