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记得Novaferon?   [复制链接]

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才高八斗

1
发表于 2015-4-6 21:11 |只看该作者 |倒序浏览 |打印
Remember Novaferon
Genova Biotech Company, Ltd.
Add: Building F, 5th floor, Wangjing Technology Park, Chaoyang District, Beijing 100102
Tel: (8610) 6439 2239
Fax: (8610) 6439 2557
Web: http://www.genova509.com/    ???
E-mail: [email protected]

THE IMPACTS OF BASELINE CLINICAL CHARACTERISTICS
AND HEPATITIS B VIRUS MUTATIONS ON CURATIVE
EFFECTS OF CHRONIC HEPATITIS B TREATED WITH
NOVAFERON
Wu Daxian, Tan Deming*, China

记得Novaferon的?他们的海报在EASL2015
杰华生物股份有限公司
地址:F栋5楼,望京科技园,北京市朝阳区100102
联系电话:(8610)64392239
传真:(8610)64392557
网址:http://www.genova509.com/
电子邮件:[email protected]

基线临床特征的影响
和乙型肝炎病毒突变ON疗效
慢性乙型肝炎的影响与经处理
Novaferon的
吴答鲜,谈得名*,中国

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2
发表于 2015-4-6 21:46 |只看该作者
没看出要点在哪?请明示!

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才高八斗

3
发表于 2015-4-6 22:08 |只看该作者
回复 战天斗hbv 的帖子

Novaferon的是在中国制成干扰素制成,在中国完成3期临床试验,SFDA批准的(?)

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4
发表于 2015-4-6 22:20 |只看该作者
StephenW 发表于 2015-4-6 22:08
回复 战天斗hbv 的帖子

Novaferon的是在中国制成干扰素制成,在中国完成3期临床试验,SFDA批准的(?) ...

哦、谢谢!不了解干扰素市场、以前没国产的?

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5
发表于 2015-4-6 22:25 |只看该作者
回复 战天斗hbv 的帖子

Novaferon is a new proprietary protein drug developed by Genova Biotech which can be used to treat a variety of malignant tumors and viral diseases. Its highly potent anti-tumor and anti-virus activities have been proven by National Institute for the Control of Pharmaceutical and Biological products: its anti-tumor and anti-virus activities are 246.7 times and 10 times higher than that of similar products, respectively!
Novaferon的是由热那亚Biotech公司开发了一种新的专有蛋白质药物,可用于治疗多种恶性肿瘤和病毒性疾病。其高度有效的抗肿瘤和抗病毒的活动已经证明了中国药品生物制品检定所:其抗肿瘤和抗病毒的活动是246.7倍,比同类产品高10倍,分别为!

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6
发表于 2015-4-7 16:40 |只看该作者
回复 StephenW 的帖子

国产长效干扰素派格宾不是早就2期临床了吗?据说效果不错,过了好几年了为啥还不上市?

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7
发表于 2015-4-8 18:19 |只看该作者
咬牙硬挺 发表于 2015-4-7 16:40
回复 StephenW 的帖子

国产长效干扰素派格宾不是早就2期临床了吗?据说效果不错,过了好几年了为啥还不上 ...

是真的么?那为啥还不上市?同问

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8
发表于 2015-4-8 19:07 |只看该作者
三期好像都过了

但是国内新药上市据说非常慢

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才高八斗

9
发表于 2015-4-9 04:00 |只看该作者
平凡结果?

RS-3641

Viral hepatitis

Hepatitis B & D - Experimental





THE IMPACTS OF BASELINE CLINICAL CHARACTERISTICS AND HEPATITIS B VIRUS MUTATIONS ON CURATIVE EFFECTS OF CHRONIC HEPATITIS B TREATED WITH NOVAFERON

Wu Daxian1, Tan Deming* 1

1Department of Infectious Diseases, Xiangya Hospitalo of Central South University, Changsha, China



Corresponding author’s email: [email protected]



Background and Aims: Background and aims: Novaferon,which is a new type of IFN, had approved by State Food and Drug Administration (SFDA)  for clinical trials of  new drugs on CHB therapy in 2009.To assess the impacts of baseline clinical characteristics of patients with chronic hepatitis B (CHB) and baseline  hepatitis B virus (HBV) gene mutations on curative effects of CHB treated with Novaferon.

Methods: Methods  Enrolled patients accepted Novaferon monotherapy for 24 weeks  and follow up for 12 weeks. Body mass index (BMI) of patients ,genotype ,basal core promoter (BCP) and precore (PC) , reverse transcriptase(RT), S region variants of HBV were determined prior to Novaferon treatment . Aminotransferase (ALT), Hepatitis B e antigen (HBeAg), HBV DNA, Hepatitis B surface antigen (HBsAg) were determined at the beginning of treatment and 12 weeks after treatment. Then the present study evaluated the influence of age , gender, genotype , BMI, baseline ALT, HBeAg, HBV-DNA, HBsAg titer as well as BCP,PC,RT and S region variants on curative effects of chronic hepatitis B treated with Novaferon。

Results: Results In total of 126 CHB patients who finished the treatedment and follow-up, 38.9% obtained virological response and 32.5%, 25.4%, 44.4%, 23.8% obtained HBeAg clearence, HBeAg  seroconversion, biochemical response and combined response respectively. The baseline DNA level of virological response group was significantly lower than no-virological response group; the baseline ALT level were significantly higher in HBeAg clearence group and HBeAg seroconversion group; female and lower BMI level was prone to acquired biochemical response. Stepwise logistic regression analysis showed that PC-P159T(ntC2288A), BCP-N118T(ntA1726C), BCP-L134L (ntA1775C/G/T) were independent influence factors for virological response. The frequencies of PC-G182C (ntG2357T) was significantly higher in groups with HBeAg clearance group and PC-S64A/T(ntT2003G/A), PC-W28STOP (ntG1896A) was significantly higher in HBeAg seroconversion groups , combined response respectively.

Conclusions: Conclusions  Novaferon was an effective therapeutic drug for CHB patients, different response type was influenced by different clinical characteristics and mutations. Baseline mutations screening could predict curative effect of Novaferon efficiently and offered the optimal drugs for CHB patients.



Disclosure of Interest: None Declared

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才高八斗

10
发表于 2015-4-9 04:02 |只看该作者

RS-3641

病毒性肝炎

乙肝&D - 实验





基线临床特征和乙型肝炎病毒突变对慢性乙型肝炎的疗效的影响治疗的Novaferon

吴Daxian1,谈得铭* 1

教研室传染病,中南大学湘雅Hospitalo,长沙,中国



通讯作者的邮箱:[email protected]



背景和目的:背景和目的:Novaferon的,这是干扰素,为新药物对慢性乙肝治疗2009.To临床试验已经批准了国家食品药品监督管理局(SFDA)的新型评估基线临床特征的影响例慢性乙型肝炎(CHB)和慢性乙肝的疗效与治疗的Novaferon基线乙型肝炎病毒(HBV)基因突变。

方法:方法入选患者接受Novaferon的单药治疗24周,随访12周。的患者中,基因型身体质量指数(BMI),基底核心启动子(BCP)和前C(PC),逆转录酶(RT),S区的HBV变体之前的Novaferon治疗决定。转氨酶(ALT),乙型肝炎e抗原(HBeAg),HBV-DNA,B型肝炎表面抗原(HBsAg)在治疗开始和治疗12周后进行了测定。然后本研究评估的年龄,性别,影响基因型,体​​重指数,基线ALT,HBeAg和HBV-DNA的HBsAg滴度以及BCP,PC上的Novaferon治疗慢性乙型肝炎的临床疗效RT和S区的变体。

结果:结果共有谁完成的treatedment和随访,38.9%获得病毒学应答,32.5%,25.4%,44.4%,23.8%获得HBeAg的clearence,HBeAg血清转换,生化反应和反应相结合,分别126例慢性乙型肝炎患者。病毒学应答组的基线DNA水平明显高于无病毒学应答组显著降低;基线ALT水平明显高于显著的HBeAg clearence组和HBeAg血清转换组;女性和较低的BMI水平容易获得的生化反应。逐步回归分析表明,PC-P159T(ntC2288A),BCP-N118T(ntA1726C),BCP-L134L(ntA1775C / G / T)是独立的影响因素病毒学应答。对PC-G182C频率(ntG2357T)是显著高于与HBeAg清除组和PC-S64A / T(ntT2003G / A)组,PC-W28STOP(ntG1896A)是显著高于HBeAg血清转换组,分别结合反应。

结论:结论的Novaferon是一种有效的治疗药物,慢性乙肝患者,不同的反应类型是由不同的临床特征和基因突变的影响。基线突变筛查可以预测的Novaferon对有效治疗效果,并提供最佳的药物为慢性乙肝患者。

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