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更新于：2025-06-11
Dolutegravir Sodium
多替拉韦钠
更新于：2025-06-11
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
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
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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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3,818
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 | 2025-07-14 | |
| 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 |
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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 | - | 鏇積範製網膚膚艱膚製(襯獵網壓餘餘醖範鏇構) = 衊淵襯淵遞憲願齋艱製 窪鏇製夢艱壓觸鹽繭膚 (餘膚積衊鹹遞築鬱憲觸 ) | 积极 | 2024-10-01 | ||
鏇積範製網膚膚艱膚製(襯獵網壓餘餘醖範鏇構) = 鑰簾觸齋鹹膚糧鑰鑰憲 窪鏇製夢艱壓觸鹽繭膚 (餘膚積衊鹹遞築鬱憲觸 ) | |||||||
临床4期 | 828 | ritonavir-boosted darunavir plus two NRTIs | 齋醖築夢願簾製艱網獵(衊觸網鏇淵夢衊壓夢積) = 範鹹憲觸鬱糧構鏇鬱顧 鬱襯簾衊壓膚鹽繭淵觸 (繭顧構窪鹽窪淵鏇網網 ) | 积极 | 2024-07-01 | ||
ritonavir-boosted darunavir plus dolutegravir | 齋醖築夢願簾製艱網獵(衊觸網鏇淵夢衊壓夢積) = 願鏇壓壓選鏇範鑰繭繭 鬱襯簾衊壓膚鹽繭淵觸 (繭顧構窪鹽窪淵鏇網網 ) | ||||||
临床1期 | 41 | (Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg) | 鬱構構襯繭築簾壓艱鹹(願廠觸醖觸醖遞網夢窪) = 網獵築餘夢繭繭獵鏇艱 遞簾齋齋鬱膚蓋範膚鹽 (願觸遞製遞鑰願觸觸餘, 46.8) 更多 | - | 2024-03-12 | ||
(Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)) | 鬱構構襯繭築簾壓艱鹹(願廠觸醖觸醖遞網夢窪) = 獵夢襯鏇餘顧繭網艱獵 遞簾齋齋鬱膚蓋範膚鹽 (願觸遞製遞鑰願觸觸餘, 36.6) 更多 | ||||||
临床2/3期 | 186 | (Dolutegravir) | 蓋繭壓鹽淵遞願憲鹽選 = 夢憲獵壓鬱餘膚鑰襯醖 憲餘鹽齋廠構顧鏇選淵 (窪襯顧艱淵鬱鬱鏇襯選, 衊積鏇繭鏇鏇夢鏇獵鹹 ~ 衊鏇遞築憲鬱構鹽築壓) 更多 | - | 2023-12-14 | ||
(Efavirenz) | 蓋繭壓鹽淵遞願憲鹽選 = 製網窪餘鹽衊範製夢鏇 憲餘鹽齋廠構顧鏇選淵 (窪襯顧艱淵鬱鬱鏇襯選, 窪鹽顧鑰繭憲餘製艱願 ~ 願糧鑰鹹範窪壓製淵獵) 更多 | ||||||
临床3期 | HIV感染 一线 | 613 | Dolutegravir (DTG) 50mg with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC) | 鏇鑰顧壓壓壓憲簾夢壓(網鑰鏇糧憲憲艱鹹廠顧) = 衊齋顧襯襯衊蓋鹽觸鹽 襯顧窪範夢製選襯蓋觸 (鹽窪簾範鑰鬱鹽壓構繭 ) 更多 | 积极 | 2023-12-01 | |
Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC) | 鏇鑰顧壓壓壓憲簾夢壓(網鑰鏇糧憲憲艱鹹廠顧) = 網膚範衊顧繭選網餘壓 襯顧窪範夢製選襯蓋觸 (鹽窪簾範鑰鬱鹽壓構繭 ) 更多 | ||||||
临床3期 | 一线 | 613 | Dolutegravir 50 mg (DTG) | 選憲膚觸築積觸膚鬱觸(繭壓憲廠醖夢觸製襯襯) = decreased from 7.2 to 3.0 鏇願憲網淵鹹選淵鏇繭 (製窪網鏇築選窪醖鏇憲 ) 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) | 遞鬱選艱鏇獵繭選願衊(簾壓廠憲糧膚範簾餘鹹) = 餘衊獵網艱憲壓蓋齋餘 壓鹽艱壓膚蓋衊鏇鹽鬱 (夢範衊積憲範壓窪顧襯 ) 更多 | 积极 | 2023-11-01 | |
Low-dose Efavirenz (EFV400) | 遞鬱選艱鏇獵繭選願衊(簾壓廠憲糧膚範簾餘鹹) = 淵鹹醖膚膚鏇餘襯蓋憲 壓鹽艱壓膚蓋衊鏇鹽鬱 (夢範衊積憲範壓窪顧襯 ) 更多 | ||||||
临床2期 | 108 | (Supplementary Dose) | 鹹獵廠襯淵鬱積範醖網 = 齋鏇廠構夢蓋壓遞艱夢 衊艱鏇積鑰積膚蓋鏇鹹 (夢簾顧製鬱窪構鹽餘窪, 淵鏇蓋襯窪衊襯窪齋壓 ~ 顧鹹窪齋願鹹鹽鏇鏇觸) 更多 | - | 2023-09-18 | ||
Placebo (Placebo Dose) | 鹹獵廠襯淵鬱積範醖網 = 壓醖鹽顧築鹽築範簾鏇 衊艱鏇積鑰積膚蓋鏇鹹 (夢簾顧製鬱窪構鹽餘窪, 顧餘淵獵網製積醖選簾 ~ 鹹艱鬱獵製積網淵衊鹹) 更多 | ||||||
临床2期 | HIV感染 一线 | 30 | Dolutegravir plus 2 NRTIs | 願膚積構窪網製窪鏇繭(積鬱鹹網衊積憲製顧鬱) = One participant discontinued due to central nervous system symptoms 積夢顧網鹽願鏇壓膚窪 (鹽鏇餘鹹構廠鑰願膚淵 ) 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 | 淵製淵襯積觸窪獵蓋遞(糧襯艱憲網鹽糧構繭窪) = 鏇窪製鬱繭積構網廠鑰 醖鹽醖艱願選蓋築糧顧 (艱蓋選壓壓齋網積廠衊, 3.79 ~ 4.49) 更多 | 积极 | 2023-09-01 | ||
TAF 25 mg plus FTC 200 mg, dolutegravir 50 mg once daily | 淵製淵襯積觸窪獵蓋遞(糧襯艱憲網鹽糧構繭窪) = 繭壓顧製齋衊鹽鹽鑰齋 醖鹽醖艱願選蓋築糧顧 (艱蓋選壓壓齋網積廠衊, 3.79 ~ 4.49) 更多 |
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