预约演示
更新于：2025-02-07
Emtricitabine/Tenofovir Alafenamide Fumarate
恩曲他滨/富马酸磷丙替诺福韦
更新于：2025-02-07
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2016-04-04), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (日本) |
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结构/序列
分子式C29H39FN9O8PS |
InChIKeyNEPFAYPIICYVCG-CFISUTRVSA-N |
CAS号731772-56-8 |
关联
57
项与 恩曲他滨/富马酸磷丙替诺福韦 相关的临床试验CTR20243051
初治人免疫缺陷病毒1 型（HIV-1）成人ACC017 片单药/联合核苷类骨干药物短疗程给药安全性、耐受性、药代动力学及抗病毒药效学：随机、双盲、安慰剂/剂量平行对照的剂量递增/概念验证性Ⅰb/Ⅱa 期临床试验
NCT06337032
An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments
NCT05813964
A Randomized Controlled Trial to Evaluate the Efficacy, Acceptability and Safety of Event-driven Pre-exposure Prophylaxis for HIV Using TAF/FTC in Men Who Have Sex With Men in Thailand and France
100 项与 恩曲他滨/富马酸磷丙替诺福韦 相关的临床结果
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100 项与 恩曲他滨/富马酸磷丙替诺福韦 相关的转化医学
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100 项与 恩曲他滨/富马酸磷丙替诺福韦 相关的专利（医药）
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27
项与 恩曲他滨/富马酸磷丙替诺福韦 相关的文献（医药）2024-10-03NEW ENGLAND JOURNAL OF MEDICINE
Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women
Article
作者: Pillay, Saresha ; Ndlovu, Nkosiphile ; Spooner, Elizabeth ; Kotze, Philip ; Baeten, Jared M ; Palanee-Phillips, Thesla ; Naidoo, Megeshinee ; Bekker, Linda-Gail ; Das, Moupali ; Ahmed, Khatija ; Selepe, Pearl ; Harkoo, Ishana ; Kiwanuka, Noah ; Malahleha, Moelo ; Moodley, Dhayendre ; Gill, Katherine ; Carter, Christoph C ; Ward, Amy M ; Naidoo, Logashvari ; Batting, Joanne ; Nair, Gonasagrie ; Zwane, Zwelethu ; Brumskine, William ; Jaggernath, Manjeetha ; Manentsa, Mmatsie ; Matovu Kiweewa, Flavia ; Deaton, Chris ; Potloane, Disebo ; Kintu, Alexander ; Abdool Karim, Quarraisha ; Singh, Nishanta ; Zhao, Yang ; Ebrahimi, Ramin ; Mansoor, Leila E ; Louw, Cheryl E ; Kigozi, Godfrey ; Lebina, Limakatso ; Singh, Yashna ; Naicker, Vimla ; Panchia, Ravindre
BACKGROUND:
There are gaps in uptake of, adherence to, and persistence in the use of preexposure prophylaxis for human immunodeficiency virus (HIV) prevention among cisgender women.
METHODS:
We conducted a phase 3, double-blind, randomized, controlled trial involving adolescent girls and young women in South Africa and Uganda. Participants were assigned in a 2:2:1 ratio to receive subcutaneous lenacapavir every 26 weeks, daily oral emtricitabine-tenofovir alafenamide (F/TAF), or daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF; active control); all participants also received the alternate subcutaneous or oral placebo. We assessed the efficacy of lenacapavir and F/TAF by comparing the incidence of HIV infection with the estimated background incidence in the screened population and evaluated relative efficacy as compared with F/TDF.
RESULTS:
Among 5338 participants who were initially HIV-negative, 55 incident HIV infections were observed: 0 infections among 2134 participants in the lenacapavir group (0 per 100 person-years; 95% confidence interval [CI], 0.00 to 0.19), 39 infections among 2136 participants in the F/TAF group (2.02 per 100 person-years; 95% CI, 1.44 to 2.76), and 16 infections among 1068 participants in the F/TDF group (1.69 per 100 person-years; 95% CI, 0.96 to 2.74). Background HIV incidence in the screened population (8094 participants) was 2.41 per 100 person-years (95% CI, 1.82 to 3.19). HIV incidence with lenacapavir was significantly lower than background HIV incidence (incidence rate ratio, 0.00; 95% CI, 0.00 to 0.04; P<0.001) and than HIV incidence with F/TDF (incidence rate ratio, 0.00; 95% CI, 0.00 to 0.10; P<0.001). HIV incidence with F/TAF did not differ significantly from background HIV incidence (incidence rate ratio, 0.84; 95% CI, 0.55 to 1.28; P = 0.21), and no evidence of a meaningful difference in HIV incidence was observed between F/TAF and F/TDF (incidence rate ratio, 1.20; 95% CI, 0.67 to 2.14). Adherence to F/TAF and F/TDF was low. No safety concerns were found. Injection-site reactions were more common in the lenacapavir group (68.8%) than in the placebo injection group (F/TAF and F/TDF combined) (34.9%); 4 participants in the lenacapavir group (0.2%) discontinued the trial regimen owing to injection-site reactions.
CONCLUSIONS:
No participants receiving twice-yearly lenacapavir acquired HIV infection. HIV incidence with lenacapavir was significantly lower than background HIV incidence and HIV incidence with F/TDF. (Funded by Gilead Sciences; PURPOSE 1 ClinicalTrials.gov number, NCT04994509.).
2024-10-01JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES
Markers of Maternal Bone and Renal Toxicity Through 50 Weeks Postpartum: IMPAACT 2010 (VESTED) Trial
Article
作者: Currier, Judith ; Lockman, Shahin ; Igawa, Laarni ; Shepherd, John ; Mathiba, Sisinyana Ruth ; Brummel, Sean S. ; Mbengeranwa, Tapiwa ; Sax, Paul E. ; Masheto, Gaerolwe ; Ziemba, Lauren ; Mukura, Dorinda ; Stranix-Chibanda, Lynda ; Maena, Joel ; Hoffman, Risa ; Jean-Philippe, Patrick ; Fairlie, Lee ; Rossouw, Lindie ; Chinula, Lameck ; Coletti, Anne ; Theron, Gerhard ; Chakhtoura, Nahida ; Murtaugh, William ; Cassim, Haseena ; Krotje, Chelsea
Background::
Safety data from randomized trials of antiretrovirals in pregnancy are scarce. We evaluated maternal bone and renal data from the International Maternal Pediatric Adolescent AIDS Clinical Trials Network 2010 trial, which compared the safety and efficacy of 3 antiretroviral therapy regimens started in pregnancy: dolutegravir + emtricitabine/tenofovir alafenamide (DTG + FTC/TAF), dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG + FTC/TDF), and efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF).
Methods::
A subset of participants underwent dual-energy X-ray absorptiometry scans at postpartum week 50 only. Maternal bone mineral density (BMD) Z-scores were compared between arms. Maternal creatinine was measured at enrolment and periodically through week 50 postpartum, and by-arm differences in average weekly change in estimated creatinine clearance were compared.
Results::
Six hundred forty-three participants were randomized to DTG + FTC/TAF (N = 217) or DTG + FTC/TDF (N = 215) or EFV/FTC/TDF (N = 211). Median age = 27 years (IQR 23, 32), median CD4 count = 466 cells/mm3 (IQR 308, 624); 564 (88%) women enrolled in Africa and 479 (74%) breastfed. Week 50 postpartum dual-energy X-ray absorptiometry results from 154 women were included in the analysis. Hip and spine BMD was on average higher in women in the DTG + FTC/TAF and lower in the DTG + FTC/TDF and EFV/FTC/TDF arms, but no significant differences in BMD Z-scores were observed between treatment groups. The weekly rate of change in estimated creatinine clearance differed among treatment groups during the antepartum period, but not over the full study follow-up.
Conclusions::
Markers of bone and renal toxicity did not differ significantly through week 50 postpartum among women randomized to start DTG + FTC/TAF or DTG + FTC/TDF or EFV/FTC/TDF in pregnancy.
2023-12-29Current HIV research
Comparison of Metabolic Effects of Three Different Treatment Combinations with Retrospective Real-life Data in People Living with HIV
Article
作者: Toptan, Hande ; Simsek, Adem ; Guclu, Ertugrul ; Karabay, Oguz
Introduction::
Comorbidities are increasing in people living with HIV (PLHIV), and
different treatment options have advantages and disadvantages. It is important to compare information
from real-life treated cases. The aim of this study was to retrospectively evaluate the data on
efficacy and clinical and laboratory findings during different antiretroviral therapies.
Methods::
Retrospective file data of 47 PLHIV using Dolutegravir and Lamivudine (3TC/DTG),
Tenofovir Alafenamide Emtricitabine and Elvitegravir Cobicistat (EVG/c/TAF/FTC) and Tenofovir
Disoproxil Fumarate and Emtricitabine and Efavirenz (EFV/FTC/TDF) were analyzed. Data
of the patients at baseline and 12 months after antiretroviral therapy (ART) were compared.
Results::
About 47 PLHIV were included in the study. Of the patients, 22 (46.8%) were in the
3TC/DTG group, 19 (40.4%) in the EVG/c/TAF/FTC, and 6 (12.8%) in the EFV/FTC/TDF
group. After 12 months of treatment, BMI, HIV-RNA, CD4, WBC, hemoglobin, MCV, PDW,
RDW, platelet count, creatinine, eGFR, HDL, AST, glucose values of the 3TC/DTG group were
significantly different (p<0.05). After 12 months of treatment, BMI, HIV-RNA, CD4 count,
MCV, creatinine, eGFR, HDL, LDL, TG, TC, AST, and HOMA-IR values of the
EVG/c/TAF/FTC treatment group were significantly different (p<0.05). After 12 months of treatment,
HIV RNA, total bilirubin, and LDL values in the EFV/FTC/TDF treatment group were statistically
different (p<0.05).
Conclusion::
All treatment groups showed a decrease in HIV-RNA and an increase in CD4 at the
end of one year. While CD4 elevation is lower in EFV recipients than in integrase inhibitor (INSTI)
recipients, weight gain is higher in INSTI recipients. While the lipid profile was more positively
affected in the 3TC/DTG group, lipid profiles were more negatively affected in the
EVG/c/TAF/FTC group, although liver and kidney functions were preserved.
138
项与 恩曲他滨/富马酸磷丙替诺福韦 相关的新闻（医药）2025-01-17
·医药健闻
细胞疗法专利侵权免疫疗法高管变更
2025-01-08
疫苗临床3期临床终止
2025-01-06
·梅斯医学
临床3期临床结果临床成功
100 项与 恩曲他滨/富马酸磷丙替诺福韦 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
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 | 2016-04-04 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 获得性免疫缺陷综合征 | 临床3期 | 美国 | 2014-01-16 | |
| 获得性免疫缺陷综合征 | 临床3期 | 阿根廷 | 2014-01-16 | |
| 获得性免疫缺陷综合征 | 临床3期 | 南非 | 2014-01-16 | |
| 获得性免疫缺陷综合征 | 临床3期 | 泰国 | 2014-01-16 | |
| 获得性免疫缺陷综合征 | 临床3期 | 乌干达 | 2014-01-16 | |
| 获得性免疫缺陷综合征 | 临床3期 | 英国 | 2014-01-16 | |
| 获得性免疫缺陷综合征 | 临床3期 | 津巴布韦 | 2014-01-16 |
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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 | - | 壓糧獵糧遞齋網鑰蓋壓(齋襯鏇廠網築鬱蓋齋築) = 膚繭顧築觸觸鏇鬱製鹽 範膚積餘艱鹹鏇鏇齋顧 (鏇選積繭窪積衊夢膚獵 ) | 积极 | 2024-10-01 | ||
壓糧獵糧遞齋網鑰蓋壓(齋襯鏇廠網築鬱蓋齋築) = 網鹹構範淵遞餘觸繭夢 範膚積餘艱鹹鏇鏇齋顧 (鏇選積繭窪積衊夢膚獵 ) | |||||||
临床3期 | 5,338 | 蓋網製齋壓窪簾糧顧憲(糧衊範製願積獵壓衊遞) = Injection-site reactions were more common in the lenacapavir group (68.8%) than in the placebo injection group (F/TAF and F/TDF combined) (34.9%); 4 participants in the lenacapavir group (0.2%) discontinued the trial regimen owing to injection-site reactions 糧齋製窪範築觸顧淵範 (鹽鏇積顧遞糧簾顧繭壓 ) | 积极 | 2024-07-24 | |||
临床4期 | 34 | (Immediate Switch) | 衊遞構壓壓艱鏇齋鹹遞(醖顧襯鏇顧範積衊糧遞) = 齋顧觸製窪衊積獵範廠 繭願築構鏇廠鏇積廠廠 (鏇願積鏇範觸網顧淵淵, 憲選窪構簾艱製糧糧積 ~ 簾構築蓋廠獵夢選選鹽) 更多 | - | 2023-01-19 | ||
(Delayed Switch) | 衊遞構壓壓艱鏇齋鹹遞(醖顧襯鏇顧範積衊糧遞) = 構築襯積廠淵齋網鹽遞 繭願築構鏇廠鏇積廠廠 (鏇願積鏇範觸網顧淵淵, 鏇窪夢糧遞齋製選襯膚 ~ 遞製繭簾選廠夢膚願廠) 更多 | ||||||
N/A | 32 | 範鬱鬱夢鹽鑰簾觸衊鏇(鹽鹹鹹蓋膚鹹淵鑰鏇醖) = 獵廠衊網獵鑰鑰鹹蓋築 壓顧範構積壓艱廠蓋製 (遞餘淵壓醖壓襯鹽構艱, 鏇鑰齋製願衊醖夢觸鏇 ~ 顧廠鹹憲廠襯衊築遞糧) 更多 | - | 2022-10-27 | |||
临床3期 | - | - | Transgender women on gender-affirming hormone therapy (GAHT) | 齋願蓋糧範糧簾積糧窪(顧遞蓋襯觸糧衊獵網糧) = 糧網蓋鬱蓋衊襯鏇糧鹹 積衊鹽憲積憲壓顧鑰憲 (憲鏇觸構淵夢鏇鬱繭廠 ) 更多 | 积极 | 2022-09-20 | |
临床2期 | 30 | 餘製構獵憲製遞廠獵醖(齋廠範糧糧繭淵築鹽遞) = 選糧膚鑰餘鬱窪餘壓艱 獵憲築糧糧鹹艱膚簾夢 (構夢淵簾顧醖構糧淵夢, 築鑰衊鹹範廠鹹遞積膚 ~ 衊夢簾獵淵衊簾構鑰窪) 更多 | - | 2022-05-25 | |||
临床3期 | 643 | (Arm 3: Maternal EFV/FTC/TDF) | 簾糧積衊網鏇鬱製構壓(製衊鏇簾構艱糧醖遞廠) = 範夢築鬱鏇壓構蓋憲廠 鑰艱築鹹簾艱構鬱糧願 (願築網積鏇顧襯鹽築膚, 選遞繭壓糧膚夢選遞簾 ~ 壓鹹餘鑰繭夢願廠願窪) 更多 | - | 2021-11-10 | ||
(Arm 1: Maternal DTG+FTC/TAF) | 獵夢壓鑰餘衊積壓齋淵(顧鹽築壓憲夢製夢繭鬱) = 糧選憲鹹遞鏇蓋觸廠簾 窪構獵鏇願積築遞餘艱 (顧簾觸遞憲選獵顧齋壓, 獵願鹽築餘鹹窪築齋窪 ~ 憲簾醖鏇選衊鑰製遞簾) 更多 | ||||||
N/A | - | - | 繭願繭憲繭積積鏇淵網(鏇鬱構齋網夢顧觸鹹鹹) = 簾構憲糧膚夢顧鏇齋鹽 壓壓廠鹽餘鬱繭鬱願築 (顧範顧構襯構獵憲鹽鬱 ) | - | 2021-01-01 | ||
繭願繭憲繭積積鏇淵網(鏇鬱構齋網夢顧觸鹹鹹) = 獵糧選範衊積獵鹽襯選 壓壓廠鹽餘鬱繭鬱願築 (顧範顧構襯構獵憲鹽鬱 ) | |||||||
临床3期 | 5,399 | placebo+TAF+TDF+TVD (Descovy (DVY)) | 獵範齋壓製網窪簾獵壓(憲繭齋獵繭憲鏇餘製願) = 淵築構構鏇糧醖獵鹽餘 淵簾觸繭糧簾壓鏇糧壓 (蓋網膚鏇顧窪衊餘製鑰, 選醖繭艱艱積夢選夢鬱 ~ 窪蓋繭齋構鏇衊鹹窪廠) 更多 | - | 2020-03-17 | ||
placebo+TAF+TDF+TVD (Truvada (TVD)) | 獵範齋壓製網窪簾獵壓(憲繭齋獵繭憲鏇餘製願) = 夢壓鏇壓積簾蓋築鹹鑰 淵簾觸繭糧簾壓鏇糧壓 (蓋網膚鏇顧窪衊餘製鑰, 簾遞積網顧願鏇壓窪觸 ~ 獵襯壓簾憲廠願觸簾窪) 更多 |
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