Original Article

Hepatology International

, Volume 5, Issue 2, pp 664-670

A comparison of 48-week treatment efficacy between clevudine and entecavir in treatment-naïve patients with chronic hepatitis B

  • Su Rin ShinAffiliated withDepartment of Medicine, Kangnam Sacred Heart Hospital, Hallym University
  • , Byung Chul YooAffiliated withDepartment of Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine Email author 
  • , Moon Seok ChoiAffiliated withDepartment of Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine
  • , Dong Ho LeeAffiliated withDigestive Disease Research Centre, Samsung Medical Centre
  • , Soon Mi SongAffiliated withDigestive Disease Research Centre, Samsung Medical Centre
  • , Joon Hyoek LeeAffiliated withDepartment of Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine
  • , Kwang Cheol KohAffiliated withDepartment of Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine
  • , Seung Woon PaikAffiliated withDepartment of Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine

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Abstract

Purpose

Clevudine and entecavir are currently available in Korea as antiviral drugs against chronic hepatitis B (CHB). We aimed to compare the efficacy of clevudine and entecavir therapy.

Methods

Treatment-naïve CHB patients who received 30 mg of clevudine or 0.5 mg of entecavir a day were analyzed. Mean reduction of hepatitis B virus (HBV) DNA levels, complete virological response (cVR, undetectable HBV DNA by real-time PCR), biochemical response (recovery to normal ALT level), and hepatitis B e antigen (HBeAg) seroconversion rate at the 48th week of treatment were assessed.

Results

A number of 59 patients in clevudine group and 61 patients in entecavir group were included. Mean HBV DNA reductions from baseline were similar in the clevudine and entecavir groups, −6.4 versus −6.8 log10 copies/mL in HBeAg-positive (p = 0.417) and −6.9 versus −7.0 log10 copies/mL in HBeAg-negative patients (p = 0.640). The proportion of patients who achieved cVR was not different between the two groups, 53 versus 55% in HBeAg-positive (p = 1.000) and 100 versus 95% in HBeAg-negative patients (p = 0.452). Biochemical response rates and HBeAg seroconversion rates were also similar in both the groups. Two (3.4%) patients in clevudine group showed virologic breakthrough with rtM204I mutation using direct sequencing analysis. Clinical myopathy occurred in two (3.4%) patients in clevudine group.

Conclusion

Mean reduction of viral loads was similar between clevudine and entecavir groups during 48 weeks. However, virologic breakthrough and significant myopathy were noted only in clevudine-treated patients. Therefore, more attention should be paid to patients receiving clevudine.

Keywords

Hepatitis B virus Clevudine Entecavir