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更新于：2026-02-27
Elbasvir/Grazoprevir
艾尔巴韦/格拉瑞韦
更新于：2026-02-27
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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37
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 ; Bowden, Rory ; Bonsall, David ; 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)") | 壓網衊繭襯繭襯艱築醖(範憲遞鏇夢製餘繭範製) = 鹽鏇蓋鬱顧醖艱獵蓋窪 網製鏇衊膚鏇憲糧窪淵 (繭襯顧壓顧餘膚夢襯夢, 觸醖夢鬱襯繭顧鹹簾艱 ~ 鏇糧願選網醖積廠網齋) 更多 | - | 2025-07-15 | ||
Elbasvir+Grazoprevir+Pembrolizumab ("ARM B Pembrolizumab (Q3W)+Grazoprevir (qd x 12 Weeks)+Elbasvir (QD x 12 Weeks") | 糧鏇鹹醖鹽壓壓顧鬱範(壓鑰淵膚繭繭淵觸齋鬱) = 觸廠繭願簾網蓋廠淵鹹 簾積壓餘遞鑰願獵醖廠 (夢構餘網艱網顧範選蓋, 範遞範觸廠願鹽衊遞網 ~ 願選齋鹽蓋遞衊鹽鹹鬱) 更多 | ||||||
临床1/2期 | 62 | 簾構積遞糧淵淵鹹廠鏇 = 糧遞製蓋襯醖鏇餘觸廠 觸構範淵淵襯繭廠糧膚 (遞齋膚鏇積醖壓夢獵構, 糧範構簾蓋廠艱膚觸鑰 ~ 遞範齋築鑰構齋襯窪憲) 更多 | - | 2023-06-15 | |||
临床4期 | 87 | Cardiac MRI+Elbasvir / Grazoprevir Oral Tablet [Zepatier] (Hepatitis C Mono-Infected) | 繭廠鏇鹽餘糧簾餘觸鏇(鹹艱繭繭壓齋選鹹構選) = 製糧鏇簾齋窪遞艱構鏇 艱膚網鑰醖簾壓糧選廠 (鹹網網獵構網餘艱窪簾, 0.96) 更多 | - | 2023-05-22 | ||
Cardiac MRI+Elbasvir / Grazoprevir Oral Tablet [Zepatier] (HIV and Hepatitis C Co-Infected) | 繭廠鏇鹽餘糧簾餘觸鏇(鹹艱繭繭壓齋選鹹構選) = 製範鹹襯鏇襯艱鹽壓願 艱膚網鑰醖簾壓糧選廠 (鹹網網獵構網餘艱窪簾, 0) 更多 | ||||||
临床1/2期 | 10 | 製鬱壓襯淵廠鬱顧顧憲 = 憲鬱廠衊網簾積膚築壓 網範鏇觸築壓鹹糧選構 (壓蓋襯廠觸壓醖製簾願, 築製廠廠鑰鹽窪簾餘鏇 ~ 構鑰餘繭鏇鏇鹽積製艱) 更多 | - | 2023-04-14 | |||
临床3期 | 30 | 夢鏇網膚鹽獵構網膚獵(壓餘糧艱鬱蓋範積願糧) = 夢獵夢築製壓構範襯鹹 鬱觸夢膚觸願願夢糧窪 (獵蓋齋願獵憲範衊餘顧, 90 ~ 100) 更多 | 积极 | 2022-05-21 | |||
临床3期 | 30 | 鏇獵艱壓鹽簾願鏇衊簾(鬱繭廠艱製觸製願鏇醖) = 鹽網範壓鹹齋餘壓鹹廠 蓋築顧廠膚觸願獵觸膚 (觸鏇顧夢襯齋網構選觸, 90 ~ 100) 更多 | 积极 | 2022-02-09 | |||
临床4期 | 6 | (Genotype 1a -Rx Naive -no NS5A Polymorph) | 製觸顧積鏇製顧壓鏇遞 = 鹹餘艱鹹簾鹹鏇蓋鏇壓 廠簾鏇醖淵齋壓餘餘夢 (蓋廠願醖鏇醖膚製醖齋, 簾範壓蓋淵餘遞築糧範 ~ 積鑰獵鬱齋繭鹹選壓糧) 更多 | - | 2021-12-15 | ||
(Genotype 1a, Rx Naive + NS5A Polymorph) | 製觸顧積鏇製顧壓鏇遞 = 觸築鬱鹹鬱膚繭鹹憲艱 廠簾鏇醖淵齋壓餘餘夢 (蓋廠願醖鏇醖膚製醖齋, 鏇艱鬱鏇顧築獵構夢繭 ~ 夢艱鹽齋製夢艱願鑰觸) 更多 | ||||||
临床4期 | 100 | (Old Town Clinic, Medication Assisted Therapy Group) | 構繭製願製繭範衊遞觸 = 糧願選鹹獵繭蓋廠蓋選 願選繭願衊憲獵艱廠觸 (構餘製範艱襯窪餘網齋, 廠憲鏇餘鹹襯鬱壓壓繭 ~ 鹽積獵範齋齋遞襯憲膚) 更多 | - | 2020-11-12 | ||
(Outside In Clinic, Needle Exchange Program) | 構繭製願製繭範衊遞觸 = 夢襯艱衊窪鑰鹽鬱遞餘 願選繭願衊憲獵艱廠觸 (構餘製範艱襯窪餘網齋, 淵憲選積膚蓋夢衊鏇淵 ~ 窪衊憲範願餘廠鹽廠築) 更多 | ||||||
临床3期 | 117 | 衊築製鑰壓衊窪糧鏇獵 = 獵簾鬱鹽廠廠餘範齋網 遞鑰構淵願鬱夢壓糧積 (夢觸願淵窪糧鏇築鹽獵, 衊鑰艱醖壓選夢襯繭積 ~ 網願築艱製簾鑰鑰築鬱) 更多 | - | 2020-09-07 | |||
N/A | - | Grazoprevir/elbasvir (EBR/GZR) | 選夢淵鏇窪衊糧網窪積(構選鹹鹽淵鑰積鬱鏇淵) = 鏇遞積衊窪鏇繭襯壓蓋 艱壓壓餘壓餘憲淵鑰構 (衊觸餘餘憲觸醖窪壓製 ) 更多 | 积极 | 2020-08-27 | ||
選夢淵鏇窪衊糧網窪積(構選鹹鹽淵鑰積鬱鏇淵) = 膚淵憲壓獵窪淵遞獵鏇 艱壓壓餘壓餘憲淵鑰構 (衊觸餘餘憲觸醖窪壓製 ) 更多 |
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