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标题: 不用IFN-治疗HCV /治疗方案 [打印本页]

作者: StephenW    时间: 2012-12-28 10:49     标题: 不用IFN-治疗HCV /治疗方案

Subject: NATAP: HCV IFN-Free Therapies

HCV IFN-Free Therapies/Regimens

In phase 3 studies now include proteases new TMC435, BI335, BMS032, NS5A BMS052, nucleotide GS7977, the Abbott IFN-free combination of 4 oral drugs. Roche, Vertex & Merck are in phase 2 with multi-oral drug regimens (see below). Vertex announced recently, in phase 2 with 3 drug oral regimen: ALS2200, their new nucleotide like GS7977 + GSK’s NS5A + Janssen protease TMC435 currently in phase 3 now. Also new in phase 3 & recruiting: Safety and Efficacy of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/-Ribavirin for the Treatment of HCV......Multicenter, Randomized, Open-Label......Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection......Safety and Efficacy of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/-Ribavirin for the Treatment of HCV........http://clinicaltrials.gov/ct2/sh ... erm=gs-5885&rank=2


This new study is recruiting: Safety and Efficacy of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/-Ribavirin in HCV Genotype 1 Subjects.....phase 2.....8 or 12 weeks therapy.....in subjects who had previously received a regimen containing a protease inhibitor for the treatment of HCV.....Safety and Efficacy of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/-Ribavirin in HCV Genotype 1 Subjects......http://clinicaltrials.gov/ct2/sh ... erm=gs-5885&rank=1


9 & Soon 11 New HCV Drugs in Phase 3

Interferon-Free 12-Week 3-4 Drug Oral Regimen Studies, 95-100% SVR Rates, Results Presented in Nov 2012 at liver conference AASLD......

AASLD: EFFICACY AND SAFETY OF THE INTERFERON-FREE COMBINATION OF FALDAPREVIR (BI 201335) + BI 207127 ± RIBAVIRIN IN TREATMENT-NAIVE PATIENTS WITH HCV GT-1 AND COMPENSATED LIVER CIRRHOSIS: RESULTS FROM THE SOUND-C2 STUDY - (11/14/12)
AASLD: INTERFERON (IFN)-FREE COMBINATION TREATMENT WITH THE HCV NS3/4A PROTEASE INHIBITOR FALDAPREVIR (BI 201335) AND THE NON-NUCLEOSIDE NS5B INHIBITOR BI 207127 ± RIBAVIRIN: FINAL RESULTS OF SOUND-C2 AND PREDICTORS OF RESPONSE - (11/14/12)

AASLD: High Rate of Sustained Virologic Response With the All-Oral Combination of Daclatasvir (NS5A Inhibitor) Plus Sofosbuvir (Nucleotide NS5B Inhibitor), With or Without Ribavirin, in Treatment-Naive Patients Chronically Infected With HCV GT 1, 2, or 3 - (11/13/12) with 12 or 24 weeks 2-drug therapy 100% cure rates

AASLD: An Interferon-Free, Ribavirin-Free 12-Week Regimen of Daclatasvir (DCV), Asunaprevir (ASV), and BMS-791325 Yielded SVR4 of 94% in Treatment-Naïve Patients with Genotype (GT) 1 Chronic Hepatitis C Virus (HCV) Infection - (11/13/12)

AASLD: Once Daily Sofosbuvir (GS-7977) Regimens in HCV Genotype 1-3: The ELECTRON Trial - (11/14/12) 100% Cure rate: GS7977+GS5885
AASLD: GILEAD ANNOUNCES 100 PERCENT SUSTAINED VIROLOGIC RESPONSE RATE (SVR4) FOR AN INTERFERON-FREE REGIMEN OF SOFOSBUVIR (GS-7977), GS-5885 AND RIBAVIRIN IN TREATMENT-NAïVE GENOTYPE 1 HEPATITIS C INFECTED PATIENTS - (11/14/12) press release

AASLD: A 12-week Interferon-free Treatment Regimen With ABT-450/r, ABT 267, ABT-333, and Ribavirin Achieves SVR12 Rates (Observed Data) of 99% in Treatment-naïve Patients and 93% in Prior Null Responders With HCV Genotype 1 Infection - (11/13/12)

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New Protease by Roche who recently started the AnnaPurna Study which looks at 4-drug oral regimen IFN-free:
AASLD: Up to 100% SVR4 rates with ritonavir-boosted danoprevir (DNVr), mericitabine and ribavirin with or without peginterferon alfa-2a (40KD) in HCV genotype 1-infected partial and null responders: results from the MATTERHORN study - (11/13/12)
AASLD: Safety and efficacy of ritonavir-boosted danoprevir (DNVr), peginterferon alfa-2a (40KD), and ribavirin with or without mericitabine in HCV genotype 1-infected treatment-experienced patients with advanced hepatic fibrosis: the MATTERHORN study - (11/13/12)

ANNAPURNA: 3 & 4 Oral IFN-Free Roche HCV Regimens Studies, Treatment Naïve or Null Responders: setrobuvir+mericitabine+danoprevir/r+rbv. ANNAPURNA Study... - (09/4/12)

ANNAPURNA: A Study of The Combination of RO5466731 ...4 oral HCV drugs IFN-free in gt1a & 1b (NNRTI ANA598 + protease danoprevir/r + nuke mericitabine + RBV, study started in Spring 2012)

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NEW NUCLEOTIDE, the same class as drug as GS-7977, this is the only other drug in the same class. these are results from 7 day monotherapy study of this drug ALS2200 showing it is potent, the company Vertex just signed a deal with 2 other companies to begin IFN-free combo studies: with GSK & their NS5A & with Janssen & their new protease TMC435:
AASLD: ALS-2200, A Novel Once-daily Nucleotide HCV Polymerase Inhibitor, Demonstrates Potent Antiviral Activity Over 7 Days in Treatmentnaïve Genotype 1 (GT1) Patients - (11/13/12)

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Merck Will Initiate Interferon-Free Phase II Clinical Trials for MK-5172, an Investigational, Once-Daily, Oral Treatment for Chronic Hepatitis C Virus - (11/08/12)

MERCK is developing these 2 potent drugs, their 2nd generation NS5A & their 2nd generation protease - AASLD: Safety and Sustained Viral Response of MK-5172 for 12 Weeks in Combination With Pegylated Interferon Alfa-2b and Ribavirin for 24 Weeks in HCV Genotype 1 Treatment-Naive Noncirrhotic Patients   - (11/13/12)
AASLD: A Combination Containing MK-5172 (HCV NS3 protease inhibitor) and MK-8742 (HCV NS5A inhibitor) Demonstrates High Barrier to Resistance in HCV Replicon - (11/13/12)

作者: StephenW    时间: 2012-12-28 10:51

主题:NATAP:HCV IFN-免用治疗

IFN-免用治疗HCV /治疗方案

在第3阶段研究包括蛋白酶的新的TMC435,BI335,BMS032,NS5A BMS052,核苷酸GS7977,雅培IFN-自由组合的4种口服药物。罗氏公司,顶点和默克多口服药物治疗(见下文),在第2阶段。顶点最近宣布,在第2阶段3药物的口服药物:ALS2200,新的核苷酸像GS7977 +葛兰素史克(GSK)的NS5A +扬森蛋白酶TMC435目前现在在第3阶段。此外,新3期招聘:Sofosbuvir/GS-5885固定剂量复合制剂(FDC)+ /-利巴韦林治疗HCV ......多中心,随机,开放标签的安全性和有效性.... Sofosbuvir/GS-5885固定剂量复合制剂(FDC)的疗效和安全性+ /  - 利巴韦林12周和24周,在治疗初治慢性基因型1丙型肝炎病毒感染的主题......安全性和有效性Sofosbuvir / GS-5885固定剂量复合制剂(FDC)+ /  - 利巴韦林治疗丙型肝炎病毒...... http://clinicaltrials.gov/ct2/sh ... erm=gs-5885&rank=2


这项新研究是招聘:安全性和有效性Sofosbuvir/GS-5885固定剂量复合制剂(FDC)+ /-利巴韦林在丙型肝炎病毒基因型1第2阶段的主题..... ..... 8周或12周的治疗.. ......谁曾收到含有一种蛋白酶抑制剂,用于治疗丙型肝炎病毒..... Sofosbuvir/GS-5885固定剂量复合制剂(FDC)+ /-利巴韦林的安全性和有效性的治疗方案,在HCV基因型1主题...... http://clinicaltrials.gov/ct2/sh ... erm=gs-5885&rank=1


9&不久,11个新的HCV药物在第3阶段

免用干扰素12周3-4药物口服药物的研究,95%-100%的SVR率,结果在2012年11月在肝脏会议AASLD ......

AASLD:干扰素-,自由组合FALDAPREVIR(BI 201335)的有效性和安全性+ BI 207127±利巴韦林治疗初治患者HCV GT-1和补偿肝硬化:从的SOUND-C2研究的结果 - (11/14 / 12)
AASLD:干扰素(IFN)-自由组合治疗HCV NS3/4A蛋白酶抑制剂FALDAPREVIR(BI 201335)和非核苷NS5B抑制剂BI 207127±利巴韦林:FINAL OF SOUND-C2和响应的预测业绩 - (11/14 / 12)

AASLD:持续的病毒学应答率随着所有的口腔组合的Daclatasvir(NS5A抑制剂)加Sofosbuvir(核苷NS5B抑制剂),有或无利巴韦林,在治疗过的患者慢性感染HCV GT 1,2,或3  - (12年11月13日),12或24周的药物治疗100%的治愈率

在治疗过的患者的基因型(GT)慢性丙型肝炎病毒(AASLD产生干扰素,免费,的利巴韦林免费12周疗程:Daclatasvir(DCV)Asunaprevir的(ASV),BMS-791325 SVR4的94% HCV)感染 - (12年11月13日)

AASLD:每日Sofosbuvir(GS-7977)方案治​​疗丙型肝炎病毒基因型1-3:电子试验 - (12年11月14日)100%的治愈率:GS7977 GS5885
AASLD:GILEAD宣布养生SOFOSBUVIR(GS-7977),GS-5885和利巴韦林治疗初治基因1型丙型肝炎感染的患者干扰素-FREE 100%的持续病毒学应答率(SVR4) - (12年11月14日)新闻稿

AASLD:为期12周的干扰素治疗方案与ABT-450 / R,ABT 267 ABT-333,和利巴韦林在治疗过的患者达到SVR12价格(观测数据)的99%和93%在之前的空应答HCV基因1型感染 - (12年11月13日)

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新的蛋白酶由罗氏公司最近开始ANNAPURNA研究,着眼于4种药物口服药物IFN-
AASLD:高达100%SVR4率与利托那韦,提高danoprevir(DNVr),mericitabine和利巴韦林带或不带聚乙二醇干扰素α-2a(40KD)在HCV基因型1感染的局部和空应答:结果从马特宏峰研究 - (11 / 13/12)
AASLD:利托那韦,提高danoprevir(DNVr),聚乙二醇干扰素α-2a(40KD),和利巴韦林的安全性和有效性或没有mericitabine在HCV基因型1感染的治疗经验的患者与先进的肝纤维化的马特宏峰(Matterhorn)的研究 - (11 / 13/12)

ANNAPURNA:3&4次口服IFN-免费罗氏HCV治疗方案的研究,治疗的天真或空应答:setrobuvir + mericitabine + danoprevir / R +利巴韦林。 ANNAPURNA研究。 - (12年9月4日)

ANNAPURNA:A研究的结合RO5466731 4次口服丙型肝炎病毒药物IFN-在gt1a及1B(NNRTI ANA598 +蛋白酶danoprevir / R +核弹mericitabine + RBV,研究开始于2012年春季)

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新的核苷酸类药物,同样为GS-7977,这是唯一的在同一类的其他药物。这些结果是从7天的单一治疗研究这种药物ALS2200它是强有力的,该公司的顶点只是签署了一项协议,与其他2家公司开始IFN-自由组合研究:与葛兰素史克和他们的NS5A与Janssen新的蛋白酶TMC435:
AASLD:ALS-2200年,一种新的每日一次的核苷酸HCV聚合酶抑制剂,展示超过7天在Treatmentnaïve基因型1(GT1)患者的抗病毒活性 - (12年11月13日)

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默克公司将启动MK-5172-干扰素免费的II期临床试验,调查,每日一次,口服治疗慢性丙型肝炎 - (12年11月8日)

默克公司是这2种有效的药物,他们的第二代NS5A和他们的第二代蛋白酶 -  AASLD:安全和持续病毒应答的MK-5172 12周24周聚乙二醇干扰素α-2b和利巴韦林联合在HCV基因型1治疗初治肝硬化的患者 - (12年11月13日)
AASLD:含MK-5172(HCV NS3蛋白酶抑制剂)和MK-8742(HCV NS5A抑制剂)的结合演示高阻隔性丙型肝炎病毒复制子 - (12年11月13日)




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