Gut Liver.
2012 Oct;6(4):486-492.
Long-Term Treatment Efficacy and Safety of Clevudine Therapy in Naive Patients with Chronic Hepatitis B
- Affiliations
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- 1Department of Internal Medicine, Research Institute of Clinical Medicine, Chonbuk National University Hospital, Chonbuk National University Medical School, Jeonju, Korea. ihkimmd@jbnu.ac.kr
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.
Keyword
MeSH Terms
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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
Alanine Transaminase
Antiviral Agents
Arabinofuranosyluracil
DNA
Hepatitis B e Antigens
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