Clevudine demonstrates potent antiviral activity in naïve chronic hepatitis B patients.

Abstract

OBJECTIVES:

Clevudine has demonstrated antiviral potency in the treatment of naïve 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 naïve chronic hepatitis B patients.

• Authors: June Sung Lee, Eun Taek Park, Seung Sik Kang, Eun Sil Gu, Jong Sun Kim, Dong Seob Jang, Kyoung Seog Lee, Jae-Su Lee, Nung Hwa Park, Chang Hwang Bae, Soon Koo Baik, Byeong Jeon Yu, Soon Hyung Lee, Eun Jong Lee, Sung Il Park, Myoung Bae, Jung Woo Shin, Jae Hong Choi, Chul Gu, Sin Kil Moon, Gab Jin Chun, Ju Hyun Kim, Hong Soo Kim, Sung-Kyu Choi
• Journal: Intervirology (Intervirology) Vol. 53 Issue 2 Pg. 83-6 ( 2010) ISSN: 1423-0100 [Electronic] Switzerland
• PMID: 19955812 (Publication Type: Clinical Trial, Phase IV, Journal Article)
• Copyright: Copyright 2009 S. Karger AG, Basel.

Chemical References

• Antiviral Agents
• Hepatitis B Surface Antigens
• Hepatitis B e Antigens
• Arabinofuranosyluracil
• Alanine Transaminase
• clevudine

Topics

• Alanine Transaminase (blood)
• Antiviral Agents (adverse effects, therapeutic use)
• Arabinofuranosyluracil (adverse effects, analogs & derivatives, therapeutic use)
• Hepatitis B Surface Antigens (blood)
• Hepatitis B e Antigens (blood)
• Hepatitis B virus (isolation & purification)
• Hepatitis B, Chronic (drug therapy)
• Humans
• Male
• Plasma (virology)
• Treatment Failure
• Treatment Outcome
• Viral Load