The Clinic's Design And Execution Of Adefovir Dipivoxil In The Treatment Of Chinese Patients With Hepatitis B

BACKGROUND AND AIMS Adefovir Dipivoxil is a new medicine for patients infected with hepatitis B virus(HBV). Adefovir Dipivoxil is more convenient for patients to take because of its long half life in vivo and it is effective to those viruses which are resistant to lamivudine.The aim to this randomized,controlang double-blind clinic trial is to determine the efficacy and safety of Adefovir Dipivoxil in treating patients with chronic hepatitis B. METHOD 240 patients are randomized to receive 10 mg Adefovir Dipivoxil per day(160 patients,Group A) or placebo(80 patients,Group B) for 12 weeks.During the following 24 weeks all of the 240 patients receive 10 mg Adefovir Dipivoxil per day.During the last 12 weeks, the patients in Group A are randomized to receive 10 mg Adefovir Dipivoxil per day(120 patients) or placebo(40 patients),the patients in Group B receive 10 mg Adefovir Dipivoxil per day.The efficacy of Adefovir Dipivoxil was assessed by the change levels of HBV DNA and ALT of serum.The safety of Adefovir Dipivoxil was evaluated by analysis of the type and severity of adverse effects. RESULTS There are no serious adverse effects related to Adefovir Dipivoxiltherapy.24 cases are observed in our study, 16 cases are in Group A and 8cases are in Group B,l cases in Group B was shedding.At the end of 12weeks,thers is significant difference in the drop of HBV DNA levels betweenthe two groups P<0.001.13 patients in Group A and 1 cases in Group B havethe HBV DNA level below 105 copys or dropped more than 21oglO contrastwith the initial HBV DNA level,the difference is significant (P<0.001) .Thedifference of ALT level change and disappearance of HBV DNA betweenthe two groups is no signifcant (P>0.05) .CONCLUSION Adefovir Dipivoxil is effective and safe in treating patientswith hepatitis B.