慢性HBeAg阳性病人24周Clevudine治疗显示持续的抗病毒效

齐欢畅2

【文摘发布】慢性HBeAg阳性病人24周Clevudine治疗显示持续的抗病毒效
Title: Twenty-four-week clevudine therapy showed potent and sustained antiviral activity in HBeAg-positive chronic hepatitis B

Author: Byung Chul Yoo 1, Ju Hyun Kim 2, Young-Hwa Chung 3, Kwan Sik Lee 4, Seung Woon Paik 1, Soo Hyung Ryu 5, Byung Hoon Han 6, Joon-Yeol Han 7, Kwan Soo Byun 8, Mong Cho 9, Heon-Ju Lee 10, Tae-Hun Kim 11, Se-Hyun Cho 7, Joong-Won Park 12, Soon-Ho Um 8, Seong Gyu Hwang 13, Young Soo Kim 14, Youn-Jae Lee 15, Chae Yoon Chon 4, Byung-Ik Kim 16, Young-Suk Lee 7, Jin-Mo Yang 7, Haak Cheoul Kim 17, Jae Seok Hwang 18, Sung-Kyu Choi 19, Young-Oh Kweon 20, Sook-Hyang Jeong 21, Myung-Seok Lee 22, Jong-Young Choi 7, Dae-Ghon Kim 23, Yun Soo Kim 2, Heon Young Lee 24, Kwon Yoo 11, Hee-Won Yoo 25, Hyo-Suk Lee

Resourse: Hepatology Volume 45, Issue 5 , Pages 1172 - 1178

Abstract
Clevudine is a pyrimidine analogue with potent and sustained antiviral activity against HBV. The present study evaluated the safety and efficacy of 30 mg clevudine once daily for 24 weeks and assessed the durable antiviral response for 24 weeks after cessation of dosing. A total of 243 hepatitis B e antigen (HBeAg)-positive chronic hepatitis B patients were randomized (3:1) to receive clevudine 30 mg once daily (n = 182) or placebo (n = 61) for 24 weeks. Patients were followed for a further 24 weeks off therapy. Median serum HBV DNA reductions from baseline at week 24 were 5.10 and 0.27 log10 copies/mL in the clevudine and placebo groups, respectively (P < 0.0001). Viral suppression in the clevudine group was sustained off therapy, with 3.73 log10 reduction at week 34 and 2.02 log10 reduction at week 48. At week 24, 59.0% of patients in the clevudine group had undetectable serum HBV DNA levels by Amplicor PCR assay (less than 300 copies/mL). The proportion of patients who achieved normalization of alanine aminotransferase (ALT) levels was 68.2% in the clevudine group and 17.5% in the placebo group at week 24 (P < 0.0001). ALT normalization in the clevudine group was well maintained during post-treatment follow-up period. The incidence of adverse events (AEs) was similar between the clevudine group and the placebo group. No resistance to clevudine was detected with 24 weeks of administration of drug. Conclusion: A 24-week clevudine therapy was well tolerated and showed potent and sustained antiviral effect without evidence of viral resistance during treatment period in HBeAg-positive chronic hepatitis B. (HEPATOLOGY 2007;45:1172-1178.)
--------------------------------------------------------------------------------
本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。
--------------------------------------------------------------------------------
Title: Twenty-four-week clevudine therapy showed potent and sustained antiviral activity in HBeAg-positive chronic hepatitis B
标题： 对HBeAg阳性慢性乙肝患者24的周克来夫定治疗显示持续有效的抗病毒活性
Author: Byung Chul Yoo 1, Ju Hyun Kim 2, Young-Hwa Chung 3, Kwan Sik Lee 4, Seung Woon Paik 1, Soo Hyung Ryu 5, Byung Hoon Han 6, Joon-Yeol Han 7, Kwan Soo Byun 8, Mong Cho 9, Heon-Ju Lee 10, Tae-Hun Kim 11, Se-Hyun Cho 7, Joong-Won Park 12, Soon-Ho Um 8, Seong Gyu Hwang 13, Young Soo Kim 14, Youn-Jae Lee 15, Chae Yoon Chon 4, Byung-Ik Kim 16, Young-Suk Lee 7, Jin-Mo Yang 7, Haak Cheoul Kim 17, Jae Seok Hwang 18, Sung-Kyu Choi 19, Young-Oh Kweon 20, Sook-Hyang Jeong 21, Myung-Seok Lee 22, Jong-Young Choi 7, Dae-Ghon Kim 23, Yun Soo Kim 2, Heon Young Lee 24, Kwon Yoo 11, Hee-Won Yoo 25, Hyo-Suk Lee
作者：Byung Chul Yoo等
Resourse: Hepatology Volume 45, Issue 5 , Pages 1172 - 1178
来源：《肝脏病学》第5期45卷，1172-1178页
Abstract
摘要：
Clevudine is a pyrimidine analogue with potent and sustained antiviral activity against HBV.
克来夫定为嘧啶类似物，对HBV具有持续有效的抗病毒活性。
The present study evaluated the safety and efficacy of 30 mg clevudine once daily for 24 weeks and assessed the durable antiviral response for 24 weeks after cessation of dosing.
当前的研究在于评估连续24周每日使用30mg克来夫定的安全和有效性，以及停止给药后24周的持续抗病毒反应。
A total of 243 hepatitis B e antigen (HBeAg)-positive chronic hepatitis B patients were randomized (3:1) to receive clevudine 30 mg once daily (n = 182) or placebo (n = 61) for 24 weeks.
共243名乙肝e抗原（HBeAg）阳性的慢性乙肝患者随机（3:1）使用克来夫定每天30mg（n = 182）或安慰剂（n = 61），均持续24周。
Patients were followed for a further 24 weeks off therapy. Median serum HBV DNA reductions from baseline at week 24 were 5.10 and 0.27 log10 copies/mL in the clevudine and placebo groups, respectively (P < 0.0001).
患者在治疗结束后接受为期24周的随访。24周时克来夫定组和安慰剂组血清HBV DNA从基础水平下降的中位数分别为5.10和0.27 log10 份/mL（P < 0.0001）。
Viral suppression in the clevudine group was sustained off therapy, with 3.73 log10 reduction at week 34 and 2.02 log10 reduction at week 48.
克来夫定组病毒抑制效应持续至治疗结束后，血清HBV DNA从基础水平下降的中位数在34周时为3.73 log10，在48周时为2.02 log10。
At week 24, 59.0% of patients in the clevudine group had undetectable serum HBV DNA levels by Amplicor PCR assay (less than 300 copies/mL).
在24周，克来夫定组59.0%的患者不能通过PCR扩增试剂盒检测。
The proportion of patients who achieved normalization of alanine aminotransferase (ALT) levels was 68.2% in the clevudine group and 17.5% in the placebo group at week 24 (P < 0.0001).
在24周，克来夫定组68.2%的患者谷丙转氨酶（ALT）恢复正常，而安慰剂组仅17.5%（P < 0.0001）。
ALT normalization in the clevudine group was well maintained during post-treatment follow-up period. The incidence of adverse events (AEs) was similar between the clevudine group and the placebo group.
克来夫定组ALT正常化在治疗后随访期间继续维持。不良反应（AEs）发生率克来夫定组和安慰剂组相近。
No resistance to clevudine was detected with 24 weeks of administration of drug. 在24周的给药期间未见克来夫定耐药性。
conclusion: A 24-week clevudine therapy was well tolerated and showed potent and sustained antiviral effect without evidence of viral resistance during treatment period in HBeAg-positive chronic hepatitis B. (HEPATOLOGY 2007;45:1172-1178.)
结论：HbeAg阳性慢性乙肝患者在克来夫定24周的治疗中耐受良好，克来夫定也显示出持续和有效的抗病毒作用，且无耐药证据。

编译：

HBeAg阳性慢性乙肝患者24周的克来夫定治疗疗效显著

Byung Chul Yoo等在2007年《肝脏病学》第5期45卷上发表的文章认为，HBeAg阳性慢性乙肝患者24周的克来夫定治疗疗效显著，患者耐受良好，无耐药迹象。（Hepatology Volume 45, Issue 5 , Pages 1172 - 1178）

克来夫定为嘧啶类似物，对HBV具有持续有效的抗病毒活性。Byung Chul Yoo等研究目的在于评估连续24周每日使用30mg克来夫定的安全和有效性，以及停止给药后24周的持续抗病毒反应。他们将243名乙肝e抗原（HBeAg）阳性的慢性乙肝患者随机（3:1）分为两组，一组使用克来夫定每天30mg（n = 182），一组使用安慰剂（n = 61），均持续24周；并在治疗结束后进行为期24周的随访。结果发现，在24周时，克来夫定组和安慰剂组血清HBV DNA从基础水平下降的中位数分别为5.10和0.27 log10 份/mL（P < 0.0001）。克来夫定组病毒抑制效应可持续至治疗结束后，血清HBV DNA从基础水平下降的中位数在34周时为3.73 log10，在48周时为2.02 log10。在24周时，克来夫定组59.0%的患者不能通过PCR扩增试剂盒进行检测；同时，克来夫定组68.2%的患者谷丙转氨酶（ALT）恢复正常，而安慰剂组仅17.5%（P < 0.0001）。克来夫定组ALT正常化在治疗后随访期间能继续维持。而不良反应（AEs）发生率克来夫定组和安慰剂组相近。在24周的给药期间未见克来夫定耐药性。最终Byung Chul Yoo等认为，HbeAg阳性慢性乙肝患者在克来夫定24周的治疗中耐受良好，克来夫定也显示出持续和有效的抗病毒作用，且无耐药证据。
--------------------------------------------------------------------------------
感谢tootoo战友的指点，已更正翻译
--------------------------------------------------------------------------------

freshnail

有战友试过吗？ 本人刚开始关注这些，不是很懂啊

特深沉

克拉夫定，韩国原创的又一种核苷类药。很早之前就跟踪报道过，不知为什么后来没有上市或是推迟上市。不见得比恩替卡韦好，

ybdn

原帖由 特深沉 于 2009-12-5 13:47 发表
克拉夫定，韩国原创的又一种核苷类药。很早之前就跟踪报道过，不知为什么后来没有上市或是推迟上市。不见得比恩替卡韦好，

韩国人的功利性也很强，以前公布的良好数据可能动过手脚，要不这药就该大力推广了。