Comparison of the antiviral effects of entecavir and adefovir dipivoxil in chronic HBV infection: a randomized control trial.

AIMS: The purpose of this study is to compare the antiviral efficacy of entecavir (ETV) and adefovir dipivoxil (ADV) at various time points during the treatment. METHODS: A randomized, controlled, open-label study was designed to analyze the kinetics of HBeAg seroconversion, HBV DNA level, and liver and renal functions in 72 ETV-treated chronic hepatitis B (CHB) patients and 66 ADV-treated CHB patients. The data was collected every 12 weeks up to 96 weeks after drug administration. RESULTS: The negative rate of HBeAg seroconversion was significantly increased at 24 weeks in ETV-treated patients, whereas in ADV-treated patients, these changes were not significant. The serum HBV DNA levels were significantly decreased from 24 weeks in both ETV- and ADV-treated patients. Other than ETV showing significantly decreased levels of HBV DNA at 24 weeks when compared with ADV, there was no difference in virological response between two treatments at any other time points. The serum alanine aminotransferase (ALT) and total bilirubin (TBIL) levels were significantly decreased 12 weeks after either ETV- or ADV-treated patients without differences between two treatments. The urea nitrogen levels were in normal range and there was no difference between two groups. CONCLUSIONS: Our study suggested that both ETV and ADV could be used as monotherapy for nucleotide-naive patients, but ETV has displayed potential efficacy in HBeAg seroconversion.