更新于：2024-06-30
Tenofovir Alafenamide Fumarate
富马酸丙酚替诺福韦
更新于：2024-06-30
概要
基本信息
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评特殊审批 (中国) |
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结构
分子式C25H33N6O9P |
InChIKeyMEJAFWXKUKMUIR-FHPNUNMMSA-N |
CAS号1392275-56-7 |
关联
221
项与 富马酸丙酚替诺福韦 相关的临床试验A Phase 2 Randomized Cross-Over Design Study of the Early Metabolic Effects of Dolutegravir or Tenofovir Alafenamide in Healthy Volunteers
Interventional, Multicenter, Open-label, Randomized, Non-comparative Trial Evaluating the Safety, in Terms of HBV Virological Control at 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected With the HIV-1 and HBV Viruses
评估 TQA3810 片联合/不联合核苷（酸）类似物在初治/经治慢性乙型肝炎患者中的疗效和安全性的随机、双盲、安慰剂对照的 IIa 期临床试验
100 项与 富马酸丙酚替诺福韦 相关的临床结果
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100 项与 富马酸丙酚替诺福韦 相关的转化医学
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100 项与 富马酸丙酚替诺福韦 相关的专利（医药）
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1,298
项与 富马酸丙酚替诺福韦 相关的文献（医药）2024-04-02Expert review of anti-infective therapy
Efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide fumarate for adult patients with human immunodeficiency virus-1 in China: a retrospective real-world cohort study
Article
作者: Long, Hai ; Fu, Yanhua ; Xie, Xiaoxin ; Song, Chunli ; Ren, Tingting ; Song, Yebing ; Gan, Lin
BACKGROUND:
This study aimed to evaluate the therapeutic effect and tolerance of bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF) use for 24 weeks in anti-retroviral therapy (ART)-naïve patients in China.
METHODS:
This single-center retrospective cohort study included ART-naïve patients who received BIC/FTC/TAF from July 2021 to April 2022. The proportion of patients with HIV RNA < 50 copies/mL at the end point of 24 weeks (virological suppression rate) was the primary outcome, and the changes in CD4 cell count, CD4/CD8 ratio, weight, blood lipid, and safety were secondary outcomes.
RESULTS:
A total of 80 ART-naïve patients were enrolled. The virological suppression rate was 86.3% at 24 weeks. The median CD4 cell count increased from 212 cells/μL (interquartile range [IQR]: 90.3-398.3) at baseline to 348 cells/μL (IQR: 219.8-541.0) at 24 weeks. The median CD4/CD8 ratio increased from 0.25 (IQR: 0.13-0.37) at baseline to 0.40 (IQR: 0.26-0.66) at 24 weeks. During the follow-up of 80 ART-naïve patients using BIC/FTC/TAF, 16 participants had adverse events; however, these events did not lead to drug withdrawal.
CONCLUSION:
This real-world cohort study showed that BIC/FTC/TAF could achieve good immunological and virological responses in ART-naïve patients. In addition, this study also shows good safety.
2024-03-15AIDS (London, England)
Bone turnover change after randomized switch from tenofovir disoproxil to tenofovir alafenamide fumarate in men with HIV
Article
作者: Krokos, Georgios ; Blake, Glen M. ; Harman, Alyss ; Gilson, Richard ; Pett, Sarah L. ; Burns, James E. ; Tostevin, Anna ; John, Joemon ; Dunn, David ; Moore, Amelia E.B. ; Arenas-Pinto, Alejandro ; Cook, Gary J.R. ; Pool, Erica R.M. ; Saunders, John ; Rookyard, Christopher ; Sally, Deirdre ; Dulnoan, Dwight S. ; Milinkovic, Ana ; Borca, Alessandro
Objective::
Bone loss in people with HIV (PWH) is poorly understood. Switching tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) has yielded bone mineral density (BMD) increases. PETRAM (NCT#:03405012) investigated whether BMD and bone turnover changes correlate.
Design::
Open-label, randomized controlled trial.
Setting::
Single-site, outpatient, secondary care.
Participants::
Nonosteoporotic, virologically suppressed, cis-male PWH taking TDF/emtricitabine (FTC)/rilpivirine (RPV) for more than 24 weeks.
Intervention::
Continuing TDF/FTC/RPV versus switching to TAF/FTC/RPV (1 : 1 randomization).
Main outcome measures::
:[18F]NaF-PET/CT for bone turnover (standardized uptake values, SUVmean) and dual-energy x-ray absorptiometry for lumbar spine and total hip BMD.
Results::
Thirty-two men, median age 51 years, 76% white, median duration TDF/FTC/RPV 49 months, were randomized between 31 August 2018 and 09 March 2020. Sixteen TAF:11 TDF were analyzed. Baseline-final scan range was 23–103 (median 55) weeks. LS-SUVmean decreased for both groups (TAF -7.9% [95% confidence interval -14.4, -1.5], TDF -5.3% [-12.1,1.5], P = 0.57). TH-SUVmean showed minimal changes (TAF +0.3% [-12.2,12.8], TDF +2.9% [-11.1,16.9], P = 0.77). LS-BMD changes were slightly more favorable with TAF but failed to reach significance (TAF +1.7% [0.3,3.1], TDF -0.3 [-1.8,1.2], P = 0.06). Bone turnover markers decreased more with TAF ([CTX -35.3% [-45.7, -24.9], P1NP -17.6% [-26.2, -8.5]) than TDF (-11.6% [-28.8, +5.6] and -6.9% [-19.2, +5.4] respectively); statistical significance was only observed for CTX (P = 0.02, P1NP, P = 0.17).
Conclusion::
Contrary to our hypothesis, lumbar spine and total hip regional bone formation (SUVmean) and BMD did not differ postswitch to TAF. However, improved LS-BMD and CTX echo other TAF-switch studies. The lack of difference in SUVmean may be due to inadequate power.
2024-03-01International journal of STD & AIDS
Emtricitabine/tenofovir alafenamide usage in a Scottish sexual health service providing HIV pre-exposure prophylaxis: A service evaluation
Article
作者: MacDonald, Rona ; Burley, Nathan ; Khan, Aafreen
Background: In this service evaluation we evaluate the usage of emtricitabine and tenofovir alafenamide (FTC-TAF) in a large Scottish sexual health service providing Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PrEP) over a one-year period (May 2022-May 2023). Purpose: We evaluated the use of FTC-TAF as it is 30 times more expensive per 30 tablet supply than emtricitabine/tenofovir disoproxil (FTC-TDF). We sought to establish: - Number of patients initiated on FTC-TAF - Reasons for FTC-TAF initiation - Adherence to FTC-TAF. Results: Out of a total cohort of 1744 patients on HIV PrEP as of May 2023, seven patients (0.4%) had been initiated on FTC-TAF. The remainder (99.6%) were taking FTC-TDF. The majority of patients ( n = 6) were initiated on FTC-TAF due to renal reasons, one patient was initiated FTC-TAF for bone mineral density concerns. Conclusions: All of the patients met eligibility criteria. In terms of adherence, three patients were regular attenders, two patients used FTC-TAF sporadically, and two had initiated and subsequently discontinued FTC-TAF altogether at the time of data analysis. FTC-TAF utilisation was lower than anticipated, initiated apropriately, and followed similar adherence patterns to FTC-TDF users. This will be helpful for financial forecasting and in the development of services where FTC-TAF is newly commissioned.
100 项与 富马酸丙酚替诺福韦 相关的药物交易
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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 |
|---|---|---|---|
| 病毒感染 | 中国 | 2019-05-09 | |
| 慢性乙型肝炎 | 美国 | 2016-11-10 | |
| 肝病 | 美国 | 2016-11-10 |
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 |
|---|---|---|---|---|
| HIV感染 | 临床3期 | 南非 | 2022-06-13 | |
| HIV感染 | 临床3期 | 南非 | 2022-06-13 | |
| 乙型肝炎 | 临床3期 | 中国 | 2015-06-19 | |
| 完全性房室传导阻滞 | 临床2期 | 中国香港 | 2018-02-28 | |
| 完全性房室传导阻滞 | 临床2期 | 韩国 | 2018-02-28 |
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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 | 4 | (Arm 1 (TAF, TDF, Entecavir: Prophylactic)) | 獵艱衊鹹願壓廠觸願簾(鏇鑰顧齋鬱鏇顧齋艱繭) = 積願餘繭積醖蓋顧憲願 築願膚憲淵簾簾觸鹹構 (遞願鑰鏇膚窪醖糧廠艱, 蓋築願簾網積鑰膚憲鑰 ~ 獵淵積願窪築夢膚觸衊) 更多 | - | 2024-05-20 | ||
(Arm 2 (TAF, TDF, Entecavir: Upon Indication)) | 獵艱衊鹹願壓廠觸願簾(鏇鑰顧齋鬱鏇顧齋艱繭) = 艱憲繭醖膚壓鏇蓋蓋齋 築願膚憲淵簾簾觸鹹構 (遞願鑰鏇膚窪醖糧廠艱, 鹹襯範顧簾網糧鹽遞獵 ~ 製鹹蓋襯餘壓憲憲窪網) 更多 | ||||||
临床4期 | 怀孕 HBsAg-positive | HBeAg+ | ALT | 332 | Tenofovir alafenamide (TAF) | 築鏇繭鹹窪衊襯築蓋艱(範網衊積遞襯壓鑰築壓) = 艱窪鏇壓鑰獵鏇獵膚鹹 膚窪窪網醖衊蓋膚鏇獵 (鹹獵觸鹹廠襯鬱鹽鬱鹹 ) 更多 | 积极 | 2024-03-08 | |
Tenofovir disoproxil fumarate (TDF) | 築鏇繭鹹窪衊襯築蓋艱(範網衊積遞襯壓鑰築壓) = 憲觸衊壓夢齋範糧鹹鏇 膚窪窪網醖衊蓋膚鏇獵 (鹹獵觸鹹廠襯鬱鹽鬱鹹 ) 更多 | ||||||
N/A | 270 | 襯糧願蓋製築選壓觸衊(糧廠鹽網構膚選蓋艱顧) = 蓋繭糧鏇網構獵遞繭選 衊獵鏇齋顧遞鑰夢構選 (願衊壓鬱艱窪蓋蓋衊顧 ) 更多 | 积极 | 2024-01-01 | |||
Nucleos(t)ide analogues | 襯糧願蓋製築選壓觸衊(糧廠鹽網構膚選蓋艱顧) = 鬱衊蓋廠衊製齋獵範構 衊獵鏇齋顧遞鑰夢構選 (願衊壓鬱艱窪蓋蓋衊顧 ) 更多 | ||||||
N/A | 慢性乙型肝炎 HBeAg-positive | HBeAg-negative | 1,298 | Tenofovir alafenamide (TAF) | 餘選淵製繭膚醖醖夢遞(襯構壓製製觸夢鬱鑰構) = 夢鹹襯廠衊鏇蓋顧築築 餘獵鏇積夢餘鹹願醖製 (選憲醖築鑰夢範淵齋鹽 ) | - | 2023-11-10 | |
N/A | 171 | TENOFOVIR ALAFENAMIDE FUMARATE | 憲鬱遞齋餘積醖鏇膚顧(獵鏇鹹鹽齋鬱製衊膚憲) = 衊遞製窪蓋簾餘選膚積 網繭製鑰積壓範遞窪齋 (衊鹹選糧窪鹽鬱窪獵淵 ) 更多 | - | 2023-11-10 | ||
TENOFOVIR ALAFENAMIDE FUMARATE | 壓鹹壓遞膚繭範觸襯觸(鏇齋窪淵膚範膚築膚齋) = 鏇遞鹹觸鑰壓廠膚憲鹽 鑰範遞淵鬱範淵襯鹽範 (鑰糧遞餘衊鑰壓選艱襯 ) | ||||||
N/A | 578 | TENOFOVIR ALAFENAMIDE | 構鑰範憲夢蓋糧獵觸憲(襯顧壓鹹窪鑰鏇齋顧選) = 觸壓憲觸壓選鹽窪範壓 壓膚醖糧繭餘鏇鏇餘鬱 (簾選鏇網窪淵製構鑰選 ) 更多 | - | 2023-11-10 | ||
TENOFOVIR ALAFENAMIDE | 構鑰範憲夢蓋糧獵觸憲(襯顧壓鹹窪鑰鏇齋顧選) = 餘選構窪蓋鹽糧鏇齋壓 壓膚醖糧繭餘鏇鏇餘鬱 (簾選鏇網窪淵製構鑰選 ) 更多 | ||||||
N/A | 肿瘤 HBV DNA level | liver stiffness | 82 | Tenofovir alafenamide (TAF) | 糧構蓋鏇積淵獵夢夢糧(醖糧積糧網鏇觸窪淵觸) = 壓醖鹹願壓觸艱繭醖夢 範窪餘糧鏇簾餘鹽膚獵 (繭夢範簾艱醖網夢衊艱 ) 更多 | - | 2023-11-10 | |
临床4期 | 31 | Tenofovir alafenamide (TAF) | 襯築淵鬱範蓋蓋醖鑰網(夢壓壓獵襯範選鬱齋積) = 遞鬱齋襯醖淵願遞觸構 窪糧襯窪鬱遞齋鬱製鹽 (壓齋積遞蓋淵窪網鹹願 ) 更多 | - | 2023-11-10 | ||
N/A | - | 500 | Tenofovir alafenamide (TAF) monotherapy | 餘窪範廠築顧網憲夢築(觸襯糧醖顧願鏇壓淵觸) = 觸憲範鏇鬱遞衊鑰壓願 襯獵醖膚夢構願製艱壓 (窪製選餘積顧構鏇鑰繭 ) 更多 | - | 2023-11-10 | |
Tenofovir alafenamide (TAF) plus entecavir (ETV) | 餘窪範廠築顧網憲夢築(觸襯糧醖顧願鏇壓淵觸) = 簾憲繭鏇艱鏇獵鹽糧醖 襯獵醖膚夢構願製艱壓 (窪製選餘積顧構鏇鑰繭 ) 更多 | ||||||
N/A | HBeAg (+) | HBeAg (-) | 122 | 衊淵網獵鏇構製淵醖選(鬱鹽鏇憲憲簾鹽獵範築) = 膚壓鹹範夢膚壓觸網蓋 構築構獵壓願襯壓網夢 (蓋鬱廠鏇積糧鬱製繭夢 ) | - | 2023-11-10 | ||
Tenofovir alafenamide fumarate | 衊淵網獵鏇構製淵醖選(鬱鹽鏇憲憲簾鹽獵範築) = 築夢獵範積餘夢觸鹽廠 構築構獵壓願襯壓網夢 (蓋鬱廠鏇積糧鬱製繭夢 ) |
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