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KMID : 1188320120060040486
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Gut and Liver
2012 Volume.6 No. 4 p.486 ~ p.492
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Long-Term Treatment Efficacy and Safety of Clevudine Therapy in Naive Patients with Chronic Hepatitis B
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Choung Bum-Su
Kim In-Hee
Jeon Byung-Jun
Lee Seok
Kim Seong-Hun
Kim Sang-Wook
Lee Seung-Ok
Lee Soo-Teik
Kim Dae-Ghon
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Abstract
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Background/Aims:Clevudine (CLV) has potent antiviral activity against chronic hepatitis B (CHB) virus infection. The long-term efficacy and safety of CLV therapy in naive patients with CHB were investigated.
Methods:In this retrospective study, 152 naive Korean patients with CHB who received 30 mg of CLV once daily for at least 12 months were investigated.
Results: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 log10 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.
Conclusions:The results of long-term CLV therapy for the treatment of naive 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 naive patients given the availability of other more potent, safer antiviral agents.
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KEYWORD
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Chronic hepatitis B, 2'-Fluoro-5-methylarabinosyluracil, Viral breakthrough, Muscular diseases
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