Long-Term Treatment Efficacy and Safety of Clevudine Therapy in Naive Patients with Chronic Hepatitis B.
- Author:
Bum Su CHOUNG
1
;
In Hee KIM
;
Byung Jun JEON
;
Seok LEE
;
Seong Hun KIM
;
Sang Wook KIM
;
Seung Ok LEE
;
Soo Teik LEE
;
Dae Ghon KIM
Author Information
1. Department of Internal Medicine, Research Institute of Clinical Medicine, Chonbuk National University Hospital, Chonbuk National University Medical School, Jeonju, Korea. ihkimmd@jbnu.ac.kr
- Publication Type:Original Article
- Keywords:
Chronic hepatitis B;
2'-Fluoro-5-methylarabinosyluracil;
Viral breakthrough;
Muscular diseases
- MeSH:
Alanine Transaminase;
Antiviral Agents;
Arabinofuranosyluracil;
DNA;
Follow-Up Studies;
Hepatitis B;
Hepatitis B e Antigens;
Hepatitis B virus;
Hepatitis B, Chronic;
Hepatitis, Chronic;
Humans;
Muscular Diseases;
Retrospective Studies;
Treatment Outcome;
Viruses
- From:Gut and Liver
2012;6(4):486-492
- CountryRepublic of Korea
- Language:English
-
Abstract:
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 > or =6 log10 IU/mL (p=0.032) and detectable serum HBV DNA (> or =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.
