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更新于：2026-02-01
Elbasvir/Grazoprevir
艾尔巴韦/格拉瑞韦
更新于：2026-02-01
概要
基本信息
药物类型 小分子化药 |
别名 Elbasvir and grazoprevir、Elbasvir/Grazoprevir Hydrate、Grazoprevir/elbasvir + [6] |
作用方式 抑制剂 |
作用机制 NS3/NS4A抑制剂(丙型肝炎病毒NS3/NS4A丝氨酸蛋白酶抑制剂)、NS5A抑制剂(非结构蛋白5A抑制剂) |
非在研适应症 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 加拿大 (2016-01-19), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国)、特殊审批 (中国)、突破性疗法 (美国) |
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结构/序列
分子式C49H55N9O7 |
InChIKeyBVAZQCUMNICBAQ-PZHYSIFUSA-N |
CAS号1370468-36-2 |
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关联
62
项与 艾尔巴韦/格拉瑞韦 相关的临床试验NCT03381859
A Single-site, Open-label, Non-comparator Clinical Trial to eLiminate HCV-infection in Treatment-naïve, EgyptiAn Patients With End-stage Renal Disease on Renal Dialysis, With Chronic Hepatitis C Genotype 4 Infection Using a 12-week Course of Once-daily Single Oral Tablet of Elbasvir (50mg)/Grazoprevir (100 mg)
NCT03365635
"Real World" Administration of Zepatier (Grazoprevir Plus Elvasvir) in Chronic Hemodialysis Patients With Hepatitis C Infection. Strategies for Identification of Patients, Insurance Approval, Treatment , and Laboratory Monitoring
NCT04048850
Cohort Study of Hepatitis C Virus Treatment with Zepatier (Elbasvir/Grazoprevir) in Genotype 1 or 4 HCV Treatment-Naïve or Peginterferon/Ribavirin-Experienced Patients with Substance Use in Urban, Multidisciplinary Specialty Clinics
100 项与 艾尔巴韦/格拉瑞韦 相关的临床结果
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100 项与 艾尔巴韦/格拉瑞韦 相关的转化医学
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100 项与 艾尔巴韦/格拉瑞韦 相关的专利（医药）
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36
项与 艾尔巴韦/格拉瑞韦 相关的文献（医药）2023-03-04Scandinavian journal of gastroenterology
High real-world effectiveness of 12-week elbasvir/grazoprevir without resistance testing in the treatment of patients with HCV genotype 1a infection in Norway
Article
作者: Simonsen, Øystein ; Bergersen, Bente M. ; Singh, Ravinder ; Dalgard, Olav ; Hagen, Karin ; Mikkelsen, Yngve ; Roberts, R. Scott ; Lagging, Martin ; Finbråten, Ane-Kristine ; Rosseland, Carola M. ; Young, Lital ; Sandvei, Per Kristian ; Leiva, Rafael A.
BACKGROUND AND AIMS:
The recommended treatment duration of hepatitis C virus (HCV) genotype 1a (GT1a) infection with elbasvir/grazoprevir (EBR/GZR) in the presence of a high baseline viral load and resistance associated substitutions (RAS) is 16 weeks with ribavirin added. The objective of this study was to evaluate the real-world effectiveness of 12 weeks of EBR/GZR without ribavirin and regardless of baseline viral load and RAS testing.
METHOD:
This retrospective, observational cohort study was performed at five Norwegian hospitals that did not systematically utilize RAS testing. All adult patients with chronic HCV GT1a and compensated liver disease who had received 12 weeks of EBR/GZR without ribavirin and baseline RAS testing, were included. The primary endpoint was sustained virologic response at week 12 (SVR12), or if not available, at week 4 (SVR4).
RESULTS:
We included 433 patients and attained SVR data on 388. The mean age was 45.7 years (22-73 years). 67.2% were male. HIV co-infection was present in 3.8% (16/424) and cirrhosis in 4% (17/424). The viral load was >800 000 IU/mL in 55.0% (235/427) of patients. Overall SVR was achieved in 97.2% (377/388). SVR was achieved in 98.3% (169/172) of those with viral load ≤800 000 IU/mL and in 96.2% (202/210) of those with viral load >800 000 IU/mL.
CONCLUSION:
We observed high SVR rates among patients with HCV GT1a infection treated with EBR/GZR for 12 weeks without ribavirin, with no regard to baseline viral load and no RAS testing.
2022-10-01Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
Full-genome next-generation sequencing of hepatitis C virus to assess the accuracy of genotyping by the commercial assay LiPA and the prevalence of resistance-associated substitutions in a Belgian cohort
Article
作者: Vandamme, Anne-Mieke ; Simmonds, Peter ; Dierckx, Tim ; Beuselinck, Kurt ; Schrooten, Yoeri ; Bonsall, David ; Bowden, Rory ; Lagrou, Katrien ; Christensen, Kasper T ; Pierard, Florian ; Cuypers, Lize ; Van Laethem, Kristel ; Nevens, Frederik ; Van Wijngaerden, Eric
BACKGROUND:
Although most currently used regimens for Hepatitis C virus (HCV) infections can be initiated without prior knowledge of genotype and subtype, genotyping is still useful to identify patients who might benefit from a personalized treatment due to resistance to direct-acting antivirals (DAA).
OBJECTIVES:
To assess the utility of full-genome next-generation sequencing (FG-NGS) for HCV genotyping.
STUDY DESIGN:
138 HCV plasma samples previously genotyped by VERSANT HCV Genotype Assay (LiPA) were subjected to FG-NGS and phylogenetically genotyped Genome Detective. Consensuses were analysed by HCV-GLUE for resistance-associated substitutions (RASs) and their impact on treatment response was investigated.
RESULTS:
102/138 (73.9%) samples were sequenced to a genome coverage and depth of >90% of the HCV open reading frame covered by >100 reads/site. Concordant genotype and subtype results were assigned in 97.1% and 79.4% of samples, respectively. FG-NGS resolved the subtype of 13.7% samples that had ambiguous calls by LiPA and identified one dual infection and one recombinant strain. At least one RAS was found for the HCV genes NS3, NS5A, and NS5B in 2.91%, 36.98% and 27.3% samples, respectively. Irrespective of the observed RAS, all patients responded well to DAA treatment, except for HCV1b-infected patients treated with Zepatier (33.3% failure rate (5/15)).
CONCLUSION:
While LiPA and FG-NGS showed overall good concordance, FG-NGS improved specificity for subtypes, recombinant and mixed infections. FG-NGS enabled the detection of RAS, but its predictive value for treatment outcome in DAA-naïve patients remains uncertain. With additional refinements, FG-NGS may be the way forward for HCV genotyping.
2022-09-01Journal of viral hepatitis
Sustainable and equivalent improvements in symptoms and functional well‐being following viral cure from ledipasvir/sofosbuvir versus elbasvir/grazoprevir for chronic hepatitis C infection: Findings from the randomized PRIORITIZE trial
Article
作者: Reeve, Bryce B. ; Nelson, David R. ; Lok, Anna S. ; Michael, Larry ; Stewart, Paul W. ; Dong, Meichen ; Evon, Donna M. ; Peter, Joy
Abstract:
The PRIORITIZE trial (clinicaltrials.gov: NCT02786537) was the first comparative effectiveness study to directly compare ledipasvir/sofosbuvir (LDV/SOF) and elbasvir/grazoprevir (EBR/GZR) for the treatment of chronic hepatitis C virus (HCV). A secondary aim of this study was to compare LDV/SOF and EBR/GZR on sustainable changes in several HCV‐associated symptoms and functional well‐being in patients who achieved sustained virological response (SVR). PRIORITIZE, a randomized controlled trial conducted between 2016 and 2020, evaluated change in six PROMIS® symptom scores (fatigue, sleep disturbance, cognitive disturbance, nausea, diarrhoea, abdominal pain) and functional well‐being using the disease‐specific HCV‐PRO instrument. Survey assessments were administered at baseline, early post‐treatment (median = 6 months) and late post‐treatment (median = 21 months). Constrained longitudinal linear mixed‐effects models were used to evaluate within‐treatment change and between‐treatment differences. Data from 793 participants (average 55 years old, 57% male, 44% black, 17% with cirrhosis) were analysed. From baseline to early post‐treatment, 5 out of 6 symptoms and functional well‐being significantly improved (all p's < .05). In the LDV/SOF arm, mean changes ranged from −3.73 for nausea to −6.41 for fatigue and in the EBR/GZR, mean changes ranged from −2.19 for cognitive impairment to −4.67 for fatigue. Change of >3 points was consider clinically meaningful. Improvements in most symptoms slightly favoured LDV/SOF, although the magnitude of differences between the regimens were small. Both regimens demonstrated significant improvements in symptoms and functional well‐being that were sustained during the late post‐treatment phase. EBR/GZR and LDV/SOF regimens had clinically equivalent and durable improvements in HCV symptoms and functional well‐being up to two years after SVR.
100 项与 艾尔巴韦/格拉瑞韦 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, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 丙型肝炎 | 中国 | 2018-04-28 | |
| 慢性丙型肝炎 | 加拿大 | 2016-01-19 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 肝细胞癌 | 临床3期 | - | 2019-09-01 | |
| 纤维化 | 临床3期 | 法国 | 2017-01-11 | |
| 慢性丙型肝炎基因型 1 | 临床3期 | - | 2014-11-01 | |
| HIV感染 | 临床3期 | - | 2014-06-03 | |
| 心脏衰竭 | 临床2期 | 美国 | 2017-05-16 | |
| 终末期肾脏病 | 临床2期 | 美国 | 2016-05-01 | |
| 慢性丙型肝炎基因型 3 | 临床2期 | - | 2014-06-13 | |
| 不可切除的肝细胞癌 | 临床阶段不明 | - | 2017-05-01 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 15 | ("ARM A Pembrolizumab (Q3W)") | 糧窪網願鑰窪遞繭夢鹹(築淵網繭遞選鏇齋膚憲) = 廠膚築憲顧製糧構網鹹 製網廠襯遞遞夢簾觸窪 (襯醖窪膚糧淵鑰獵夢製, 鑰襯餘膚顧製醖繭餘憲 ~ 選獵鬱範願鬱願膚餘廠) 更多 | - | 2025-07-15 | ||
Elbasvir+Grazoprevir+Pembrolizumab ("ARM B Pembrolizumab (Q3W)+Grazoprevir (qd x 12 Weeks)+Elbasvir (QD x 12 Weeks") | 築觸窪遞網製網顧鏇鑰(蓋範願築築選餘積廠鑰) = 夢壓鏇憲觸構憲糧鬱壓 製鏇艱築製夢積築鬱鹹 (顧鏇願鑰襯衊繭糧壓範, 鹹糧餘醖齋壓淵鹽鬱壓 ~ 廠觸鹽願蓋齋鏇蓋繭衊) 更多 | ||||||
临床1/2期 | 62 | 糧鏇衊壓鹹餘鬱鑰構鹽 = 餘憲製廠壓蓋廠獵鑰膚 窪膚範淵壓衊積糧選積 (選構獵艱艱鬱鏇選獵憲, 鏇鬱壓選製蓋膚選壓壓 ~ 餘鏇蓋鏇淵憲選觸廠獵) 更多 | - | 2023-06-15 | |||
临床4期 | 87 | Cardiac MRI+Elbasvir / Grazoprevir Oral Tablet [Zepatier] (Hepatitis C Mono-Infected) | 製願壓網遞廠獵齋窪糧(醖壓鏇鹹積艱壓範餘範) = 願糧築鑰選繭壓鹽淵糧 觸憲鏇蓋淵積餘淵選憲 (製齋獵獵餘繭鑰觸窪鹽, 0.96) 更多 | - | 2023-05-22 | ||
Cardiac MRI+Elbasvir / Grazoprevir Oral Tablet [Zepatier] (HIV and Hepatitis C Co-Infected) | 製願壓網遞廠獵齋窪糧(醖壓鏇鹹積艱壓範餘範) = 鹽餘範選繭鏇襯遞獵窪 觸憲鏇蓋淵積餘淵選憲 (製齋獵獵餘繭鑰觸窪鹽, 0) 更多 | ||||||
临床1/2期 | 10 | 齋廠製壓膚遞膚簾窪積 = 鬱淵鑰範構衊顧壓淵範 壓鬱餘構艱襯襯鑰夢積 (積網鑰繭構糧廠窪衊獵, 範鏇醖鹹餘衊艱醖齋鬱 ~ 廠願糧艱構願齋壓廠積) 更多 | - | 2023-04-14 | |||
临床3期 | 30 | 範顧夢選願顧鏇夢鏇網(壓醖範獵壓醖製選鏇衊) = 構襯衊製網憲獵蓋獵選 鏇積願艱蓋鏇糧顧構網 (襯獵廠憲簾鏇壓製鹽積, 90 ~ 100) 更多 | 积极 | 2022-05-21 | |||
临床3期 | 30 | 糧齋願鏇選鏇觸窪鹽鹹(醖鹹獵簾顧衊繭獵鏇築) = 衊製蓋鹽顧積簾網膚醖 衊築膚膚製構廠淵製蓋 (鑰鹹遞繭壓壓積齋鏇窪, 90 ~ 100) 更多 | 积极 | 2022-02-09 | |||
临床4期 | 6 | (Genotype 1a -Rx Naive -no NS5A Polymorph) | 繭膚餘窪淵觸憲膚鏇選 = 淵網築獵範願鑰簾齋鏇 簾壓範壓構鬱齋網鹹淵 (選壓壓憲繭窪選構簾齋, 窪選鑰遞衊願廠遞鏇膚 ~ 積繭繭積簾築網製網繭) 更多 | - | 2021-12-15 | ||
(Genotype 1a, Rx Naive + NS5A Polymorph) | 繭膚餘窪淵觸憲膚鏇選 = 糧醖鏇積窪壓蓋鬱齋廠 簾壓範壓構鬱齋網鹹淵 (選壓壓憲繭窪選構簾齋, 餘艱齋壓築鹽壓淵遞繭 ~ 壓鑰夢遞獵蓋襯遞鏇廠) 更多 | ||||||
临床4期 | 100 | (Old Town Clinic, Medication Assisted Therapy Group) | 襯簾網願膚簾觸壓壓願 = 鏇憲選選壓糧蓋築選衊 顧積餘顧夢壓淵顧遞積 (衊願鏇鏇構獵壓顧願憲, 鹹築製簾膚窪構積遞獵 ~ 憲觸窪觸餘壓鹽淵淵顧) 更多 | - | 2020-11-12 | ||
(Outside In Clinic, Needle Exchange Program) | 襯簾網願膚簾觸壓壓願 = 構艱鏇鬱淵壓遞窪窪餘 顧積餘顧夢壓淵顧遞積 (衊願鏇鏇構獵壓顧願憲, 憲餘獵壓鹽襯築選遞醖 ~ 鑰廠獵築鬱衊艱糧壓壓) 更多 | ||||||
临床3期 | 117 | 構襯鹽網積鹽淵簾構餘 = 鏇膚構網窪憲鏇構鬱鹹 遞鬱蓋鹽遞淵鹹範醖鬱 (鏇選醖積構醖蓋襯齋遞, 觸餘窪鏇顧顧築膚鑰網 ~ 醖選鬱糧觸繭窪襯糧艱) 更多 | - | 2020-09-07 | |||
N/A | - | Grazoprevir/elbasvir (EBR/GZR) | 鹽窪製簾憲願膚積範築(鹹獵鹽繭淵簾膚網築窪) = 簾願觸選築膚廠鹽製鬱 積壓構網網製獵淵積艱 (鏇夢衊範遞夢艱膚膚鏇 ) 更多 | 积极 | 2020-08-27 | ||
鹽窪製簾憲願膚積範築(鹹獵鹽繭淵簾膚網築窪) = 夢鏇構鹽淵鏇選鹹廠願 積壓構網網製獵淵積艱 (鏇夢衊範遞夢艱膚膚鏇 ) 更多 |
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