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默克的抗新冠药物很好,但不是万能药

默克的抗新冠药物很好,但不是万能药

YASMIN TAYAG 2021年10月08日
molnupiravir最有希望的作用之一,就是它有预防重症病例的潜力,从而防止更多的死亡。

今天我们要谈论的是人们期待已久的新冠药物。

自疫情初期以来,研究人员一直在寻找一种可以轻松治疗新冠病毒的抗病毒药物。现在,molnupiravir似乎能满足这种需求。这种药物几乎可以将新冠导致的住院和死亡风险降低50%。

该药物由默克(Merck)制药公司生产,该公司于10月1日公布了其令人兴奋的试验结果,股价由此大幅上涨,一些人称其为“游戏规则颠覆者”。虽然目前已有针对新冠的治疗方法,但都必须在医院或临床环境中通过静脉滴注进行。与之不同的是,molnupiravir是药片的形式,每天服用两次,连续服用五天——这或使在家治疗成为可能。

如果默克公司的研究结果符合同行审查,并获得美国食品及药物管理局批准,那么,从公共卫生的角度来看,molnupiravir可能会使新冠治疗更易于管理。但出于实际原因(包括检测和成本的需要),这种药并不是万能药。这种药的出现,并不会改变广泛接种疫苗和其他公共卫生措施的迫切需求。

南曼杰·邦普斯是约翰霍普金斯大学医学院(Johns Hopkins University School of Medicine)药理学和分子科学系的教授和主任,她告诉我,molnupiravir是“工具箱中的一个重要补充工件”,可以帮助减少住院治疗和死亡。但她同时补充说,疫苗接种“仍然是我们抗击疫情的最有力工具”,因为其可以从源头防止染病。

molnupiravir最有希望的作用之一,就是它有预防重症病例的潜力,从而防止更多的死亡,让人们远离本已负担过重的医院。但一个问题便是,治疗需要尽早开始:在默克公司的试验中,药物在出现症状的5天内就开始使用了。而在现实世界中,这将意味着在家中逐渐感到不适的患者,将需要尽快进行新冠检测,因为很可能的是,需要阳性的核酸检测结果才能获得molnupiravir处方。这说起来容易,但做起来难——因为美国许多地区缺乏广泛的、可轻易完成的检测渠道,更不用说等待PCR检测结果的漫长时间了。如果患者们不能尽早确诊,那么molnupiravir可能就失去意义了。

“任何治疗方法都有一个最佳效果的时间窗口。”邦普斯说,“我们需要更多地了解这种药物,以及在临床试验之外它将如何在普通人群中发挥作用;但局限性依旧存在,疾病进展到一定程度后,它将无法起作用。”令人欣慰的是,10月6日,拜登政府承诺提供10亿美元用于新冠家庭检测,预计到12月,政府每月将提供2亿次检测,之后还将提供更多。

人们还对molnupiravir的价格表示担忧——每个疗程大约700美元,一些国家或将无法负担。据Intercept报道,拜登政府已经以12亿美元的价格从默克公司购买了170万疗程——这一价格相当于40倍的加成。默克公司表示,在其他国家,其将根据国民收入的不同对该药物进行不同的定价,并计划提供仿制药。

对这种药物持谨慎乐观态度,并不是空穴来风:关于这种药物的副作用、对接种疫苗者和孕妇的影响以及患者坚持5天疗程之后的情况等等,仍有很多东西还有待了解。邦普斯还指出,“即使进行了治疗,仍有发展成严重疾病的风险”。这就是疫苗接种和其他阻止新冠传播的措施仍然至关重要的原因。“我们不能仅仅依靠对新冠的治疗来抗击疫情。”邦普斯说。

在上周试验数据公布后,Moderna和BioNTech等疫苗制造商的股价下跌,而默克的股价上涨——人们对治疗与疫苗的非此即彼的态度,着实令人不安。最有可能的解释或许是,伊维菌素和羟氯喹等未经证实的治疗方法在疫苗怀疑论者中很受欢迎。专家认为,如果molnupiravir获得美国食药监局批准,公共卫生部门必须向公众的传达信息是:治疗和疫苗应该协同合作,而不是相互竞争。

正如邦普斯所说,治疗构成了工具箱的重要部分,但接种疫苗仍然是我们拥有的最好的预防方法。(财富中文网)

编译:杨二一

今天我们要谈论的是人们期待已久的新冠药物。

自疫情初期以来,研究人员一直在寻找一种可以轻松治疗新冠病毒的抗病毒药物。现在,molnupiravir似乎能满足这种需求。这种药物几乎可以将新冠导致的住院和死亡风险降低50%。

该药物由默克(Merck)制药公司生产,该公司于10月1日公布了其令人兴奋的试验结果,股价由此大幅上涨,一些人称其为“游戏规则颠覆者”。虽然目前已有针对新冠的治疗方法,但都必须在医院或临床环境中通过静脉滴注进行。与之不同的是,molnupiravir是药片的形式,每天服用两次,连续服用五天——这或使在家治疗成为可能。

如果默克公司的研究结果符合同行审查,并获得美国食品及药物管理局批准,那么,从公共卫生的角度来看,molnupiravir可能会使新冠治疗更易于管理。但出于实际原因(包括检测和成本的需要),这种药并不是万能药。这种药的出现,并不会改变广泛接种疫苗和其他公共卫生措施的迫切需求。

南曼杰·邦普斯是约翰霍普金斯大学医学院(Johns Hopkins University School of Medicine)药理学和分子科学系的教授和主任,她告诉我,molnupiravir是“工具箱中的一个重要补充工件”,可以帮助减少住院治疗和死亡。但她同时补充说,疫苗接种“仍然是我们抗击疫情的最有力工具”,因为其可以从源头防止染病。

molnupiravir最有希望的作用之一,就是它有预防重症病例的潜力,从而防止更多的死亡,让人们远离本已负担过重的医院。但一个问题便是,治疗需要尽早开始:在默克公司的试验中,药物在出现症状的5天内就开始使用了。而在现实世界中,这将意味着在家中逐渐感到不适的患者,将需要尽快进行新冠检测,因为很可能的是,需要阳性的核酸检测结果才能获得molnupiravir处方。这说起来容易,但做起来难——因为美国许多地区缺乏广泛的、可轻易完成的检测渠道,更不用说等待PCR检测结果的漫长时间了。如果患者们不能尽早确诊,那么molnupiravir可能就失去意义了。

“任何治疗方法都有一个最佳效果的时间窗口。”邦普斯说,“我们需要更多地了解这种药物,以及在临床试验之外它将如何在普通人群中发挥作用;但局限性依旧存在,疾病进展到一定程度后,它将无法起作用。”令人欣慰的是,10月6日,拜登政府承诺提供10亿美元用于新冠家庭检测,预计到12月,政府每月将提供2亿次检测,之后还将提供更多。

人们还对molnupiravir的价格表示担忧——每个疗程大约700美元,一些国家或将无法负担。据Intercept报道,拜登政府已经以12亿美元的价格从默克公司购买了170万疗程——这一价格相当于40倍的加成。默克公司表示,在其他国家,其将根据国民收入的不同对该药物进行不同的定价,并计划提供仿制药。

对这种药物持谨慎乐观态度,并不是空穴来风:关于这种药物的副作用、对接种疫苗者和孕妇的影响以及患者坚持5天疗程之后的情况等等,仍有很多东西还有待了解。邦普斯还指出,“即使进行了治疗,仍有发展成严重疾病的风险”。这就是疫苗接种和其他阻止新冠传播的措施仍然至关重要的原因。“我们不能仅仅依靠对新冠的治疗来抗击疫情。”邦普斯说。

在上周试验数据公布后,Moderna和BioNTech等疫苗制造商的股价下跌,而默克的股价上涨——人们对治疗与疫苗的非此即彼的态度,着实令人不安。最有可能的解释或许是,伊维菌素和羟氯喹等未经证实的治疗方法在疫苗怀疑论者中很受欢迎。专家认为,如果molnupiravir获得美国食药监局批准,公共卫生部门必须向公众的传达信息是:治疗和疫苗应该协同合作,而不是相互竞争。

正如邦普斯所说,治疗构成了工具箱的重要部分,但接种疫苗仍然是我们拥有的最好的预防方法。(财富中文网)

编译:杨二一

Today, we’re talking about the long-awaited COVID pill.

Since the earliest days of the pandemic, researchers have been searching for an antiviral drug that could easily treat the coronavirus. Now, we may finally have it in the form of molnupiravir—a pill that appears to cut the risk of hospitalization and death due to COVID-19 by 50%.

The pill is produced by the drugmaker Merck, which released results from its trials last Friday to great excitement (and a sharp uptick in stock price), with some calling it a “game changer.” While therapies for COVID-19 already exist, they must be administered in hospitals or clinical settings through an IV drip. Molnupiravir, a pill meant to be taken twice a day for five days, would make it possible to treat people at home.

If Merck’s results hold up to peer review and the drug receives FDA approval, molnupiravir will probably make handling COVID-19 more manageable from a public health perspective. But for practical reasons, including the need for testing and cost, the pill is not a silver bullet. It won’t change the urgent need for widespread vaccination and other public health measures meant to prevent infection.

Namandjé Bumpus, a professor and director of the Department of Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine, told me that molnupiravir is an “important addition to the toolbox” and could lead to fewer hospitalizations and deaths. However, vaccination is “still our most powerful tool in combatting the pandemic” because it prevents people from getting sick in the first place, she added.

One of the most promising things about molnupiravir is its potential to prevent severe illness—thereby preventing more deaths and keeping people out of already overburdened hospitals. One catch is that treatment needs to start early: in Merck’s trials, it began within five days of first symptoms. In the real world, this would mean that a person who starts feeling ill at home would need to be tested for COVID-19 as soon as possible because a positive test result will most likely be needed in order to get a prescription for molnupiravir. That’s easier said than done, given the lack of accessible and widespread testing in many parts of the country, not to mention long wait times for PCR test results. If people can’t confirm their COVID-19 cases early, then the availability of molnupiravir may be moot.

“With any treatment there is a window of time where it will work best,” said Bumpus. “We need to learn more about this drug and how it might work in the general population outside of a clinical trial setting, but a limitation could be that after a certain point of disease progression it won't work as well.” Promisingly, on Wednesday the Biden administration pledged $1 billion for at-home COVID-19 tests, which by December is poised to make 200 million tests available each month, and even more after that.

Concerns have also been raised about the price of molnupiravir, which, at about $700 per course, will be unaffordable for some nations. The Biden administration has already purchased 1.7 million courses from Merck for $1.2 billion—a price representing a 40x markup, as the Intercept pointed out. Merck has said that in other countries it will price the drug differently depending on national income and is planning to make generic versions available.

It makes sense to be cautiously optimistic about the drug, but there is much left to learn about the drug’s side effects, its effect on vaccinated people and pregnant people, and patient adherence to a five-day course. And, noted Bumpus, “even with treatment there is still a risk of progression to severe disease.” That’s why vaccination and other measures for stopping the spread of COVID-19 remain crucial. “We will not be able to rely on treatment of COVID-19 alone to combat the pandemic,” said Bumpus.

After trial data were released last week, stock prices for vaccine-makers like Moderna and BioNTech fell as Merck’s stock rose, suggesting a troubling either-or attitude to treatment versus vaccination (which is perhaps best illustrated by the popularity of unproven treatments like ivermectin and hydroxycholoroquine among vaccine skeptics). If molnupiravir receives FDA approval, it will be critical for public health authorities to send the message that treatment and vaccination are meant to work in tandem, not compete with each other, say experts.

“Treatment is an important part of the toolbox,” said Bumpus, “but vaccination is the best method we have for prevention.”

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