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更新于：2025-11-01
Abacavir hydroxyacetate
更新于：2025-11-01
概要
基本信息
在研机构- |
权益机构- |
最高研发阶段无进展临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
分子式C16H20N6O3 |
InChIKeyZBBZROWQLKCFQK-KOLCDFICSA-N |
CAS号1446418-48-9 |
关联
17
项与 Abacavir hydroxyacetate 相关的临床试验CTRI/2022/06/043058
Single dose, randomization blinded, two-period, two-treatment, twosequence, crossover, oral bioequivalence study of Mylanâ??s Test product Abacavir, Dolutegravir and Lamivudine tablets for oral suspension 60mg/5mg/30mg with Reference Product Triumeq Dispersible Tablets (5mg GSK1349572/60mg Abacavir/30 mg Lamivudine) Manufactured for: ViiV Healthcare UK Limited, 980 Great West Road, Brentford,Middlesex,TW8 9GS, UK, in Healthy adult male and female (not of childbearing potential) human volunteers under fasting conditions.
CTRI/2022/06/043078
Single dose, randomization blinded, two-period, two-treatment, twosequence,crossover, oral bioequivalence study of Mylanâ??s Test product Abacavir, Dolutegravir and Lamivudine tablets for oral suspension 60mg/5mg/30mg with Reference Product Triumeq Dispersible Tablets (5mg GSK1349572/60mg Abacavir/30 mg Lamivudine) Manufactured for: ViiV Healthcare UK Limited, 980 Great West Road, Brentford,Middlesex, TW8 9GS, UK, in Healthy adult male and female (not of childbearing potential) human volunteers under fed conditions.
CTRI/2022/02/040129
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 fed conditions
100 项与 Abacavir hydroxyacetate 相关的临床结果
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100 项与 Abacavir hydroxyacetate 相关的转化医学
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100 项与 Abacavir hydroxyacetate 相关的专利（医药）
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2,236
项与 Abacavir hydroxyacetate 相关的文献（医药）2025-12-01INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS
Effectiveness and safety of tenofovir alafenamide fumarate–based therapy compared with tenofovir disoproxil fumarate- and abacavir-based therapy in children and young people living with HIV in Europe
Article
作者: Collins, Intira Jeannie ; O’Rourke, John ; Navarro, Marisa ; Naver, Lars ; Marczynska, Magdalena ; Paioni, Paolo ; Vieira, Vinicius ; Crichton, Siobhan ; Sirvent, Jorge Gómez ; Castro, Hannah ; Judd, Ali ; Chiappini, Elena ; Jackson, Charlotte ; Königs, Christoph ; Nordly, Sannie Brit ; Goetghebuer, Tessa ; Foster, Caroline ; Spoulou, Vana ; Doerholt, Katja ; Bamford, Alasdair ; Ene, Luminita ; Vallejo, Beatriz Alvarez ; Soeria-Atmadja, Sandra ; Chappell, Elizabeth ; Noguera-Julian, Antoni ; Marongiu, Andrea ; Medina-Claros, Antonio F
OBJECTIVE:
Effectiveness and safety outcomes were compared between those on tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) or abacavir (ABC), among children and young people living with HIV (CYPLHIV) aged 6-<25 years.
RESULTS:
577 CYPLHIV received TAF, 428 TDF and 426 ABC. 96%/83%/55% were ART-experienced, median age at drug start was 15·8/14·6/12·5 years, and median duration of follow-up was 1·6/2·3/3·0 years, respectively. Among all ART-experienced CYPLHIV at drug start there was no difference in the proportion virologically suppressed at 48 weeks. However, in those suppressed at drug start, the proportion suppressed at 48 weeks was higher on TDF than TAF (p=0·008). There was no difference in time to suppression (amongst unsuppressed at start) or to viral failure. Among those on TAF, there were four serious adverse events, of which 1 (renal colic) was considered related to TAF and led to discontinuation. The rate of treatment-emergent grade≥1 laboratory events was highest on TAF (adjusted incidence rate ratio vs. TAF: TDF 0·74(0·56-0·99, p=0·046); ABC 0·69(0·53-0·88), p=0·004). Rates of grade≥1 LDL and total cholesterol events on TAF were comparable on ABC, but higher than TDF, with no difference in bone/renal markers. There was no significant difference in grade≥3 events (p>0·500), although numbers were small. The risk of discontinuation (for reasons other than optimisation/simplification/unknown reason) was lowest for TAF.
CONCLUSION:
Virological outcomes were similar across drugs. Rates of any grade laboratory events were highest on TAF, driven by higher rates of lipid events. As TAF uptake increases, studies with long-term follow-up are required.
2025-10-01Therapeutic Advances in Infectious Disease
Patient-reported outcomes among people living with HIV switching to dual therapy with dolutegravir/lamivudine: results from the PROBI study
Article
作者: Marcellin, Fabienne ; Brown Hajdukova, Eva ; Chassany, Olivier ; Alain, Tristan ; Duracinsky, Martin ; Hocqueloux, Laurent ; Rousset Torrente, Olivia ; Zucman, David ; Allavena, Clotilde
Background::
Simplification of antiretroviral regimens has the potential to improve both patient-reported outcomes (PROs) and therapeutic adherence in people living with HIV (PLWH). Dual therapy with dolutegravir (DTG) plus lamivudine (3TC) demonstrated good safety and efficacy, but its impact on PROs remains to be documented.
Objectives::
To evaluate PROs among adult PLWH switching from standard multi-drug therapy to the DTG/3TC combined therapy Dovato
®
.
Design::
A non-comparative, 6-month observational study in 25 French medical centers.
Methods::
Sociodemographic and biomedical data were collected from medical records and PROs from self-administered questionnaires at treatment switch (Day, D0) and at months (M) 1 and 6. Primary endpoints included changes between D0 and M6 in perceived toxicity, treatment acceptability, PLWH’s preferences, and the score value of the treatment impact dimension of health-related quality of life (HRQL) (PROQOL-HIV) during follow-up. Secondary endpoints encompassed scores in other HRQL dimensions and self-reported symptoms. Multivariable standard and mixed-effects linear regression models were used to identify factors associated with PRO values and changes over time. Additionally, binary logistic regression was used to identify factors associated with the discontinuation of combined DTG/3TC regimen.
Results::
In the study population (260 PLWH, 64.6% male, mean ± SD age: 51 ± 12 years, 16 ± 10 years since HIV diagnosis), 20 individuals stopped treatment during follow-up, without resumption. Men, individuals previously receiving abacavir/3TC/DTG, and those with better daily comfort and perceived treatment efficacy were less likely to stop treatment. Treatment impact-related HRQL, acceptability of treatment, and number of self-reported symptoms significantly improved at M1 and M6. Mental and cognitive HRQL improved at M6.
Conclusion::
Dolutegravir and lamivudine dual oral therapy improved several dimensions in HRQL and delivered a simplified treatment regimen designed for eligible patients, supporting a patient-centered approach to managing HIV care. Attention should be maintained on the reasons for treatment discontinuation, especially among women.
Trial registration::
Patient-Reported Outcomes HV BItherapy (PROBI) was registered as number NCT04788784 on
https://clinicaltrials.gov/study/NCT04788784?term=PROBI&rank=2
.
2025-10-01CLINICAL BIOCHEMISTRY
Gaps in guideline adherence: evaluating HLA-B*57:01 screening for abacavir sensitivity and the implementation of evidence-based HIV care
Article
作者: Astles, Rex ; Buchacz, Kate ; Kalman, Lisa V ; Xia, Yang ; O'Shea, Jesse ; Huang, Ya-Lin A
OBJECTIVE:
Approximately 5-8 % of the population carries the HLA-B*57:01 allele, which increases the risk of severe hypersensitivity reactions to abacavir. Current guidelines and an FDA black box warning recommend HLA-B*57:01 screening for all patients before starting abacavir. We assessed the proportion of patients who undergo screening before initiating abacavir to evaluate adherence to guidelines.
DESIGN:
A retrospective cohort study using national IQVIA® PharMetrics Plus reimbursement data.
METHODS:
Data from the 2014-2022 IQVIA® PharMetrics Plus March 2023 dataset were analyzed. We identified patients aged ≥ 18 years who were newly prescribed abacavir, with ≥ 12 months of continuous enrollment before their first abacavir prescription. We examined the proportion of individuals who received HLA-B*57:01 screening any time before their initial abacavir prescription and conducted a multivariable logistic regression analysis on the receipt of HLA-B*57:01 screening adjusting for sex, age, year, and region.
RESULTS:
We identified 7,391 patients newly prescribed abacavir between 2014 and 2022. Approximately 46 % received an HLA-B*57:01 screen before initiation of abacavir. Annual screening rates ranged from 44 % to 50 % between 2015 and 2018 and dropped to 17 % by 2022. Screening was less likely to occur after 2018, compared to earlier in the study period, and more likely for younger as well as male patients.
CONCLUSIONS:
These findings highlight broader challenges in HIV guideline adherence, emphasizing the need for ongoing evaluation and systematic interventions to improve implementation and patient safety.
100 项与 Abacavir hydroxyacetate 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 斑块状银屑病 | 临床2期 | 美国 | 2015-08-01 | |
| HIV感染 | 临床2期 | - | 2003-01-01 |
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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4期 | HIV感染 维持 | 249 | Dual therapy with darunavir/ritonavir and lamivudine | 觸築鹽憲鹽簾顧鏇鏇鏇(鬱膚壓憲顧齋遞積餘遞) = 繭餘鏇廠窪網鏇壓窪願 鑰廠顧膚餘廠願衊繭夢 (廠觸壓願窪窪襯鬱構願 ) | 积极 | 2017-11-29 | |
Triple therapy with darunavir/ritonavir plus 2 nucleos(t)ides | 觸築鹽憲鹽簾顧鏇鏇鏇(鬱膚壓憲顧齋遞積餘遞) = 範願壓範糧築夢築壓膚 鑰廠顧膚餘廠願衊繭夢 (廠觸壓願窪窪襯鬱構願 ) | ||||||
临床4期 | 515 | Abacavir/Lamivudine/Atazanavir with Ritonavir | 選夢選窪襯艱選鹹艱遞(願夢窪艱構夢壓鬱憲壓) = 衊夢顧廠憲觸鬱鑰鑰齋 壓淵鹹糧築糧觸構範壓 (構築艱衊構顧餘醖廠艱 ) 更多 | - | 2013-02-01 | ||
Abacavir/Lamivudine/Atazanavir without Ritonavir | 選夢選窪襯艱選鹹艱遞(願夢窪艱構夢壓鬱憲壓) = 觸夢簾網廠憲觸遞艱壓 壓淵鹹糧築糧觸構範壓 (構築艱衊構顧餘醖廠艱 ) 更多 | ||||||
临床3期 | 369 | Abacavir/lamivudine (ABC/3TC) + Atazanavir/ritonavir (ATV/r) | 範鹽襯蓋鹽繭膚窪築糧(餘鏇鹽獵鹽顧觸範淵範) = 鹹夢餘窪鑰廠鏇鹽餘網 夢構獵鏇願襯構顧鬱築 (鬱膚蓋顧獵積糧願糧簾 ) 更多 | 积极 | 2012-10-31 | ||
Abacavir/lamivudine (ABC/3TC) + Atazanavir (ATV) | 範鹽襯蓋鹽繭膚窪築糧(餘鏇鹽獵鹽顧觸範淵範) = 艱製膚製範襯觸獵顧憲 夢構獵鏇願襯構顧鬱築 (鬱膚蓋顧獵積糧願糧簾 ) 更多 | ||||||
N/A | - | 鑰鏇簾廠築選廠鑰簾糧(鏇簾獵膚構簾糧鹹簾襯) = 廠選觸構鬱淵製鬱餘範 衊遞獵觸淵夢積夢簾襯 (醖鹹構觸積獵顧襯構鏇 ) 更多 | - | 2007-02-01 | |||
鑰鏇簾廠築選廠鑰簾糧(鏇簾獵膚構簾糧鹹簾襯) = 願觸鹽簾顧夢鑰鏇餘選 衊遞獵觸淵夢積夢簾襯 (醖鹹構觸積獵顧襯構鏇 ) 更多 | |||||||
N/A | 37 | 壓遞齋顧廠蓋積淵夢壓(艱觸壓廠繭糧廠艱艱糧) = 糧夢鹹繭衊獵窪蓋窪鹹 鹹蓋夢觸網獵夢艱構淵 (糧糧齋範醖鏇廠構顧觸 ) | - | 2003-01-01 | |||
壓遞齋顧廠蓋積淵夢壓(艱觸壓廠繭糧廠艱艱糧) = 膚糧製顧遞膚鏇鬱鹽獵 鹹蓋夢觸網獵夢艱構淵 (糧糧齋範醖鏇廠構顧觸 ) |
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