Twenty-four-week clevudine therapy showed potent and sustained antiviral activity in HBeAg-positive chronic hepatitis B

Chul Yoo Byung, Hyun Kim Ju, Young Hwa Chung, Sik Lee Kwan, Woon Paik Seung, Hyung Ryu Soo, Hoon Han Byung, Joon Yeol Han, Kwan Soo Byun, Mong Cho, Heon Ju Lee, Tae Hun Kim, Se Hyun Cho, Joong Won Park, Soon-Ho Um, Gyu Hwang Seong, Soo Kim Young, Youn Jae Lee, Yoon Chon Chae, Byung Ik KimYoung Suk Lee, Jin Mo Yang, Cheoul Kim Haak, Seok Hwang Jae, Sung Kyu Choi, Young Oh Kweon, Sook Hyang Jeong, Myung Seok Lee, Jong Young Choi, Dae Ghon Kim, Soo Kim Yun, Young Lee Heon, Kwon Yoo, Hee Won Yoo, Hyo Suk Lee

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Abstract

Clevudine is a pyrimidine analogue with potent and sustained antiviral activity against HBV. The present study evaluated the safety and efficacy of 30 mg clevudine once daily for 24 weeks and assessed the durable antiviral response for 24 weeks after cessation of dosing. A total of 243 hepatitis B e antigen (HBeAg)-positive chronic hepatitis B patients were randomized (3:1) to receive clevudine 30 mg once daily (n = 182) or placebo (n = 61) for 24 weeks. Patients were followed for a further 24 weeks off therapy. Median serum HBV DNA reductions from baseline at week 24 were 5.10 and 0.27 log10 copies/mL in the clevudine and placebo groups, respectively (P < 0.0001). Viral suppression in the clevudine group was sustained off therapy, with 3.73 log10 reduction at week 34 and 2.02 log10 reduction at week 48. At week 24, 59.0% of patients in the clevudine group had undetectable serum HBV DNA levels by Amplicor PCR assay (less than 300 copies/mL). The proportion of patients who achieved normalization of alanine aminotransferase (ALT) levels was 68.2% in the clevudine group and 17.5% in the placebo group at week 24 (P < 0.0001). ALT normalization in the clevudine group was well maintained during post-treatment follow-up period. The incidence of adverse events (AEs) was similar between the clevudine group and the placebo group. No resistance to clevudine was detected with 24 weeks of administration of drug. Conclusion: A 24-week clevudine therapy was well tolerated and showed potent and sustained antiviral effect without evidence of viral resistance during treatment period in HBeAg-positive chronic hepatitis B.

Original languageEnglish
Pages (from-to)1172-1178
Number of pages7
JournalHepatology
Volume45
Issue number5
DOIs
Publication statusPublished - 2007 May 1

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ASJC Scopus subject areas

  • Hepatology

Cite this

Byung, C. Y., Ju, H. K., Chung, Y. H., Kwan, S. L., Seung, W. P., Soo, H. R., Byung, H. H., Han, J. Y., Byun, K. S., Cho, M., Lee, H. J., Kim, T. H., Cho, S. H., Park, J. W., Um, S-H., Seong, G. H., Young, S. K., Lee, Y. J., Chae, Y. C., ... Lee, H. S. (2007). Twenty-four-week clevudine therapy showed potent and sustained antiviral activity in HBeAg-positive chronic hepatitis B. Hepatology, 45(5), 1172-1178. https://doi.org/10.1002/hep.21629