[转帖]慢性HBeAg阳性病人24周Clevudine治疗显示持续的抗病毒效果

jangle

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。

来源：丁香园 excelblade

jangle

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.)

jonchan

不知道长时间使用会怎么样，毕竟现在只有24周的数据。

每天使用30mg，不知道对身体有什么副作用。

抗病毒药物降价才是硬道理。