Clevudine is highly efficacious in hepatitis B e antigen-negative chronic hepatitis B with durable off-therapy viral suppression

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

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Abstract

Clevudine is a pyrimidine analog with potent and sustained antiviral activity against HBV. In the present study, we evaluated the safety and efficacy of clevudine 30 mg daily for 24 weeks and assessed the durability of antiviral response for 24 weeks after cessation of dosing in hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (e-CHB). We randomized a total of 86 patients (3:1) to receive clevudine 30 mg (n = 63) or placebo (n = 23) daily for 24 weeks. We followed patients for an additional 24 weeks after withdrawal of treatment. The median changes in HBV DNA from baseline were -4.25 and -0.48 log10 copies/mL at week 24 in the clevudine and placebo groups, respectively (P < 0.0001). Viral suppression in the clevudine group was sustained after withdrawal of therapy, with 3.11 log10 reduction at week 48. At week 24 and week 48, 92.1% and 16.4% of patients in the clevudine group had undetectable serum HBV DNA levels by Amplicor PCR assay (<300 copies/mL). The proportion of patients who achieved ALT normalization was 74.6% and 33.3% in the clevudine and placebo groups at week 24, respectively (P = 0.0006). ALT normalization in the clevudine group was well-maintained during the post-treatment follow-up period. The incidence of adverse events was similar in the 2 groups. No resistance to clevudine was detected during treatment. Conclusion: A 24-week clevudine therapy was well-tolerated and showed potent and sustained antiviral effect without evidence of viral resistance in e-CHB patients. However, treatment for longer than 24 weeks would be needed to achieve durable remission.

Original languageEnglish
Pages (from-to)1041-1048
Number of pages8
JournalHepatology
Volume46
Issue number4
DOIs
Publication statusPublished - 2007 Oct 1

ASJC Scopus subject areas

  • Hepatology

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    Byung, C. Y., Ju, H. K., Kim, T. H., Kwang, C. K., Um, S. H., Young, S. K., Kwan, S. L., Byung, H. H., Chae, Y. C., Han, J. Y., Soo, H. R., Haak, C. K., Kwan, S. B., Seong, G. H., Kim, B. I., Cho, M., Yoo, K., Lee, H. J., Jae, S. H., ... Lee, H. S. (2007). Clevudine is highly efficacious in hepatitis B e antigen-negative chronic hepatitis B with durable off-therapy viral suppression. Hepatology, 46(4), 1041-1048. https://doi.org/10.1002/hep.21800