Clevudine therapy for 24 weeks further reduced serum hepatitis B virus DNA levels and increased ALT normalization rates without emergence of viral breakthrough than 12 weeks of clevudine therapy.

Abstract

OBJECTIVES:

The objectives of the study were to evaluate the safety and antiviral activity of 24-week treatment with clevudine 30 mg in HBeAg(+) chronic hepatitis B patients. Biochemical and serological responses were also assessed.

METHOD:

Twenty-one patients received clevudine 30 mg for 24 weeks and were followed up for another 24 weeks off therapy.

RESULTS:

Median decreases from baseline in HBV DNA were 4.65 and 1.96 log(10) copies/ml at week 24 (end of treatment) and week 48 (24 weeks off therapy), respectively. Analysis of individual data showed that HBV DNA levels were below the lower limit of detection (300 copies/ml) by Amplicor PCR assay in 19, 57, 19 and 0% at week 12, 24, 34 and 48, respectively. The proportion of patients with normal ALT were 67, 81 and 75% at week 24 (end of treatment), 34 and 48 (24 weeks off therapy), respectively. The rates of HBeAg loss were 24 and 20% at week 24 and 48, respectively. No viral breakthrough during treatment was observed.

CONCLUSION:

Clevudine 30 mg treatment for 24 weeks was well tolerated and exhibited more potent antiviral activity and a higher ALT normalization rate than 12-week treatment with durable efficacy at week 24 off therapy.

• Authors: Kwan Sik Lee, Kwan Soo Byun, Young-Hwa Chung, Seung Woon Paik, Joon-Yeol Han, Kwon Yoo, Hee-Won Yoo, Byung Chul Yoo, Hyo-Suk Lee
• Journal: Intervirology (Intervirology) Vol. 50 Issue 4 Pg. 296-302 ( 2007) ISSN: 1423-0100 [Electronic] Switzerland
• PMID: 17622789 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2007 S. Karger AG, Basel.

Chemical References

• Antiviral Agents
• DNA, Viral
• Hepatitis B e Antigens
• Arabinofuranosyluracil
• Alanine Transaminase
• clevudine

Topics

• Alanine Transaminase (blood)
• Antiviral Agents (administration & dosage, adverse effects, therapeutic use)
• Arabinofuranosyluracil (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• DNA, Viral (blood)
• Hepatitis B e Antigens (blood)
• Hepatitis B virus (drug effects, genetics, isolation & purification, physiology)
• Hepatitis B, Chronic (drug therapy, virology)
• Humans
• Male
• Treatment Outcome