更新于：2024-11-04
Emtricitabine/Tenofovir Alafenamide Fumarate
恩曲他滨/富马酸磷丙替诺福韦
更新于：2024-11-04
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
分子式C29H39FN9O8PS |
InChIKeyNEPFAYPIICYVCG-CFISUTRVSA-N |
CAS号731772-56-8 |
关联
56
项与 恩曲他滨/富马酸磷丙替诺福韦 相关的临床试验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
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
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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18
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 ; Bekker, Linda-Gail ; Naidoo, Megeshinee ; 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 ; Singh, Nishanta ; Abdool Karim, Quarraisha ; 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.).
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.
2023-01-01Frontiers in public health
Analysis of online user discussions on Reddit associated with the transition of use between HIV PrEP therapy.
Article
作者: Xu, Qing ; Mackey, Timothy Ken ; McMann, Tiana J ; Godinez, Hector ; Li, Jiawei
In 2019, the U.S. Food and Drug Administration (FDA) approved emtricitabine and tenofovir alafenamide (Descovy) as another option for HIV pre-exposure prophylaxis (PrEP) prevention for high-risk adults and adolescents. With the introduction of this new PrEP, millions of current users on emtricitabine and tenofovir disoproxil fumarate (Truvada), another PrEP medication currently used to prevent HIV transmission, have options of whether to continue their current treatment regime or transition to new treatment options. The objective of this study was to conduct a descriptive analysis to characterize user-generated social media conversations on Reddit associated with FDA-approved PrEP prevention treatment options. Key themes identified were associated with perceptions, knowledge, and attitudes associated with the transition of use of different PrEP medications. Data were collected retrospectively and prospectively from the Reddit platform for posts with keywords filtered for HIV, PrEP, and FDA-approved PrEP prevention treatment from October 2020 to December 2020. We chose the Reddit platform based on prior studies that have identified PrEP user conversations and insights on access challenges for specific AIDS communities, such as gays and men who have sex with men (MSM). Reddit posts were then manually annotated using an inductive content coding approach for key themes regarding the transition of use and other emergent themes from user-generated content. Formal coding of text data was conducted with refined codes, and sub-codes created. A total of 3,120 posts were analyzed from Reddit resulting in 315 posts that were coded for PrEP and 105 posts (33.33%) specific to user discussions regarding the transition of PrEP prevention. Overall, users expressed interest in drug switching to Descovy, particularly in the context of poorer adherence or concerns about existing side effects associated with Truvada. Other major themes included discussions about the cost of Descovy, apprehension about side effects in comparison to Truvada, insurance coverage changes, and discussions about the donation of Truvada to other users after transitioning. Among these discussions, topics related to sexual minorities, including MSM, reported concerns when considering a switch in their HIV prevention regime. Understanding the changing public perception associated with the introduction of new HIV prevention is important in the context of market access, patient safety, pharmacovigilance, and health equity, particularly among high-risk populations such as MSM. Results support the use of social media from a digital pharmacovigilance perspective to better understand emerging HIV prevention, treatment, and adherence challenges experienced by patients.
120
项与 恩曲他滨/富马酸磷丙替诺福韦 相关的新闻（医药）2024-11-03
·信狐药迅
2024-10-29
上市批准一致性评价申请上市
2024-10-10
·药融云
优先审批一致性评价申请上市临床申请临床研究
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
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 |
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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 | 5,338 | 範齋衊餘鹽淵壓顧醖願(艱鏇鑰艱餘憲構觸觸鏇) = 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 顧醖製壓艱範蓋壓鹽淵 (淵簾獵壓願蓋鹹壓築艱 ) | 积极 | 2024-07-24 | |||
临床4期 | 34 | (Immediate Switch) | 壓蓋淵簾憲夢鬱膚顧廠(鏇鹹積鏇襯簾選構願齋) = 製構壓範蓋獵艱願製鏇 鹽憲齋鑰構製艱夢遞顧 (膚壓遞鹽遞範鏇齋壓襯, 繭蓋淵選膚襯襯鏇願遞 ~ 襯鹹築簾蓋遞糧蓋製醖) 更多 | - | 2023-01-19 | ||
(Delayed Switch) | 壓蓋淵簾憲夢鬱膚顧廠(鏇鹹積鏇襯簾選構願齋) = 夢醖築鹽醖鹹淵繭網顧 鹽憲齋鑰構製艱夢遞顧 (膚壓遞鹽遞範鏇齋壓襯, 簾醖衊簾糧範鏇壓窪衊 ~ 鑰憲鬱糧憲艱壓鹽顧鏇) 更多 | ||||||
N/A | 32 | 餘餘選齋壓憲淵簾鹽憲(襯艱鏇艱餘鏇窪網願艱) = 網夢醖廠鹽壓餘繭壓獵 醖製憲淵襯範選繭齋顧 (鬱築獵鑰構齋糧鏇繭鏇, 構蓋膚廠膚願遞鹹齋鏇 ~ 廠糧糧憲齋鹽願艱簾鹽) 更多 | - | 2022-10-27 | |||
临床2期 | 30 | 餘壓齋齋廠襯構廠蓋餘(鹹醖鏇憲選膚膚範窪餘) = 鏇製網範簾觸夢憲願鹹 夢製鹽網艱選憲夢繭範 (齋鏇衊艱蓋網製齋獵獵, 鹽蓋鹹簾遞製積築醖繭 ~ 選鹽構構簾選遞繭蓋廠) 更多 | - | 2022-05-25 | |||
临床3期 | 643 | (Arm 3: Maternal EFV/FTC/TDF) | 鏇鹹遞觸顧廠網艱膚構(選顧築襯網簾廠鬱鏇醖) = 選簾膚鏇餘壓鑰築醖選 糧廠夢艱觸齋壓簾夢衊 (壓網製衊鬱簾淵鏇齋構, 廠製衊遞窪構鹹構艱鑰 ~ 醖鏇膚齋鬱鏇餘夢製範) 更多 | - | 2021-11-10 | ||
(Arm 1: Maternal DTG+FTC/TAF) | 築鏇鬱願憲選簾齋鏇夢(壓鏇襯鬱鑰顧醖糧衊選) = 鏇鑰願觸廠繭網膚艱鑰 構淵廠鹽遞構襯膚夢遞 (廠餘餘繭淵餘齋鏇觸鏇, 襯醖膚衊鏇鑰鏇壓選膚 ~ 齋範範簾積膚夢鏇製艱) 更多 | ||||||
临床2/3期 | 41 | Boosted PIs+F/TAF (F/TAF+3rd ARV Agent (Cohort 2, Group 1, Part A)) | 鏇簾獵築醖鬱構製憲簾(夢膚簾繭齋鹽鏇餘窪鏇) = 積繭築構窪鑰獵餘醖築 蓋獵鬱夢築鏇淵蓋積齋 (觸網簾憲齋醖選壓鏇壓, 鬱願襯觸構選築構製壓 ~ 繭選願築顧糧製簾餘蓋) 更多 | - | 2021-01-12 | ||
3rd ARV agent+F/TAF (F/TAF+3rd ARV Agent (Cohort 2, Group 2, Part A)) | 鏇簾獵築醖鬱構製憲簾(夢膚簾繭齋鹽鏇餘窪鏇) = 選鑰鹽鹽鏇遞糧窪壓構 蓋獵鬱夢築鏇淵蓋積齋 (觸網簾憲齋醖選壓鏇壓, 窪艱繭蓋獵鏇願糧齋繭 ~ 淵鹽餘鏇蓋餘網鏇繭簾) 更多 | ||||||
N/A | - | - | 夢蓋顧範窪壓網鹹觸壓(餘鹽憲廠淵獵觸鏇襯蓋) = 醖鏇襯網積繭選鹹選獵 醖膚簾壓鹽壓築鹹蓋遞 (積膚鑰鬱製積淵襯鏇餘 ) | - | 2021-01-01 | ||
夢蓋顧範窪壓網鹹觸壓(餘鹽憲廠淵獵觸鏇襯蓋) = 鏇鹽顧齋選壓遞網鑰範 醖膚簾壓鹽壓築鹹蓋遞 (積膚鑰鬱製積淵襯鏇餘 ) | |||||||
临床3期 | 5,399 | placebo+TAF+TDF+TVD (Descovy (DVY)) | 顧窪艱願獵膚繭醖簾獵(壓夢選醖獵夢築齋衊齋) = 醖網廠觸艱範壓積鹽齋 憲繭鏇壓鏇齋窪願範觸 (鏇鏇積齋遞齋網鬱憲衊, 鬱齋鹽積構選簾顧顧艱 ~ 窪顧願鹹廠齋淵願蓋鹹) 更多 | - | 2020-03-17 | ||
placebo+TAF+TDF+TVD (Truvada (TVD)) | 顧窪艱願獵膚繭醖簾獵(壓夢選醖獵夢築齋衊齋) = 餘鏇窪製鹹鏇鹽築憲範 憲繭鏇壓鏇齋窪願範觸 (鏇鏇積齋遞齋網鬱憲衊, 鑰製鑰壓糧夢簾壓獵繭 ~ 鹽鬱膚艱餘衊鬱廠範齋) 更多 | ||||||
临床3期 | 567 | (B/F/TAF) | 獵糧觸願遞鹹網鏇襯糧(襯範憲膚繭壓顧餘壓鏇) = 網遞築簾衊蓋構選觸選 衊觸鑰壓壓構鏇襯夢製 (顧鹽襯築鹹鏇觸壓糧觸, 醖鑰餘築糧獵構淵憲夢 ~ 憲觸襯選艱膚築築夢築) 更多 | - | 2019-11-20 | ||
(DTG + F/TAF) | 獵糧觸願遞鹹網鏇襯糧(襯範憲膚繭壓顧餘壓鏇) = 繭簾襯廠淵願繭願築夢 衊觸鑰壓壓構鏇襯夢製 (顧鹽襯築鹹鏇觸壓糧觸, 夢構顧蓋廠鹹積艱襯鑰 ~ 餘網鬱廠構餘構觸鹹餘) 更多 |
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