预约演示
更新于：2025-07-15
Abacavir sulfate/Dolutegravir sodium/Lamivudine
多替阿巴拉米
更新于：2025-07-15
概要
基本信息
药物类型 小分子化药 |
别名 ABACAVIR/DOLUTEGRAVIR/LAMIVUDINE、Abacavir/GSK-1349572/lamivudine、Dolutegravir Sodium/Abacavir Sulfate/Lamivudine + [15] |
作用方式 抑制剂 |
作用机制 HIV-1 integrase抑制剂(HIV整合酶抑制剂)、RT抑制剂(逆转录酶抑制剂) |
在研适应症 |
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 美国 (2014-08-22), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C20H19F2N3NaO5 |
InChIKeyFOZLBAIXQATFFW-VSLILLSYSA-N |
CAS号1051375-19-9 |
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关联
26
项与 多替阿巴拉米 相关的临床试验NCT06658977
Open Label Rollover Study of Triumeq in Patients With Amyotrophic Lateral Sclerosis (ALS) Following the Lighthouse II Trial
NCT05393193
Point-of-Care HIV Testing and Early Dolutegravir Use for Infants
CTRI/2022/02/040130
An open label, balanced, randomized, two-treatment, two-sequence, two-period, cross-over, single-dose, oral bioequivalence study of Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension 60mg/5mg/30mg (1 Ã? 5 Tablets) (Test) of Aurobindo Pharma Limited, India with Dolutegravir (GSK1349572)/Abacavir/Lamivudine Dispersible Tablets 5 mg/60 mg/30 mg (1 Ã? 5 Tablets) (Reference) of ViiV Healthcare, UK in 54 healthy, adult, male subjects under fasting conditions
100 项与 多替阿巴拉米 相关的临床结果
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100 项与 多替阿巴拉米 相关的转化医学
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100 项与 多替阿巴拉米 相关的专利（医药）
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34
项与 多替阿巴拉米 相关的文献（医药）2025-01-01JOURNAL OF CLINICAL PHARMACOLOGY
A Model‐Based Approach Supporting Abacavir/Dolutegravir/Lamivudine Fixed‐Dose Combination Approval in Children Living with HIV‐1
Article
作者: Tan, Lionel K. ; Hyatt, Stephen ; Brothers, Cindy ; Goyal, Navin ; Buchanan, Ann M. ; Adkison, Kimberly ; McKenna, Michael ; Chandasana, Hardik
Abstract:
In March 2022, the US Food and Drug Administration expanded indications of TRIUMEQ, a once‐daily fixed‐dose combination (FDC) containing abacavir (ABC), dolutegravir (DTG), and lamivudine (3TC) to include pediatric patients weighing at least 10 kg for the treatment of HIV‐1. Prior to this extension, the ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablet was approved for use only in the adult/adolescent population, weighing ≥40 kg while each component of the FDC was approved for its use in pediatric patients at least 3 months and older. A new child‐friendly formulation was developed as an FDC dispersible tablet (DT) of ABC 60 mg/DTG 5 mg/3TC 30 mg for pediatric patients with a body weight ≥ 6 kg. The present work demonstrates the utility of applying a model‐informed drug development (MIDD) approach to expedite ABC/DTG/3TC FDC approval for pediatric patients (≥10 to <40 kg) based on data from the existing individual components and formulation bridging. Population pharmacokinetic models developed for pediatric participants across all three components of ABC/DTG/3TC FDC were employed for exposure prediction and incorporated relative bioavailability data. The predicted plasma exposures of ABC, DTG, and 3TC for FDC doses were consistent with those observed for the single entities in pediatric and adult studies. Thus, safety and efficacy observed in the individual component studies could be adequately extrapolated to the FDC that results in similar exposure. The current work demonstrates the significance of MIDD approaches in facilitating expedited access to child‐friendly formulations in the HIV‐1 therapeutic area.
2024-09-01HIV MEDICINE
De‐simplifying antiretroviral therapy from a single‐tablet to a two‐tablet regimen: Acceptance, patient‐reported outcomes, and cost savings in a multicentre study
Article
作者: Langebeek, N. ; Weijsenfeld, A. M. ; Brinkman, K. ; van Luin, M. ; Vanhommerig, J. W. ; van Crevel, R. ; de Zoete, B. G. J. A. ; Gisolf, E. H. ; van der Valk, M. ; Grintjes, K. ; Oosterhof, P. ; Burger, D. M. ; Lammers, A. J. J. ; van Hulzen, A. G. W.
Abstract:
Background:
Antiretroviral therapy (ART), which is increasingly used by people with HIV, accounts for significant care costs, particularly because of single‐tablet regimens (STRs). This study explored de‐simplification to a two‐tablet regimen (TTR) for cost reduction. The objectives of this study were: (1) acceptance of de‐simplification, (2) patient‐reported outcomes, and (3) cost savings.
Methods:
All individuals on Triumeq®, Atripla® or Eviplera® in five HIV clinics in the Netherlands were eligible. Healthcare providers informed individuals of this study. After inclusion, individuals were free to de‐simplify. An electronic questionnaire was sent to assess study acceptance, adherence, quality of life (SF12) and treatment satisfaction (HIVTSQ). After 3 and 12 months, questionnaires were repeated. Cost savings were calculated using Dutch drug prices.
Results:
In total, 283 individuals were included, of whom 55.5% agreed to de‐simplify their ART, with a large variability between treatment centres: 41.1–74.2%. Individuals who were willing to de‐simplify tended to be older, had a longer history of HIV diagnosis, and used more co‐medication than those who preferred to remain on an STR regimen. Patient‐reported outcomes, including quality of life and treatment satisfaction, showed no significant difference between people with HIV who switched to a TTR and those who remained on an STR regimen. Furthermore, we observed a 17.8% reduction in drug costs in our cohort of people with HIV who were initially on an STR.
Conclusions:
De‐simplification from an STR to a TTR within the Dutch healthcare setting has been demonstrated as feasible, leads to significant cost reductions and should be discussed with every eligible person with HIV in the Netherlands.
2023-11-01Molecular neurobiology
The Molecular Link Between TDP-43, Endogenous Retroviruses and Inflammatory Neurodegeneration in Amyotrophic Lateral Sclerosis: a Potential Target for Triumeq, an Antiretroviral Therapy.
Review
作者: Dubowsky, Megan ; Theunissen, Frances ; Rogers, Mary-Louise ; Carr, Jillian M
Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND), is a progressive neurological disorder, characterised by the death of upper and lower motor neurons. The aetiology of ALS remains unknown, and treatment options are limited. Endogenous retroviruses (ERVs), specifically human endogenous retrovirus type K (HERV-K), have been proposed to be involved in the propagation of neurodegeneration in ALS. ERVs are genomic remnants of ancient viral infection events, with most being inactive and not retaining the capacity to encode a fully infectious virus. However, some ERVs retain the ability to be activated and transcribed, and ERV transcripts have been found to be elevated within the brain tissue of MND patients. A hallmark of ALS pathology is altered localisation of the transactive response (TAR) DNA binding protein 43 kDa (TDP-43), which is normally found within the nucleus of neuronal and glial cells and is involved in RNA regulation. In ALS, TDP-43 aggregates within the cytoplasm and facilitates neurodegeneration. The involvement of ERVs in ALS pathology is thought to occur through TDP-43 and neuroinflammatory mediators. In this review, the proposed involvement of TDP-43, HERV-K and immune regulators on the onset and progression of ALS will be discussed. Furthermore, the evidence supporting a therapy based on targeting ERVs in ALS will be reviewed.
100 项与 多替阿巴拉米 相关的药物交易
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研发状态
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 |
|---|---|---|---|
| HIV感染 | 美国 | 2014-08-22 |
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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1/2期 | 57 | (Weight Band #1 (6 to Less Than 10 kg at Study Entry)) | 憲襯膚觸膚廠繭齋壓餘(築鏇顧衊顧壓襯鑰襯鏇) = 繭鑰膚簾簾繭衊獵艱窪 壓獵鏇廠鹽遞網餘鏇淵 (簾膚襯窪簾顧製衊鹽範, 33.8) 更多 | - | 2023-02-13 | ||
(Weight Band #2 (10 to Less Than 14 kg at Study Entry)) | 憲襯膚觸膚廠繭齋壓餘(築鏇顧衊顧壓襯鑰襯鏇) = 憲壓膚積製遞餘窪餘網 壓獵鏇廠鹽遞網餘鏇淵 (簾膚襯窪簾顧製衊鹽範, 50.6) 更多 | ||||||
临床3期 | 4 | DTG+3TC+ABC (DTG/ABC/3TC - Mother) | 糧窪顧齋膚衊膚網餘遞(糧夢齋醖壓獵鬱鬱衊選) = 衊齋繭艱蓋壓糧構膚鏇 艱鹹夢糧網築鑰壓構廠 (顧夢築顧齋鏇餘廠夢觸, 遞襯廠積鹹夢蓋窪襯築 ~ 鬱選廠獵廠鹹網鑰築鏇) 更多 | - | 2022-02-18 | ||
DTG+3TC+ABC (DTG/ABC/3TC - Infant) | 糧範選壓齋壓築餘齋糧(艱壓觸鏇範築襯蓋淵鹹) = 製鑰網鬱鬱願選鏇鹽築 醖積醖鹹鬱衊醖鬱網糧 (淵顧襯糧齋積餘壓鬱艱, 1.71) 更多 | ||||||
临床3期 | 499 | DTG+3TC+ABC (DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase) | 淵夢鏇構鏇齋構獵觸憲 = 築遞觸齋糧範遞鹽醖積 簾醖餘範鹹夢蓋網餘壓 (製憲鬱醖鹹壓齋齋製餘, 顧窪鏇醖繭獵膚鹽鬱憲 ~ 鬱鏇鬱蓋鹽選範齋築範) 更多 | - | 2016-10-31 | ||
淵夢鏇構鏇齋構獵觸憲 = 築蓋齋壓衊衊齋獵鹽夢 簾醖餘範鹹夢蓋網餘壓 (製憲鬱醖鹹壓齋齋製餘, 襯遞繭廠餘獵糧夢築鏇 ~ 廠製築顧艱選鏇淵鹽醖) 更多 | |||||||
临床3期 | 495 | 蓋鹽簾觸網糧衊壓壓積(憲蓋鹹遞簾壓繭夢蓋製) = 顧築顧顧餘醖艱糧鑰簾 願願廠壓憲鑰廠築繭選 (選蓋窪觸鹽遞繭夢夢製 ) 更多 | - | 2016-01-01 |
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