富马酸替诺福韦二吡呋酯(Tenofovir Disoproxil Fumarate) - 药物靶点：DNA polymerase x RT_在研适应症：乙型肝炎，慢性乙型肝炎，HIV感染_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Bis(POC)PMPA、TDF、tenofovir disoproxil

+ [13]

靶点

DNA polymerase x RT

作用机制

DNA polymerase抑制剂(DNA聚合酶抑制剂)、RT抑制剂(逆转录酶抑制剂)

治疗领域

免疫系统疾病感染消化系统疾病+ [1]

在研适应症

乙型肝炎慢性乙型肝炎HIV感染

非在研适应症

终末期肝病淋巴瘤

原研机构

Gilead Sciences, Inc.

在研机构

香港吉立亚科学有限公司北京代表处

Gilead Sciences, Inc.Gilead Sciences Ireland UC

+ [6]

非在研机构

CHARTWELL RX SCIENCES LLCCASI Pharmaceuticals, Inc.

最高研发阶段批准上市

首次获批日期

美国 (2001-10-26),

HIV感染

最高研发阶段(中国)临床3期

特殊审评加速批准 (美国)、孤儿药 (美国)、优先审评 (中国)、孤儿药 (日本)

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结构

分子式C23H34N5O14P

InChIKeyVCMJCVGFSROFHV-WZGZYPNHSA-N

CAS号202138-50-9

关联

274

项与富马酸替诺福韦二吡呋酯相关的临床试验

NCT03304717 / Not yet recruiting临床1/2期IIT

Reverse Transcriptase Inhibitors in Aicardi Goutières Syndrome

The overall objectives are to explore the safety and efficacy of Reverse Transcriptase Inhibitors Tenofovir (TDF)/ Emtricitabine (FTC) administered in AGS affected children 2 to 18 years of age.

开始日期2024-12-01

申办/合作机构

The Children's Hospital of Philadelphia

[+5]

NCT06338826 / Not yet recruiting临床2期IIT

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

The main objective of this study is to evaluate at 96 weeks the safety with respect to hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapy

开始日期2024-05-01

申办/合作机构

ANRS, Emerging Infectious Diseases

CTR20240626 / Recruiting临床2期

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

主要目的：评价 TQA3810 片联合/不联合口服核苷（酸）类药物在初治/经治慢乙肝患者中的安全性和耐受性；次要目的评价 TQA3810 片联合/不联合口服核苷（酸）类药物在初治/经治慢乙肝患者中的疗效；评价 TQA3810 片联合/不联合口服核苷（酸）类药物在初治/经治慢乙肝患者中的药代动力学（PK）特征；评价 TQA3810 片联合/不联合口服核苷（酸）类药物在初治/经治慢乙肝患者中的药效学（PD）特征；评价 TQA3810 在初治/经治慢乙肝患者中的血药浓度-QT 间期定量分析（C-QT）研究；

开始日期2024-03-13

申办/合作机构

正大天晴药业集团股份有限公司

100 项与富马酸替诺福韦二吡呋酯相关的临床结果

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100 项与富马酸替诺福韦二吡呋酯相关的转化医学

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100 项与富马酸替诺福韦二吡呋酯相关的专利（医药）

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4,574

项与富马酸替诺福韦二吡呋酯相关的文献（医药）

2024-04-12·The Journal of infectious diseases

Tenofovir Douche as HIV Preexposure Prophylaxis for Receptive Anal Intercourse: Safety, Acceptability, Pharmacokinetics, and Pharmacodynamics (DREAM 01)

Article

作者: Bumpus, Namandje N ; Weld, Ethel D ; Manohar, Madhuri ; Seigel, Aaron ; Parsons, Teresa ; Bakshi, Rahul P ; Carballo-Dieguez, Alex ; Bagia, Christina ; Marzinke, Mark A ; Anton, Peter ; Engstrom, Jared ; Spiegel, Hans M L ; Edick, Stacey ; Fuchs, Edward J ; Al-Khouja, Amer ; Hendrix, Craig W ; Giguere, Rebecca ; Rohan, Lisa C ; Brand, Rhonda ; Ho, Ken ; Wang, Lin ; Jacobson, Cindy ; Elliott, Julie ; McGowan, Ian ; Hartman, Douglas J

Abstract:

Background:

Despite highly effective HIV preexposure prophylaxis (PrEP) options, no options provide on-demand, nonsystemic, behaviorally congruent PrEP that many desire. A tenofovir-medicated rectal douche before receptive anal intercourse may provide this option.

Methods:

Three tenofovir rectal douches—220 mg iso-osmolar product A, 660 mg iso-osmolar product B, and 660 mg hypo-osmolar product C—were studied in 21 HIV-negative men who have sex with men. We sampled blood and colorectal tissue to assess safety, acceptability, pharmacokinetics, and pharmacodynamics.

Results:

The douches had high acceptability without toxicity. Median plasma tenofovir peak concentrations for all products were several-fold below trough concentrations associated with oral tenofovir disoproxil fumarate (TDF). Median colon tissue mucosal mononuclear cell (MMC) tenofovir-diphosphate concentrations exceeded target concentrations from 1 hour through 3 to 7 days after dosing. For 6–7 days after a single product C dose, MMC tenofovir-diphosphate exceeded concentrations expected with steady-state oral TDF 300 mg on-demand 2-1-1 dosing. Compared to predrug baseline, HIV replication after ex vivo colon tissue HIV challenge demonstrated a concentration-response relationship with 1.9 log10 maximal effect.

Conclusions:

All 3 tenofovir douches achieved tissue tenofovir-diphosphate concentrations and colorectal antiviral effect exceeding oral TDF and with lower systemic tenofovir. Tenofovir douches may provide a single-dose, on-demand, behaviorally congruent PrEP option, and warrant continued development.Clinical Trials Registration . NCT02750540.

2024-04-01·AIDS research and human retroviruses

Effectiveness, Weight Changes, and Metabolic Outcomes on Switch to Generic Dolutegravir/Lamivudine Among People with HIV in Western India: An Observational Study

Article

作者: Pujari, Sanjay ; Dabhade, Diagamber ; Bele, Vivek ; Joshi, Kedar ; Gaikwad, Sunil ; Panchawagh, Suhrud ; Chitalikar, Abhishek ; Rohekar, Chaitrangi

We assessed the effectiveness and safety of switching to generic dolutegravir/lamivudine (DTG/3TC) among People living with Human Immunodeficiency Virus (PWH) in Western India. In this single-center, retrospective observational study, PWH, who switched to DTG/3TC, were followed for virologic, immunologic, and clinical effectiveness, and safety, including weight changes, hyperglycemia, and dyslipidemia. Multivariate linear mixed-effects models were used to predict average change in weight adjusted for age, sex, duration of previous antiretroviral (ARV) regimens, and baseline weight. From May 2017 to July 2022, out of 434 PWH switched to DTG/3TC, 304 with at least 1 follow-up visit were included. Median [interquartile range (IQR)] age was 54 (IQR 49-61) years and 70.1% were male. Prevalence of baseline comorbidities was 57.9% (hypertension-41.5%, chronic kidney disease-40.9%, and diabetes mellitus-18.8%). Reasons for switch were affordability (47.4%), desire for simplification (41.8%), ARV toxicities (19.1%), and concern about potential toxicities (10.2%). Median (IQR) duration of follow-up on DTG/3TC was 40 (IQR 31-49) weeks. No virologic failure was observed. Rates of virologic suppression [viral load (VL) ≤20 copies/mL or target not detected (TND)] at 12, 24, 48, 72, 96 and 120 weeks were 95.2%, 95.9%, 90%, 100%, 81.3%, and 88.4%, respectively. Only 9 (3%) PWH permanently discontinued DTG/3TC. Predicted adjusted mean weight gain of +3.3 kg was observed at 96 weeks. Switching from tenofovir disoproxil fumarate (TDF)/emtricitabine or lamivudine (XTC)/non-nucleoside reverse transcriptase inhibitor (NNRTI) and duration on DTG/3TC were significantly associated with weight gain. Apart from trend in worsening hyperglycemia (nine PWH with new onset diabetes), no clinically significant change in lipids and estimated glomerular filtration rate (eGFR) was documented. Switching to DTG/3TC is an effective and safe option among virologically suppressed PWH with high comorbidity burden in India. In view of the several advantages of DTG/3TC, it may be considered for potential scale-up in the right population, both in private and public health care settings in India.

2024-04-01·AIDS (London, England)

Urine tenofovir and dried blood spot tenofovir diphosphate concentrations and viraemia in people taking efavirenz and dolutegravir-based antiretroviral therapy

Article

作者: Fanshawe, Thomas R ; Samsunder, Natasha ; Sookrajh, Yukteshwar ; Hayward, Gail N ; Dorward, Jienchi ; Butler, Christopher C ; Moodley, Pravikrishnen ; Turner, Philip J ; Lessells, Richard ; Garrett, Nigel ; Govender, Katya ; Drain, Paul K

Objective::

We aimed to determine whether urine tenofovir (TFV) and dried blood spot (DBS) tenofovir diphosphate (TFV-DP) concentrations are associated with concurrent HIV viraemia.

Design::

Cross-sectional study among people with HIV (PWH) receiving tenofovir disoproxil fumarate (TDF)-based antiretroviral therapy (ART).

Methods::

We used dual tandem liquid chromatography and mass spectrometry to measure urine TFV and DBS TFV-DP concentrations, and evaluated their associations with concurrent viraemia at least 1000 copies/ml using logistic regression models. In exploratory analyses, we used receiver operating curves (ROCs) to estimate optimal urine TFV and DBS TFV-DP thresholds to predict concurrent viraemia.

Results::

Among 124 participants, 68 (54.8%) were women, median age was 39 years [interquartile range (IQR) 34–45] and 74 (59.7%) were receiving efavirenz versus 50 (40.3%) receiving dolutegravir. Higher concentrations of urine TFV [1000 ng/ml increase, odds ratio (OR) 0.97 95% CI 0.94–0.99, P = 0.005] and DBS TFV-DP (100 fmol/punch increase, OR 0.76, 95% CI 0.67–0.86, P < 0.001) were associated with lower odds of viraemia. There was evidence that these associations were stronger among people receiving dolutegravir than among people receiving efavirenz (urine TFV, P = 0.072; DBS TFV-DP, P = 0.003). Nagelkerke pseudo-R2 for the DBS TFV-DP models was higher for the urine TFV models, demonstrating a stronger relationship between DBS TFV-DP and viraemia. Among people receiving dolutegravir, a DBS TFV-DP concentration of 483 fmol/punch had 88% sensitivity and 85% specificity to predict concurrent viraemia ≥1000 copies/ml.

Conclusion::

Among PWH receiving TDF-based ART, urine TFV concentrations, and in particular DBS TFV-DP concentrations, were strongly associated with concurrent viraemia, especially among people receiving dolutegravir.

153

项与富马酸替诺福韦二吡呋酯相关的新闻（医药）

2024-06-28

·梅斯医学

半年一针，100%有效，HIV预防迎来重大突破

6月20日，美国生物制药公司吉利德公告称，其艾滋病预防药物lenacapavir在女性艾滋病暴露前预防第三期临床试验中实现100%有效。其中，2134名女性使用该药物后，无一感染艾滋病。这是有史以来首个零感染的3期HIV预防试验。 Lenacapavir三期临床试验据介绍，PURPOSE 1是一项3期、双盲、随机研究，正在评估皮下注射、每年给药两次的lenacapavir和每日口服的达可挥（恩曲他滨200mg/丙酚替诺福韦25mg，F/TAF）用于暴露前预防（PrEP）的安全性和有效性，研究对象为来自南非25个地方和乌干达3个地方超过5300名16-25岁顺性别女性和青春期女孩。对这些药物进行平行试验，一组为接受每年给药两次的lenacapavir，另一组为每日口服达可挥。此外，第三组为每日口服舒发泰（恩曲他滨200mg/富马酸替诺福韦二吡呋酯300mg）。受试者按2:2:1的比例被随机分配到lenacapavir、达可挥和舒发泰组。在lenacapavir组的2134名女性中，没有发生一例HIV感染（发病率为0.00每100人年）。而Descovy组的发病率为每100人年2.02例，Truvada组为1.69例。也就是说，每年2针的情况下，lenacapavir能够实现艾滋病0感染。吉利德方面称，PURPOSE 1试验达到了其关键疗效终点，显示出每年给药两次的lenacapavir相较于每日口服舒发泰和HIV背景发病率的优越性。吉利德表示，预计将在2024年底或2025年初从PURPOSE项目的另一关键试验PURPOSE 2中获得结果，该试验评估每年给药两次的lenacapavir作为PrEP在与男性发生性行为的顺性别男性，以及跨性别男性、跨性别女性，还有与出生时生理性别为男性者发生性关系的非二元性别者中的疗效，试验开展地点包括阿根廷、巴西、墨西哥、秘鲁、南非、泰国和美国。半年注射一次，有助于提高依从性和持久性据吉利德官网新闻稿，南非开普敦大学德斯蒙德·图图艾滋病毒中心主任、国际艾滋病协会前主席琳达—盖尔·贝克表示，每年注射两次lenacapavir，有助于提高PrEP药物的依从性和持久性，有助于解决某些人在服用或储存口服PrEP药物时，可能面临的歧视。 “衣壳抑制剂的作用机制是从多个层面抑制病毒的生命周期，阻止艾滋病毒成熟，防止其从细胞中释放、扩散。”广东省深圳市第三人民医院院长卢洪洲6月22日告诉人民日报健康客户端记者，现在的艾滋病毒暴露前预防用药多数也可以做到接近100%的保护率，但大多需要坚持每日用药，从依从性的角度来说，一年两针的暴露前预防取得的进展是突破性的。据报道，来自加拿大皇家银行资本市场的行业分析师指出，市场研究表明，未感染的HIV高风险人群，对每年两次皮下注射药物的接受度很高，预计用于PrEP的lenacapavir（针剂）未来几年的销售额将超17亿美元。真实世界效果未知 “从目前的临床试验结果看，这款药的疗效很好。”国内一所三甲医院感染科的主任医师陈彬告诉《中国新闻周刊》。不过，陈彬也表示，这一数据不能代表未来真实世界的效果，真实世界数据和临床试验数据不同，临床试验入组的受试者一定是满足筛选条件之后，才能被纳入分析，比如身体比较健康的、免疫功能相对较好的人。因此，当药物推向更广泛的真实世界之后，预防HIV的效果未必能达到100％。然而价格问题同样是业内讨论的焦点。Lenacapavir和Descovy目前在美国的年用药费用均达到数万美元。2023年，Descovy的年营收为20亿美元。对此吉利德表示，鉴于目前这一里程碑式的数据，以及公司对艾滋病防控的持续承诺，公司将进一步对高发病率、资源有限国家（主要为中、低收入国家）的药物可及性问题发表公开声明。陈彬认为，未来如果Lenacapavir能上市，价格可能是影响药物可及性及患者依从性的主要因素。撰文 | 阿拉斯加宝编辑 | 阿拉斯加宝 ●司美格鲁肽「减肥适应症」在中国获批！体重平均减轻16.8kg，但需注意阳痿风险...... ● 震撼！大三甲上海同济院长被查，或成标志性案件！半年来至少22位三甲书记、院长落马！中纪委6月三次点名医药腐败：一刻不停推进反腐 ●震惊！多家医院出现一级甲等医疗事故！医生惊出冷汗：只要患者死亡，必判医方赔偿！倒推过错，带着上帝视角去挑错，如何保持客观？版权说明：梅斯医学（MedSci）是国内领先的医学科研与学术服务平台，致力于医疗质量的改进，为临床实践提供智慧、精准的决策支持，让医生与患者受益。欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。点击下方「阅读原文」立刻下载梅斯医学APP！

临床3期临床失败

2024-06-24

·PMLiVE

Gilead shares positive phase 3 results for twice-yearly HIV PrEP drug in women

Gilead Sciences’ twice-yearly injectable pre-exposure prophylaxis (PrEP) drug lenacapavir has demonstrated 100% efficacy in protecting women against human immunodeficiency virus (HIV), according to new late-stage results shared by the company. The phase 3 PURPOSE 1 study randomised more than 5,300 women and adolescent girls aged 16 to 25 years across sites in South Africa and Uganda to receive lenacapavir or one of Gilead’s once-daily oral PrEP drugs, Descovy (emtricitabine/tenofovir alafenamide) and Truvada (emtricitabine/ tenofovir disoproxil fumarate). There were zero incident cases of HIV infection among the 2,134 women in the lenacapavir group and 16 among 1,068 of those in the Truvada group, Gilead said, adding that twice-yearly lenacapavir was superior to background HIV incidence (bHIV). The results also showed that HIV incidence in the Descovy group was numerically similar to that in the Truvada group and not statistically superior to bHIV, and lenacapavir was generally well tolerated with no significant or new safety concerns identified. Based on these results, an independent data monitoring committee has recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants. Merdad Parsey, Gilead’s chief medical officer, said: “With zero infections and 100% efficacy, twice-yearly lenacapavir has demonstrated its potential as an important new tool to help prevent HIV infections. “We look forward to additional results from the ongoing PURPOSE clinical programme and continuing toward our goal of helping to end the HIV epidemic for everyone, everywhere.” PrEP is highly effective for preventing HIV when taken as prescribed. However, there are challenges surrounding adherence to daily oral therapies, including stigma and treatment persistence. Lenacapavir was approved by the US Food and Drug Administration in 2022 under the brand name Sunlenca for use alongside other antiretrovirals to treat heavily treatment-experienced adults with multi-drug-resistant HIV-1 infection. It is hoped that lenacapavir for PrEP could help address treatment barriers and increase adherence, given its twice-yearly dosing schedule. The results come just one month after Gilead announced promising results from an open-label extension study of its investigational PPAR delta agonist, seladelpar, in patients with primary biliary cholangitis.

临床结果临床3期上市批准临床1期

2024-06-21

·药通社

2134例艾滋药物临床试验，100%预防背后的产业震荡

2024 CMC（CRO&MAH&CMO）博览会，将于8月15-16日在苏州国际博览中心C、D、E馆召开，内容涵盖前沿法规政策、MAH、改良型新药、吸入制剂、透皮制剂、中药、缓控释制剂、注射剂、原料药、辅料领域热点话题。一键报名 · 见证合作！ 6月20日，吉利德科学公布了一则艾滋病药物数据，研发的Lenacapavir预防艾滋病100％有效。图源 | 吉利德官网这次试验选择在南非25个站点以及乌干达3个站点。在一个区域内对疾病人口进行统计时，一般计算其发病率、阳性率，而在乌干达地区统计的则是“每千名未感染人口”，其区域内艾滋病泛滥程度可见一斑。早在2001年，乌干达就有临床机构介入进行艾滋病疫苗试验。图源 | CEIC 2017年相关数据显示，南非艾滋病感染率高达12.57%，其中15岁到49岁妇女的感染率达到了21.17%，而本次试验人群的年龄正是16到25岁之间。图源 | CDC 所以在这个区域开展临床试验，从严谨性看是没问题的。当然刻意让志愿者暴露于风险中是不道德的，所以本次实验给安慰剂组提供了其他药物，而非完全不做干涉。 5,300多名受试者按照2:2:1的比例随机分配接受Lenacapavir、Descovy和Truvada用于HIV暴露前预防（PrEP）。据了解，Descovy、Truvada是每日一次的口服药；Lenacapavir则是一款衣壳抑制剂，每半年一针，通过皮下注射。结果显示，在Lenacapavir组2,134名女性中，HIV感染病例为0例。而在Truvada组1,068名中，HIV感染病例为16例，发病率为1.69例/100人；Descovy组2,136名中有39例发病病例，发病率为2.02例/100人。每年两次的给药，能证实帮助预防艾滋病传播。在此次试验数据加持下，吉利德股票断层大涨。图源 | 雪球目前吉利德正在阿根廷、巴西、墨西哥、秘鲁、南非、泰国和美国的男男性行为者、跨性别男性和女性中进行多项实验以评估药效。该研究的结果预计将在 2024 年底或 2025年初公布。吉利德的计划是将两项关键试验的数据结合起来，寻求FDA的批准。这不是吉利德首次针对艾滋病药物进行研发，此前的Truvada被批准用于未感染人群的预防用药。纵观这些年吉利德对于艾滋病用药的研发史，Viread（2001年）、Emtriva（2003年）、Truvada（2004年）、Atripla（2006年）、Complera（2011年）、Stribild（2012年）、Tybost（2014年）、Descovy（2015年）、Genvoya（2015年）、Odefsey（2016年）、Biktarvy（2018年）。其实也能看出，推出新药，势必是将旧款药物打入冷宫。理论上讲，如果一个药物能持续发挥作用，能保护健康人群不受感染，那随着时间推进，患病人群退出，最后这个疾病消失，而后药物退市。就长远的经济角度看，这对药企的存活是不利的，但吉利德不是第一次干这种事，此前，丙肝治疗药物索磷布韦就呈现出“碾压性药效”，同其他药企一起把丙肝药物做成了小市场。凭借药效更好、副作用更低、治疗方式更便捷等诸多优势，吉利德丙肝治疗系列药物上市第三年，收入达191亿美金，吸金能力惊人。但由于药效太好，患者群体规模持续下降，公司丙肝药物收入迅速断崖式下滑。2020年，吉利德丙肝药物收入规模已经缩水至20亿美金。吉利德丙肝药物年收入从近200亿美金缩水至20亿美金，只用了5年时间。就目前看，艾滋病在全球范围内的传播形式依然严峻，如果这款新药能大幅度降低患病人员数量，那釜底抽薪式的类疫苗效果，最终可能使得艾滋病小众化。而现有药物治疗艾滋病，多数为长期用药，本身就有用药抵触性，但不断的感染也形成了稳定的市场需求，这正是相关药企的谋生之道。吉利德这款药的出现，直接把后续的需求人群斩断，使得绝大多数相关药企被迫减产，或者新做临床扩大治疗领域，否则只能停产。吉利德这次不仅仅要干掉相关竞品，也同样冲击了自己旗下的同类药品，甚至对整个艾滋病治疗与疫苗产业形成了影响。华尔街报告显示，lenacapavir在HIV预防和治疗方面的全球峰值销售额约为30亿美元。威廉·布莱尔（William Blair）分析师表示，这种药物可能达到40亿美元。当一款药能百分百预防传染性疾病，那其他药就应该想想退路了，期待这次吉利德能成功阻击。参考文献：Watch out, GSK. Gilead’s twice-yearly PrEP drug shows 100% efficacy for HIV prevention丙肝神药消亡史：灭了病毒，没了销路吉利德官网

疫苗临床研究财报临床终止

100 项与富马酸替诺福韦二吡呋酯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01982	-	J05AF07	DB00300

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
乙型肝炎	欧盟	Gilead Sciences Ireland UC	2002-02-04
乙型肝炎	冰岛	Gilead Sciences Ireland UC	2002-02-04
乙型肝炎	列支敦士登	Gilead Sciences Ireland UC	2002-02-04
乙型肝炎	挪威	Gilead Sciences Ireland UC	2002-02-04
慢性乙型肝炎	欧盟	Gilead Sciences Ireland UC	2002-02-04
慢性乙型肝炎	冰岛	Gilead Sciences Ireland UC	2002-02-04
慢性乙型肝炎	列支敦士登	Gilead Sciences Ireland UC	2002-02-04
慢性乙型肝炎	挪威	Gilead Sciences Ireland UC	2002-02-04
HIV感染	美国	Gilead Sciences, Inc.	2001-10-26

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
淋巴瘤	临床2期	美国	GSK Plc	2015-12-01
终末期肝病	临床2期	美国	Gilead Sciences, Inc.	2006-04-01
终末期肝病	临床2期	加拿大	Gilead Sciences, Inc.	2006-04-01
终末期肝病	临床2期	法国	Gilead Sciences, Inc.	2006-04-01
终末期肝病	临床2期	德国	Gilead Sciences, Inc.	2006-04-01
终末期肝病	临床2期	希腊	Gilead Sciences, Inc.	2006-04-01
终末期肝病	临床2期	意大利	Gilead Sciences, Inc.	2006-04-01
终末期肝病	临床2期	波兰	Gilead Sciences, Inc.	2006-04-01
终末期肝病	临床2期	新加坡	Gilead Sciences, Inc.	2006-04-01
终末期肝病	临床2期	西班牙	Gilead Sciences, Inc.	2006-04-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03887702 (CTgov)	临床3期	乙型肝炎 \| 恶性实体肿瘤	4	Tenofovir Alafenamide+Tenofovir Disoproxil Fumarate+Entecavir (Arm 1 (TAF, TDF, Entecavir: Prophylactic))	醖簾膚醖積壓範窪繭繭(醖窪夢鑰夢衊窪鑰壓顧) = 壓製築積鹹遞憲遞鏇構鹽糧簾廠觸衊衊顧鹽餘 (網製構獵鏇餘觸製獵窪, 艱憲獵繭餘顧餘網遞襯 ~ 膚鏇夢遞構繭窪築醖糧) 更多	-	2024-05-20
				Tenofovir Alafenamide+Tenofovir Disoproxil Fumarate+Entecavir (Arm 2 (TAF, TDF, Entecavir: Upon Indication))	醖簾膚醖積壓範窪繭繭(醖窪夢鑰夢衊窪鑰壓顧) = 鑰蓋餘醖遞簾簾積鏇齋鹽糧簾廠觸衊衊顧鹽餘 (網製構獵鏇餘觸製獵窪, 齋蓋獵觸鑰獵糧蓋糧遞 ~ 膚願憲夢齋鑰齋積餘窪) 更多
AASLD2023	N/A	失代偿性肝硬化	3	REP 2139-Mg 250 mg	蓋襯窪壓獵膚齋鬱糧製(獵製選壓壓網網範製製) = No significant adverse events (including ALT elevation) have been observed to date 獵膚鑰淵繭鬱壓艱觸鬱 (淵構齋淵淵鏇襯網遞顧 )	-	2023-11-10
EASL2023	N/A	慢性乙型肝炎一线	3,809	Tenofovir disoproxil fumarate (TDF)	蓋積顧鹹鹽選壓齋廠鏇(觸觸廠鏇鏇窪願觸構範) = 願鏇簾築構顧壓鑰遞夢積簾衊廠積餘鹹觸鬱觸 (憲醖衊壓蓋鹹餘糧廠獵 )	-	2023-06-21
				Tenofovir alafenamide (TAF)	蓋積顧鹹鹽選壓齋廠鏇(觸觸廠鏇鏇窪願觸構範) = 築憲餘膚製醖憲鬱蓋憲積簾衊廠積餘鹹觸鬱觸 (憲醖衊壓蓋鹹餘糧廠獵 )
EASL2023	临床4期	慢性乙型肝炎	130	BSV-BSV group	襯繭鏇憲衊製鹹齋觸顧(製餘齋餘餘願醖積膚夢) = There were no adverse events in the BSV-BSV and TDF-BSV groups from 48 to 96 weeks while there were three in the TDF-TDF and BSV-TDF groups. 觸鬱廠餘鏇願窪繭醖膚 (築積鬱築艱醖鏇鏇範顧 )	-	2023-06-21
				BSV-TDF group
EASL2023	N/A	慢性乙型肝炎	-	Tenofovir disoproxil fumarate (TDF)	鏇醖範糧鹽鬱衊壓繭壓(鬱築鹹廠糧簾糧鬱衊壓) = 鏇糧選醖積壓鬱艱鬱簾餘遞選顧憲艱築鏇廠夢 (簾遞顧顧遞壓襯淵蓋遞 )	-	2023-06-21
				Tenofovir alafenamide (TAF)	鏇醖範糧鹽鬱衊壓繭壓(鬱築鹹廠糧簾糧鬱衊壓) = 淵範餘網築鹽顧鏇網膚餘遞選顧憲艱築鏇廠夢 (簾遞顧顧遞壓襯淵蓋遞 )
EASL2023	N/A	慢性乙型肝炎	159	Tenofovir disoproxil fumarate (TDF)	選獵鹹壓簾齋廠積獵齋(製廠網鏇選願網觸蓋選) = 觸積壓構艱築衊選憲淵觸鏇襯淵願繭憲憲齋糧 (餘範艱鹽鬱廠製醖觸觸 )	-	2023-06-21
				Entecavir (ETV)	選獵鹹壓簾齋廠積獵齋(製廠網鏇選願網觸蓋選) = 齋觸鬱艱艱壓醖鹹觸憲觸鏇襯淵願繭憲憲齋糧 (餘範艱鹽鬱廠製醖觸觸 )
EASL2022	N/A	慢性乙型肝炎	48	Tenofovir disoproxil fumarate (TDF)	網簾餘衊鬱簾鬱鏇艱襯(觸簾選醖鹹範築蓋遞廠) = 獵簾觸鹽餘憲鬱網襯餘壓顧遞選網構願遞築醖 (醖鑰壓餘遞網簾醖範選 )	积极	2022-06-25
EASL2022	N/A	慢性乙型肝炎一线	42	Tenofovir disoproxil fumarate (TDF)	襯憲鬱觸選餘糧齋憲製(選餘餘鑰獵膚蓋襯鹹夢) = 願壓鹽鑰鹹鏇鏇願遞廠壓願製鏇夢網選蓋艱蓋 (窪窪憲壓鹹顧觸窪醖餘 )	-	2022-06-25
				Tenofovir alafenamide fumarate (TAF)	衊顧淵糧壓獵鏇鹹壓艱(齋遞淵膚範膚壓憲醖壓) = 簾簾廠獵繭夢餘餘繭鬱鑰鹹構夢積衊簾製簾網 (積憲夢築網積顧壓鏇廠 )
EASL2022	N/A	乙型肝炎 HBV DNA \| ALP \| Z value for BMD	-	Tenofovir alafenamide fumarate (TAF)	廠糧膚鬱顧繭鑰窪鑰製(顧範築製窪顧選鏇願膚) = 醖築鏇遞襯淵網獵糧築襯醖簾觸鹹餘遞餘鹹齋 (遞蓋醖鹽築憲遞醖積鬱 )	-	2022-06-23
				Tenofovir disoproxil fumarate (TDF)	廠糧膚鬱顧繭鑰窪鑰製(顧範築製窪顧選鏇願膚) = 鹹淵觸製廠獵憲淵廠齋襯醖簾觸鹹餘遞餘鹹齋 (遞蓋醖鹽築憲遞醖積鬱 )
NCT02224456 (CTgov)	临床4期	慢性乙型肝炎 \| 纤维化 \| 代偿期肝硬化	197	Tenofovir Disoproxil Fumarate	餘選積鏇鏇築蓋鏇願窪(網選餘鹽鏇淵艱淵遞糧) = 艱鹽顧醖獵構積淵鏇齋觸願積鹹鹹遞遞顧壓築 (淵餘壓齋齋積鹹壓網醖, 淵積淵顧憲繭築繭餘鹹 ~ 襯顧蓋繭積築網鹹遞夢) 更多	-	2022-02-14