A randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis B patients

Won Young Tak, Jin Mo Yang, Byung Ik Kim, Soon Koo Baik, Gab Jin Cheon, Kwan Soo Byun, Do Young Kim, Byung Chul Yoo

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Purpose: 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. Conclusion: 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.

Original languageEnglish
Pages (from-to)375-381
Number of pages7
JournalHepatology International
Volume8
Issue number3
DOIs
Publication statusPublished - 2014 Jan 1

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Chronic Hepatitis B
Therapeutics
Antiviral Agents
Clevudine
adefovir
Myalgia
Muscle Weakness
Muscular Diseases
Alanine Transaminase
Hepatitis B virus

Keywords

  • Adefovir
  • Clevudine
  • Combination therapy
  • Hepatitis B virus
  • Resistance
  • Viral kinetics

ASJC Scopus subject areas

  • Hepatology

Cite this

A randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis B patients. / Tak, Won Young; Yang, Jin Mo; Kim, Byung Ik; Baik, Soon Koo; Cheon, Gab Jin; Byun, Kwan Soo; Kim, Do Young; Yoo, Byung Chul.

In: Hepatology International, Vol. 8, No. 3, 01.01.2014, p. 375-381.

Research output: Contribution to journalArticle

Tak, Won Young ; Yang, Jin Mo ; Kim, Byung Ik ; Baik, Soon Koo ; Cheon, Gab Jin ; Byun, Kwan Soo ; Kim, Do Young ; Yoo, Byung Chul. / A randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis B patients. In: Hepatology International. 2014 ; Vol. 8, No. 3. pp. 375-381.
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abstract = "Purpose: 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. Conclusion: 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.",
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AU - Tak, Won Young

AU - Yang, Jin Mo

AU - Kim, Byung Ik

AU - Baik, Soon Koo

AU - Cheon, Gab Jin

AU - Byun, Kwan Soo

AU - Kim, Do Young

AU - Yoo, Byung Chul

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AB - Purpose: 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. Conclusion: 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.

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KW - Clevudine

KW - Combination therapy

KW - Hepatitis B virus

KW - Resistance

KW - Viral kinetics

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