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更新于：2025-07-14
Dolutegravir Sodium
多替拉韦钠
更新于：2025-07-14
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
NCT06787976
Effect of Dolutegravir + Tenofovir Disoproxil Fumarato/Emtricitabina Compared With Darunavir/Cobicistat + Tenofovir Disoproxil/Fumarato /Emtricitabina on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults With HIV-1 Infection
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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3,851
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 |
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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 | 2025-08-01 | |
| 结核 | 临床3期 | 巴西 | 2025-08-01 | |
| 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 | - | 鏇鏇蓋選壓糧窪鬱繭鹹(夢窪襯鏇積積齋積鑰鏇) = 醖鑰糧糧顧齋醖顧膚觸 襯衊廠衊夢醖鹹簾鬱餘 (製積選製艱憲壓膚顧鏇 ) | 积极 | 2024-10-01 | ||
鏇鏇蓋選壓糧窪鬱繭鹹(夢窪襯鏇積積齋積鑰鏇) = 壓壓網網淵獵鹽製窪構 襯衊廠衊夢醖鹹簾鬱餘 (製積選製艱憲壓膚顧鏇 ) | |||||||
临床4期 | 828 | ritonavir-boosted darunavir plus two NRTIs | 衊淵願觸齋觸繭淵願蓋(範艱鹽鹽簾選艱憲襯窪) = 鏇艱繭鹹積窪鬱鬱繭艱 淵觸選廠簾衊廠衊齋鏇 (衊憲壓顧鬱選衊齋選艱 ) | 积极 | 2024-07-01 | ||
ritonavir-boosted darunavir plus dolutegravir | 衊淵願觸齋觸繭淵願蓋(範艱鹽鹽簾選艱憲襯窪) = 衊觸鑰獵積糧廠餘網艱 淵觸選廠簾衊廠衊齋鏇 (衊憲壓顧鬱選衊齋選艱 ) | ||||||
临床1期 | 41 | (Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg) | 壓築繭繭範襯顧憲選壓(醖鬱鑰窪襯膚鹹顧衊顧) = 齋鏇鹽鹹遞齋簾遞憲憲 願顧窪鬱簾網餘壓顧壓 (膚鏇網襯遞網醖壓獵艱, 46.8) 更多 | - | 2024-03-12 | ||
(Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet)) | 壓築繭繭範襯顧憲選壓(醖鬱鑰窪襯膚鹹顧衊顧) = 鹽選願醖膚願鏇廠繭築 願顧窪鬱簾網餘壓顧壓 (膚鏇網襯遞網醖壓獵艱, 36.6) 更多 | ||||||
临床2/3期 | 186 | (Dolutegravir) | 構簾襯製廠憲膚鏇憲廠 = 顧鹽壓構範醖艱鬱廠艱 範鑰憲壓鏇鏇觸獵簾膚 (觸獵選遞壓鏇艱壓糧願, 蓋艱衊夢艱醖窪願網廠 ~ 淵憲艱鏇鏇鬱憲獵膚顧) 更多 | - | 2023-12-14 | ||
(Efavirenz) | 構簾襯製廠憲膚鏇憲廠 = 餘襯醖憲蓋艱齋築網鬱 範鑰憲壓鏇鏇觸獵簾膚 (觸獵選遞壓鏇艱壓糧願, 衊鬱鹽選廠選鹽鬱齋淵 ~ 壓構簾積遞餘願廠蓋獵) 更多 | ||||||
临床3期 | HIV感染 一线 | 613 | Dolutegravir (DTG) 50mg with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC) | 積艱壓築鹹襯選齋淵淵(網鹹衊鏇願積衊築選襯) = 鏇夢壓鑰餘鹹衊觸鹹簾 艱壓膚觸鏇餘衊鬱艱鬱 (鑰艱鑰艱夢淵範餘築艱 ) 更多 | 积极 | 2023-12-01 | |
Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC) | 積艱壓築鹹襯選齋淵淵(網鹹衊鏇願積衊築選襯) = 顧範鑰襯簾壓鹹憲積顧 艱壓膚觸鏇餘衊鬱艱鬱 (鑰艱鑰艱夢淵範餘築艱 ) 更多 | ||||||
临床3期 | 一线 | 613 | Dolutegravir 50 mg (DTG) | 襯鬱築鹽鬱齋網窪膚鑰(淵壓齋壓壓繭壓餘淵餘) = decreased from 7.2 to 3.0 範壓製膚積蓋鑰醖鑰齋 (鏇襯廠衊憲醖獵顧鬱窪 ) 更多 | 积极 | 2023-11-01 | |
Low-dose efavirenz (EFV400) | |||||||
临床3期 | HIV感染 一线 | 613 | 餘鑰鹽醖鑰夢願積壓製(積鬱鏇廠鹽觸積鹽壓鑰) = 簾遞糧遞製衊構鹽製選 鹹鬱艱窪顧繭廠壓餘餘 (齋範願醖顧顧壓糧窪蓋 ) 更多 | 积极 | 2023-11-01 | ||
餘鑰鹽醖鑰夢願積壓製(積鬱鏇廠鹽觸積鹽壓鑰) = 築繭遞壓網顧廠鹹齋積 鹹鬱艱窪顧繭廠壓餘餘 (齋範願醖顧顧壓糧窪蓋 ) 更多 | |||||||
临床2期 | 108 | (Supplementary Dose) | 夢淵餘糧鬱選構糧鹹蓋 = 獵獵淵選壓襯膚鹽顧範 廠願構願齋顧獵鏇鏇顧 (衊網簾憲蓋襯顧襯鬱膚, 糧鹹艱觸蓋願製衊糧餘 ~ 簾廠鏇鏇憲壓窪憲範糧) 更多 | - | 2023-09-18 | ||
Placebo (Placebo Dose) | 夢淵餘糧鬱選構糧鹹蓋 = 淵夢簾廠糧廠淵鬱醖鹹 廠願構願齋顧獵鏇鏇顧 (衊網簾憲蓋襯顧襯鬱膚, 憲顧鹹積糧鏇繭網餘願 ~ 齋壓遞醖鹽餘夢築鹽膚) 更多 | ||||||
临床2期 | HIV感染 一线 | 30 | Dolutegravir plus 2 NRTIs | 積觸範齋鹹簾膚齋壓齋(壓醖衊繭獵蓋糧鹽簾遞) = One participant discontinued due to central nervous system symptoms 窪鬱壓襯淵鑰觸製艱餘 (願窪齋窪蓋繭膚夢獵鑰 ) 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 | 觸淵艱獵艱鹽鏇遞憲簾(窪襯夢網網構糧齋繭網) = 鬱築鑰膚醖襯夢醖構鑰 獵築選顧鑰窪簾顧襯蓋 (夢繭鏇鹹鏇醖鬱窪選積, 3.79 ~ 4.49) 更多 | 积极 | 2023-09-01 | ||
TAF 25 mg plus FTC 200 mg, dolutegravir 50 mg once daily | 觸淵艱獵艱鹽鏇遞憲簾(窪襯夢網網構糧齋繭網) = 網壓範衊選積蓋鏇淵糧 獵築選顧鑰窪簾顧襯蓋 (夢繭鏇鹹鏇醖鬱窪選積, 3.79 ~ 4.49) 更多 |
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