Forty-eight weeks treatment with clevudine and adefovir for chronic hepatitis B infection：a double-blind randomized study

Abstract:

Objective：To compare the efficacy and safety of clevudine（CLV） and adefovir（ADV） treatment for chronic hepatitis B patients（CHB）. Methods：Totally 18 CHB patients enrolled from our hospital between April and May 2010 were treated with daily dose of CLV 30 mg（n=9，experiment group） or ADV 10 mg（n=9，control group） randomly for at least 48 weeks. Liver and renal functions were tested；serum HBV DNA and HBV markers were detected for all patients before treatment at the 4th，8th，12th，24th，36th and the 48th week during treatment，respectively. Adverse drug reactions were observed. Results：At the 48th week during treatment，me－dian log10 HBV DNA in two groups were 2.081±0.228 and 3.017±1.578，respectively（P=0.115）. Partial virological response rates were similar（88.89%） in the two groups（P=1.000）. Complete virological response rates were 77.78 and 66.67% in experimental and con－trol groups（P=1.000）. Normalization rates of alanine aminotransferase were 66.67 and 77.78% in experimental and control groups（P=1.000）. HBeAg seroconversion rates were 33.33% and 0.00% in experimental and control groups（P >0.05）. One patient in experi－ment group showed virologic breakthrough with rtL180M and rtM204I mutation at the 47th week during follow-up. Conclusions：CLV showed potent antiviral activity for CHB patients；its safety is similar to ADV.