Clevudine Demonstrates Potent Antiviral Activity in Naive Chronic Hepatitis B Patients
- Authors
- Lee, June Sung; Park, Eun Taek; Kang, Seung Sik; Gu, Eun Sil; Kim, Jong Sun; Jang, Dong Seob; Lee, Kyoung Seog; Lee, Jae-Su; Park, Nung Hwa; Bae, Chang Hwang; Baik, Soon Koo; Yu, Byeong Jeon; Lee, Soon Hyung; Lee, Eun Jong; Park, Sung Il; Bae, Myoung; Shin, Jung Woo; Choi, Jae Hong; Gu, Chul; Moon, Sin Kil; Chun, Gab Jin; Kim, Ju Hyun; Kim, Hong Soo; Choi, Sung-Kyu
- Issue Date
- 2010
- Publisher
- S. Karger AG
- Keywords
- Hepatitis B virus; Post marketing surveillance; Viral replication; Viral breakthrough; Clevudine
- Citation
- Intervirology, v.53, no.2, pp 83 - 86
- Pages
- 4
- Journal Title
- Intervirology
- Volume
- 53
- Number
- 2
- Start Page
- 83
- End Page
- 86
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/18579
- DOI
- 10.1159/000264197
- ISSN
- 0300-5526
1423-0100
- Abstract
- Objectives: Clevudine has demonstrated antiviral potency in the treatment of naive chronic hepatitis B patients in pivotal studies. The objectives of this study were to evaluate the safety and efficacy of a 1-year treatment with clevudine in chronic hepatitis B patients. Methods: This is a post-marketing surveillance using case report forms which were submitted to the health authorities. Results: Analysis of individual data showed that hepatitis B virus (HBV) DNA after a 1-year treatment was <141,500 copies/ml in 96% of hepatitis B e antigen ( HBeAg)-positive and 100% of HBeAg-negative patients. The proportion of patients with HBV DNA <2,000 copies/ml after a 1-year treatment was 74%: 71% of HBeAg-positive and 93% of HBeAg-negative patients. Most of the patients with HBV DNA below the detection limit with each assay at week 24 showed sustained viral suppression up to week 48. The proportion of patients who showed normal alanine aminotransferase at week 48 was 86% in HBeAg-positive patients and 87% in HBeAg-negative patients. The rates of HBeAg-loss were 21%. Two patients showed viral breakthrough during treatment. Conclusion: Clevudine monotherapy demonstrates potent antiviral activity as well as biochemical and serological response with a 0.7% rate of viral breakthrough in naive chronic hepatitis B patients. Copyright (C) 2009 S. Karger AG, Basel
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