title: A randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis B patients.
abstract: OBJECTIVE
  Clevudine 30 mg showed potent antiviral activity with a marked post-treatment antiviral effect. However, long-term treatment with clevudine monotherapy induced resistance and myopathy in some cases. The objective of this study is to evaluate the preliminary efficacy and safety of the combination of clevudine 20 mg and adefovir compared to clevudine monotherapy.
  
  
  METHODS
  Seventy-four patients were randomized to either a combination of clevudine 20 mg and adefovir or clevudine 20 or 30 mg and were treated for 2 years. The viral kinetics for 24 weeks, virological response [VR; hepatitis B virus (HBV) DNA less than 300 copies/ml], and the biochemical response [BR; normal alanine aminotransferase (ALT)] were assessed.
  
  
  RESULTS
  There was no difference in baseline characteristics among the three groups. Viral kinetics study showed no statistically significant difference among them during 24 weeks. The combination group showed 95 % virological response with a statistically significant difference compared to the clevudine 30 mg (67 %) and 20 mg (71 %) groups (p = 0.0376). Biochemical response rates were similar in all groups (78-94 %). No resistance was reported in the combination group, while 20 % of patients treated with clevudine 30 mg or 20 mg reported resistance during 2 years. Muscle-related symptoms such as myalgia (1 in clevudine 30 mg, 1 in the combination group) and muscle weakness (1 in clevudine 30 mg, 2 in clevudine 20 mg) were reported in five patients (7 %); of these, three patients discontinued the study.
  
  
  CONCLUSIONS
  We concluded that the combination of clevudine 20 mg and adefovir produced a potent antiviral response together with a good resistance profile compared to clevudine monotherapy at 96 weeks in this pilot study.
authors.affiliation: Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Republic of Korea.
authors.forename: Won Young
authors.initials: WY
authors.lastname: Tak
authors.affiliation: Department of Internal Medicine, The Catholic University Medical College St. Vincent's Hospital, Suwon, Republic of Korea.
authors.forename: Jin Mo
authors.initials: JM
authors.lastname: Yang
authors.affiliation: Division of Gastroenterology and Hepatology, Kangbook Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Byung Ik
authors.initials: BI
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea.
authors.forename: Soon Koo
authors.initials: SK
authors.lastname: Baik
authors.affiliation: Department of Internal Medicine, GangNeung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Republic of Korea.
authors.forename: Gab Jin
authors.initials: GJ
authors.lastname: Cheon
authors.affiliation: Department of Internal Medicine, Korea University Guro Hospital, Seoul, Republic of Korea.
authors.forename: Kwan Soo
authors.initials: KS
authors.lastname: Byun
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Do Young
authors.initials: DY
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Byung Chul
authors.initials: BC
authors.lastname: Yoo
keywords: Adefovir; Clevudine; Combination therapy; Hepatitis B virus; Resistance; Viral kinetics
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