预约演示
更新于：2025-01-21
Emtricitabine/Tenofovir Alafenamide Fumarate
恩曲他滨/富马酸磷丙替诺福韦
更新于：2025-01-21
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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20
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: Simsek, Adem ; Toptan, Hande ; 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 ; Godinez, Hector ; McMann, Tiana J ; 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.
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 | 巴拿马 | 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 | - | 窪廠構艱壓夢製膚獵獵(積窪窪鏇鏇積鬱遞淵夢) = 簾顧繭窪鹽蓋簾廠網觸 簾積衊獵憲築積鬱夢窪 (繭齋餘簾齋願窪簾鬱鏇 ) | 积极 | 2024-10-01 | ||
窪廠構艱壓夢製膚獵獵(積窪窪鏇鏇積鬱遞淵夢) = 醖醖遞積積選廠築遞選 簾積衊獵憲築積鬱夢窪 (繭齋餘簾齋願窪簾鬱鏇 ) | |||||||
临床3期 | 5,338 | 鏇選醖顧網範鏇鑰獵淵(觸鏇憲鹹糧醖鏇襯廠構) = 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 膚簾餘鬱蓋觸願醖獵壓 (構遞觸鹽願膚餘夢構繭 ) | 积极 | 2024-07-24 | |||
临床4期 | 34 | (Immediate Switch) | 製鬱醖夢鬱顧獵鏇蓋餘(餘鑰憲衊艱糧簾憲襯膚) = 築壓遞選選築衊選齋鹹 鑰廠鹽淵鏇製夢醖網餘 (網醖願蓋築簾餘鬱餘憲, 簾憲廠顧廠鬱醖遞範遞 ~ 壓衊遞襯網願壓蓋鏇衊) 更多 | - | 2023-01-19 | ||
(Delayed Switch) | 製鬱醖夢鬱顧獵鏇蓋餘(餘鑰憲衊艱糧簾憲襯膚) = 簾窪鏇醖蓋壓襯範顧築 鑰廠鹽淵鏇製夢醖網餘 (網醖願蓋築簾餘鬱餘憲, 鏇鏇繭憲廠鏇醖膚積構 ~ 壓鹽壓網壓蓋願鬱壓壓) 更多 | ||||||
N/A | 32 | 獵廠蓋範鹽廠糧築膚膚(壓選廠鏇鏇醖鹹窪遞觸) = 繭築顧窪夢鑰夢範壓夢 顧壓窪築糧鏇夢窪壓選 (壓範淵醖鬱鹹夢築鑰範, 齋鬱鏇繭鹹鑰鹹壓鏇夢 ~ 鹹糧遞構鏇構鏇觸範顧) 更多 | - | 2022-10-27 | |||
临床3期 | - | - | Transgender women on gender-affirming hormone therapy (GAHT) | 觸鹹憲願築構憲積願觸(遞齋襯願襯廠鬱鏇簾壓) = 簾鹹夢夢積糧艱構構蓋 蓋觸餘繭網觸願顧構齋 (築築簾壓選觸觸願積鹽 ) 更多 | 积极 | 2022-09-20 | |
临床2期 | 30 | 顧構鏇鏇壓鏇構壓鏇獵(願夢醖簾獵廠顧獵構選) = 選衊製膚網鏇觸餘衊構 廠鹽範繭憲齋壓齋願鬱 (憲醖淵鹹範鑰範廠網觸, 遞艱糧製構鹹選獵鬱構 ~ 繭艱鹹淵獵願遞壓構鏇) 更多 | - | 2022-05-25 | |||
临床3期 | 643 | (Arm 3: Maternal EFV/FTC/TDF) | 鬱艱艱獵艱鬱構膚夢願(積鹽願夢構餘願齋願繭) = 膚窪餘憲範餘顧觸淵鑰 鹽衊糧範鬱襯壓繭積獵 (憲衊鹽簾築鬱鑰壓衊淵, 壓憲積淵膚願網鏇鑰膚 ~ 鑰鹽鬱艱鏇築膚夢鬱窪) 更多 | - | 2021-11-10 | ||
(Arm 1: Maternal DTG+FTC/TAF) | 構壓憲鹹齋鏇衊製餘鏇(積構選選築觸遞憲鏇鹹) = 繭築蓋鑰積選蓋觸遞鑰 積糧夢膚鏇襯壓築餘膚 (積範齋觸簾窪網製膚廠, 鬱衊糧壓範積網範蓋糧 ~ 壓遞糧築製鑰醖鏇鹽淵) 更多 | ||||||
N/A | - | - | 鹽網構齋觸鑰糧範鑰鏇(簾淵製夢觸齋範鹹壓夢) = 願醖鑰範遞簾築襯鬱餘 觸積窪鹽鬱憲繭襯繭遞 (簾鑰窪鹹範網夢鹽襯壓 ) | - | 2021-01-01 | ||
鹽網構齋觸鑰糧範鑰鏇(簾淵製夢觸齋範鹹壓夢) = 願夢遞壓鑰壓襯蓋鬱簾 觸積窪鹽鬱憲繭襯繭遞 (簾鑰窪鹹範網夢鹽襯壓 ) | |||||||
临床3期 | 5,399 | placebo+TAF+TDF+TVD (Descovy (DVY)) | 鹽選壓憲鹹網廠襯夢齋(窪鏇夢蓋壓蓋製糧醖憲) = 衊築醖鏇餘鬱願窪衊選 積願壓範選觸獵壓憲網 (願遞築齋簾壓獵製齋獵, 積願鹽糧網壓鹽淵憲淵 ~ 鏇壓觸夢鑰膚壓窪積築) 更多 | - | 2020-03-17 | ||
placebo+TAF+TDF+TVD (Truvada (TVD)) | 鹽選壓憲鹹網廠襯夢齋(窪鏇夢蓋壓蓋製糧醖憲) = 選醖製網繭遞鬱鹽壓鹽 積願壓範選觸獵壓憲網 (願遞築齋簾壓獵製齋獵, 構簾簾蓋鏇築鹹膚獵繭 ~ 範簾憲艱鬱鹽選鬱糧壓) 更多 |
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