Clevudine demonstrates potent antiviral activity in naïve chronic hepatitis B patients

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 MoonGab Jin Chun, Ju Hyun Kim, Hong Soo Kim, Sung Kyu Choi

Research output: Contribution to journalArticle

8 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)83-86
Number of pages4
JournalIntervirology
Volume53
Issue number2
DOIs
Publication statusPublished - 2010 Feb 1

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Chronic Hepatitis B
Antiviral Agents
Hepatitis B e Antigens
Hepatitis B virus
DNA
Clevudine
Therapeutics
Marketing
Alanine Transaminase
Limit of Detection
Safety

All Science Journal Classification (ASJC) codes

  • Virology
  • Infectious Diseases

Cite this

Lee, J. S., Park, E. T., Kang, S. S., Gu, E. S., Kim, J. S., Jang, D. S., ... Choi, S. K. (2010). Clevudine demonstrates potent antiviral activity in naïve chronic hepatitis B patients. Intervirology, 53(2), 83-86. https://doi.org/10.1159/000264197
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. / Clevudine demonstrates potent antiviral activity in naïve chronic hepatitis B patients. In: Intervirology. 2010 ; Vol. 53, No. 2. pp. 83-86.
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title = "Clevudine demonstrates potent antiviral activity in na{\"i}ve chronic hepatitis B patients",
abstract = "Objectives: Clevudine has demonstrated antiviral potency in the treatment of na{\"i}ve 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 na{\"i}ve chronic hepatitis B patients.",
author = "Lee, {June Sung} and Park, {Eun Taek} and Kang, {Seung Sik} and Gu, {Eun Sil} and Kim, {Jong Sun} and Jang, {Dong Seob} and Lee, {Kyoung Seog} and Lee, {Jae Su} and Park, {Nung Hwa} and Bae, {Chang Hwang} and Baik, {Soon Koo} and Yu, {Byeong Jeon} and Lee, {Soon Hyung} and Lee, {Eun Jong} and Park, {Sung Il} and Myoung Bae and Shin, {Jung Woo} and Choi, {Jae Hong} and Chul Gu and Moon, {Sin Kil} and Chun, {Gab Jin} and Kim, {Ju Hyun} and Kim, {Hong Soo} and Choi, {Sung Kyu}",
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Lee, JS, Park, ET, Kang, SS, Gu, ES, Kim, JS, Jang, DS, Lee, KS, Lee, JS, Park, NH, Bae, CH, Baik, SK, Yu, BJ, Lee, SH, Lee, EJ, Park, SI, Bae, M, Shin, JW, Choi, JH, Gu, C, Moon, SK, Chun, GJ, Kim, JH, Kim, HS & Choi, SK 2010, 'Clevudine demonstrates potent antiviral activity in naïve chronic hepatitis B patients', Intervirology, vol. 53, no. 2, pp. 83-86. https://doi.org/10.1159/000264197

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

In: Intervirology, Vol. 53, No. 2, 01.02.2010, p. 83-86.

Research output: Contribution to journalArticle

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T1 - Clevudine demonstrates potent antiviral activity in naïve chronic hepatitis B patients

AU - Lee, June Sung

AU - Park, Eun Taek

AU - Kang, Seung Sik

AU - Gu, Eun Sil

AU - Kim, Jong Sun

AU - Jang, Dong Seob

AU - Lee, Kyoung Seog

AU - Lee, Jae Su

AU - Park, Nung Hwa

AU - Bae, Chang Hwang

AU - Baik, Soon Koo

AU - Yu, Byeong Jeon

AU - Lee, Soon Hyung

AU - Lee, Eun Jong

AU - Park, Sung Il

AU - Bae, Myoung

AU - Shin, Jung Woo

AU - Choi, Jae Hong

AU - Gu, Chul

AU - Moon, Sin Kil

AU - Chun, Gab Jin

AU - Kim, Ju Hyun

AU - Kim, Hong Soo

AU - Choi, Sung Kyu

PY - 2010/2/1

Y1 - 2010/2/1

N2 - 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.

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