新药跟踪: Entecavir (01-03-03)

liver411

(如需要, 谢谢热心人帮网友简单翻译)

[B]Entecavir Is Superior to Epivir-HBV in Reducing HBV DNA Levels Among Patients with Chronic Hepatitis B[/B]

By Ronald Baker, PhD

There are currently 3 FDA-approved agents for the treatment of chronic hepatitis B: Epivir-HBV (GlaxoSmithKline), Intron A (Schering-Plough) and Hepsera (Gilead Sciences). A number of new agents are in development for the treatment of hepatitis B. Entecavir is a promising new experimental nucleoside analog drug from Bristol-Myers Squibb that has entered Phase III clinical trials for efficacy, the final stage of testing prior to FDA evaluation for approval as a prescription drug.

Entecavir shows superior effectiveness compared to Epivir-HBV (lamivudine; 3TC) in reducing HBV DNA levels in patients with chronic HBV, according to results of a Phase II study published in the December issue of Gastroenterology. The 24-week randomized, double blind study was conducted in 169 patients with chronic hepatitis B. The multicenter study took place at sites in China, Malaysia, The Philippines, Belgium, Canada and the US.

The safety and efficacy of entecavir at various doses (0.01 mg/day, 0.1 mg/day, or 0.5 mg/day orally) were compared with Epivir-HBV (100 mg/day orally). Patients with chronic HBV (hepatitis B "e" antigen [HBeAg]-positive and -negative) were evaluated for efficacy using the two treatments.

Compared with Epivir-HBV, entecavir reduced HBV DNA by an additional 0.97 log (10) at the 0.1-mg/day dose and an additional 1.28 log (10) at the 0.5-mg/day dose (P < 0.0001). A clear dose-response relationship was observed for entecavir with the higher doses showing significantly greater HBV suppression.

In patients treated with entecavir 0.5 mg/day, 83.7% had an HBV-DNA level below the lower limit of detection of the Quantiplex branched DNA (bDNA) assay (Bayer-Versant Diagnostics), compared with 57.5% treated with 100 mg/day lamivudine (P = 0.008).

In both treatment arms, very few patients achieved HBeAg loss and/or seroconversion by week 22. More patients treated with the 0.1-mg/day and 0.5-mg/day doses of entecavir had normalization of alanine transaminase (ALT) levels at week 22 compared with lamivudine (P = not significant). Entecavir was well tolerated; most adverse events were mild to moderate, transient, and comparable in all study arms.

The authors conclude, "This study showed that entecavir has potent antiviral activity against HBV at 0.1-mg/day and 0.5-mg/day doses, both of which were superior to lamivudine in chronically infected HBV patients."

1/03/03

Reference
CL Lai and others. Entecavir is superior to lamivudine in reducing hepatitis B virus DNA in patients with chronic hepatitis B infection. Gastroenterology 2002 Dec; 123(6): 1831-1838.


Copyright 2002 by HIV and Hepatitis. All Rights Reserved.


(内部交流)

极

我不是学医，专业名词不懂，希望翻译不偏差太远

Entecavir优于Epivir-HBV在抑制慢性乙肝患者的HBV DNA水平
作者 Ronald Baker, PhD
目前有三种FDA批准用于治疗慢性乙肝：Epivir-HBV (GlaxoSmithKline), Intron A (Schering-Plough) and Hepsera (Gilead Sciences). 大量新的方法正在研究用于治疗慢性乙肝，Entecavir是一种有希望的新的核苷类药物，已经用于第三阶段的临床实验，在提供给FDA评估用于处方药之前做最后实验。
根据第二阶段的实验结果，Entecavir显示了很好效果在对比Epivir-HBV (lamivudine; 3TC) 用于抑制慢性乙肝患者的HBV DNA水平。24周的随机，双盲研究实验在169名慢性乙肝患者，这些许多研究分别来自中国，Malaysia, The Philippines, Belgium, Canada and the US.
Entecavir的安全性，有效性测试在不同的剂量(0.01 mg/day, 0.1 mg/day, or 0.5 mg/day orally)并与Epivir-HBV (100 mg/day orally)做对比. 慢性乙肝患者(hepatitis B "e" antigen [HBeAg]-positive and -negative)被分别使用这两种治疗最后被评估有效。
对比Epivir-HBV, Entecavir抑制HBV DNA多0.97 log (10) at the 0.1-mg/day dose 和多 1.28 log (10) at the 0.5-mg/day dose (P < 0.0001). 一个明显的剂量-应答关系被观测到，更大剂量的使用Entecavir能更有效抑制HBV。
使用entecavir 0.5 mg/day的病人，83.7% HBV-DNA 水平低于 Quantiplex branched DNA (bDNA) assay (Bayer-Versant Diagnostics)的测试水平,  对比使用 100 mg/day lamivudine (P = 0.008)为57.5%.
在两种治疗方法中，有极少数病人达到HBeAg转阴或者血清转换通过22治疗。大多数病人使用0.1-mg/day 和 0.5-mg/day 的 entecavir其ALT转为正常水平在22周里，对比于 lamivudine (P = not significant).  Entecavir 非常耐受，大多数的突变是中性的，短暂和可对比的在所有的研究方法中。
作者总结：这个研究显示了Entecavir能有效的抗HBV在使用0.1-mg/day 和 0.5-mg/day剂量，都是优于lamivudine 在治疗HBV患者。
参考
CL Lai and others. Entecavir 优于 lamivudine在抑制慢性乙肝患者的HBV DNA水平。Gastroenterology 2002 Dec; 123(6): 1831-1838.
Copyright 2002 by HIV and Hepatitis. 所有权利保留.

半条活鱼

何时能投入使用啊！

九阴真君

曾听说国内明年投产。贵施宝公司已在上海盖厂房。

猪芩

厂房是我老婆设计的啊

半条活鱼

我记得去年您夫人就在设计厂房了，怎么还没完哪。

[此贴子已经被作者于2003-3-28 10:16:35编辑过]

苦难人生

以下是引用猪芩在2003-3-28 7:48:00的发言：
厂房是我老婆设计的啊

那你是否可便宜买药?

咪咪

难道还在设计之中？

轩辕

不知道副作用大不大，停药是不是会反弹？

jazz_2000

以下是引用苦难人生在2003-3-28 11:55:00的发言：
那你是否可便宜买药?

厂房设计关药厂什么事？？？呵呵，差远了。他如果没有药厂方面的熟人是拿不到便宜一点的药的