[A clinical study of adefovir dipivoxil, made in China, for treatment of hepatitis B e antigen-positive patients with chronic hepatitis B].
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.
Lin
Xiao-Hong
XH
Department of Infectious Diseases, First Hospital of Beijing University, Beijing 100034, China.
Si
Chong-Wen
CW
Yu
Yan-Yan
YY
Li
Jun
J
Chen
Xin-Yue
XY
Ren
Xi-Min
XM
Liu
Pei
P
Zhang
Shu-Lin
SL
Kang
Xiao-Ping
XP
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
D000998:Antiviral Agents; D006513:Hepatitis B e Antigens; D063065:Organophosphonates; D000225:Adenine; C106812:adefovir dipivoxil