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更新于：2026-09-10
Dolutegravir Sodium/Rilpivirine Hydrochloride
多替拉韦利匹韦林
更新于：2026-09-10
概要
基本信息
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2017-11-21), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C20H19F2N3NaO5 |
InChIKeyFOZLBAIXQATFFW-VSLILLSYSA-N |
CAS号1051375-19-9 |
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关联
9
项与 多替拉韦利匹韦林 相关的临床试验NCT05674656
Phase 1/2 Study of Switching to Fixed Dose Combination Dolutegravir/Rilpivirine Among Virologically Suppressed Children, 6 to Less Than 12 Years of Age, Living With HIV-1
CTR20230945
多替拉韦利匹韦林片的人体生物等效性研究
CTIS2024-515419-24-00
Study of a novel combination of immunovirologic and genetic parameters in early-treated HIV-1 patients undergone to antiretroviral therapy interruption (ATI) aimed at defining an algorithm predictive of post-treatment control (PCT)
100 项与 多替拉韦利匹韦林 相关的临床结果
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100 项与 多替拉韦利匹韦林 相关的转化医学
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100 项与 多替拉韦利匹韦林 相关的专利（医药）
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6
项与 多替拉韦利匹韦林 相关的文献（医药）2025-12-02AIDS REVIEWS
New Dual Combination of Dolutegravir-Rilpivirine for Switching to Maintenance Antiretroviral Therapy
Review
作者: Ribera, Esteban
Advances in antiretroviral therapy have led to dramatic improvements in survival of HIV-infected persons. However, HIV cure remains elusive and lifelong treatment is needed. Attempts for reducing long-term drug exposure, toxicities, and cost, while maintaining viral suppression, have led to explore whether maintenance strategies with less than triple therapy could be feasible using the newest more potent antiretrovirals. While monotherapies have failed to do so with selection of drug resistance, some dual combinations have proven its efficacy when used sequentially in patients with viral suppression under standard triple regimens. Furthermore, the advent of coformulations makes easier long-term drug adherence. Herein, we review the current experience with the new single tablet regimen of dolutegravir (DTG) and rilpivirine (RPV) (Juluca®). It is the first approved two-drug single-tablet regimen and the first dual nuc-sparing coformulation. Two randomized, non-inferiority clinical trials (SWORD-1 and -2) and five observational studies have evaluated DTG-RPV in treatment-experienced patients. Despite distinct inclusion criteria, more than 95% of patients kept plasma HIV-RNA undetectable for at least 48 weeks. Along with virological efficacy being non-inferior to triple regimens, the tolerance of DTG-RPV was good, being discontinuations due to adverse events only 0.8-7.9%. Moreover, improvements were seen in lipid profiles in patients switched from protease inhibitors, and in renal and bone biomarkers in those switched from tenofovir disoproxil fumarate. Finally, resistance is rare failing on DTG-RPV. In summary, DTG-RPV is a novel two-drug coformulation that can be effectively and safely used in treatment-experienced patients with viral suppression if the virus is fully susceptible to both drugs. Its unique features make this drug one of the best options as long-term regimen or lifelong maintenance HIV therapy.
2023-05-04The International journal of risk & safety in medicine
Two cases of drug induced hypersensitivity to dolutegravir-rilpivirine fixed-dose combination: A case report
Article
作者: Del Fabro, Giovanni ; Mileto, Palmiro ; Castelli, Francesco ; Quiros-Roldan, Eugenia
BACKGROUND: Two-drug regimens antiretroviral therapies are increasingly prescribed to HIV patients, as they are recommended by international guidelines, and they show an excellent efficacy, safety, and tolerability profile. Regimens administered as single tablets (STRs) are usually preferred by patients and they are associated with higher adherence. CASE REPORT: We report two cases of drug-induced hypersensitivity (DIH) that occurred after switching from dolutegravir (DTG) plus rilpivirine (RPV) in separate pills to a fixed dose combination containing the same molecules (DTG/RPV; Juluca®). Following the DIH event, DTG/RPV coformulation was discontinued. At symptomatic resolution, they continued to receive DTG plus RPV in separate pills uneventfully. The component present only in the DTG/RPV coformulation was iron oxide red (E172), contained in the film-coating. Iron oxide red is an approved colorant, used as drug excipient. Patch test with DTG/RV coformulation performed several months after the DIH event was negative. Drug allergy to excipients remains underappreciated and underreported and frequently leads to inappropriate medication discontinuation. CONCLUSION: Our case underscores the role of meticulous medication allergy history in differentiating true medication allergy from excipient allergy. This observation may be useful in the era of antiretroviral simplification to two-drug regimens.
2022-10-21Cureus
Effect of Dolutegravir on Plasma Glucose Among Human Immunodeficiency Virus Patients in a Community Health Center Setting
Article
作者: Bahamdain, Foud
Background Dolutegravir has become one of the initial backbones in antiretroviral therapy regimens for most patients with HIV in several recent clinical guidelines. However, dolutegravir has been associated with severe cases of hyperglycemia and the new-onset of diabetes in multiple case reports and clinical trials. A community health center noticed an increasing number of new-onset hyperglycemia incidences in patients on dolutegravir. Method Retrospective chart review of patients who started on dolutegravir or dolutegravir combination regimen (Triumreq®, Juluca®, GlaxoSmithKline (GSK), Research Triangle Park, NC) between the dates of January 1st, 2013 and January 1st, 2018 who have been treated in community healthcare centers. Baseline blood sugar and/or hemoglobin A1C before starting dolutegravir, at three to six months of treatment, and at the end of the study were compared between subjects. Four hundred twenty-two subjects were enrolled. Results Dolutegravir had little effect on plasma glucose among 72% of the subjects (n=305). However, 7% of the subjects (n=28) on dolutegravir treatment with no glucose intolerance met the criteria for prediabetes at three to six months of therapy. One of the subjects had developed diabetes three to six months after dolutegravir was initiated. In addition, at the end of the study, 13% of patients developed prediabetes (n=56) and 1.4% developed diabetes (n=6). Among the 24 subjects that had diabetes before dolutegravir was initiated, 83% required intensification of their diabetes regimen. Conclusion Dolutegravir may cause a moderate increase in plasma sugar after three to six months of therapy. Further increases in plasma sugar have been noticed in up to 13% of subjects meeting the criteria for prediabetes. Due to the existence of confounding variables, patients with diabetes should not be switched from dolutegravir.
100 项与 多替拉韦利匹韦林 相关的药物交易
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研发状态
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 | 2017-11-21 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 140 | (DTG/RPV FDC Regimen) | 衊積膚淵憲獵鏇遞壓網 = 鬱簾鬱窪蓋鬱構範選觸 選選製鬱顧蓋簾顧積糧 (憲網襯顧獵築蓋鹹範製, 鹽壓構鑰遞遞鏇廠襯繭 ~ 夢蓋築膚艱築網積繭顧) 更多 | - | 2024-12-24 | ||
(Continued ART Regimen) | 衊積膚淵憲獵鏇遞壓網 = 鏇鏇選廠遞齋製餘顧憲 選選製鬱顧蓋簾顧積糧 (憲網襯顧獵築蓋鹹範製, 選齋壓簾壓鹽廠鑰衊憲 ~ 簾餘艱壓夢選遞簾蓋遞) 更多 | ||||||
N/A | 14,533 | Dolutegravir/rilpivirine (DTG/RPV) | 範襯鬱廠鏇築糧淵膚鬱(鑰願選網構觸壓齋選膚) = 積艱醖廠衊遞鑰鬱構襯 鏇選製襯積觸構鬱夢遞 (齋艱襯獵構糧餘觸積鹽 ) 更多 | 积极 | 2024-07-22 | ||
Dolutegravir (DTG)-based standard 3-drug regimens (3DRs) | 鏇遞獵壓膚齋襯網蓋憲(繭餘壓築鑰顧鹹蓋糧齋) = 觸簾構願觸膚顧鹽築鏇 構繭遞願網襯顧壓築憲 (醖網憲積醖願觸襯選壓 ) 更多 | ||||||
临床4期 | 8 | (Hemodialysis Group) | 鏇選簾艱衊廠繭選鏇鹹(簾淵構艱製廠範糧壓糧) = 積壓範構獵選顧艱衊鹽 廠餘夢廠壓齋襯淵鹹淵 (淵願製齋衊顧鏇餘廠糧, 447) 更多 | - | 2024-05-21 | ||
(Normal Renal Function Group) | 鏇選簾艱衊廠繭選鏇鹹(簾淵構艱製廠範糧壓糧) = 窪繭淵製鏇範簾鹽繭築 廠餘夢廠壓齋襯淵鹹淵 (淵願製齋衊顧鏇餘廠糧, 415) 更多 | ||||||
临床1期 | 16 | DTG+FDC+RPV | 襯鬱簾糧廠構糧構餘醖(願壓鬱齋鹹窪憲襯顧範) = 鬱蓋鏇遞獵襯齋鏇鑰衊 構襯顧膚範積憲衊製願 (鬱鹹膚窪鏇齋襯餘繭蓋, 26.2) 更多 | - | 2020-07-14 |
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