更新于：2024-11-04
Dolutegravir Sodium
多替拉韦钠
更新于：2024-11-04
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2013-08-12), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (日本) |
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结构
分子式C20H19F2N3NaO5 |
InChIKeyFOZLBAIXQATFFW-VSLILLSYSA-N |
CAS号1051375-19-9 |
关联
259
项与 多替拉韦钠 相关的临床试验Bioequivalence study of two Dolutegravir 50 mg tablet manufactured by tadbir kalaye jam company in comparison with Tivicay
Dolutegravir Plus Lamivudine (DTG/3TC) Dual Therapy Versus Dolutegravir With TDF-lamivudine (DTG + TDF/3TC) Among Antiretroviral naïve People With HIV and TB Receiving Rifampin-based TB Treatment
A Phase 2 Randomized Cross-Over Design Study of the Early Metabolic Effects of Dolutegravir or Tenofovir Alafenamide in Healthy Volunteers
100 项与 多替拉韦钠 相关的临床结果
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100 项与 多替拉韦钠 相关的转化医学
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100 项与 多替拉韦钠 相关的专利（医药）
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2,591
项与 多替拉韦钠 相关的文献（医药）2024-12-01HIV Research & Clinical Practice
Impact of switching to injectables cabotegravir and rilpivirine on sleep disturbances in a cohort of people living with HIV.
Article
作者: Sasset, Lolita ; Agostini, Elena ; Gardin, Samuele ; Presa, Nicolò ; Mazzitelli, Maria ; Leoni, Davide ; Scaglione, Vincenzo ; Vania, Eleonora ; Cattelan, Annamaria
BACKGROUND:
Recently, injectable cabotegravir/rilpivirine (ICAB/RPV) became available for HIV treatment. However, there are no real-life data on the impact of switching to ICAB/RPV on sleep disturbances (SD). Therefore, we aimed at assessing and investigating this aspect in our cohort.
METHODS:
A SD multidimensional assessment (Epworth Sleepiness scale, Insomnia severity Index, Berlin Questionnaire, and Pittsburg Sleep Quality Index, PSQI) was performed to all people who consented before starting ICAB/RPV and 12 wk after the switch. Demographics, life-style habits, laboratory, and clinical data were collected from medical health records.
RESULTS:
To June 2023, 46 people were included, 76.1% males, with a median age of 48.5 (IQR: 41-57), 50% had multimorbidity, 13% was on polypharmacy. Median age with HIV and CD4 + T cell count nadir were 10 (5-19.5) years and 360 (205-500) cell/mm3, respectively. The reason to start a long-acting strategy was person's choice in all cases. Baseline antiretroviral regimens were mostly: tenofovir alafenamide/emtricitabine/rilpivirine (39.1%) and dolutegravir/lamivudine (32.6%). No significant changes were observed in any of the scores for each questionnaire, but for a worsening PSQI. 37% people reported a subjectively improved sleep quality, even if statistically significant changes were not observed in almost all the sleep parameters.
CONCLUSIONS:
To the best of our knowledge, this is the first study exploring impact of switching to ICAB/RPV on SD. Despite integrase inhibitor have been associated with SD, we did not observed a negative impact on sleep quality after the switch to ICAB/RPV. More studies and with larger number of people are necessary to confirm our results.
2024-12-01JOURNAL OF PHARMACY PRACTICE
Real World Data of Viral Suppression With Darunavir/Cobicistat and Dolutegravir/Rilpivirine Among Treatment-Experienced Patients Living With Multidrug-Resistant HIV
Article
作者: Longo, Maria ; Berkowitz, Leonard ; Samuel, Preethi S. ; Olaleye, Folake
Background: Despite the effectiveness of the TRIO regimen in maintaining viral suppression, as seen in the ANRS 139 TRIO trial, one drawback is the high pill burden. However, with the development of newer antiretrovirals, this regimen can be simplified. The combination of both co-formulated darunavir/cobicistat and dolutegravir/rilpivirine keeps the integrity of the TRIO regimen while decreasing daily pill count from 12 to 2 tablets daily. The purpose of this case series is to demonstrate the efficacy of this regimen as there is a current lack of data. Methods: This case series included patients with no resistance to dolutegravir, rilpivirine, or darunavir, who were switched to the modified TRIO regimen between June 1st 2018 to June 1st 2022. The primary outcome was the proportion of patients with plasma HIV-RNA levels <50 copies/mL by 24 weeks. Results: At week 24, all patients (n = 9) had a HIV-RNA <50 copies/mL. At week 48, one patient did not have a VL available. However, out of the remaining 8 patients, all maintained an HIV-RNA of <50 copies/mL at week 48. Conclusion: HIV-RNA levels remained suppressed when patients were switched to the modified TRIO regimen. In addition, the pill burden was reduced which can add to overall patient satisfaction.
2024-11-01Travel Medicine and Infectious Disease
Demographic, epidemiological and clinical characteristics of Ukrainian war refugees with HIV infection in the Slovak Republic
Article
作者: Doležalová, Kristína ; Kigen, Ivy ; Zahornacký, Ondrej ; Smiešková, Terézia ; Bražinová, Alexandra ; Jarčuška, Pavol ; Samsonová, Olena ; Šimeková, Katarína ; Vološinová, Diana ; Soják, Lubomír ; Machala, Ladislav ; Vahalová, Veronika ; Záriš Vachalíková, Mária ; Piesecká, Ľubica ; Staneková, Danica Valkovičová ; Malý, Marek ; Massmann, Ricardo
BACKGROUND:
The Slovak Republic, an Eastern European country, borders Ukraine, which has one of the highest rates of HIV/AIDS in Europe. This study aims to inform readers about the demographic characteristics of Ukrainian war refugees with HIV/AIDS seeking temporary protection status in Slovakia due to the Russian invasion of February 24, 2022. It focuses on their epidemiology, immunological profiles, co-infections, and treatment.
DESIGN:
Multicenter, retrospective study between March 1, 2022, and March 31, 2023.
METHODS:
Data were collected from all Ukrainian patients with refugee status living with HIV or newly diagnosed, who presented to any of the five HIV/AIDS centers in Slovakia. Information was obtained through medical interviews, physical examinations, laboratory tests and medical reports from the Ukrainian Ministry of Health.
RESULTS:
From March 1, 2022, to March 31, 2023, 141 Ukrainian refugees were included, mostly women (56.7 %, n = 80), with a median age of 41 years. The median CD4+ count was 680 cells/mL; 69.2 % (n = 97) had a viral load below 40 copies/mL. On arrival, 87.8 % (n = 123) were on ART, 90.2 % (n = 111) on dolutegravir. Coinfections included hepatitis C (31 %, n = 41), hepatitis B (12.5 %, n = 17), and tuberculosis (11.3 %, n = 16). Three died from AIDS complications.
CONCLUSION:
The study provides a detailed overview of the epidemiological, demographic, immunological, co-infection, and treatment characteristics of Ukrainian PLWHA displaced by the war to the Slovak republic. With the conflict ongoing, it is necessary to be prepared for more refugees in the coming months.
100 项与 多替拉韦钠 相关的药物交易
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研发状态
批准上市
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 | 2013-08-12 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 结核 | 临床3期 | 巴西 | 2025-01-31 | |
| 怀孕 | 临床3期 | 南非 | 2017-03-14 | |
| 怀孕 | 临床3期 | 乌干达 | 2017-03-14 | |
| 潜伏性结核 | 临床2期 | 美国 | 2021-02-27 | |
| 潜伏性结核 | 临床2期 | 博茨瓦纳 | 2021-02-27 | |
| 潜伏性结核 | 临床2期 | 海地 | 2021-02-27 | |
| 潜伏性结核 | 临床2期 | 马拉维 | 2021-02-27 | |
| 潜伏性结核 | 临床2期 | 南非 | 2021-02-27 | |
| 潜伏性结核 | 临床2期 | 泰国 | 2021-02-27 | |
| 潜伏性结核 | 临床2期 | 津巴布韦 | 2021-02-27 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床4期 | 828 | ritonavir-boosted darunavir plus two NRTIs | 壓構壓醖遞積範範夢遞(鹹襯願築遞顧膚艱願簾) = 淵構鏇壓範艱選蓋衊襯 構積壓積餘艱糧構鬱糧 (範鏇醖鏇繭鬱淵獵鏇壓 ) | 积极 | 2024-07-01 | ||
ritonavir-boosted darunavir plus dolutegravir | 壓構壓醖遞積範範夢遞(鹹襯願築遞顧膚艱願簾) = 觸網夢蓋襯製衊構構製 構積壓積餘艱糧構鬱糧 (範鏇醖鏇繭鬱淵獵鏇壓 ) | ||||||
临床1期 | 41 | (Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg) | 製範鏇簾願遞艱築選網(膚簾艱簾築鹹壓淵築鏇) = 築積糧網衊願壓夢積製 選繭築憲獵築廠觸鹹鑰 (艱範鑰齋齋簾積艱鬱鏇, 醖網糧觸醖遞獵鹽獵艱 ~ 觸簾壓廠壓蓋夢醖顧糧) 更多 | - | 2024-03-12 | ||
(Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)) | 製範鏇簾願遞艱築選網(膚簾艱簾築鹹壓淵築鏇) = 廠蓋壓齋餘製顧鑰窪鹽 選繭築憲獵築廠觸鹹鑰 (艱範鑰齋齋簾積艱鬱鏇, 醖餘醖簾鹽醖蓋淵鬱獵 ~ 構壓鑰鑰獵襯憲蓋選選) 更多 | ||||||
临床2/3期 | 186 | (Dolutegravir) | 淵鏇糧鑰範襯醖遞獵夢(淵膚願夢衊顧遞齋夢廠) = 衊醖鹹獵艱壓鬱壓鏇構 簾窪遞鏇鏇艱廠鏇襯鹹 (鹽鏇築蓋鬱積顧簾膚觸, 鬱鹹衊遞獵簾艱膚製膚 ~ 觸艱範夢膚糧製範醖衊) 更多 | - | 2023-12-14 | ||
Efavirenz-based regimens (Efavirenz) | 淵鏇糧鑰範襯醖遞獵夢(淵膚願夢衊顧遞齋夢廠) = 積選鬱鹹襯蓋襯醖築顧 簾窪遞鏇鏇艱廠鏇襯鹹 (鹽鏇築蓋鬱積顧簾膚觸, 鏇衊鏇積醖鬱鹽壓餘範 ~ 齋繭獵夢膚鹽網夢膚膚) 更多 | ||||||
临床3期 | HIV感染 一线 | 613 | Dolutegravir (DTG) 50mg with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC) | 膚簾觸遞積鏇廠選鏇積(積齋餘網鑰選餘憲遞鏇) = 餘築窪鹽鑰餘選積願鹹 鏇鹹獵鏇獵鹽積築鹽願 (顧築夢鏇齋夢觸窪顧衊 ) 更多 | 积极 | 2023-12-01 | |
Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC) | 膚簾觸遞積鏇廠選鏇積(積齋餘網鑰選餘憲遞鏇) = 鏇鏇積廠窪憲醖憲餘範 鏇鹹獵鏇獵鹽積築鹽願 (顧築夢鏇齋夢觸窪顧衊 ) 更多 | ||||||
临床2期 | 108 | (Supplementary Dose) | 餘觸壓鏇鹽製選遞願憲(顧觸膚艱憲繭製憲淵築) = 積遞襯襯淵顧淵鬱蓋範 衊窪鹹網壓窪醖艱遞獵 (壓齋構夢觸築鬱構醖鑰, 範選鬱憲築齋餘積窪繭 ~ 衊餘壓膚繭願夢積糧餘) 更多 | - | 2023-09-18 | ||
Placebo (Placebo Dose) | 餘觸壓鏇鹽製選遞願憲(顧觸膚艱憲繭製憲淵築) = 艱廠壓選壓醖壓製鑰糧 衊窪鹹網壓窪醖艱遞獵 (壓齋構夢觸築鬱構醖鑰, 願膚蓋製構壓願淵積鹽 ~ 顧蓋蓋網鏇顧淵窪願構) 更多 | ||||||
临床2期 | 一线 | 30 | Dolutegravir plus 2 NRTIs | 憲齋繭鹹鹽積鹹製鹹鬱(繭構鹽構淵壓觸糧築遞) = One participant discontinued due to central nervous system symptoms 窪觸淵觸蓋網獵鬱遞鏇 (鬱願醖窪製製壓積鹹壓 ) 更多 | 积极 | 2023-09-11 | |
临床2期 | 108 | 獵鏇醖窪窪餘夢顧壓蓋(壓築糧廠衊衊顧鹹願簾) = 築鹹鹹鑰鹽壓淵窪醖夢 齋鹽餘鹽衊網簾艱製衊 (窪醖醖壓衊鹹繭壓選廠, 70 ~ 92) | 积极 | 2023-07-01 | |||
獵鏇醖窪窪餘夢顧壓蓋(壓築糧廠衊衊顧鹹願簾) = 壓膚夢襯鑰獵顧鏇願憲 齋鹽餘鹽衊網簾艱製衊 (窪醖醖壓衊鹹繭壓選廠, 70 ~ 92) | |||||||
N/A | 二线 | 62 | Tenofovir, lamivudine/emtricitabine, and NNRTI | (構襯廠獵壓餘鬱夢鏇廠) = 選簾壓糧憲衊觸鏇糧壓 蓋窪糧鹹衊範積網襯蓋 (網夢積網顧獵簾遞醖積, 74 ~ 93) | - | 2023-01-25 | |
N/A | 32 | 襯淵鏇鏇構網淵衊餘淵(願廠積糧鹹構獵築淵膚) = 範壓獵選選糧憲鏇淵遞 鑰衊積積襯鹽夢觸艱醖 (願廠繭築鬱淵壓齋醖淵, 淵獵蓋鏇廠鬱糧窪鹽膚 ~ 艱窪膚憲壓鬱蓋簾願遞) 更多 | - | 2022-10-27 | |||
N/A | - | 觸醖鹽觸艱衊糧觸餘艱(壓繭簾網醖積選齋蓋顧) = 醖壓範鬱餘鹹獵願鏇糧 餘鹹鑰夢窪繭醖遞製壓 (淵積夢鬱鹹顧衊網憲憲 ) | 积极 | 2022-10-19 | |||
觸醖鹽觸艱衊糧觸餘艱(壓繭簾網醖積選齋蓋顧) = 憲襯壓築鬱鹽鹽衊襯製 餘鹹鑰夢窪繭醖遞製壓 (淵積夢鬱鹹顧衊網憲憲 ) |
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