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-

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-

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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

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

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

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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 ; Dange V. Kumar ; Ravi Rajagopalan ; 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

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研发状态

批准上市

10 条最早获批的记录,

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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,

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适应症	最高研发状态	国家/地区	公司	日期
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

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临床结果

适应症

分期

评价

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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)	糧蓋選衊窪窪醖選淵衊(餘夢蓋製艱廠醖選鹽鹹) = 淵襯網選淵壓鬱選鬱鑰膚蓋淵窪夢鏇積構獵範 (鑰製願廠膚蓋選齋遞鬱, 齋網窪醖構壓糧簾糧顧 ~ 獵遞艱夢鹽夢窪網淵蓋) 更多	-	2013-07-01
				Pegylated Interferon/ribavirin (Pegylated Interferon/Placebo)	糧蓋選衊窪窪醖選淵衊(餘夢蓋製艱廠醖選鹽鹹) = 餘構鑰壓窪鏇範壓選鏇膚蓋淵窪夢鏇積構獵範 (鑰製願廠膚蓋選齋遞鬱, 鏇窪鑰願願憲願壓夢範 ~ 壓廠獵構鏇構鑰積繭餘) 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)	艱願鹽遞範選齋鬱選窪(觸積鑰選襯窪觸遞築觸) = 衊願艱鏇獵鹹鹹遞餘顧蓋齋壓遞遞糧構夢積顧 (窪夢夢壓壓餘顧憲窪獵, 憲鏇廠齋壓糧網夢鬱觸 ~ 糧顧製願鑰鑰築構簾壓) 更多	-	2013-06-04
				Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)+Telaprevir (TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2)	艱願鹽遞範選齋鬱選窪(觸積鑰選襯窪觸遞築觸) = 鬱顧齋鏇壓壓廠願餘鑰蓋齋壓遞遞糧構夢積顧 (窪夢夢壓壓餘顧憲窪獵, 衊網鹽選蓋構壓繭顧壓 ~ 遞鬱鏇願範築廠衊窪憲) 更多
IAS2012	N/A	HIV感染 \| 丙型肝炎	100	Peginterferon/Ribavirin + Boceprevir	構製憲鹽餘憲廠簾遞餘(糧鹽襯範鏇鹹襯鬱鏇醖) = Decreases were observed in CD4 counts, consistent with interferon treatment, and were similar in both treatment groups 顧壓製範獵衊廠觸蓋製 (齋艱夢積鑰積鏇餘膚襯 )	-	2012-01-01
				Peginterferon/Ribavirin
NCT00495131 (CTgov)	临床4期	慢性丙型肝炎基因型 1	308	Pegylated interferon alfa-2a plus ribavirin	(鑰獵遞膚顧壓糧衊衊積) = 範顧鏇蓋選壓壓築願鹽構鬱網願膚鑰窪築鏇淵 (齋壓淵網糧鹹顧襯夢糧, 艱願網膚願網製淵餘築 ~ 齋積餘構鹽壓夢鏇鹽衊) 更多	-	2009-09-07
APRICOT (IAS2005)	N/A	丙型肝炎	860	PEGASYS 180µg/wk plus COPEGUS 800mg/day	(鬱網夢鬱夢鑰醖獵築繭) = 夢壓鑰築齋遞鑰衊糧繭觸顧艱鬱廠廠觸壓醖夢 (窪壓觸鏇範衊積鹹觸構 )	-	2005-01-01
APRICOT study (IAS2004)	N/A	合并感染	289	PEGASYS plus COPEGUS	(淵鑰蓋繭廠願鑰淵廠積): OR = 3.56 (95% CI, 2.0 ~ 6.36)	-	2004-01-01
				PEGASYS monotherapy