title: Long-term treatment efficacy and safety of clevudine therapy in naïve patients with chronic hepatitis B.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  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 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Internal Medicine, Research Institute of Clinical Medicine, Chonbuk National University Hospital, Chonbuk National University Medical School, Jeonju, Korea.
authors.forename: Bum Su
authors.initials: BS
authors.lastname: Choung
authors.forename: In Hee
authors.initials: IH
authors.lastname: Kim
authors.forename: Byung Jun
authors.initials: BJ
authors.lastname: Jeon
authors.forename: Seok
authors.initials: S
authors.lastname: Lee
authors.forename: Seong Hun
authors.initials: SH
authors.lastname: Kim
authors.forename: Sang Wook
authors.initials: SW
authors.lastname: Kim
authors.forename: Seung Ok
authors.initials: SO
authors.lastname: Lee
authors.forename: Soo Teik
authors.initials: ST
authors.lastname: Lee
authors.forename: Dae-Ghon
authors.initials: DG
authors.lastname: Kim