Gilead公布Remdesivir三期临床数据

红茶.

Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19
-- Study Demonstrates Similar Efficacy with 5- and 10-Day Dosing Durations of Remdesivir --


FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 29, 2020-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the open-label, Phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of the investigational antiviral remdesivir in hospitalized patients with severe manifestations of COVID-19 disease. The study demonstrated that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course (Odds Ratio: 0.75 [95% CI 0.51 – 1.12] on Day 14). No new safety signals were identified with remdesivir across either treatment group. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.


“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “These study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir. The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir. This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care.”


Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19. This study sought to determine whether a shorter, 5-day course of remdesivir would achieve similar efficacy results as the 10-day treatment regimen used in multiple ongoing studies of remdesivir. Secondary objectives included rates of adverse events and additional measures of clinical response in both treatment groups. Patients were required to have evidence of pneumonia and reduced oxygen levels that did not require mechanical ventilation at the time of study entry. Clinical improvement was defined as an improvement of two or more points from baseline on a predefined seven-point scale, ranging from hospital discharge to increasing levels of oxygen support to death. Patients achieved clinical recovery if they no longer required oxygen support and medical care or were discharged from the hospital.


In this study, the time to clinical improvement for 50 percent of patients was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group. More than half of patients in both treatment groups were discharged from the hospital by Day 14 (5-day: 60.0%, n=120/200 vs.10-day: 52.3% n=103/197; p=0.14). At Day 14, 64.5 percent (n=129/200) of patients in the 5-day treatment group and 53.8 percent (n=106/197) of patients in the 10-day treatment group achieved clinical recovery.


Clinical outcomes varied by geography. Outside of Italy, the overall mortality rate at Day 14 was 7 percent (n=23/320) across both treatment groups, with 64 percent (n=205/320) of patients experiencing clinical improvement at Day 14 and 61 percent (n=196/320) of patients discharged from the hospital.


Impact of Earlier Treatment


In an exploratory analysis, patients in the study who received remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than 10 days of symptoms. Pooling data across treatment arms, by Day 14, 62 percent of patients treated early were able to be discharged from the hospital, compared with 49 percent of patients who were treated late.


“These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course,” said Aruna Subramanian, MD, Clinical Professor of Medicine, Chief, Immunocompromised Host Infectious Diseases, Stanford University School of Medicine, and one of the lead investigators of the study. “While additional data are still needed, these results help to bring a clearer understanding of how treatment with remdesivir may be optimized, if proven safe and effective.”


Remdesivir was generally well-tolerated in both the 5-day and 10-day treatment groups. The most common adverse events occurring in more than 10 percent of patients in either group were nausea (5-day: 10.0%, n=20/200 vs. 10-day: 8.6%, n=17/197) and acute respiratory failure (5-day: 6.0%, n=12/200 vs. 10-day: 10.7%, n= 21/197). Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3 percent (n=28/385) of patients, with 3.0 percent (n=12/397) of patients discontinuing remdesivir treatment due to elevated liver tests.

About the SIMPLE Trials


Gilead initiated two randomized, open-label, multi-center Phase 3 clinical trials for remdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19 infection.


The first SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing regimens of remdesivir in hospitalized patients with severe manifestations of COVID-19. The initial phase of the study randomized 397 patients in a 1:1 ratio to receive remdesivir 200 mg on the first day, followed by remdesivir 100 mg each day until day 5 or 10, administered intravenously, in addition to standard of care. An expansion phase of the study was recently added and will enroll an additional 5,600 patients, including patients on mechanical ventilation. The study is being conducted at 180 trial sites around the world, including sites in the United States, China, France, Germany, Hong Kong, Italy, Japan, Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan and the United Kingdom.


A second SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing durations of remdesivir administered intravenously in patients with moderate manifestations of COVID-19, compared with standard of care. The results from the first 600 patients of this study are expected at the end of May.


About Remdesivir


Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS. In vitro testing conducted by Gilead has demonstrated that remdesivir is active against the virus that causes COVID-19. The safety and efficacy of remdesivir for the treatment of COVID-19 are being evaluated in multiple ongoing Phase 3 clinical trials.


About Gilead Sciences


Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.


For more information on Gilead’s response to the coronavirus outbreak please visit the company’s dedicated page: https://www.gilead.com/purpose/advancing-global-health/covid-19.


Forward-Looking Statement


This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. Remdesivir is an investigational agent that has not been licensed or approved anywhere globally, and it has not been demonstrated to be safe or effective for any use, including for the treatment of COVID-19. There is the possibility of unfavorable results from ongoing and additional clinical trials involving remdesivir and the possibility that Gilead and other parties may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of remdesivir or that FDA and other regulatory agencies may not approve remdesivir, and any marketing approvals, if granted, may have significant limitations on its use. As a result, remdesivir may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s periodic reports filed with the U.S. Securities and Exchange Commission, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

红茶.

Gilead宣布重度COVID-19患者抗病毒药物瑞姆昔韦3期试验的结果
-研究证明了伦德西韦的5天和10天给药持续时间具有相似的功效-


加州福斯特市。-（美国商业资讯）-4月 2020年9月29日- 吉利德科学公司（纳斯达克股票代码：GILD）今天宣布了一项开放标签的3期SIMPLE试验的主要结果，该试验评估了住院严重COVID-19疾病患者的抗病毒药物瑞姆昔韦的5天和10天给药时间。该研究表明，与接受5天治疗的患者相比，接受瑞地昔韦10天治疗过程的患者的临床状况得到了类似的改善（第14天的赔率：0.75 [95％CI 0.51 – 1.12]）。在任何一个治疗组中，雷姆昔韦均未发现新的安全信号。吉利德计划在未来几周内提交完整的数据，以便在同行评审的期刊上发表。


“与传统的药物开发不同，我们正在尝试与不断发展的全球大流行一起评估研究人员。多项并行的研究正在帮助告知瑞姆昔韦是否对COVID-19是一种安全有效的治疗方法，以及如何最好地利用该药物，”梅达·帕西，医学博士，博士，首席医学官， 吉利德科学。“这些研究结果补充了安慰剂对照的瑞姆昔韦的研究数据，该研究由国立过敏与传染病研究所并帮助确定瑞姆昔韦的最佳治疗时间。这项研究表明，某些患者可能需要接受5天的治疗方案，这可能会大大增加使用我们目前提供的雷姆昔韦治疗的患者数量。在大流行的情况下，这一点尤其重要，以帮助医院和医护人员治疗更多急需护理的患者。”


Remdesivir尚未在全球任何地方获得许可或批准，并且尚未被证明对COVID-19的治疗是安全或有效的。这项研究试图确定较短的5天疗程的remdesivir是否会达到与进行多次remdesivir的10​​天治疗方案相似的疗效结果。次要目标包括两个治疗组的不良事件发生率和临床反应的其他衡量指标。入选研究时，患者需要有肺炎和氧气水平降低的证据，不需要机械通气。临床改善被定义为在预定义的七点量表上比基线改善两个或更多点，范围从出院到增加的氧气支持水平直至死亡。


在本研究中，50％患者的临床改善时间在5天治疗组中为10天，在10天治疗组中为11天。两个治疗组中超过一半的患者在第14天出院（5天：60.0％，n = 120/200与10天：52.3％，n = 103/197； p = 0.14）。在第14天，在5天治疗组中有64.5％（n = 129/200）的患者和在10天治疗组中有53.8％（n = 106/197）的患者实现了临床恢复。


临床结果因地理位置而异。在外面意大利，两个治疗组在第14天的总死亡率为7％（n = 23/320），其中在第14天有64％（n = 205/320）的患者临床改善，而61％（n = 196/320） ）出院的患者。


早期治疗的影响


在一项探索性分析中，与症状超过10天后接受治疗的患者相比，研究中在症状发作后10天内接受瑞姆昔韦的患者的结局有所改善。到第14天，汇总各治疗组的数据，有62％的早期治疗患者可以出院，而49％的晚期治疗患者可以出院。


“这些数据令人鼓舞，因为它们表明接受短于5天疗程的伦德西韦的患者与接受10天治疗疗程的患者经历了相似的临床改善，” 阿鲁纳·苏巴拉曼，医学博士，医学临床教授，免疫功能低下的宿主传染病负责人， 斯坦福大学医学院，以及该研究的首席研究员之一。“尽管仍需要其他数据，但这些结果有助于使人们更清楚地了解，如果证明瑞姆昔韦治疗安全有效，那么如何优化瑞姆昔韦治疗。”


在5天和10天治疗组中，雷姆昔韦普遍耐受良好。两组中超过10％的患者最常见的不良事件是恶心（5天：10.0％，n = 20/200，而10天：8.6％，n = 17/197）和急性呼吸衰竭（5天：6.0％，n = 12/200，而10天：10.7％，n = 21/197）。7.3％（n = 28/385）的患者发生3级或更高水平的肝酶（ALT）升高，而由于肝测试升高而中断瑞姆昔韦治疗的患者为3.0％（n = 12/397）。




关于SIMPLE试用


吉利德（Gilead）在COVID-19感染率高的国家/地区开展了两个随机，开放标签，多中心3期临床试验，用于remdesivir（SIMPLE研究）。


SIMPLE的第一个试验正在评估雷姆昔韦在住院期间严重表现为COVID-19的患者中5天和10天给药方案的安全性和有效性。该研究的初始阶段将397例患者以1：1的比例随机分配，第一天接受200 mg瑞地昔韦，然后每天5 mg或每天10 mg瑞地昔韦静脉内给药，除了标准的护理外。最近增加了研究的扩展阶段，将招募另外5600名患者，包括接受机械通气的患者。这项研究正在全球180个试验地点进行，其中包括美国， 中国， 法国， 德国， 香港， 意大利， 日本， 韩国， 荷兰人， 新加坡， 西班牙， 瑞典， 瑞士， 台湾 和 英国。


与标准治疗方法相比，另一项SIMPLE试验正在评估中度表现为COVID-19的患者中静脉内施用雷姆昔韦的5天和10天给药时间的安全性和有效性。该研究的前600名患者的结果有望在5月底获得。

xiana100

接受5天治疗与接受10天治疗的患者取得了相似的治疗结果，两组患者的中位临床改善时间分别为10天与11天，除意大利外，两个治疗组中第14天的总死亡率为7%，64%的患者在14天内出现临床改善，61%的患者出院，该试验纳入的均为重症患者。

xiana100

按7%的死亡率的话 和头疼医头 脚疼医脚 好像没什么区别

yuansoul

恭喜 辍一个 中药安慰剂蛋生了

山顶洞人

yuansoul 发表于 2020-4-30 06:00
恭喜 辍一个 中药安慰剂蛋生了

还不如清肺汤

早已离开

吹，使劲吹。还叫“人民的希望”。我看就是为了炒作。实际还不如中药了。

yuansoul

早已离开 发表于 2020-4-30 08:57
吹，使劲吹。还叫“人民的希望”。我看就是为了炒作。实际还不如中药了。

相当 不如 安慰剂

长期使用的名字

版主，中文译文疏忽了，两个不能并列的名称

红茶.

长期使用的名字 发表于 2020-4-30 09:41
版主，中文译文疏忽了，两个不能并列的名称

机翻的，我这么懒的人才不会自己来。

xqliu

了解

syhorchid

了解一下

118317474

我帮不了你