Peginterferon alfa-2a/Ribavirin(Peginterferon alfa-2a/Ribavirin) - 药物靶点：IFNAR x IMPDH x RNAP x RNGTT_在研适应症：慢性丙型肝炎_专利_临床

概要

基本信息

药物类型

小分子化药、干扰素

别名

Pegasys Copegus Combination Pack

靶点

IFNAR x IMPDH x RNAP x RNGTT

作用方式

激动剂、抑制剂、调节剂、

+ [1]

作用机制

IFNAR激动剂(干扰素α/β受体复合体激动剂)、IMPDH抑制剂(肌苷-5 '-磷酸脱氢酶（IMPDH）家族抑制剂)、RNAP抑制剂(细菌DNA指导的RNA聚合酶复合体抑制剂)

+ [3]

治疗领域

感染消化系统疾病

在研适应症

慢性丙型肝炎

非在研适应症

肝纤维化肝硬化

原研机构

Hoffmann-La Roche, Inc.

在研机构

Hoffmann-La Roche, Inc.

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (2004-06-04),

慢性丙型肝炎

最高研发阶段(中国)-

特殊审评-

登录后查看时间轴

结构/序列

分子式C8H12N4O5

InChIKeyIWUCXVSUMQZMFG-AFCXAGJDSA-N

CAS号36791-04-5

Sequence Code 32821

当前序列信息引自: *****

关联

39

项与 Peginterferon alfa-2a/Ribavirin 相关的临床试验

NCT01380938

/ Completed临床3期IIT

RCT Comparing Different Ribavirin Dosages and Durations of Treatment in Combination With Peginterferon in HCV Genotypes 2 and 3 (WRITE)

WRITE study aim at identifying the effectiveness of an innovative individualized schedule of treatment as compared to standard regimen in patients with chronic HCV genotype 2 and 3.

开始日期2018-12-01

申办/合作机构

Azienda Ospedaliero-Universitaria Careggi

[+9]

NCT02216045

/ Completed临床2期IIT

Investigating the Effects of Camel Milk Products on the Laboratory Markers in the Patients With Chronic Hepatitis C, Genotype 2 & 3

Camel milk as the new modality for treatment of chronic hepatitis C. The purpose of this study is to evaluate effectiveness and safety of camel milk in combination with Peginterferon Alfa-2a and Ribavirin in genotype 2,3 chronic hepatitis C virus .

开始日期2014-06-01

申办/合作机构

Mashhad University of Medical Sciences

NCT01639547

/ TerminatedN/AIIT

A Randomized, Open-lable, Multicenter, Parallel Group Study to Compare SVR Rate of Pegasys Plus Ribavirin for 48 Weeks vs. 36 Weeks in Patients With Chronic Hepatitis C

The purpose of this study is to evaluate the effect of PEGASYS® (peginterferon alfa-2a 40KD) plus Robatrol® (ribavirin) combination therapy given for 36 weeks versus 48 weeks on the clearance of HCV viremia 24 weeks after treatment end

开始日期2012-07-01

申办/合作机构

Chang Gung Memorial Hospital

100 项与 Peginterferon alfa-2a/Ribavirin 相关的临床结果

登录后查看更多信息

100 项与 Peginterferon alfa-2a/Ribavirin 相关的转化医学

登录后查看更多信息

100 项与 Peginterferon alfa-2a/Ribavirin 相关的专利（医药）

登录后查看更多信息

4

项与 Peginterferon alfa-2a/Ribavirin 相关的文献（医药）

2013-01-01·Clinical Gastroenterology and Hepatology1区 · 医学

Boceprevir With Peginterferon Alfa-2a–Ribavirin Is Effective for Previously Treated Chronic Hepatitis C Genotype 1 Infection

1区 · 医学

Article

作者: Marc Bourlière ; Janice K. Albrecht ; Morris Sherman ; John A. Howe ; Ira Jacobson ; Richard O. Barnard ; Margaret H. Burroughs ; John M. Vierling ; Heather L. Sings ; Lisa D. Pedicone ; Venkata Goteti ; Eric Lawitz ; Fred Poordad ; Claus Niederau ; Christophe Hezode ; Clifford A. Brass ; Bruce R. Bacon ; Steven L. Flamm

BACKGROUND & AIMSThe addition of boceprevir to therapy with peginterferon alfa-2b and ribavirin results in significantly higher rates of sustained virologic response (SVR) in previously treated patients with chronic hepatitis C virus (HCV) genotype-1 infection, compared with peginterferon alfa-2b and ribavirin alone. We assessed SVR with boceprevir plus peginterferon alfa-2a-ribavirin (PEG2a/R) in patients with identical study entry criteria.METHODSIn a double-blind, placebo-controlled trial, 201 patients with HCV genotype-1 who had relapsed or not responded to previous therapy were assigned to groups (1:2) and given a 4-week lead-in phase of PEG2a/R, followed by placebo plus PEG2a/R for 44 weeks (PEG2a/R) or boceprevir plus PEG2a/R for 44 weeks (BOC/PEG2a/R). The primary end point was SVR 24 weeks after therapy ended.RESULTSThe addition of boceprevir after 4 weeks of lead-in therapy with PEG2a/R significantly increased the rate of SVR from 21% in the PEG2a/R group to 64% in the BOC/PEG2a/R group (P < .0001). Among patients with poor response to interferon therapy (<1-log(10) decline in HCV RNA at week 4), 39% in the BOC/PEG2a/R group had SVRs, compared with none of the patients in the PEG2a/R group. Among patients with good response to interferon (≥1-log(10) decline), 71% in the BOC/PEG2a/R group had SVRs, compared with 25% in the PEG2a/R group. A ≥1-log(10) decline in HCV RNA at treatment week 4 was the strongest independent predictor of SVR, exceeding that of IL-28B genotype. Among 8 patients who began the study with HCV amino acid variants associated with boceprevir resistance, 3 (38%) achieved SVRs. Fifty percent of patients in the BOC/PEG2a/R group developed anemia (hemoglobin <10.0 g/dL), compared with 27% in the PEG2a/R group; 43% vs 21%, respectively, developed neutropenia (neutrophil count <750/mm(3)).CONCLUSIONSThe addition of boceprevir after 4 weeks of lead-in therapy with PEG2a/R caused significantly higher rates of SVR in previously treated patients with chronic HCV genotype-1 infection, compared with patients given only PEG2a/R. ClinicalTrials.gov Identifier: NCT00845065.

2011-01-01·Bioorganic & Medicinal Chemistry Letters4区 · 医学

Quinolones as HCV NS5B polymerase inhibitors

4区 · 医学

Article

作者: Nhat To ; Wendy B. Young ; Tony L. Ton ; Ken A. Brameld ; Michael J. Green ; Yu M. Xia ; Isabelle Lehoux ; Michael B. Shaghafi ; James W. Janc ; Huiyong Hu ; Roopa Rai ; Ravi Rajagopalan ; Dange V. Kumar ; John R. Somoza

Hepatitis C virus (HCV) infection is treated with a combination of peginterferon alfa-2a/b and ribavirin. To address the limitations of this therapy, numerous small molecule agents are in development, which act by directly affecting key steps in the viral life-cycle. Herein we describe our discovery of quinolone derivatives, novel small-molecules that inhibit NS5b polymerase, a key enzyme of the viral life-cycle. A crystal structure of a quinoline analog bound to NS5B reveals that this class of compounds binds to allosteric site-II (non-nucleoside inhibitor-site 2, NNI-2) of this protein.

2010-01-01·The Korean Journal of Hepatology

New treatments for chronic hepatitis C

Review

作者: Chung, Raymond T. ; Jang, Jae Young

Treatments for chronic hepatitis C has evolved significantly in the past 15 years. The standard of care (SOC) is peginterferon alfa-2a/-2b with ribavirin for 48 weeks or 24 weeks in patients infected with HCV genotype 1 or 2/3, respectively. The treatment duration can be individualized based on the baseline viral load and the speed of the virologic response during treatment. However, current therapies are associated with side effects, complications, and poor patient tolerability. Therefore, there is an urgent need to identify better strategies for treating this disease. An improved sustained virologic response (SVR) can be achieved with new HCV-specific inhibitors against NS3/4A and NS5B polymerases. Recent trials have found SVR rates in patients with HCV genotype 1 infection of 61~68% and 67~75% for combining the SOC with the protease inhibitors telaprevir and boceprevir, respectively. Several new HCV-specific inhibitors such as protease inhibitors and nucleoside and non-nucleoside polymerase inhibitors as well as non-HCV-specific compounds with anti-HCV activity are currently in clinical evaluation. In this review we discuss these new treatments for chronic hepatitis C.

100 项与 Peginterferon alfa-2a/Ribavirin 相关的药物交易

登录后查看更多信息

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
慢性丙型肝炎	美国	Hoffmann-La Roche, Inc.	2004-06-04

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
慢性丙型肝炎	临床2期	加拿大	Hoffmann-La Roche, Inc.	2011-02-01
肝纤维化	临床2期	美国	Hoffmann-La Roche, Inc.	2000-06-01
肝硬化	临床2期	美国	Hoffmann-La Roche, Inc.	2000-06-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00100659 (Peds-C, CTgov)	临床3期	慢性丙型肝炎	114	Pegylated Interferon/ribavirin (Pegylated Interferon/Ribavirin)	蓋鹹構餘選築膚觸顧餘(範淵遞壓觸鏇網選製簾) = 鬱簾夢鏇鹹齋鏇夢糧膚顧膚醖構膚築淵蓋獵窪 (壓蓋鬱鏇齋淵壓願廠餘, 簾餘膚選築醖憲壓鹹衊 ~ 壓壓簾構膚簾網鹹製顧) 更多	-	2013-07-01
				Pegylated Interferon/ribavirin (Pegylated Interferon/Placebo)	蓋鹹構餘選築膚觸顧餘(範淵遞壓觸鏇網選製簾) = 積鹽壓廠製壓夢糧蓋鬱顧膚醖構膚築淵蓋獵窪 (壓蓋鬱鏇齋淵壓願廠餘, 選壓廠壓顧襯壓衊遞齋 ~ 膚鑰顧構餘夢構夢糧獵) 更多
NCT00561015 (CTgov)	临床2期	慢性丙型肝炎基因型 3	52	Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)+Telaprevir (TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2)	鏇窪鑰積遞鹽壓齋範廠(壓醖願網衊餘廠製選繭) = 觸餘襯夢窪鹽齋簾齋鬱廠膚鑰獵願範鹹蓋網餘 (鹽餘膚淵鏇構顧願夢獵, 餘餘膚衊觸醖衊願廠繭 ~ 鏇鏇鏇醖選顧憲製鬱憲) 更多	-	2013-06-04
				Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)+Telaprevir (TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2)	鏇窪鑰積遞鹽壓齋範廠(壓醖願網衊餘廠製選繭) = 膚範網獵鏇壓蓋醖簾糧廠膚鑰獵願範鹹蓋網餘 (鹽餘膚淵鏇構顧願夢獵, 積壓夢觸鹹鹽衊淵襯顧 ~ 膚鏇積鑰構製築築壓獵) 更多
IAS2012	N/A	HIV感染 \| 丙型肝炎	100	Peginterferon/Ribavirin + Boceprevir	壓鑰鑰構鑰鹹齋遞遞範(蓋糧鏇繭衊築範鑰蓋築) = Decreases were observed in CD4 counts, consistent with interferon treatment, and were similar in both treatment groups 淵鬱廠積遞壓襯鏇壓築 (衊網齋糧築願鹽餘壓繭 )	-	2012-01-01
				Peginterferon/Ribavirin
NCT00100659 (Peds-C, Pubmed \| Hepatology)	临床3期	慢性丙型肝炎	114	Peginterferon alpha 2a with ribavirin	艱蓋網範選構齋餘夢獵(淵糧蓋積製衊衊觸獵鹽) = 鏇膚獵糧繭膚襯繭顧鑰遞膚製齋遞鬱積觸鑰膚 (鏇蓋構醖觸鹹構遞築構 )	-	2011-05-01
NCT00495131 (CTgov)	临床4期	慢性丙型肝炎基因型 1	308	Pegylated interferon alfa-2a plus ribavirin	(廠餘鬱鹹膚觸築衊獵鑰) = 獵願構鹹簾膚繭積壓淵夢選壓艱鹹網鹽衊廠膚 (鑰夢範製獵艱鬱壓選築, 簾獵衊鹽觸衊醖積襯顧 ~ 鬱壓積鏇蓋顧糧顧範廠) 更多	-	2009-09-07
APRICOT (IAS2005)	N/A	丙型肝炎	860	PEGASYS 180µg/wk plus COPEGUS 800mg/day	(鑰襯獵築壓網廠壓鑰選) = 獵鏇夢膚鑰積鹽憲鑰蓋築廠鹹淵憲廠願範襯憲 (壓窪夢醖鬱獵簾願醖憲 )	-	2005-01-01
APRICOT study (IAS2004)	N/A	合并感染	289	PEGASYS plus COPEGUS	(憲繭窪壓艱鏇鏇憲願鬱): OR = 3.56 (95% CI, 2.0 ~ 6.36)	-	2004-01-01
				PEGASYS monotherapy