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

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

    Research output: Contribution to journalArticlepeer-review

    13 Citations (Scopus)

    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 log10 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.

    Original languageEnglish
    Pages (from-to)296-302
    Number of pages7
    JournalIntervirology
    Volume50
    Issue number4
    DOIs
    Publication statusPublished - 2007 Jul

    Keywords

    • Clinical trial
    • Covalently closed circular woodchuck hepatitis virus DNA
    • Hepatitis B virus
    • Viral replication

    ASJC Scopus subject areas

    • Virology
    • Infectious Diseases

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