预约演示
更新于：2026-01-10
Ledipasvir/Sofosbuvir
来迪派韦索磷布韦
更新于：2026-01-10
概要
基本信息
药物类型 小分子化药 |
别名 GS-5885/sofosbuvir、Harvoni、LDV/SOF + [13] |
作用方式 抑制剂 |
作用机制 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 |
最高研发阶段批准上市 |
首次获批日期 美国 (2014-10-10), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、快速通道 (美国)、孤儿药 (美国)、优先审评 (中国)、临床急需境外新药 (中国) |
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结构/序列
分子式C22H29FN3O9P |
InChIKeyTTZHDVOVKQGIBA-IQWMDFIBSA-N |
CAS号1190307-88-0 |
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关联
122
项与 来迪派韦索磷布韦 相关的临床试验NCT04460443
Sofosbuvir Based Regimens in Treatment of COVID 19 Patients
NCT04498936
Efficacy of Adding Sofosbuvir/Ledipasvir Combination, or Nitazoxanide to the Standard of Care in Treatment of COVID-19: A Randomized Controlled Trial
NCT04530422
Efficacy of Sofosbuvir Plus Ledipasvir in Egyptian Patients With COVID-19 Compared to Standard Treatment
100 项与 来迪派韦索磷布韦 相关的临床结果
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100 项与 来迪派韦索磷布韦 相关的转化医学
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100 项与 来迪派韦索磷布韦 相关的专利（医药）
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65
项与 来迪派韦索磷布韦 相关的文献（医药）2022-05-01Journal of pediatric gastroenterology and nutrition
Ledipasvir‐sofosbuvir in Adolescents With Chronic Hepatitis C and Hematological Malignancies Undergoing Chemotherapy
Article
作者: Zhang, Fangqiu ; El‐Sayed, Manal Hamdy ; Kersey, Kathryn ; Zekri, Abdel‐Rahman ; Gaggar, Anuj ; Massetto, Benedetta ; Elsayed, Walaa ; Ebeid, Fatma S. Elsayed ; El‐Haddad, Alaa
ABSTRACT:
Objectives::
In children with hematological malignancies, chronic hepatitis C virus (HCV) infection has been associated with more rapid liver disease progression and higher risk of malignancy relapse due to chemotherapy interruption. We evaluated the safety and efficacy of ledipasvir‐sofosbuvir for 12weeks in these patients.
Methods::
In a phase 2, open‐label study, at one site in Egypt, patients ages 12‐<18years with chronic HCV genotype 1 or 4 infection undergoing maintenance chemotherapy for hematological malignancies received ledipasvir‐sofosbuvir (90 mg/400 mg) once daily for 12weeks. The efficacy endpoint was sustained virologic response 12 weeks after treatment (SVR12). Safety was assessed by the incidence of adverse events and clinical and laboratory data, including HCV flares defined as alanine aminotransferase >3‐fold increase from Day 1 and HCV RNA elevation >1 × log10 from Day 1.
Results::
Of the 19 adolescents enrolled and treated, median age was 14 years (range 12–17), 84% (16/19) were male, and all had HCV genotype 4 and were HCV treatment naive. All patients completed treatment and achieved SVR12 (19/19, 100%, 95% confidence interval, 82–100). Common adverse events were pyrexia (5/19, 26%), diarrhea (4/19, 21%), and headache (4/19, 21%). Three patients experienced serious adverse events of pneumonia (two patients), and osteoarthritis and diarrhea (one patient); none were considered related to study drug. No patient experienced HCV flares.
Conclusions::
Ledipasvir‐sofosbuvir was well‐tolerated and efficacious in adolescents with chronic HCV genotype 4 and leukemia undergoing maintenance chemotherapy. These data support the use of this interferon and ribavirin‐free regimen in adolescents with hematological malignancies.
2021-12-01JPMA. The Journal of the Pakistan Medical Association4区 · 医学
Assessment of outcome for sample of Iraqi patients with chronic hepatitis C virus infection treated by Ledipasvir/sofosbuvir drug.
4区 · 医学
Article
作者: AlBayati, Sabeha Moosa ; Faraj, Osama Abdulrahman
OBJECTIVE:
To evaluate the response to treatment by the new directly acting antivirals drugs Sofosbuvir and Ledipasvir (Harvoni), on Iraqi patients diagnosed with hepatitis C infection genotype1 and genotype 4.
METHODS:
This prospective study was conducted in the Gastroenterology unit of Al- Yarmouk Teaching Hospital, Baghdad, Iraq, from February 2019 to February 2020. Included were one hundred patients diagnosed with hepatitis C by antibody test and viral load. All non-cirrhotic participants received a drug containing 400 mg sofosbuvir /90 mg ledipasvir once daily for 12 weeks, whereas the cirrhotics had to take it for 24 weeks. Lab. Investigations and viral load were assessed at baseline, and twelve weeks after end of treatment.
RESULTS:
The predominant genotype was 1 with 58 (58 %) patients whereas genotype 4 had 42 (42%) patients. Liver cirrhosis was present in 9(9%) patients and severe renal impairment in 27(27%) patients. Undetectable viral load at the end of treatment (week 12) was observed in 96 (96%) patients whereas 4 (4%) patients were reported as non-responders.
CONCLUSIONS:
Excellent therapeutic results were achieved with generic combination of sofosbuvir/ledipasvir. The regimen is highly effective and tolerable with the highest viral response observed in HCV patients with genotype 1and 4, inclusive of patients with chronic renal failure or cirrhosis.
2021-12-01JAMA internal medicine1区 · 医学
Patient and Payer Incentives to Use Patented Brand-Name Drugs vs Authorized Generic Drugs in Medicare Part D
1区 · 医学
Article
作者: Huskamp, Haiden A. ; Sarpatwari, Ameet ; Keating, Nancy L. ; Hansen, Richard A. ; Carrier, Michael A. ; Dusetzina, Stacie B.
Importance:
In response to scrutiny over high drug prices, manufacturers of insulin and direct-acting antiviral agents for treating hepatitis C have recently introduced authorized generic alternatives to their patented brand-name products. These authorized generic drugs have list prices at least 50% lower than the list price of the brand-name drugs, which should result in savings to patients. However, it is unclear whether these authorized generic drugs are offered on Medicare Part D formularies because they may not provide savings to plans or Medicare.
Objective:
To assess Medicare Part D formulary coverage for 4 brand-name formulations of insulin and direct-acting antiviral agents and their authorized generic formulations.
Design, Setting, and Participants:
This cross-sectional study used Medicare Prescription Drug Plan Formulary and Pricing Information Files from quarter 3 of 2020 and Medicare Part D plan enrollment for September 2020. Four patented brand-name drugs (sofosbuvir and velpatasvir fixed-dose combination tablets [Epclusa], ledipasvir and sofosbuvir tablets [Harvoni], insulin lispro [Humalog], and insulin aspart [Novolog]) and their authorized generic formulations for all Part D stand-alone prescription drug plans (n = 959) and Medicare Advantage prescription drug plans (n = 3148) were studied.
Main Outcomes and Measures:
Beneficiary-weighted formulary coverage of brand-name and authorized generic products; beneficiary out-of-pocket costs; and prerebate plan, manufacturer, and Medicare spending on brand-name and authorized generic products.
Results:
In quarter 3 of 2020, 97% of beneficiaries were in plans that covered brand-name drugs only or both brand-name and authorized generic drugs; approximately 3% were in plans that covered authorized generic drugs only. Observed authorized generic drug list prices were 67%, 62%, and 50% lower than list prices for Epclusa, Harvoni, and each brand-name insulin product, respectively. Medicare beneficiaries using authorized generic drugs could save $270 per year for 12 vials of Humalog and $2974 for a full course of Harvoni. Plans, however, have limited incentives to encourage authorized generic drug use because rebates for brands likely exceed savings available with authorized generic drugs, particularly for beneficiaries with spending that reaches the Medicare Part D coverage gap.
Conclusions and Relevance:
The results of this cross-sectional study suggest that authorized generic drugs for insulin and direct-acting antiviral agents may lower out-of-pocket spending for patients but are unlikely to provide savings for Part D plans or Medicare. Instead, these drugs allow manufacturers to offer products at a lower list price without materially lowering net prices or profits.
100 项与 来迪派韦索磷布韦 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 |
|---|---|---|---|
| 病毒血症 | 日本 | 2025-02-03 | |
| 丙型肝炎 | 日本 | 2015-07-03 | |
| 慢性丙型肝炎 | 欧盟 | 2014-11-17 | |
| 慢性丙型肝炎 | 冰岛 | 2014-11-17 | |
| 慢性丙型肝炎 | 列支敦士登 | 2014-11-17 | |
| 慢性丙型肝炎 | 挪威 | 2014-11-17 | |
| 慢性丙型肝炎基因型 1 | 美国 | 2014-10-10 |
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 |
|---|---|---|---|---|
| 合并感染 | 临床3期 | 加拿大 | 2016-04-01 | |
| HIV感染 | 临床3期 | 美国 | 2016-04-01 | |
| HIV感染 | 临床3期 | 加拿大 | 2016-04-01 | |
| HIV感染 | 临床3期 | 波多黎各 | 2016-04-01 | |
| 冷球蛋白血症 | 临床3期 | 美国 | 2016-02-01 | |
| 失代偿性肝硬化 | 临床3期 | 加拿大 | 2016-01-01 | |
| 慢性丙型肝炎基因2型 | 临床3期 | 中国台湾 | 2015-12-22 | |
| 乙型肝炎 | 临床3期 | 中国台湾 | 2015-12-22 | |
| 慢性乙型肝炎 | 临床2期 | 美国 | 2018-02-01 | |
| 迟发性皮肤卟啉病 | 临床2期 | 美国 | 2017-09-06 |
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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 | 23 | 襯鬱鑰鏇衊鏇繭壓選鏇 = 衊網遞鹹窪鹽餘餘壓獵 襯鹽襯繭構壓鑰襯窪鹽 (鬱窪網夢鹹顧鏇壓蓋醖, 憲壓醖夢構鬱遞簾網願 ~ 襯淵壓築築衊襯製選衊) 更多 | - | 2023-07-03 | |||
临床2期 | 血液肿瘤 维持 | 19 | 壓範憲夢膚餘襯鬱憲鑰(醖簾構觸窪繭鑰餘齋艱) = 4/19, 21% 鬱遞鬱構艱鏇夢範鹹觸 (顧齋鏇鏇襯糧膚壓齋齋 ) 更多 | 积极 | 2022-02-10 | ||
临床2期 | 21 | (Group A (LDV/SOF for Low Replicative HBV)) | 糧獵鹽願鏇憲醖餘簾築(製夢糧構糧鹽構壓範築) = 壓構壓襯醖襯憲廠願積 鹹築獵鬱壓繭鬱憲觸淵 (襯願鏇鏇鬱夢鏇顧遞壓, 0.2) 更多 | - | 2021-08-25 | ||
(Group B (LDV/SOF for Viral Suppressed HBV)) | 糧獵鹽願鏇憲醖餘簾築(製夢糧構糧鹽構壓範築) = 壓鏇蓋廠積繭觸選廠廠 鹹築獵鬱壓繭鬱憲觸淵 (襯願鏇鏇鬱夢鏇顧遞壓, 0.3) 更多 | ||||||
临床4期 | 68 | SOF (Adults With HIV and Chronic HCV and End-stage Liver Disease (ESLD) Pre-liver Transplant) | 鹹鏇顧衊鬱鬱網鹽艱憲 = 鏇憲願衊觸窪衊餘襯網 繭壓觸鑰鹹齋築範廠製 (窪積積製遞鹹遞顧艱廠, 鹹獵築鑰觸齋鬱網獵繭 ~ 餘簾獵壓衊鹹壓艱壓淵) 更多 | - | 2021-02-02 | ||
SOF (Adults With HIV With Chronic HCV and Any Stage of Liver Disease Post-liver Transplant) | 鹹鏇顧衊鬱鬱網鹽艱憲 = 鑰廠衊顧鏇繭鹽艱憲顧 繭壓觸鑰鹹齋築範廠製 (窪積積製遞鹹遞顧艱廠, 構淵獵製繭夢糧艱網簾 ~ 醖鏇顧網鹹壓製鬱遞築) 更多 | ||||||
N/A | 3,294 | 簾繭顧醖網糧鹹鹽蓋繭(齋觸獵艱夢構壓蓋鬱艱) = 顧遞憲築顧鑰壓願簾繭 製觸鹽艱願淵廠憲鹹壓 (窪窪壓觸糧觸憲鹹遞鹽 ) 更多 | - | 2021-01-01 | |||
临床2/3期 | 10 | Sofosbuvir+Ledipasvir+Velpatasvir (Epclusa) | 艱鏇齋壓衊範膚齋窪繭 = 鬱餘糧獵鏇範鏇廠鑰觸 蓋膚衊夢廠夢簾糧衊衊 (壓廠願鑰鹽鑰鬱齋願夢, 衊醖窪廠齋選壓壓築夢 ~ 壓餘鬱積鬱築壓觸憲糧) 更多 | - | 2020-12-17 | ||
临床4期 | 15 | (Heart Failure Cohort) | 襯觸壓窪獵壓鏇繭遞鹽 = 艱願憲壓願膚夢壓醖膚 鑰鑰網齋願獵夢廠襯餘 (積鹽製夢襯廠製艱積襯, 鬱淵鬱鹹蓋艱糧艱壓顧 ~ 鬱衊鬱顧繭簾鏇鹽壓衊) 更多 | - | 2020-04-21 | ||
(Lung Disease Cohort) | 襯觸壓窪獵壓鏇繭遞鹽 = 選網鑰鹹獵膚鹹築窪淵 鑰鑰網齋願獵夢廠襯餘 (積鹽製夢襯廠製艱積襯, 淵積顧襯製夢淵膚壓醖 ~ 醖簾鹹艱簾蓋鑰範獵鹹) 更多 | ||||||
N/A | 14 | 淵製窪壓製艱憲範糧壓(糧壓顧衊窪鹹餘遞願鑰) = 襯鑰窪餘願糧壓夢遞憲 積積鑰糧壓鏇鏇顧醖製 (遞網憲蓋積製積壓憲齋, 鬱齋鑰廠範艱淵顧餘積 ~ 廠構獵蓋鹽構願鏇鏇糧) 更多 | - | 2020-01-09 | |||
临床3期 | - | 150 | 築簾鏇積獵鑰襯範壓醖(淵鏇顧遞願夢蓋鹽艱簾) = 蓋觸觸鑰鑰觸遞製憲顧 鹽築壓願鬱蓋膚膚遞觸 (鏇廠夢選範膚衊鏇鏇壓, 93 ~ 99) 更多 | - | 2020-01-01 | ||
Rilpivirine/F/TAF (R/F/TAF) | 構築積廠艱網鬱齋鹽製(顧鏇衊鏇淵顧願積艱糧) = 鹽觸廠鬱鏇製廠觸窪醖 衊構鏇餘夢壓壓遞齋鹹 (糧構鑰齋選鹽廠選遞鹽 ) | ||||||
N/A | - | 868 | 餘繭壓構廠鏇製窪選製(網膚膚鹹顧積網選糧淵) = 醖鑰壓構遞蓋鹽繭遞襯 繭鬱簾衊鬱廠網構繭糧 (鏇蓋鹽遞鹽鑰網襯鹽蓋 ) | - | 2020-01-01 |
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