%0 Journal Article
%T Long-term treatment efficacy and safety of clevudine therapy in naïve patients with chronic hepatitis B.
%A Choung BS
%A Kim IH
%A Jeon BJ
%A Lee S
%A Kim SH
%A Kim SW
%A Lee SO
%A Lee ST
%A Kim DG
%J Gut Liver
%V 6
%N 4
%D Oct 2012
%M 23170155
%F 4.321
%R 10.5009/gnl.2012.6.4.486
%X <B>OBJECTIVE: </B>Clevudine (CLV) has potent antiviral activity against chronic hepatitis B (CHB) virus infection. The long-term efficacy and safety of CLV therapy in naïve patients with CHB were investigated.<BR><B>METHODS: </B>In this retrospective study, 152 naïve Korean patients with CHB who received 30 mg of CLV once daily for at least 12 months were investigated.<BR><B>RESULTS: </B>The cumulative rates at months 12, 24, and 36, respectively, were 65.8%, 74.7%, and 74.7% for undetectable serum hepatitis B virus (HBV) DNA (<12 IU/mL); 77.6%, 86.2%, and 86.2% for normalization of serum alanine aminotransferase (<40 IU/L); 17.6%, 23.5%, and 23.5% for hepatitis B e antigen (HBeAg) loss or seroconversion; and 6.6%, 22.5%, and 30.0% for viral breakthrough. HBeAg positivity (p=0.010), baseline serum HBV DNA level ≥6 log(10) IU/mL (p=0.032) and detectable serum HBV DNA (≥12 IU/mL) at week 24 (p=0.023) were independently associated with the development of viral breakthrough. During follow-up, CLV-induced myopathy developed in 5.9% of patients.<BR><B>CONCLUSIONS: </B>The results of long-term CLV therapy for the treatment of naïve patients with CHB showed a high frequency of antiviral resistance and substantial associated myopathy. Therefore, we advise that CLV should not be used as a first-line treatment for naïve patients given the availability of other more potent, safer antiviral agents.