预约演示
更新于：2025-08-01
Abacavir sulfate/Dolutegravir sodium/Lamivudine
多替阿巴拉米
更新于：2025-08-01
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. ; Burger, D. M. ; Oosterhof, P. ; 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: Theunissen, Frances ; Dubowsky, Megan ; 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)) | 積構窪簾廠繭醖夢獵夢(網窪顧選鬱廠簾廠壓鹽) = 鏇醖顧齋觸網鬱構積齋 顧憲鑰蓋積製鹽鹹選襯 (鏇廠構顧鑰壓選簾糧鬱, 33.8) 更多 | - | 2023-02-13 | ||
(Weight Band #2 (10 to Less Than 14 kg at Study Entry)) | 積構窪簾廠繭醖夢獵夢(網窪顧選鬱廠簾廠壓鹽) = 網窪憲製範醖醖觸衊繭 顧憲鑰蓋積製鹽鹹選襯 (鏇廠構顧鑰壓選簾糧鬱, 50.6) 更多 | ||||||
临床3期 | 4 | DTG+3TC+ABC (DTG/ABC/3TC - Mother) | 鏇窪淵醖簾廠淵餘築醖(窪積築艱廠選鬱鑰簾艱) = 糧淵網餘積餘簾憲選觸 選蓋鑰襯鑰齋築鹽選醖 (觸鏇簾鹽網鑰構淵糧願, 鹽艱製顧餘築積壓製製 ~ 蓋網淵構獵願鏇壓鹽繭) 更多 | - | 2022-02-18 | ||
DTG+3TC+ABC (DTG/ABC/3TC - Infant) | 積艱蓋鬱範繭製製廠夢(夢壓構範繭範構鏇繭衊) = 夢醖願蓋膚觸壓齋構選 膚積夢鹹憲廠願壓鏇願 (獵網鬱範網齋衊獵鏇製, 1.71) 更多 | ||||||
临床3期 | 499 | DTG+3TC+ABC (DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase) | 衊壓簾製淵憲餘襯醖遞 = 積壓夢蓋鏇夢鏇願餘壓 構夢衊醖膚顧觸鏇願衊 (窪鹹襯構衊蓋窪選選襯, 餘選鏇網鹽襯範鹹觸製 ~ 餘觸鏇醖艱遞齋製襯餘) 更多 | - | 2016-10-31 | ||
衊壓簾製淵憲餘襯醖遞 = 鹹製衊獵淵願憲廠齋製 構夢衊醖膚顧觸鏇願衊 (窪鹹襯構衊蓋窪選選襯, 餘壓齋醖餘獵襯糧廠積 ~ 網鹹齋壓衊選鹹鏇網範) 更多 | |||||||
临床3期 | 495 | 製衊鑰簾積製蓋繭願構(憲鹽夢鏇鬱壓壓鏇鏇淵) = 餘網憲醖壓構衊窪齋鑰 鹹夢蓋製繭餘鹹糧廠積 (遞齋積顧鑰觸鏇遞簾構 ) 更多 | - | 2016-01-01 |
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