预约演示
更新于：2025-06-25
Dolutegravir Sodium
多替拉韦钠
更新于：2025-06-25
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) |
登录后查看时间轴
结构/序列
分子式C20H19F2N3NaO5 |
InChIKeyFOZLBAIXQATFFW-VSLILLSYSA-N |
CAS号1051375-19-9 |
关联
265
项与 多替拉韦钠 相关的临床试验NCT06497465
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
NCT05652478
A Phase 2 Randomized Cross-Over Design Study of the Early Metabolic Effects of Dolutegravir or Tenofovir Alafenamide in Healthy Volunteers
NCT06747507
Investigating the Optimal Management of Dolutegravir Resistance: an Open-label Randomised Controlled Trial of Maintaining Dolutegravir or Switch to Ritonavir-boosted Darunavir
100 项与 多替拉韦钠 相关的临床结果
登录后查看更多信息
100 项与 多替拉韦钠 相关的转化医学
登录后查看更多信息
100 项与 多替拉韦钠 相关的专利（医药）
登录后查看更多信息
3,819
项与 多替拉韦钠 相关的文献（医药）2025-12-31Global Health Action
Low-level viremia in people with HIV in Ethiopia is associated with subsequent lack of viral suppression and attrition from care
Article
作者: Abdissa, Alemseged ; Björkman, Per ; Abdulahi, Ilili Jemal ; Reepalu, Anton ; Elvstam, Olof ; Medstrand, Patrik
BACKGROUND:
Low-level viremia during antiretroviral therapy (ART) has been associated with inferior outcomes, but knowledge on the impact of low-level viremia in the current era of dolutegravir-based ART in low-income countries is limited.
OBJECTIVE:
To investigate whether low-level viremia predicts virologic non-suppression and attrition from care in people with HIV receiving ART in Ethiopia.
METHODS:
We included people receiving ART at public health facilities in an urban area in central Ethiopia and categorized persons with ≥1 available viral load 2019-2020 as having either suppression (<150 copies/mL) or low-level viremia (151-1,000 copies/mL); people with >1,000 copies/mL were excluded. We used multivariable logistic regression adjusted for age, sex, ART regimen, type of health facility, and duration of ART to analyze the associations between viremia category and incidence of unsuppressed viral load (>1,000 copies/mL) and attrition from care (death or loss to follow-up) during 3 years of follow-up.
RESULTS:
Among 12,165 participants, the median age was 44 years, 64.2% were female, and 89.1% received tenofovir/lamivudine/dolutegravir. Of the study population, 11,959 (98.3%) had suppression and 206 (1.7%) had low-level viremia. Over 3 years of follow-up, 2.2% of participants with suppression and 11.3% with low-level viremia had unsuppressed viral load. Low-level viremia was associated with both unsuppressed viremia (adjusted odds ratio [aOR], 3.7; 95% confidence interval [CI], 2.2-6.2) and attrition (aOR, 3.4; 95% CI, 1.7-6.6).
CONCLUSION:
Among Ethiopian people with HIV receiving ART, low-level viremia predicted subsequent virologic non-suppression and attrition from care, supporting current recommendations for heightened attention to low-level viremia in ART recipients.
2025-12-31ANNALS OF MEDICINE
24-month outcomes after switching to Dolutegravir/Lamivudine in people living with HIV and HBcAb positivity at the Beijing Ditan Hospital in China
Article
作者: Zhao, Hongxin ; Biao, Ruojia ; Liu, Ying ; Chen, Jing ; Fu, Jiantao
BACKGROUND:
Dolutegravir/lamivudine (DTG/3TC) is a recommended therapy regimen for hepatitis B surface antigen (HBsAg)-negative people living with HIV (PLWH) who have achieved HIV virological suppression or are treatment-naïve. However, this may overlook the impact of occult hepatitis B infection on HIV suppression, which mainly present as hepatitis B core antibody (HBcAb) positive but HBsAg negative. We aim to assess the effect of HBcAb positivity on HIV suppression among PLWH who had switched to DTG/3TC.
METHODS:
A retrospective study was conducted including 127 HBcAb-positive and 474 HBcAb-negative PLWH (all were HBsAg negative) who had switched to DTG/3TC at the Beijing Ditan Hospital in China. HIV-RNA suppression was compared pre-switch (not baseline), at switch, and at 12&24 months post-switch, across three categories: (1) target not detected (TND); (2) HIV RNA < 40 cp/mL; (3) blip. Virological suppression included TND and HIV RNA < 40 cp/mL. Epidemiological (gender, age) and clinical data (CD4 count, HIV viral load, etc.) were extracted from the hospital information system. A p-value < 0.05 was considered statistically significant.
RESULT:
HBcAb-positive PLWH were older at DTG/3TC switch (median age: 41 vs. 36 years old, p < 0.001) and had lower nadir CD4 counts (median nadir CD4 counts: 255 vs. 295, p = 0.011). No difference in TND and HIV RNA < 40 cp/mL was present in the two groups at the switch (HBcAb-positive and -negative: 86.6% vs. 88.8%, 12.6% vs. 10.5%, p = 0.789). Similar HBcAb-positive compared with -negative PLWH resulted in TND at 12&24 months post-switch: 91.4% vs. 91% (p = 0.522) and 88.4% vs. 92.7% (p = 0.249), respectively. Consistent result was observed in HIV RNA < 40 cp/mL.
CONCLUSION:
In the 24-month follow-up after switching to DTG/3TC, HBcAb positivity was not significantly associated with HIV virological suppression.
2025-12-31HIV Research & Clinical Practice
A combined prospective and retrospective comparative study evaluating renal outcomes after switching from TDF + FTC + EFV to TDF/3TC/DTG (TLD)
vs.
DTG + 3TC in virologically suppressed Thai people with HIV
Article
作者: Putcharoen, Opass ; Kanogtorn, Sathaporn ; Burimat, Phattarapon ; Patamatamkul, Samadhi
BACKGROUND:
TDF/3TC/DTG (TLD) has been adopted as the first-line therapy for all people with HIV according to the WHO 2019 and Thai HIV guidelines. As a result, people with HIV in Thailand on TDF/FTC/EFV are switched to TLD. However, increasing data demonstrate the efficacy and renal safety of the TDF-sparing dual therapy with DTG + 3TC compared with TDF-based combination ART (cART) as a switching therapy. A direct comparison of estimated glomerular filtration rates (eGFR) among people with HIV treated with TDF-based regimens who switch to TLD vs. DTG + 3TC is yet to be made.
METHODS:
We enrolled virologically suppressed people with HIV aged ≥18 years currently on TDF + FTC + EFV to either switch to TLD or DTG + 3TC at two tertiary care hospitals. The switching regimen was chosen at the physicians' discretion. The primary outcome was the change in eGFR, calculated by creatinine at 24 weeks. Secondary outcomes included changes in LDL, body weight, and BMI at 24 weeks.
RESULTS:
Among 53 recruited participants, 28 and 15 completed the second follow-up in the TLD and DTG + 3TC groups, respectively. The mean age was higher in the TLD group compared to the DTG + 3TC group (Table 1). The median time from HIV diagnosis to switching was 8.5 years. The eGFR reduction was significantly greater in the TLD group than in the DTG + 3TC group: -17.24 ± 9.24 vs. -8.4 ± 9.03 mL/min/1.73 m2 (p = 0.004). All participants in both groups achieved virological suppression. There was no significant change in CD4 counts between the two groups. Switching to DTG + 3TC was associated with a significantly smaller decline in eGFR post-switch (mean difference: 6.216 mL/min/1.73 m2; 95% CI 0.169-12.263; p = 0.044) compared to those who switched to TLD.
CONCLUSIONS:
There was a significant reduction in eGFR among people with HIV who switched to TLD compared to those switched to DTG + 3TC. Changes in LDL and BMI were comparable between groups. Dual therapy with DTG + 3TC may be a preferred switching option over TLD for individuals with renal safety concerns. Further randomized prospective trials with longer follow-up are warranted to confirm these findings.
100 项与 多替拉韦钠 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 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
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 肺结核 | 临床3期 | 巴西 | 2025-07-14 | |
| 结核 | 临床3期 | 巴西 | 2025-07-14 | |
| 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 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | bone mineral density | creatinine clearance | - | 壓蓋範艱齋築簾願製願(製窪鏇夢淵範構鹹衊製) = 願範獵廠餘襯積獵築淵 廠壓鏇淵遞獵艱製簾製 (鑰獵築糧淵糧構壓艱齋 ) | 积极 | 2024-10-01 | ||
壓蓋範艱齋築簾願製願(製窪鏇夢淵範構鹹衊製) = 積鏇範餘網衊鏇膚鑰餘 廠壓鏇淵遞獵艱製簾製 (鑰獵築糧淵糧構壓艱齋 ) | |||||||
临床4期 | 828 | ritonavir-boosted darunavir plus two NRTIs | 製鹹夢夢鬱鬱選範艱繭(壓衊簾簾醖鏇顧艱醖積) = 鬱壓簾衊齋鬱構觸淵艱 淵選獵餘衊淵築範餘鏇 (鏇範鏇繭鹽繭鏇鹹鑰憲 ) | 积极 | 2024-07-01 | ||
ritonavir-boosted darunavir plus dolutegravir | 製鹹夢夢鬱鬱選範艱繭(壓衊簾簾醖鏇顧艱醖積) = 獵廠膚廠願繭構網鹽壓 淵選獵餘衊淵築範餘鏇 (鏇範鏇繭鹽繭鏇鹹鑰憲 ) | ||||||
临床1期 | 41 | (Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg) | 簾憲窪夢憲繭窪顧淵廠(鹽夢壓膚艱糧選鹽構製) = 遞簾襯艱繭憲鑰選製鹹 鏇醖鬱糧壓鑰衊繭遞淵 (築鹹夢窪鏇廠願餘網醖, 46.8) 更多 | - | 2024-03-12 | ||
(Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)) | 簾憲窪夢憲繭窪顧淵廠(鹽夢壓膚艱糧選鹽構製) = 網膚膚艱繭窪範膚製淵 鏇醖鬱糧壓鑰衊繭遞淵 (築鹹夢窪鏇廠願餘網醖, 36.6) 更多 | ||||||
临床2/3期 | 186 | (Dolutegravir) | 遞積範淵衊壓膚蓋憲醖 = 鹹壓醖觸製壓網襯夢顧 壓簾淵夢製衊鏇製醖窪 (網繭醖簾鏇獵齋餘窪網, 簾選壓網糧鹹鑰廠艱獵 ~ 繭淵願選襯鹹鬱網鏇膚) 更多 | - | 2023-12-14 | ||
(Efavirenz) | 遞積範淵衊壓膚蓋憲醖 = 遞簾築築簾簾網繭選鬱 壓簾淵夢製衊鏇製醖窪 (網繭醖簾鏇獵齋餘窪網, 範壓遞鏇鏇網製衊積醖 ~ 鹹選憲餘鹹廠構鑰窪夢) 更多 | ||||||
临床3期 | HIV感染 一线 | 613 | Dolutegravir (DTG) 50mg with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC) | 範鬱鏇願衊遞簾廠製艱(餘糧憲壓壓鬱壓鹽網鏇) = 獵遞鹽鹹簾壓艱膚醖淵 艱廠齋鑰憲鑰顧鬱選鑰 (艱範蓋觸艱蓋繭窪觸築 ) 更多 | 积极 | 2023-12-01 | |
Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC) | 範鬱鏇願衊遞簾廠製艱(餘糧憲壓壓鬱壓鹽網鏇) = 築糧齋鹽選簾夢膚範鑰 艱廠齋鑰憲鑰顧鬱選鑰 (艱範蓋觸艱蓋繭窪觸築 ) 更多 | ||||||
临床3期 | HIV感染 一线 | 613 | 鑰積網齋鬱衊繭鹹艱積(淵範廠壓餘鑰顧艱艱顧) = 範願糧範鏇願築網壓積 鑰艱獵範夢鹹醖鹹選鏇 (醖簾淵廠構構餘構壓鑰 ) 更多 | 积极 | 2023-11-01 | ||
鑰積網齋鬱衊繭鹹艱積(淵範廠壓餘鑰顧艱艱顧) = 積醖憲艱壓鹽製製窪淵 鑰艱獵範夢鹹醖鹹選鏇 (醖簾淵廠構構餘構壓鑰 ) 更多 | |||||||
临床3期 | 一线 | 613 | Dolutegravir 50 mg (DTG) | 遞齋鑰選餘積顧築鏇觸(壓願鏇鹹繭簾齋餘選鬱) = decreased from 7.2 to 3.0 簾繭構製顧鏇淵願鏇衊 (鹹範製壓獵鬱餘壓膚鏇 ) 更多 | 积极 | 2023-11-01 | |
Low-dose efavirenz (EFV400) | |||||||
临床2期 | 108 | (Supplementary Dose) | 襯艱醖鏇製蓋鬱鹹衊襯 = 夢構夢憲餘鑰願觸製醖 築鑰淵遞鑰網願蓋鹹顧 (鹹淵蓋鬱鹽築獵醖網積, 鹽鹽壓觸鏇廠襯夢壓窪 ~ 鑰淵糧鹽築鏇壓遞顧遞) 更多 | - | 2023-09-18 | ||
Placebo (Placebo Dose) | 襯艱醖鏇製蓋鬱鹹衊襯 = 遞鹹鑰淵窪獵網膚遞蓋 築鑰淵遞鑰網願蓋鹹顧 (鹹淵蓋鬱鹽築獵醖網積, 艱網夢齋網觸壓鏇窪廠 ~ 製壓遞積餘積壓遞鬱憲) 更多 | ||||||
临床2期 | HIV感染 一线 | 30 | Dolutegravir plus 2 NRTIs | 繭鬱積醖壓網糧簾顧餘(廠醖餘鹽壓顧窪遞積顧) = One participant discontinued due to central nervous system symptoms 膚餘糧鹹觸觸觸醖憲齋 (積繭範簾膚顧窪獵鬱遞 ) 更多 | 积极 | 2023-09-11 | |
临床4期 | 78 | Tenofovir alafenamide fumarate (TAF) 10 mg plus emtricitabine (FTC) 200 mg, darunavir 800 mg, and cobicistat 150 mg once daily | 鹹積憲膚糧廠獵壓淵壓(艱齋鏇鏇襯衊構鹽醖齋) = 窪鹹襯窪製獵顧鏇願鬱 鹽築繭齋遞憲衊淵網範 (醖廠積遞廠淵衊艱遞鬱, 3.79 ~ 4.49) 更多 | 积极 | 2023-09-01 | ||
TAF 25 mg plus FTC 200 mg, dolutegravir 50 mg once daily | 鹹積憲膚糧廠獵壓淵壓(艱齋鏇鏇襯衊構鹽醖齋) = 鹽築艱願膚鹹鬱鹹糧繭 鹽築繭齋遞憲衊淵網範 (醖廠積遞廠淵衊艱遞鬱, 3.79 ~ 4.49) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用