Clevudine Demonstrates Potent Antiviral Activity in Naive Chronic Hepatitis B Patients

被引：7

作者：

Lee, June Sung ^{[2
]}

Park, Eun Taek ^{[3
]}

Kang, Seung Sik ^{[4
]}

Gu, Eun Sil ^{[5
]}

Kim, Jong Sun ^{[6
]}

Jang, Dong Seob ^{[7
]}

Lee, Kyoung Seog ^{[8
]}

Lee, Jae-Su ^{[9
]}

Park, Nung Hwa ^{[10
]}

Bae, Chang Hwang ^{[11
]}

Baik, Soon Koo ^{[12
]}

Yu, Byeong Jeon ^{[13
]}

Lee, Soon Hyung ^{[14
]}

Lee, Eun Jong ^{[15
]}

Park, Sung Il ^{[16
]}

Bae, Myoung ^{[17
]}

Shin, Jung Woo ^{[18
]}

Choi, Jae Hong ^{[19
]}

Gu, Chul ^{[20
]}

Moon, Sin Kil ^{[21
]}

Chun, Gab Jin ^{[22
]}

Kim, Ju Hyun ^{[23
]}

Kim, Hong Soo ^{[24
]}

Choi, Sung-Kyu ^{[1
]}

机构：

[1] Chonnam Natl Univ Hosp, Dept Internal Med, 671 Jebongno Donggu, Kwangju 501757, South Korea

[2] Inje Univ, Ilsanpaik Hosp, Goyang, South Korea

[3] Inje Univ, Paik Hosp, Pusan, South Korea

[4] Yegi Clin, Seoul, South Korea

[5] Hyoin Med Clin, Inchon, South Korea

[6] Yonsei Somang Internal Med Clin, Gympo, South Korea

[7] Serim Hosp, Bupyung, South Korea

[8] Han Ma Eum Med Ctr, Chang Won, South Korea

[9] Lee Jae Su Internal Med Clin, Chonju, South Korea

[10] Ulsan Univ Hosp, Ulsan, South Korea

[11] Hopyung Asan Med Clin, Namyangju, South Korea

[12] Yonsei Univ, Wonju Coll Med, Wonju, South Korea

[13] Yu Byeong Jeon Internal Med Clin, Kwangju, South Korea

[14] Lee Soon Hyung Internal Med Clin, Jeonju, South Korea

[15] Lee Eun Jong Internal Med Clin, Dongdu Cheon, South Korea

[16] Donggunsan Hosp, Gunsan, South Korea

[17] Hanil Hosp, Kwangju, South Korea

[18] Ulsan Univ Hosp, Ulsan, South Korea

[19] Hana Hosp, Hanmaum Med Fdn, Chonju, South Korea

[20] Yeosu Chunnam Hosp, Yeosu, South Korea

[21] Pohang SM Christian Hosp, Pohang, South Korea

[22] Gangneung Asan Hosp, Kangnung, South Korea

[23] Gachon Univ, Gil Hosp, Inchon, South Korea

[24] Soonchunhyang Univ, Chunan, South Korea

来源：

INTERVIROLOGY | 2010年 / 53卷 / 02期

关键词：

Hepatitis B virus; Post marketing surveillance; Viral replication; Viral breakthrough; Clevudine; THERAPY SHOWED POTENT; ADEFOVIR DIPIVOXIL; LAMIVUDINE; VIRUS; ENTECAVIR; NUCLEOSIDE; TRIAL; RATES; DNA;

D O I：

10.1159/000264197

中图分类号：

Q93 [微生物学];

学科分类号：

071005 ; 100705 ;

摘要：

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

引用

页码：83 / 86

页数：4

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