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Clevudine is highly efficacious in hepatitis B e antigen-negative chronic hepatitis B with durable off-therapy viral suppression

Authors
 Kwan Sik Lee  ;  Byung Chul Yoo  ;  Hyo-Suk Lee  ;  Hee-Won Yoo  ;  Sook-Hyang Jeong  ;  Heon Young Lee  ;  Young-Oh Kweon  ;  Jong-Young Choi  ;  Se-Hyun Cho  ;  Young-Hwa Chung  ;  Dae-Ghon Kim  ;  Myung-Seok Lee  ;  Joong-Won Park  ;  Jin-Mo Yang  ;  Youn-Jae Lee  ;  Sung-Kyu Choi  ;  Young-Suk Lee  ;  Yun Soo Kim  ;  Jae Seok Hwang  ;  Heon-Ju Lee  ;  Kwon Yoo  ;  Mong Cho  ;  Byung-Ik Kim  ;  Seong Gyu Hwang  ;  Kwan Soo Byun  ;  Haak Cheoul Kim  ;  Soo Hyung Ryu  ;  Joon-Yeol Han  ;  Chae Yoon Chon  ;  Byung Hoon Han  ;  Young Soo Kim  ;  Soon-Ho Um  ;  Kwang Cheol Koh  ;  Tae-Hun Kim  ;  Ju Hyun Kim 
Citation
 HEPATOLOGY, Vol.46(4) : 1041-1048, 2007 
Journal Title
HEPATOLOGY
ISSN
 0270-9139 
Issue Date
2007
MeSH
Adolescent ; Adult ; Alanine Transaminase/blood ; Antiviral Agents/adverse effects ; Antiviral Agents/pharmacology ; Antiviral Agents/therapeutic use* ; Arabinofuranosyluracil/adverse effects ; Arabinofuranosyluracil/analogs & derivatives* ; Arabinofuranosyluracil/pharmacology ; Arabinofuranosyluracil/therapeutic use ; DNA, Viral/blood ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Resistance, Viral ; Female ; Genotype ; Hepatitis B e Antigens/blood* ; Hepatitis B virus/drug effects* ; Hepatitis B virus/genetics ; Hepatitis B virus/immunology* ; Hepatitis B, Chronic/blood ; Hepatitis B, Chronic/drug therapy* ; Hepatitis B, Chronic/immunology ; Humans ; Male ; Middle Aged ; Time Factors
Abstract
Clevudine is a pyrimidine analog with potent and sustained antiviral activity against HBV. In the present study, we evaluated the safety and efficacy of clevudine 30 mg daily for 24 weeks and assessed the durability of antiviral response for 24 weeks after cessation of dosing in hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (e-CHB). We randomized a total of 86 patients (3:1) to receive clevudine 30 mg (n = 63) or placebo (n = 23) daily for 24 weeks. We followed patients for an additional 24 weeks after withdrawal of treatment. The median changes in HBV DNA from baseline were −4.25 and −0.48 log10 copies/mL at week 24 in the clevudine and placebo groups, respectively (P < 0.0001). Viral suppression in the clevudine group was sustained after withdrawal of therapy, with 3.11 log10 reduction at week 48. At week 24 and week 48, 92.1% and 16.4% of patients in the clevudine group had undetectable serum HBV DNA levels by Amplicor PCR assay (<300 copies/mL). The proportion of patients who achieved ALT normalization was 74.6% and 33.3% in the clevudine and placebo groups at week 24, respectively (P = 0.0006). ALT normalization in the clevudine group was well-maintained during the post-treatment follow-up period. The incidence of adverse events was similar in the 2 groups. No resistance to clevudine was detected during treatment. Conclusion: A 24-week clevudine therapy was well-tolerated and showed potent and sustained antiviral effect without evidence of viral resistance in e-CHB patients. However, treatment for longer than 24 weeks would be needed to achieve durable remission.
Full Text
http://onlinelibrary.wiley.com/doi/10.1002/hep.21800/abstract
DOI
10.1002/hep.21800
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Lee, Kwan Sik(이관식) ORCID logo https://orcid.org/0000-0002-3672-1198
Chon, Chae Yoon(전재윤)
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/96090
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