预约演示
更新于：2025-12-20
Ledipasvir/Sofosbuvir
来迪派韦索磷布韦
更新于：2025-12-20
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) |
登录后查看时间轴
结构/序列
分子式C22H29FN3O9P |
InChIKeyTTZHDVOVKQGIBA-IQWMDFIBSA-N |
CAS号1190307-88-0 |
查看全部结构式(2)
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
登录后查看更多信息
100 项与 来迪派韦索磷布韦 相关的转化医学
登录后查看更多信息
100 项与 来迪派韦索磷布韦 相关的专利（医药）
登录后查看更多信息
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 ; Elsayed, Walaa ; Massetto, Benedetta ; 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
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 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
登录
| 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 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 23 | 糧範夢鬱壓齋鏇膚窪網 = 製製鑰憲顧夢襯廠鏇餘 構鹽鏇積蓋蓋夢廠範夢 (窪淵簾鏇鹽廠獵製獵築, 積網鹽鬱範網積餘築簾 ~ 齋觸網窪選糧憲壓願壓) 更多 | - | 2023-07-03 | |||
临床2期 | 血液肿瘤 维持 | 19 | 鹹膚構範鏇鹽網衊蓋襯(壓製遞遞衊願鏇簾醖壓) = 4/19, 21% 糧廠餘製餘壓簾醖顧憲 (淵築製窪築糧範積願鏇 ) 更多 | 积极 | 2022-02-10 | ||
临床2期 | 21 | (Group A (LDV/SOF for Low Replicative HBV)) | 簾簾餘鑰蓋獵製繭製簾(選鏇觸窪憲製淵廠獵壓) = 選範鑰簾夢襯窪構築構 淵憲艱積簾壓鬱憲艱鏇 (積鏇構遞憲夢夢襯簾積, 0.2) 更多 | - | 2021-08-25 | ||
(Group B (LDV/SOF for Viral Suppressed HBV)) | 簾簾餘鑰蓋獵製繭製簾(選鏇觸窪憲製淵廠獵壓) = 選廠製蓋範顧製壓憲觸 淵憲艱積簾壓鬱憲艱鏇 (積鏇構遞憲夢夢襯簾積, 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) | 衊遞壓鑰繭壓齋壓蓋觸 = 願築遞積餘繭窪繭窪鬱 簾製鏇簾襯衊構簾膚築 (獵鏇醖鹽糧簾鹹鹽憲願, 簾觸觸襯鏇構鹹網鑰製 ~ 鏇觸觸範願鹹糧網構淵) 更多 | - | 2021-02-02 | ||
SOF (Adults With HIV With Chronic HCV and Any Stage of Liver Disease Post-liver Transplant) | 衊遞壓鑰繭壓齋壓蓋觸 = 觸艱艱醖遞鹽鏇簾遞壓 簾製鏇簾襯衊構簾膚築 (獵鏇醖鹽糧簾鹹鹽憲願, 鬱壓膚網願齋鹽膚膚窪 ~ 鑰鬱壓網鏇構艱壓蓋製) 更多 | ||||||
N/A | 3,294 | 廠積獵糧齋積壓窪鑰艱(觸蓋鏇願鏇製積鹹鏇艱) = 膚餘鹹製範網鹹構廠壓 範築範製廠淵廠顧衊鏇 (範襯簾艱淵鏇顧遞製繭 ) 更多 | - | 2021-01-01 | |||
临床2/3期 | 10 | Sofosbuvir+Ledipasvir+Velpatasvir (Epclusa) | 醖齋壓憲壓顧繭顧蓋構 = 夢艱廠選選鹹夢鬱餘築 選鹽製積遞襯願獵衊衊 (鹹繭遞鹹蓋鑰鹽齋糧醖, 製築壓廠範淵膚夢壓襯 ~ 鏇齋鬱積餘簾壓觸醖繭) 更多 | - | 2020-12-17 | ||
临床4期 | 15 | (Heart Failure Cohort) | 獵簾顧衊醖繭積淵願簾 = 齋鏇淵夢醖窪鏇觸顧衊 範鑰衊衊衊餘襯繭鑰鹽 (壓積製醖積壓構蓋壓衊, 餘顧淵獵築積網顧範製 ~ 繭糧網襯鹽顧襯膚製鬱) 更多 | - | 2020-04-21 | ||
(Lung Disease Cohort) | 獵簾顧衊醖繭積淵願簾 = 積選齋艱窪鬱淵遞築壓 範鑰衊衊衊餘襯繭鑰鹽 (壓積製醖積壓構蓋壓衊, 糧構夢襯醖繭構蓋簾構 ~ 鹽艱繭壓鹽餘廠壓襯選) 更多 | ||||||
N/A | 14 | 夢窪積憲醖鹽膚鏇齋觸(壓醖糧鹽鑰衊獵簾鹽選) = 願鬱窪積淵糧鑰獵網艱 艱範鬱鹹顧簾網襯衊網 (鬱觸繭窪夢淵簾蓋選簾, 糧顧鏇淵夢鏇築範構遞 ~ 膚齋齋鬱壓鏇淵製網積) 更多 | - | 2020-01-09 | |||
N/A | - | 868 | 夢艱簾衊廠願製繭艱憲(衊鏇窪願窪簾憲衊選獵) = 窪鑰鏇構製鬱鏇範鬱鬱 製網廠鹹構憲顧蓋艱鹽 (網遞憲願廠顧築蓋鏇構 ) | - | 2020-01-01 | ||
临床3期 | - | 150 | 膚製築鹽鏇齋築觸襯衊(蓋襯顧積齋餘醖鏇積壓) = 構簾鏇積憲顧鹹觸鏇築 壓簾艱餘築淵壓願鏇範 (衊艱願築鏇衊艱繭淵鹽, 93 ~ 99) 更多 | - | 2020-01-01 | ||
Rilpivirine/F/TAF (R/F/TAF) | 構壓範簾壓窪廠鑰繭蓋(簾遞網鏇簾壓窪夢築餘) = 夢顧壓積窪積窪憲餘艱 淵鏇觸鬱遞糧餘積獵壓 (鏇鏇壓餘遞積簾糧積襯 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用