LdT的抗病毒能力显著超越拉米

zasxz

Greater Antiviral Effect with Telbivudine (LdT) in a Phase IIb Comparative Trial of LdT, Epivir-HBV and the Combination in Hepatitis B Patients

One promising HBV drug now in Phase II testing is telbivudine (L杁eoxythymidine [LdT]). LdT showed marked antiviral effects, with no identified safety issues, in a recent 4-week trial in chronic hepatitis B (CHB) patients, which prompted the current multi-national one-year trial.

This randomized multicenter study compared the one-year efficacy and safety of LdT 400 or 600 mg/day, and LdT 400 or 600 mg/day combined with Epivir-HBV (lamivudine), to standard lamivudine (Lam) 100 mg/day in adults with CHB.

The primary efficacy measure was serum HBV DNA reduction over time, assayed by PCR. Key secondary endpoints included serum ALT normalization, HBeAg loss or seroconversion, and safety.

104 HBeAg-seropositive patients with CHB were enrolled. At week 52, median reductions in serum HBV DNA, in log10 copies/mL, for the 5 treatment groups were: 4.66 for Lam, 6.43 for LdT 400 mg/d, 6.09 for LdT 600 mg/d, 6.40 for LdT 400 mg/d + Lam, and 6.05 for LdT 600 mg/d + Lam. Key efficacy results at Week 52 for comparisons of treatment type (Lam vs LdT vs Combination) are as follows:

                               Lam                 LdT               Lam + LdT

Mean HBV DNA ↓     -4.57              -6.09*            -5.99*  
HBV DNA-neg by PCR  6/19 (32%)   28/44 (64%)*   20/41 (49%)  
ALT normalization       12/19 (63%)  36/42 (86%)*  31/40 (78%)
HBeAg loss                 5/18 (28%)  14/42 (33%)  7/41 (17%)  
*p < 0.05 vs. Lam
         
All study treatments were well tolerated.

The authors conclude, 揃eneficial treatment effects were consistently greater for LdT vs Lam monotherapy, but there was no advantage for LdT + Lam over LdT alone. LdT appears likely to afford better anti-HBV efficacy, with no identified safety issues to date. International Phase III trials of LdT are underway.?/span>

10/01/03

Reference
CL Lai and others. A Phase IIb Comparative Trial of LdT, Lamivudine, and the Combination in Hepatitis B Patients: Greater Antiviral Effect with LdT. Abstract V-1723 (Slide session).Abstracts of the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy. September 14-17, 2003. Chicago, IL.

泊人无忧

你以为这是在美国吗

belstein

以下是引用泊人无忧在2003-10-7 22:31:00的发言：
你以为这是在美国吗

美国的今天就是我们的明天

天狼星星

国际多中心研究初步结果显示LdT病毒清除效果比LAM好
国际多中心研究初步结果显示LdT病毒清除效果比LAM好

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香港威尔士亲王医院Ｌａｉ等报告，汰比呋定（ｔｅｌｂｉｖｕｄｉｎｅ，ＬｄＴ）单独应用或与拉米夫定?ＬＡＭ?联合应用治疗慢乙肝病人，病毒清除效果比单用ＬＡＭ好。

Ⅰ／Ⅱ期研究证明，ＬｄＴ是一种有效的抗ＨＢＶ药。该项多中心随机、双盲研究评估了ＬｄＴ、ＬＡＭ和ＬｄＴ＋ＬＡＭ治疗代偿期ＣＨＢ病人的疗效和安全性。病人随机分为５组，分别应用ＬｄＴ（６００ｍｇ／ｄ）、ＬｄＴ（４００ｍｇ／ｄ）、ＬｄＴ（６００ｍｇ／ｄ）＋ＬＡＭ（１００ｍｇ／ｄ）、ＬｄＴ（４００ｍｇ／ｄ）＋ ＬＡＭ（１００ｍｇ／ｄ）、ＬＡＭ（１００ｍｇ／ｄ），疗程５２周。治疗１２周和５２周后进行总结。

研究共纳入５个国家和地区的１０４例病人，其中亚洲人占８７％，白种人占１０％；８１％为男性；平均年龄为３７岁（１６～６８岁）。病人能很好耐受治疗，未发生严重不良反应和治疗相关的实验室检查异常。疗效分析表明，治疗组都有明显早期抗病毒作用，血清ＨＢＶ ＤＮＡ均有所降低，研究者对３０例完成１２周治疗的病人进行分析（每组５～７例）。

治疗１２周初步资料显示（见表１），治疗１周后，含ＬｄＴ组（ＬｄＴ和ＬｄＴ＋ＬＡＭ）的抗病毒作用比单用ＬＡＭ好；治疗４周后，两者差异进一步扩大，差异愈来愈明显。

在４～１２周期间，ＬＡＭ组患者ＨＢＶ ＤＮＡ下降幅度比含ＬｄＴ组小。治疗１２周后，含ＬｄＴ组病人ＨＢＶ ＤＮＡ水平降至＜５ｌｏｇ１０、＜４ｌｏｇ１０、＜３ｌｏｇ１０者比ＬＡＭ组病人多，分别为７６％、５２％、２４％和４０％、２０％、０％。

　 表1 治疗12周初步结果

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HBV DNA下降幅度(log10)

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1周 12周

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LAM 100 mg 组 2.27±0.1 3.87±0.4
LdT 400 mg 组 2.44±0.3 4.34±0.3
LdT 600 组 2.15±0.3 4.64±0.6
LdT 400 mg + LAM 100 mg 组 2.38±0.2 4.97±0.6
LdT 600 mg + LAM 100 mg 组 2.8±0.3 5.05±0.3

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侯凤琴 摘译 责任编辑 郑桂香

感染专刊

羊的门

什么时候能上市？？哎又遥远了

wenjun0534

是啊，等的化儿都谢了