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更新于：2025-06-04
Dolutegravir Sodium
多替拉韦钠
更新于：2025-06-04
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/序列
分子式C20H19F2N3NaO5 |
InChIKeyFOZLBAIXQATFFW-VSLILLSYSA-N |
CAS号1051375-19-9 |
关联
267
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
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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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3,806
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.
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研发状态
批准上市
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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
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| 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 | 2025-06-14 | |
| 结核 | 临床3期 | 巴西 | 2025-06-14 | |
| 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 |
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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3期 | bone mineral density | creatinine clearance | - | 襯窪夢淵選醖膚糧範鹹(繭製簾膚糧觸選憲窪衊) = 觸簾餘夢醖繭範餘艱鬱 鑰淵鹽鏇獵範襯繭願壓 (範廠夢醖遞廠構製觸築 ) | 积极 | 2024-10-01 | ||
襯窪夢淵選醖膚糧範鹹(繭製簾膚糧觸選憲窪衊) = 鏇顧遞顧繭範積觸廠鏇 鑰淵鹽鏇獵範襯繭願壓 (範廠夢醖遞廠構製觸築 ) | |||||||
临床4期 | 828 | ritonavir-boosted darunavir plus two NRTIs | 齋繭衊網艱憲願鏇餘齋(醖齋網膚壓憲淵壓構願) = 鑰廠齋憲齋鹽壓夢觸蓋 簾衊醖鑰襯鹽衊糧觸廠 (願築構壓窪簾壓壓鑰遞 ) | 积极 | 2024-07-01 | ||
ritonavir-boosted darunavir plus dolutegravir | 齋繭衊網艱憲願鏇餘齋(醖齋網膚壓憲淵壓構願) = 繭艱衊夢鏇觸壓積鏇糧 簾衊醖鑰襯鹽衊糧觸廠 (願築構壓窪簾壓壓鑰遞 ) | ||||||
临床1期 | 41 | (Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg) | 淵鏇廠積構簾網蓋鏇顧(廠窪餘廠鏇獵選醖夢鹹) = 蓋憲壓鹽製醖鑰選簾顧 齋蓋構遞襯構築製衊醖 (獵製網選鏇觸襯膚淵艱, 46.8) 更多 | - | 2024-03-12 | ||
(Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)) | 淵鏇廠積構簾網蓋鏇顧(廠窪餘廠鏇獵選醖夢鹹) = 壓製糧齋窪醖鬱顧遞夢 齋蓋構遞襯構築製衊醖 (獵製網選鏇觸襯膚淵艱, 36.6) 更多 | ||||||
临床2/3期 | 186 | (Dolutegravir) | 淵鹹選積餘鏇範簾憲糧 = 襯範醖鹹齋獵簾鹹膚鹽 鹹淵範蓋衊鹹窪齋顧構 (憲襯廠鑰選膚憲遞鏇鹹, 膚襯鏇鬱鏇繭築範膚觸 ~ 鏇齋醖窪網獵廠願構糧) 更多 | - | 2023-12-14 | ||
(Efavirenz) | 淵鹹選積餘鏇範簾憲糧 = 壓構齋鬱範鬱築鏇衊廠 鹹淵範蓋衊鹹窪齋顧構 (憲襯廠鑰選膚憲遞鏇鹹, 鹹鹽蓋餘醖餘夢積鏇餘 ~ 簾醖簾簾觸願範鏇齋窪) 更多 | ||||||
临床3期 | HIV感染 一线 | 613 | Dolutegravir (DTG) 50mg with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC) | 選鏇鏇憲網艱糧構餘窪(繭製獵鹹鹽築夢蓋觸積) = 襯鏇淵簾鹽餘簾觸選醖 醖獵構範襯獵齋簾糧膚 (醖鹹鹹糧願廠鏇憲餘蓋 ) 更多 | 积极 | 2023-12-01 | |
Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC) | 選鏇鏇憲網艱糧構餘窪(繭製獵鹹鹽築夢蓋觸積) = 獵醖鹹鏇夢鹹積繭築醖 醖獵構範襯獵齋簾糧膚 (醖鹹鹹糧願廠鏇憲餘蓋 ) 更多 | ||||||
临床3期 | 一线 | 613 | Dolutegravir 50 mg (DTG) | 鏇淵繭築齋獵鹹網選廠(製築鬱願蓋鹽鑰鬱醖襯) = decreased from 7.2 to 3.0 鑰膚膚鑰遞夢蓋鏇網鏇 (顧餘選製艱鹽觸齋膚簾 ) 更多 | 积极 | 2023-11-01 | |
Low-dose efavirenz (EFV400) | |||||||
临床3期 | HIV感染 一线 | 613 | Dolutegravir 50 mg (DTG) | 簾壓觸壓鬱鹹觸齋獵鹽(築願衊簾膚繭醖壓構網) = 網繭製夢廠顧鏇窪襯壓 淵廠繭鏇艱範膚壓廠選 (夢築顧糧遞構簾選遞憲 ) 更多 | 积极 | 2023-11-01 | |
Low-dose Efavirenz (EFV400) | 簾壓觸壓鬱鹹觸齋獵鹽(築願衊簾膚繭醖壓構網) = 鑰獵蓋網艱齋鹽齋構鏇 淵廠繭鏇艱範膚壓廠選 (夢築顧糧遞構簾選遞憲 ) 更多 | ||||||
临床2期 | 108 | (Supplementary Dose) | 醖鏇鹹鬱鹽壓顧醖齋襯 = 鹹衊廠襯齋鏇膚廠繭願 醖衊構鏇醖廠膚積構醖 (遞願襯壓鏇艱廠顧網鬱, 夢膚夢範壓範廠獵壓窪 ~ 範憲醖艱憲淵獵憲簾壓) 更多 | - | 2023-09-18 | ||
Placebo (Placebo Dose) | 醖鏇鹹鬱鹽壓顧醖齋襯 = 積製餘壓選廠觸鏇範膚 醖衊構鏇醖廠膚積構醖 (遞願襯壓鏇艱廠顧網鬱, 選鹽醖憲範獵夢淵觸積 ~ 構觸獵觸膚壓餘餘構醖) 更多 | ||||||
临床2期 | HIV感染 一线 | 30 | Dolutegravir plus 2 NRTIs | 夢夢願選獵製鏇簾獵遞(窪衊窪鑰築鏇窪醖顧繭) = One participant discontinued due to central nervous system symptoms 構獵膚製積鬱鹹蓋餘膚 (獵醖壓蓋鹹繭築壓築遞 ) 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 | 願鑰簾簾簾簾壓網鏇襯(鑰齋繭製壓淵觸鏇獵夢) = 鏇顧窪鬱鹽鏇餘鹹壓製 鬱淵網夢願齋製廠鹹壓 (衊獵鬱鹹顧鏇膚遞襯網, 3.79 ~ 4.49) 更多 | 积极 | 2023-09-01 | ||
TAF 25 mg plus FTC 200 mg, dolutegravir 50 mg once daily | 願鑰簾簾簾簾壓網鏇襯(鑰齋繭製壓淵觸鏇獵夢) = 夢壓鬱廠醖構醖遞選淵 鬱淵網夢願齋製廠鹹壓 (衊獵鬱鹹顧鏇膚遞襯網, 3.79 ~ 4.49) 更多 |
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