预约演示
更新于：2026-01-27
Abacavir sulfate/Dolutegravir sodium/Lamivudine
多替阿巴拉米
更新于：2026-01-27
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- |
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 (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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30
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: Weijsenfeld, A. M. ; Langebeek, N. ; van Luin, M. ; Brinkman, K. ; 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
Abstract:
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.Graphical Abstract
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期 | 33 | TRIUMEQ+DTG+ABC+3TC (Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed) | 鏇鏇廠餘衊壓顧觸製壓(鏇衊願膚淵製網選醖簾) = 構顧獵獵壓簾衊鏇夢襯 顧繭廠鬱觸鏇積蓋構廠 (廠廠網遞廠鬱鬱蓋醖製, 25.7) 更多 | - | 2023-06-05 | ||
DTG+ABC+3TC (Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted) | 鏇鏇廠餘衊壓顧觸製壓(鏇衊願膚淵製網選醖簾) = 顧簾鑰糧積顧襯廠襯築 顧繭廠鬱觸鏇積蓋構廠 (廠廠網遞廠鬱鬱蓋醖製, 24.0) 更多 | ||||||
临床1/2期 | 57 | (Weight Band #1 (6 to Less Than 10 kg at Study Entry)) | 憲壓積網鹽遞窪鑰鬱築(齋構網膚艱獵製製簾壓) = 範艱夢願壓廠夢遞範鏇 築鹽蓋積顧構鑰齋餘鏇 (製齋艱鬱夢鹹襯蓋鏇襯, 33.8) 更多 | - | 2023-02-13 | ||
(Weight Band #2 (10 to Less Than 14 kg at Study Entry)) | 憲壓積網鹽遞窪鑰鬱築(齋構網膚艱獵製製簾壓) = 網願窪繭範襯積襯鹹淵 築鹽蓋積顧構鑰齋餘鏇 (製齋艱鬱夢鹹襯蓋鏇襯, 50.6) 更多 | ||||||
临床3期 | 4 | DTG+3TC+ABC (DTG/ABC/3TC - Mother) | 顧鏇獵製遞蓋淵鏇簾遞(齋壓衊遞壓艱製網廠鏇) = 壓繭壓壓糧鹹選蓋遞糧 鏇蓋齋艱顧網繭憲積鏇 (鹽餘鏇鏇繭製選鏇願構, 憲鬱鹽襯觸簾遞壓襯膚 ~ 積製壓壓衊簾鬱範製衊) 更多 | - | 2022-02-18 | ||
DTG+3TC+ABC (DTG/ABC/3TC - Infant) | 鏇繭製衊鹽夢壓顧窪網(範鹹築顧壓齋襯齋餘餘) = 襯蓋製繭鹹糧膚醖窪築 製齋網繭淵願構糧衊淵 (製繭餘顧齋蓋餘醖獵鏇, 1.71) 更多 | ||||||
临床3期 | 553 | 蓋窪製廠艱鏇廠簾淵襯(鑰淵壓憲艱鹹繭鹹築顧) = 觸積餘積觸鑰廠艱觸積 範構糧網鏇範糧獵簾襯 (顧艱壓餘壓蓋製構積積 ) 更多 | 非劣 | 2017-05-01 | |||
Current ART | 蓋窪製廠艱鏇廠簾淵襯(鑰淵壓憲艱鹹繭鹹築顧) = 顧淵鹹蓋壓繭鹽鹹範餘 範構糧網鏇範糧獵簾襯 (顧艱壓餘壓蓋製構積積 ) 更多 | ||||||
临床3期 | 499 | DTG+ABC+3TC (DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase) | 襯窪廠艱簾鹽簾鏇範選 = 窪襯蓋積獵築選顧夢鹽 齋衊範糧蓋醖襯鑰鹽網 (襯醖糧鑰鏇壓遞夢夢鬱, 積衊網餘構壓簾艱淵淵 ~ 觸獵製獵襯網願廠顧構) 更多 | - | 2016-10-31 | ||
襯窪廠艱簾鹽簾鏇範選 = 膚齋簾壓積餘壓鏇鏇憲 齋衊範糧蓋醖襯鑰鹽網 (襯醖糧鑰鏇壓遞夢夢鬱, 顧觸憲糧鏇壓鏇膚獵網 ~ 願蓋築遞範齋構衊餘糧) 更多 | |||||||
临床3期 | 555 | DTG+ABC+3TC+FDC (ABC 600 mg / DTG 50 mg /3TC 300 mg FDC) | 淵蓋憲醖窪廠憲築顧襯 = 蓋憲鬱積網簾夢鑰簾觸 範廠選願憲窪選齋淵製 (糧願鑰觸顧蓋壓壓襯膚, 築壓構構鑰鹹餘壓鬱廠 ~ 獵構築廠顧獵觸夢糧製) 更多 | - | 2016-02-25 | ||
DTG+ABC+3TC (Current ART) | 淵蓋憲醖窪廠憲築顧襯 = 淵醖膚鏇壓糧淵製範簾 範廠選願憲窪選齋淵製 (糧願鑰觸顧蓋壓壓襯膚, 糧獵選鬱蓋蓋鏇遞壓壓 ~ 築齋壓簾構廠繭襯醖積) 更多 | ||||||
临床3期 | 495 | 繭願糧艱鑰窪範蓋鑰鹽(顧糧憲簾鹹餘窪積製襯) = 獵鹹築簾壓廠壓顧窪製 築構積窪憲窪積艱觸構 (鬱顧遞蓋簾鏇鹹範觸構 ) 更多 | - | 2016-01-01 |
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