| Objective:To compare the efficacy and safety of Clevudine(CLV) andadefovir(ADV) treatment for the chronic hepatitis B patients（CHB）.Methods:18CHB patients were treated with daily dose of CLV30mg(9patients) or ADV10mg(9patients) randomly for at least48weeks.Patients were followed for an additional48weeks after cessation of dosingin the two groups. Liver and renal functions were tested, serum HBV DNA,hepatitis B viral markers and serum ALT level were detected beforetreatment and at weeks4,8,12,24,36,48,60,72,84,96,respectively. Clinicalefficacy, adverse drug reactions and genotypic resistance were analyzed.Results: At weeks48,8patients in CLV group and9patients in ADVgroup were included for analysis. The mean changes in serum HBV DNAfrom baseline at weeks48in the CLV and ADV groups were-4.157and-3.746log10IU/ml, respectively(P>0.05).The proportion of patients whoachieved complete virological response was not different in the twogroups,87.50%versus66.67%(P>0.05).Viral suppression in the two groups were sustained after withdrawal of treatment. At weeks96,thereduction of serum mean HBV DNA in the CLV group was4.002log10IU/ml and3.757log10IU/ml in the ADV group(P>0.05), and87.50%ofpatients in the CLV group and66.67%of patients in the ADV group hadundetectable HBV DNA levels by Amplicor PCR assay(<100IU/ml)(P>0.05).At weeks48, normalization of ALT had no significant difference intwo groups,75.00versus77.78%(P>0.05). ALT normalization in twogroups were well-maintained during the post-treatment follow-up. Atweeks48,one patient in the clevudine group developed HBeAgseroconversion, while no patient in adefovir group. One patient inclevudine group showed virologic breakthrough with rtL180M,rtM204Imutation.Conclusion: Clevudine showed potent antiviral activity and sustainedantiviral effect after cessation of therapy in CHB patients. The safety ofclevudine is similar to that of adefovir. |
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