(引用 笑天:数据说话,各自解读, 形势需要In that 397-patient trial, Gilead said 62% of patients treated early with remdesivir were discharge
...)Gilead server down原文找不到
新闻报告里前几次报告的死亡率,副作用都没提到[笑天 (4-30 9:47, Long ago)]
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(引用 笑天:Gilead server down原文找不到
新闻报告里前几次报告的死亡率,副作用都没提到)订单爆棚?
[笑天 (4-30 9:50, Long ago)]
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(引用 笑天:Gilead server down原文找不到 新闻报告里前几次报告的死亡率,副作用都没提到)都散了吧,这货就一爱崇洋舔美的。大部分确诊的不用任何药物,身体自行抗体免疫自我痊愈,去看看新加坡那一万多人有哪个是用药的?有哪个死的?按你这说法我随便开发个大力神丸给这新加坡一万多人吃,反正没人死,然后每天都有人出院痊愈,再对外公布说咱家的大力神丸有多牛逼赚个盆满钵满。呵呵[18厘米的烦恼 (4-30 10:07, Long ago)] [ 传统版 | sForum ][登录后回复]23楼
(引用 18厘米的烦恼:都散了吧,这货就一爱崇洋舔美的。大部分确诊的不用任何药物,身体自行抗体免疫自我痊愈,去看看新加坡那一万多人有哪个是用药的?有哪个...)你这货又是哪一路的?随便给别人扣帽子的人是什么货?
这个数据是在重症患者群的trial,杠之前请认真读一下。
[乌贼的马甲 (4-30 10:28, Long ago)]
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来了,结果自己看http://investors.gilead.com/news-releases/news-release-details/gilead-announces-results-phase-3-trial-investigational-antiviral
http://investors.gilead.com/news-releases/news-release-details/gilead-sciences-statement-positive-data-emerging-national[笑天 (4-30 10:31, Long ago)]
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(引用 笑天:来了,结果自己看http://investors.gilead.com/news-releases/news-release-details/gilead-announces-results-phase-3-trial-investigat...)显然不符合常规的报告对照组呢?
[笑天 (4-30 10:32, Long ago)]
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(引用 笑天:显然不符合常规的报告对照组呢?
)4月23号的报告https://www.statnews.com/2020/04/23/data-on-gileads-remdesivir-released-by-accident-show-no-benefit-for-coronavirus-patients/
https://www.cnbc.com/2020/04/23/gilead-says-draft-of-coronavirus-treatment-results-contain-inappropriate-characterization-and-are-inconclusive.html
According to the summary of the China study, remdesivir was “not associated with a difference in time to clinical improvement” compared to a standard of care control. After one month, it appeared 13.9% of the remdesivir patients had died compared to 12.8% of patients in the control arm. The difference was not statistically significant.
[笑天 (4-30 10:51, Long ago)]
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(引用 笑天:显然不符合常规的报告对照组呢? )最新的数据不是双盲,是根据clinical trial得出来的如果被分到安慰剂那组,死亡率还是蛮高的 [乌贼的马甲 (4-30 10:57, Long ago)] [ 传统版 | sForum ][登录后回复]28楼
(引用 乌贼的马甲:最新的数据不是双盲,是根据clinical trial得出来的如果被分到安慰剂那组,死亡率还是蛮高的 )我猜测现在的重症患者没几个敢参加双盲的如果被分到安慰剂那组,死亡率还是挺高的 [乌贼的马甲 (4-30 10:59, Long ago)] [ 传统版 | sForum ][登录后回复]29楼
(引用 笑天:显然不符合常规的报告对照组呢?
)你弄错了,不是这个试验一共三个试验发布。gilead发布的是5天和10天的对比,没有显著差别,就是用10天的药是浪费的,只要用5天的药就够了,可以节省些药用来治更多的人。
还有一个证明有效的大规模双盲对比试验是这个
https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19
最后,那个由于入组人数不足提前终止的中日友好医院的双盲对比验,得出的结论,在此次临床试验中,瑞德西韦对重症新冠肺炎患者临床症状没有明显改善效果,其有效性仍有待研究。也就是之前WHO提前泄露的那个。
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext
最后说一下,好像世界上不存在针对病毒的特效药,不需要反复重复强调“不是特效”,因为这本来就是预期中的。大规模双盲对比试验证明死亡率没有改善,但可以减少30%的住院时间,可以节省很多床位。但是,大部分国家通过隔离和扩容,床位不足问题目前已经不严重了。了胜于无吧。
[快快跑 (4-30 11:03, Long ago)]
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(引用 乌贼的马甲:我猜测现在的重症患者没几个敢参加双盲的如果被分到安慰剂那组,死亡率还是挺高的
)我相信数据是真实的换了个积极的说法而已
但是3期报告这样不是科学报告可以接受的
new release 没问题,随便怎么解释。
Gilead的三期是双盲设计的
https://www.businessinsider.sg/coronavirus-treatment-data-on-gilead-remdesivir-who-2020-4?r=US&IR=T
The trial ended up including 237 participants, with 158 receiving remdesivir and 79 receiving a placebo. It was designed to enroll 453 people.
The summary said that about 14% of those taking remdesivir had died after a month, compared with about 13% of those in the placebo group, [笑天 (4-30 11:03, Long ago)]
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(引用 快快跑:你弄错了,不是这个试验一共三个试验发布。gilead发布的是5天和10天的对比,没有显著差别,就是用10天的药是浪费的,只要用5天的药就够了...)读了一下,这个就是最新的 5-10天比较
其他的完全没有涉及[笑天 (4-30 11:07, Long ago)]
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(引用 笑天:读了一下,这个就是最新的 5-10天比较 其他的完全没有涉及)另外两个也是最新的April 29, 2020认真读一读吧[快快跑 (4-30 11:13, Long ago)] [ 传统版 | sForum ][登录后回复]33楼
(引用 快快跑:你弄错了,不是这个试验一共三个试验发布。gilead发布的是5天和10天的对比,没有显著差别,就是用10天的药是浪费的,只要用5天的药就够了...)你帮某些懒人把数据链接都找全了对病毒没有特效药这点我同意,我觉得瑞德西韦之于新冠有点像tamiflu之于流感,做不到药到病除,但是能有效的减缓病症和缩短患病时间。
[乌贼的马甲 (4-30 11:16, Long ago)]
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(引用 18厘米的烦恼:都散了吧,这货就一爱崇洋舔美的。大部分确诊的不用任何药物,身体自行抗体免疫自我痊愈,去看看新加坡那一万多人有哪个是用药的?有哪个...)赞这个层主赞这个层主
连花清瘟胶囊作为我们祖国文化精粹的代表在这次瘟疫中遭到了强烈的打压[ImHResIDeNt (4-30 11:18, Long ago)]
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(引用 快快跑:另外两个也是最新的April 29, 2020认真读一读吧)自己和自己比,5天和10天比按我的理解,只能(要)用5天, 10天反而更差, 对不对呢?
[笑天 (4-30 11:21, Long ago)]
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(引用 快快跑:另外两个也是最新的April 29, 2020认真读一读吧)读吧看这个药到底怎么样?
有效还是”需要“?[笑天 (4-30 11:24, Long ago)]
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(引用 笑天:读吧看这个药到底怎么样?
有效还是”需要“?)火了,全文再此Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19
April 29, 2020 at 8:35 AM EDT
PDF Version
-- 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.
Key efficacy and safety results from the study are included in the table below.
5-Day RDV
10-Day RDV
Baseline adjusted
n=200
n=197
p-value1
Clinical Efficacy Outcomes at Day 14
≥ 2-point improvement in ordinal scale
129 (65)
107 (54)
0.16
Clinical recovery
129 (65)
106 (54)
0.17
Discharge
120 (60)
103 (52)
0.44
Death
16 (8)
21 (11)
0.70
Safety
Any adverse event (AE)
141 (71)
145 (74)
0.86
Grade ≥3 study drug-related AE
8 (4)
10 (5)
0.65
Study drug-related serious adverse event (SAE)
3 (2)
4 (2)
0.73
AE leading to discontinuation
9 (5)
20 (10)
0.07
1Adjusted for baseline clinical status
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.
[笑天 (4-30 11:25, Long ago)]
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(引用 笑天:自己和自己比,5天和10天比按我的理解,只能(要)用5天, 10天反而更差, 对不对呢? ...)只能说五天non inferior 或者10天 non superior[douknnowme (4-30 11:26, Long ago)] [ 传统版 | sForum ][登录后回复]39楼
(引用 快快跑:你弄错了,不是这个试验一共三个试验发布。gilead发布的是5天和10天的对比,没有显著差别,就是用10天的药是浪费的,只要用5天的药就够了...)比如tamiflu 对付流感这种。万众期待的就是特效药啊 [本文发送自华新iOS APP] [Calicocat (4-30 11:26, Long ago)] [ 传统版 | sForum ][登录后回复]40楼