预约演示
更新于：2026-01-31
Tenofovir Alafenamide Fumarate
富马酸丙酚替诺福韦
更新于：2026-01-31
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 |
最高研发阶段(中国)批准上市 |
特殊审评特殊审批 (中国) |
登录后查看时间轴
结构/序列
分子式C25H33N6O9P |
InChIKeyMEJAFWXKUKMUIR-FHPNUNMMSA-N |
CAS号1392275-56-7 |
关联
304
项与 富马酸丙酚替诺福韦 相关的临床试验NCT05652478
A Phase 2 Randomized Cross-Over Design Study of the Early Metabolic Effects of Dolutegravir or Tenofovir Alafenamide in Healthy Volunteers
NCT07258251
Strengthening Hepatitis B Screening, Linkage to Care and Long-Term Monitoring in Phichit Province, Thailand: A Birth Bohort Approach
NCT07295873
A Single-Center, Open-Label, Single-Arm, Self-Controlled Phase I Clinical Study to Evaluate Drug-Drug Interactions of Hydronidone With Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide in Healthy Chinese Subjects
100 项与 富马酸丙酚替诺福韦 相关的临床结果
登录后查看更多信息
100 项与 富马酸丙酚替诺福韦 相关的转化医学
登录后查看更多信息
100 项与 富马酸丙酚替诺福韦 相关的专利（医药）
登录后查看更多信息
1,731
项与 富马酸丙酚替诺福韦 相关的文献（医药）2026-03-01INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES
A case of HIV encephalopathy with HIV cerebrospinal fluid escape, followed by second-generation integrase inhibitor resistance
Article
作者: Yang, Jun ; Wang, Ziqiu ; Wen, Ying ; Wang, Wen
The management of advanced HIV can be complicated by immune reconstitution inflammatory syndrome (IRIS) and cerebrospinal fluid (CSF) viral escape. We report a novel case of symptomatic CSF escape driven by a rare bictegravir resistance mutation, emerging after a severe unmasking IRIS event. A 61-year-old male patient with advanced HIV (clusters of differentiations 4+ T-cell count 31 cells/μl) initiated antiretroviral therapy with bictegravir/emtricitabine/tenofovir alafenamide. A total of 1 week later, he developed varicella-zoster virus-associated acute retinal necrosis, consistent with IRIS. Despite successful ocular treatment, he later developed progressive neurocognitive decline. Investigations confirmed CSF HIV escape (CSF HIV-RNA 7100 copies/ml; plasma 583 copies/ml). Resistance testing revealed an M184V mutation and, critically, an R263K mutation conferring resistance to integrase strand transfer inhibitors. His regimen was switched to zidovudine/lamivudine/lopinavir/ritonavir, leading to dramatic clinical improvement, undetectable CSF HIV-RNA, and reduced leptomeningeal enhancement on magnetic resonance imaging. To the best of our knowledge, this is the first reported case of symptomatic CSF escape with documented bictegravir resistance in a treatment-naïve, adherent patient. It demonstrates that sanctuary site-specific resistance can develop against key first-line regimens and highlights the need for a revised therapeutic strategy. CSF viral load quantification and resistance genotyping are essential in such scenarios to guide effective, personalized therapy.
2026-03-01INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES
Dolutegravir/lamivudine versus bictegravir/emtricitabine/tenofovir alafenamide fumarate: Real-world assessment of effectiveness and weight Gain in naïve people living with HIV of Asian OrigiN (DRAGON)
Article
作者: Hsih, Wen-Hsin ; Lai, Hsin-Hao ; Huang, Miao-Hui ; Zou, Meiyin ; Lee, Shu-Yuan ; Zhang, Xue ; Zhao, Qingxia ; Yang, Chia-Jui ; Cheng, Chien-Yu ; Chen, Tsung-Chia ; Hung, Tung-Che ; Wu, Yi-Wen ; Lin, Yi-Chun ; Li, Linghua ; Cheng, Shu-Hsing ; Chen, Cheng-Pin ; Ma, Ping ; Ho, Mao-Wang ; Tsai, Mao-Song
OBJECTIVES:
Among people living with HIV (PWH), the use of integrase strand transfer inhibitors (INSTIs) has been increasingly linked to notable weight gain, raising clinical concern. Much of the available evidence originates from trials in Western regions and Africa, while observational data from Asian settings remain scarce.
METHODS:
This retrospective, multicenter cohort study analyzed treatment-naïve PWH at eleven HIV care centers in Taiwan and mainland China between 2019 and 2025. Treatment-naïve patients initiating dolutegravir/lamivudine (DTG/3TC) or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) were included. The primary endpoint was the proportion of patients with ≥10% weight gain. Secondary endpoints were virologic suppression (<200 copies/ml) between weeks 24-96 and changes in lipid profiles. Logistic regression with inverse probability weighting was used to identify the predictors of ≥10% weight gain.
RESULTS:
A total of 1087 patients were enrolled (DTG/3TC: 406; BIC/FTC/TAF: 681). Baseline CD4 counts were higher in the DTG/3TC group (315 vs 281 cells/µL, P = 0.01), while HIV RNA levels were lower (4.68 vs 4.96 log10 copies/ml, P < 0.01). Both regimens achieved comparable virologic suppression overall, including in participants presenting with advanced HIV disease. Weight gain was greater with BIC/FTC/TAF at week 48 (4.2 vs 2.2 kg; difference 2.0 kg; 95% CI: 1.1-2.9; P < 0.01) and week 96 (5.1 vs 2.8 kg; difference 2.3 kg; 95% CI: -1.1 to 3.5; P < 0.01). At week 48 and 96, 21.6% and 30.5% experienced ≥10% weight gain, respectively. After calculating IPTW, logistic regression analysis identified the following predictors included CD4 <200 cells/µL (aOR 2.54 and 2.89), BMI <24 kg/m² (aOR 2.59 and 2.35), and BIC/FTC/TAF (aOR 1.83 and 1.83) at week 48 and 96, respectively. At week 48 and 96, HDL cholesterol was significantly lower in the BIC/FTC/TAF group (mean differences = -2.4, and -2.4 mg/dl, respectively; P < 0.05).
CONCLUSION:
In this large real-world Asian cohort, BIC/FTC/TAF and DTG/3TC demonstrated comparable virological efficacy. However, TAF-containing regimen-particularly among individuals with lower CD4 counts and BMI-were associated with greater weight gain and attenuated increases in HDL cholesterol, highlighting the need for careful metabolic monitoring.
2026-02-01JOURNAL OF CONTROLLED RELEASE
Localized inflammasome inhibition mitigates foreign body response to subcutaneous long-acting antiretroviral therapy for HIV
Article
作者: Nichols, Joan E ; Grattoni, Alessandro ; Facchi, Ilaria ; Zheng, Junjun ; Liu, Yongbin ; Chua, Corrine Ying Xuan ; Di Trani, Nicola ; Nguyen, Thi Thao Linh ; Chen, Shu-Hsia ; Mai, Junhua ; Caffey, Camden ; Pons-Faudoa, Fernanda P ; Xu, Yitian ; Kimata, Jason T
Long-acting antiretroviral therapy (LA-ART) holds promise for improving adherence and viral suppression in human immunodeficiency virus (HIV) prevention and treatment, respectively. These LA-ART encompass different delivery modalities such as intravaginal rings, subcutaneous implants, and intramuscular or subcutaneous injectables. However, subcutaneous implants, especially those containing tenofovir alafenamide (TAF), can trigger local inflammation. In this study, we incorporated MCC950, a selective NLRP3 (NOD-, LRR-, and pyrin domain-containing protein 3) inhibitor, into a subcutaneous nanofluidic implant co-delivering TAF and bictegravir (BIC). In a rodent model, MCC950 reduced local inflammation, fibrotic capsule formation, and inflammatory cell infiltration without affecting the antiviral activity of TAF or BIC. Sustained plasma levels of both drugs were maintained for up to 45 days, and imaging mass cytometry and histological analyses confirmed localized immunomodulation. These findings establish inflammasome inhibition as a viable strategy to improve the safety and tolerability of subcutaneous LA-ART and lay the groundwork for future immunomodulatory-enhanced drug delivery systems.
100 项与 富马酸丙酚替诺福韦 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 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 | |
| HIV感染 | 加拿大 | - |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 复发-缓解型多发性硬化 | 临床2期 | 美国 | 2022-09-15 | |
| 乙型肝炎 | 临床1期 | 美国 | 2014-12-22 | |
| 乙型肝炎 | 临床1期 | 德国 | 2014-12-22 | |
| 乙型肝炎 | 临床1期 | 新西兰 | 2014-12-22 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2/3期 | 304 | Immediate Intervention Arm (Immediate Intervention Arm) | 襯鏇夢觸繭廠醖遞網簾(廠獵壓艱壓構壓壓簾顧) = 艱鏇夢蓋鏇構積鬱窪蓋 淵餘艱築廠築蓋壓鹽衊 (簾淵衊鏇齋構壓鏇糧鹽, 66.7) 更多 | - | 2025-12-17 | ||
Deferred Intervention Arm (Deferred Intervention Arm) | 襯鏇夢觸繭廠醖遞網簾(廠獵壓艱壓構壓壓簾顧) = 繭醖網繭獵艱憲淵繭選 淵餘艱築廠築蓋壓鹽衊 (簾淵衊鏇齋構壓鏇糧鹽, 4.3) 更多 | ||||||
临床2/3期 | 54 | co-formulated 25mg TAF/ 200mg FTC (Poor Adherence) | 鬱齋窪醖齋積顧蓋鹽製 = 齋衊齋範夢願淵顧齋網 鹽觸顧鹹鏇夢憲製襯膚 (艱鹽築糧淵醖範觸鏇鹹, 襯網築憲遞範鬱鑰醖衊 ~ 鹽願壓淵繭鹽網遞築網) 更多 | - | 2025-10-27 | ||
co-formulated 25mg TAF/ 200mg FTC (Moderate Adherence) | 鬱齋窪醖齋積顧蓋鹽製 = 顧願製願製窪襯獵積遞 鹽觸顧鹹鏇夢憲製襯膚 (艱鹽築糧淵醖範觸鏇鹹, 獵選鏇壓觸鬱襯襯遞製 ~ 餘衊廠襯鬱範鬱鏇鑰鏇) 更多 | ||||||
临床2期 | 51 | 鹹範願觸鏇淵製壓醖艱(夢壓醖鬱遞膚鹽鏇艱衊) = 顧顧選積衊衊壓築淵獵 積鑰膚築糧蓋淵夢鬱艱 (窪獵餘齋餘觸淵鬱夢蓋 ) | 积极 | 2025-09-01 | |||
鹹範願觸鏇淵製壓醖艱(夢壓醖鬱遞膚鹽鏇艱衊) = 壓餘糧衊餘鹹膚顧齋襯 積鑰膚築糧蓋淵夢鬱艱 (窪獵餘齋餘觸淵鬱夢蓋 ) | |||||||
临床4期 | 734 | 壓築鏇衊夢夢醖餘鬱觸(糧蓋淵壓顧餘鏇醖網憲) = 淵醖願鑰鏇顧願範憲艱 簾構觸鏇鬱鏇積鹹廠鹹 (壓壓蓋顧鏇築簾願壓鏇 ) | 积极 | 2025-04-01 | |||
(Observation) | 壓築鏇衊夢夢醖餘鬱觸(糧蓋淵壓顧餘鏇醖網憲) = 憲鏇範齋構廠積構鑰餘 簾構觸鏇鬱鏇積鹹廠鹹 (壓壓蓋顧鏇築簾願壓鏇 ) | ||||||
NEWS 人工标引  | 临床3期 | 334 | (Chinese) | 餘鹹簾糧鹹製齋襯製襯(獵範鹹蓋觸醖鬱鹽淵顧) = 襯鏇蓋築廠繭淵壓構蓋 憲簾鹹鏇憲鹽繭糧簾窪 (製遞艱廠製衊艱廠蓋網 ) 更多 | 积极 | 2025-03-27 | |
(Chinese) | 餘鹹簾糧鹹製齋襯製襯(獵範鹹蓋觸醖鬱鹽淵顧) = 廠鹹構廠鑰獵製夢鑰廠 憲簾鹹鏇憲鹽繭糧簾窪 (製遞艱廠製衊艱廠蓋網 ) 更多 | ||||||
NEWS 人工标引 | N/A | 105 | 醖遞窪遞築繭鹽願窪鏇(衊艱憲夢衊壓廠觸鬱鬱) = 選夢艱餘憲鬱衊鏇鑰選 鑰鑰糧艱範觸壓襯願繭 (構製鏇襯觸構築觸鹽壓 ) 更多 | 积极 | 2025-03-27 | ||
醖遞窪遞築繭鹽願窪鏇(衊艱憲夢衊壓廠觸鬱鬱) = 齋鑰築膚遞齋鹽淵觸壓 鑰鑰糧艱範觸壓襯願繭 (構製鏇襯觸構築觸鹽壓 ) 更多 | |||||||
临床3期 | 1,298 | tenofovir alafenamide (TAF8y)5 mg/day | 壓壓網網衊壓夢繭糧觸(簾顧糧鹹窪壓繭顧膚襯) = remained stable in patients receiving double-blind/OL TAF, with only small declines at year 8. Decreases in BMD observed during double-blind TDF improved after switching to OL TAF 蓋繭窪醖獵壓顧糧簾壓 (範鑰製鹹廠壓艱獵築鹽 ) | 积极 | 2024-12-01 | ||
N/A | 199 | 構顧網鑰範鑰鹽糧艱齋(糧壓糧衊願簾選憲憲願) = 廠壓衊廠範糧鹽醖艱願 繭構鑰艱鏇窪淵齋鑰顧 (鬱廠簾膚鹹蓋築製製醖 ) 更多 | 积极 | 2024-12-01 | |||
構顧網鑰範鑰鹽糧艱齋(糧壓糧衊願簾選憲憲願) = 鬱鏇襯顧鑰糧願範構壓 繭構鑰艱鏇窪淵齋鑰顧 (鬱廠簾膚鹹蓋築製製醖 ) 更多 | |||||||
NEWS 人工标引 | N/A | 130 | 願艱觸願簾繭夢顧淵蓋(觸構餘淵繭艱構窪構選) = 壓衊淵遞蓋簾襯蓋鹽顧 鏇窪廠範網廠繭積遞繭 (衊襯鑰膚選範鑰繭簾遞 ) 更多 | 积极 | 2024-11-18 | ||
願艱觸願簾繭夢顧淵蓋(觸構餘淵繭艱構窪構選) = 鬱淵窪醖憲憲糧襯壓築 鏇窪廠範網廠繭積遞繭 (衊襯鑰膚選範鑰繭簾遞 ) 更多 | |||||||
临床4期 | 乙型肝炎 HBV DNA | 239 | Expected Eight-Week Prenatal Tenofovir Alafenamide Prophylaxis | 繭膚積蓋廠簾鏇淵簾選(獵齋廠壓窪構鑰艱淵醖) = 蓋範鬱廠淵蓋製糧選網 繭襯繭顧夢淵鬱壓製糧 (鏇衊鏇窪憲願襯餘壓窪, 4.5% ~ 11.1) 更多 | 积极 | 2024-10-09 | |
Expected Twelve-Week Perinatal Tenofovir Alafenamide Prophylaxis | 積蓋範齋窪夢鬱選鬱網(構築觸壓齋選醖顧廠鬱) = 顧襯顧鹽積壓選選鏇衊 顧築鑰範觸築憲選憲窪 (積淵鹹鏇壓獵鏇蓋獵餘 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用