Article first published online: 23 JUL 2007
Copyright © 2007 American Association for the Study of Liver Diseases
Volume 46, Issue 4, pages 1041–1048, October 2007
How to Cite
Yoo, B. C., Kim, J. H., Kim, T.-H., Koh, K. C., Um, S.-H., Kim, Y. S., Lee, K. S., Han, B. H., Chon, C. Y., Han, J.-Y., Ryu, S. H., Kim, H. C., Byun, K. S., Hwang, S. G., Kim, B.-I., Cho, M., Yoo, K., Lee, H.-J., Hwang, J. S., Kim, Y. S., Lee, Y.-S., Choi, S.-K., Lee, Y.-J., Yang, J.-M., Park, J.-W., Lee, M.-S., Kim, D.-G., Chung, Y.-H., Cho, S.-H., Choi, J.-Y., Kweon, Y.-O., Lee, H. Y., Jeong, S.-H., Yoo, H.-W. and 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: 1041–1048. doi: 10.1002/hep.21800
NIH clinical trial registration number: NCT00313274.
Potential conflict of interest: Nothing to report.
- Issue published online: 25 SEP 2007
- Article first published online: 23 JUL 2007
- Manuscript Accepted: 10 APR 2007
- Manuscript Received: 11 JAN 2007
- Bukwang Pharmaceutical Co. Ltd.
- Korea Health 21 R&D Project, Ministry of Health & Welfare, Republic of Korea. Grant Number: 02-PJ2-PG4-PT01-0034
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. (HEPATOLOGY 2007.)