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更新于：2026-02-27
Sofosbuvir/velpatasvir/voxilaprevi
索磷维伏
更新于：2026-02-27
概要
基本信息
药物类型 小分子化药 |
别名 Sofosbuvir, Velpatasvir and Voxilaprevir、索磷布韦/维帕他韦/伏西瑞韦、Vosevi + [2] |
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)、NS5B polymerase抑制剂(丙型肝炎病毒NS5B RNA依赖的RNA聚合酶抑制剂) |
非在研适应症 |
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 (2017-07-18), |
最高研发阶段(中国)批准上市 |
特殊审评临床急需境外新药 (中国) |
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结构/序列
分子式C49H54N8O8 |
InChIKeyFHCUMDQMBHQXKK-CDIODLITSA-N |
CAS号1377049-84-7 |
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关联
21
项与 索磷维伏 相关的临床试验NCT05717400
Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy
NCT06180590
A Prospective Cohort Study: the Efficacy of Vosevi in Treating Direct Antiviral Agent Therapy Failure Patients
NCT05467826
Efficacy and Safety of Sofosbuvir/Velpatasvir Plus Ribavirin for 12 Weeks or Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks in DAA Treatment Naïve HCV Subjects With GT3b, Compensated Cirrhosis in China
100 项与 索磷维伏 相关的临床结果
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100 项与 索磷维伏 相关的转化医学
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100 项与 索磷维伏 相关的专利（医药）
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10
项与 索磷维伏 相关的文献（医药）2023-08-01Journal of hepatology
A randomized-controlled trial of SOF/VEL/VOX with or without ribavirin for retreatment of chronic hepatitis C
Article
作者: Lee, Samuel S ; Emadeldeen, Mohammed ; Hassany, Mohamed ; Congly, Stephen E ; Liu, Hongqun ; El-Kassas, Mohamed ; Esmat, Gamal ; El-Raey, Fathiya ; Gomaa, Ahmed Ali
BACKGROUND & AIMS:
The combination of sofosbuvir, velpatasvir and voxilaprevir (SOF/VEL/VOX) is recommended for the retreatment of patients with HCV infection in whom previous direct-acting antiviral (DAA) treatment failed. However, whether ribavirin further increases the therapeutic efficacy of SOF/VEL/VOX retreatment remains unclear. We aimed to test this hypothesis in a randomized-controlled trial.
METHODS:
We randomly assigned 315 patients with DAA treatment failure from five Egyptian sites into two groups. Group A (n = 158) received SOF/VEL/VOX for 12 weeks, and group B (n = 157) received SOF/VEL/VOX + weight-based ribavirin for 12 weeks. Therapeutic efficacy was defined as SVR12 (sustained virologic response 12 weeks after treatment end). Safety and tolerability were evaluated by monitoring treatment-related adverse events (AEs) and laboratory abnormalities.
RESULTS:
Males comprised 53.9% of group A and 57.1% of group B (p = 0.58); mean ages were 51.8 and 47.3 years in group A and B, respectively. Seventeen patients in each group were lost to follow-up. SVR12 rates were 87.3% (138/158) by intention-to-treat analysis and 97.8% (138/141) by per-protocol analysis in group A; and 87.9% (138/157) and 98.5% (138/140), respectively, in group B (p = n.s. for intention-to-treat and per-protocol analyses). Both regimens were well-tolerated, with no deaths and only one serious AE (anemia) in group B, which required ribavirin discontinuation. Fifty-five patients in group A vs. 77 in group B experienced any AE (p = 0.002).
CONCLUSION:
This randomized-controlled trial showed equal, high efficacy of both regimens for the retreatment of previous DAA failures, although ribavirin was associated with more AEs. Therefore SOF/VEL/VOX monotherapy should be the preferred retreatment strategy. CLINCIALTRIALS.
GOV NUMBER:
NCT04695769.
IMPACT AND IMPLICATIONS:
HCV treatment guidelines recommend retreatment of direct-acting antiviral (DAA) treatment failures with the combination of sofosbuvir, velpatasvir and voxilaprevir (SOF/VEL/VOX) for 12 weeks. However, whether ribavirin exerts an additional/synergistic effect remains unclear. The present study confirmed that SOF/VEL/VOX without ribavirin is the best regimen for retreatment of DAA treatment failures, and thus will help guide clinicians caring for patients who are not cured with a first course of DAA therapy.
2022-06-01The lancet. Gastroenterology & hepatology1区 · 医学
Safety and efficacy of sofosbuvir–velpatasvir–voxilaprevir for re-treatment of chronic hepatitis C virus infection in patients with previous direct-acting antiviral treatment failure in Rwanda (SHARED-3): a single-arm trial
1区 · 医学
Article
作者: Grant, Philip M ; Serumondo, Janvier ; Manirambona, Linda ; Musabeyezu, Emmanuel ; Shumbusho, Fabienne ; Kateera, Fredrick ; Murangwa, Anthere ; Nsanzimana, Sabin ; Mukabatsinda, Constance ; Kabihizi, Jules ; Makuza, Jean Damascene ; Muvunyi, Claude Mambo ; Gupta, Neil ; Camus, Gregory
BACKGROUND:
Hepatitis C virus (HCV) genotype 4 non-a/d subtypes, which frequently have NS5A resistance-associated substitutions, are highly prevalent in sub-Saharan Africa. These subtypes, particularly genotype 4r, have been associated with higher rates of failure of treatment regimens containing the NS5A inhibitors ledipasvir or daclatasvir, which are the most accessible direct-acting antivirals in low-income countries. Clinical evidence regarding the efficacy of re-treatment options for these subtypes is limited. We aimed to evaluate the safety and efficacy of sofosbuvir-velpatasvir-voxilaprevir for the treatment of adults in Rwanda with chronic HCV infection, predominantly of genotype 4, and a history of direct-acting antiviral treatment failure.
METHODS:
In this single-arm prospective trial, we enrolled adults (aged ≥18 years) with a HCV RNA titre of at least 1000 IU/mL, and a documented history of direct-acting antiviral failure. Patients were assessed for eligibility at a single study site after referral from hospitals with HCV treatment programmes throughout Rwanda, and participants for whom sofosbuvir-ledipasvir treatment had failed in the previous SHARED trial were also included. Participants with decompensated liver disease or hepatitis B virus co-infection were excluded. Participants were treated once daily with an oral fixed-dose combination tablet containing sofosbuvir (400 mg), velpatasvir (100 mg), and voxilaprevir (100 mg) for 12 weeks. The primary endpoint was the proportion of participants with a sustained virological response 12 weeks after completion of treatment (SVR12) in the intention-to-treat population. Viral sequencing of NS3, NS5A, and NS5B genes was done at baseline in all participants and at end of follow-up (week 24) in participants with treatment failure. The study is registered with ClinicalTrials.gov (NCT03888729) and is completed.
FINDINGS:
Between Sept 23, 2019, and Jan 10, 2020, 49 individuals were screened and 40 participants were enrolled. 20 (50%) were female, 20 (50%) were male, median age was 63 years (IQR 56-68), and median HCV viral load was 6·2 log10 IU/mL (5·8-6·5) at baseline. The genotype subtypes identified were 4r (18 [45%] participants), 4k (six [15%]), 4b (five [13%]), 4q (four [10%]), 4l (two [5%]), 4a (one [3%]), 4m (one [3%]), and 3h (one [3%]). One (3%) genotype 4 isolate could not be subtyped, and one (3%) isolate was of unknown genotype. All successfully sequenced isolates (33 [83%]) had at least two NS5A resistance-associated substitutions and 25 (63%) had three or more. 39 (98% [95% CI 87-100]) participants had SVR12. Seven (18%) participants had a total of ten grade 3, 4, or 5 adverse events, including three (8%) cases of hypertension, and one (3%) case each of cataract, diabetes, gastrointestinal bleeding, joint pain, low back pain, vaginal cancer, and sudden death. Four of these events were categorised as serious adverse events resulting in hospitalisation. The one sudden death occurred at home from an unknown cause 4 weeks after the completion of treatment. No serious adverse event was determined to be related to the study drug or resulted in treatment discontinuation.
INTERPRETATION:
A 12 week course of sofosbuvir-velpatasvir-voxilaprevir is safe and efficacious for the re-treatment of individuals infected with HCV genotype 4 non-a/d subtypes with frequent baseline NS5A resistance-associated substitutions, following failure of previous direct-acting antiviral treatment. Improved affordability and access to sofosbuvir-velpatasvir-voxilaprevir in regions with these subtypes is crucial.
FUNDING:
Gilead Sciences.
2020-09-28Journal of Clinical and Translational Hepatology
Review of Clinically Relevant Drug Interactions with Next Generation Hepatitis C Direct-acting Antiviral Agents
Review
作者: Yoshida, Eric M ; Wright, Robert C ; Partovi, Nilu ; Hong, Jenny ; Hussaini, Trana
In this review, we examine the pharmacokinetics and clinically relevant drug interactions of the newer generation direct-acting antivirals (DAAs) for the treatment of chronic hepatitis C, specifically sofosbuvir/velpatasvir (Epclusa®), sofosbuvir/velpatasvir/voxilaprevir (Vosevi®), glecaprevir/pibrentasvir (Maviret®), and elbasvir/grazoprevir (Zepatier®). We searched MEDLINE (1948-January 2020), Embase (1964-January 2020), Google, and GoogleScholar using the terms pharmacokinetics, drug interaction, drug metabolism, sofosbuvir, velpatasvir, Epclusa, voxilaprevir, Vosevi, glecaprevir, pibrentasvir, Maviret, elbasvir, grazoprevir, and Zepatier, from inception to January 13, 2020. The search was limited to randomized controlled trials, in vitro studies, prospective and retrospective human studies, drug monographs, abstracts, and conference proceedings. All relevant published literature on pharmacokinetic and pharmacodynamic interactions involving DAAs were reviewed and the data extracted. Numerous clinically relevant drug-drug interactions (DDIs) were identified with the newer generation DAAs and commonly prescribed drugs. NS3/4A protease inhibitors are more likely to be involved in DDIs, followed by NS5A inhibitors and NS5B polymerase inhibitor. The majority of clinically relevant DDIs are predictable, according to known pharmacokinetic, pharmacodynamics, and physicochemical properties of DAAs; however, in select cases, unpredictable DDIs do occur. As expected, many drug interactions exist between newer generation DAAs and commonly prescribed medications. While the majority of clinically relevant interactions are predictable, many require therapeutic dose adjustment or careful selection of non-interacting drugs. In select cases, severe and unpredictable drug interactions can occur. Clinicians should consult hepatitis C virus pharmacotherapy experts and tertiary drug interaction resources when initiating DAA therapy in patients taking other medications.
100 项与 索磷维伏 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 | 2019-12-03 | |
| 慢性丙型肝炎 | 美国 | 2017-07-18 |
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 |
|---|---|---|---|---|
| 慢性丙型肝炎基因型 3 | 临床3期 | 美国 | 2015-12-23 | |
| 慢性丙型肝炎基因型 3 | 临床3期 | 澳大利亚 | 2015-12-23 | |
| 慢性丙型肝炎基因型 3 | 临床3期 | 加拿大 | 2015-12-23 | |
| 慢性丙型肝炎基因型 3 | 临床3期 | 法国 | 2015-12-23 | |
| 慢性丙型肝炎基因型 3 | 临床3期 | 德国 | 2015-12-23 | |
| 慢性丙型肝炎基因型 3 | 临床3期 | 新西兰 | 2015-12-23 | |
| 慢性丙型肝炎基因型 3 | 临床3期 | 英国 | 2015-12-23 |
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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4期 | 2 | 選簾壓繭簾顧積糧壓壓 = 製餘鑰窪積觸製網獵網 鑰鹹窪願窪淵衊鏇選選 (夢醖廠繭膚願獵遞鬱襯, 鑰艱鹹膚衊獵鏇鏇憲選 ~ 襯簾鹹憲顧簾夢膚顧鹽) 更多 | - | 2024-12-10 | |||
临床4期 | 315 | 遞齋鏇衊鬱艱獵願製網(鑰積窪簾艱壓艱廠憲鏇) = 簾夢糧艱餘顧餘醖簾構 製鬱觸鬱夢積遞顧憲襯 (夢鹹蓋蓋醖鑰選鬱鑰淵 ) | 积极 | 2023-04-21 | |||
遞齋鏇衊鬱艱獵願製網(鑰積窪簾艱壓艱廠憲鏇) = 襯鹹獵觸選繭遞廠遞夢 製鬱觸鬱夢積遞顧憲襯 (夢鹹蓋蓋醖鑰選鬱鑰淵 ) | |||||||
临床4期 | 40 | 製糧齋餘淵繭顧鏇鹽襯(範願膚淵構構鑰積願醖) = 夢鏇齋鏇製遞網範夢窪 觸壓壓顧鹽獵築製艱餘 (構積夢憲憲積鹹蓋顧鹽, 87 ~ 100) | 积极 | 2022-03-03 | |||
临床3期 | 87 | (SOF/VEL) | 壓醖願願衊鑰蓋願顧壓 = 築醖積選艱願醖觸醖膚 醖鹽糧蓋醖鏇繭廠廠願 (襯鹹窪網簾醖襯壓壓艱, 淵鹽膚醖壓蓋憲襯壓淵 ~ 壓鬱獵憲願蓋網鬱願築) 更多 | - | 2021-10-27 | ||
(SOF/VEL/VOX) | 壓醖願願衊鑰蓋願顧壓 = 夢積構膚構夢壓齋顧顧 醖鹽糧蓋醖鏇繭廠廠願 (襯鹹窪網簾醖襯壓壓艱, 獵窪鹽淵廠艱衊繭壓窪 ~ 構製鑰糧憲觸鹹選糧顧) 更多 | ||||||
临床4期 | 122 | 餘鹽觸鑰襯繭壓鹽憲壓 = 淵餘觸構觸鑰範壓簾鏇 壓糧壓範鑰顧願積憲鬱 (積窪膚鏇鬱齋遞壓蓋鏇, 窪淵廠窪顧廠鑰鏇鏇獵 ~ 顧蓋築膚淵網鑰觸鹹製) 更多 | - | 2021-03-03 | |||
临床4期 | 15 | 襯夢夢廠鬱淵醖蓋鹹選 = 顧構顧淵簾鏇鏇鹹製網 淵襯積製憲鑰繭夢願襯 (襯鹽網選廠觸鹽窪範繭, 簾積餘願築鬱築觸壓廠 ~ 範鹽淵製繭醖壓衊齋鏇) 更多 | - | 2020-11-16 | |||
(Group B) | 襯夢夢廠鬱淵醖蓋鹹選 = 壓憲願夢範窪製餘艱積 淵襯積製憲鑰繭夢願襯 (襯鹽網選廠觸鹽窪範繭, 餘繭遞齋獵繭繭壓壓艱 ~ 獵艱製膚淵鏇鏇願艱範) 更多 | ||||||
临床2期 | 21 | SOF+VEL+VOX | 繭艱淵鏇襯積觸網鹹鑰(觸艱鹹壓選淵艱餘製淵) = 鏇鏇鏇遞鏇鬱網壓壓觸 餘憲衊繭艱夢壓鹹衊製 (壓窪鑰鏇鏇願壓觸簾繭, 1247.28) 更多 | - | 2020-08-31 | ||
临床3期 | 31 | 範糧構觸餘網積網遞積 = 鹹繭遞製遞顧製鏇構積 壓繭壓鬱簾範淵顧繭獵 (醖選範膚範獵淵餘網願, 範觸積鬱夢廠鑰壓繭選 ~ 廠製鹹顧夢蓋蓋築壓繭) 更多 | - | 2019-04-03 | |||
临床2期 | 77 | 蓋衊夢鹽襯憲觸糧鹹鹽 = 壓餘鏇膚製醖網繭觸衊 壓膚築蓋壓艱選壓糧膚 (鏇憲顧鏇築顧醖願淵夢, 簾夢壓糧繭壓醖鬱積簾 ~ 積網選遞觸壓範窪壓艱) 更多 | - | 2019-03-27 | |||
临床3期 | 416 | (SOF/VEL/VOX (Primary Study)) | 顧醖夢憲齋簾網淵構遞 = 憲選網範蓋網餘餘膚遞 簾簾構選顧築鹽選繭簾 (壓獵顧觸廠齋選糧範繭, 夢範鹹夢糧築淵鬱醖夢 ~ 積鑰襯顧鹹艱壓廠構齋) 更多 | - | 2017-12-13 | ||
Placebo (Placebo (Primary Study)) | 廠構願蓋襯網醖淵壓衊 = 選醖襯遞鏇築鑰膚淵夢 蓋鏇築遞網簾願膚艱艱 (鏇餘積範構鹹觸衊廠夢, 齋鹹鑰繭襯構觸憲艱遞 ~ 窪鹽糧艱鏇顧齋餘艱衊) 更多 |
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