欧洲肝病学会:新型药物 LB80380 v 恩替卡韦-IIb期临床试验,香港

StephenW

Novel Drug Has Comparable Antiviral Activity With Entecavir in Treatment-Naïve HBV: Presented at EASLhttp://www.docguide.com/novel-drug-has-comparable-antiviral-activity-entecavir-treatment-na-ve-hbv?hash=c8431e6c&eid=19247&alrhash=2f4244-e14fac0ff7ef1d5b0c78458126191858

By Chris Berrie
BERLIN -- April 4, 2011 -- LB80380 has comparable antiviral activity, with the same safety profile, as entecavir in treatment-naïve patients with chronic hepatitis B virus (HBV), researchers said here at the 46th Annual Meeting of the European Association of the Study of the Liver (EASL).
Although low serum L-carnitine levels can occur with LB80380, these are normalised in all patients with carnitine supplementation, according to Ching-Lung Lai, MD, University of Hong Kong, and Queen Mary Hospital, Hong Kong.
“[LB80380] is a novel nucleotide analogue of guanosine monophosphate which is potent activity against hepatitis B virus,” said Dr. Lai on April 2.
The researchers investigated clinical activity, safety, and tolerability of two LB80380 doses in comparison with entecavir, as a noninferiority study.
Treatment-naïve patients with chronic were assigned to open-label entecavir 0.5 mg/day (n = 35) or double-blind LB80380 90 mg plus placebo (n = 34) or LB80380 90 mg plus 60 mg (n = 33), daily.
Alanine transaminase (ALT) levels needed to be >1.2x upper limit of normal (ULN) and <10x ULN, with compensated liver disease.
The 3 treatment groups saw similar mean HBV DNA decreases at week 24: -5.31, -4.99, -5.03 log10 IU/mL, respectively.
Undetectable HBV DNA was seen for 62.9%, 58.8%, and 63.6% of patients; normalised ALT levels for 85.7%, 73.5%, and 81.8% of patients; hepatitis B e antigen (HBeAg) loss for 14.3%, 15.8%, and 11.1% of patients; and HBeAg seroconversion for 4.8%, 5.3%, and 11.1% of patients.
Incidence and severity of adverse events with low with no differences across the treatment groups. This was the same for the laboratory analyses, except for serum L-carnitine levels. These fell below the reference range in with LB80380 treatment. “Patients were given just commercial L-carnitine supplements, and all of them returned to normal,” added Dr. Lai. At least one L-carnitine supplement was received by 55.6%/71.8% of patients in the LB80380 90-mg/150-mg groups.
[Presentation title: A Phase 2b Study of the Efficacy and Safety of LB80380 Versus Entecavir in Treatment-Naïve Patients With Chronic Hepatitis B. Abstract 1353]

StephenW

新型药物有比较恩替卡韦在治疗初治乙型肝炎抗病毒活性
：在欧洲肝病学会主办


克里斯贝里

柏林 - 2011年4月4日 - LB80380具有抗病毒活性比较，具有相同的安全性，如慢性乙型肝炎病毒（HBV）治疗初治患者恩替卡韦，研究人员表示，在此间举行的第46届年会的欧洲协会会议肝脏的（欧洲肝病学会）的研究。

虽然低血清L -肉碱水平可能会发生LB80380，这些都是归在所有患者肉碱补充，根据清龙丽，医学博士，香港大学及玛丽医院，香港。

“[LB80380]鸟苷酸是一种新型核苷类似物是强有力的抗乙型肝炎病毒的活性，博士说：”4月2日丽。

研究人员研究临床活性，安全性和恩替卡韦的两个剂量的耐受性比较LB80380，作为一个非劣性研究。

与治疗慢性乙型肝炎的初治患者被分配到开放标签恩替卡韦0.5毫克/天（n = 35）或双盲LB80380 90毫克加安慰剂组（n = 34）或LB80380 90毫克加60毫克（33例），每日。

丙氨酸转氨酶（ALT）水平需要> 1.2倍正常（正常值上限）和“<10倍正常值上限的上限，与代偿性肝脏疾病。

3治疗组看到类似的HBV DNA的平均24周的跌幅：-5.31，-4.99，-5.03 log10的国际单位/毫升，分别为。

有人看见，HBV DNA转阴为62.9％，58.8％和63.6％的患者ALT水平正常化为85.7％，73.5％和81.8％的患者乙肝e抗原（HBeAg）的损失为14.3％，15.8％和11.1％的患者和e抗原为4.8％，5.3％和11.1％的患者血清转化。

发生率和低不良事件与整个治疗组无明显差异的严重性。这是该实验室的分析相同，但血清L -肉碱水平。这些低于参考范围与LB80380治疗。 “患者给予是商业L -肉碱的补充，其中全部恢复正常，”赖博士补充说。至少有一架L -肉碱的补充收到55.6％/ 71.8％的患者在90-mg/150-mg组LB80380。

[演讲题目：第2b期的疗效和安全性的LB80380对战恩替卡韦在治疗初治患者的研究慢性乙型肝炎摘要1353]

benben00

药效很好啊，值得期待

StephenW

benben00 发表于 2011-4-6 09:14
药效很好啊，值得期待

这药似乎有副作用, 需要谨慎.

lin12345

interdetect

回复 StephenW 的帖子

“ LB80380 has comparable antiviral activity, with the same safety profile, as entecavir in treatment-naïve patients”

Above was mentioned in your artical, how can you conclude LB80380 有副作用？any 证据？

StephenW

interdetect 发表于 2011-4-6 13:47
回复 StephenW 的帖子

“ LB80380 has comparable antiviral activity, with the same safety profile, as ...

Simple, if you read carefully.

"This was the same for the laboratory analyses, except for serum L-carnitine levels. These fell below the reference range in with LB80380 treatment. “Patients were given just commercial L-carnitine supplements, and all of them returned to normal,” added Dr. Lai. At least one L-carnitine supplement was received by 55.6%/71.8% of patients in the LB80380 90-mg/150-mg groups."

interdetect

回复 StephenW 的帖子

肉毒碱是广泛存在于自然界中的一种高极性、小分子季胺类化合物，为人体必需营养素，有重要的生化功能和临床应用价值。人类对肉毒碱的需求主要是通过生物合成和摄入饮食来满足。

1. 请问如果排除了这条，其他方面LB80380与恩替相当的话？LB80380是不是更有价值？毕竟我们可以靠饮食来补充。
2. 你所陈述的“LB80380的这个不良反应”VS“恩替的致癌性”相比，哪个更严重？二者取其一，你选哪个？

说明：我不跟你争论。你回答，我不再回复下去。

StephenW

interdetect 发表于 2011-4-6 14:24
回复 StephenW 的帖子

肉毒碱是广泛存在于自然界中的一种高极性、小分子季胺类化合物，为人体必需营养素， ...

1. 请问如果排除了这条，其他方面LB80380与恩替相当的话？LB80380是不是更有价值？毕竟我们可以靠饮食来补充。No, why is LB80380 better than ENT. LB80380 has a side effect that needs to be corrected by taking a supplement.
2. 你所陈述的“LB80380的这个不良反应”VS“恩替的致癌性”相比，哪个更严重？二者取其一，你选哪个？You ask a loaded question. Is causing cancer a side-effect of Entecavir? If it is, you are saying the sFDA approved the use of a drug with cancer causing side-effect? ENT is approved by FDA and TGA, I would use it. If LB80380 is approved by FDA and TGA, I would use it too.

Now I answer your question. Just answer me:
Since 2005, did FDA issue any cancer warning about ENT?

aa1021

谢谢楼主分享.