今天我們要談論的是人們期待已久的新冠藥物。
自疫情初期以來,研究人員一直在尋找一種可以輕松治療新冠病毒的抗病毒藥物。現在,molnupiravir似乎能滿足這種需求。這種藥物幾乎可以將新冠導致的住院和死亡風險降低50%。
該藥物由默克(Merck)制藥公司生產,該公司于10月1日公布了其令人興奮的試驗結果,股價由此大幅上漲,一些人稱其為“游戲規則顛覆者”。雖然目前已有針對新冠的治療方法,但都必須在醫院或臨床環境中通過靜脈滴注進行。與之不同的是,molnupiravir是藥片的形式,每天服用兩次,連續服用五天——這或使在家治療成為可能。
如果默克公司的研究結果符合同行審查,并獲得美國食品及藥物管理局批準,那么,從公共衛生的角度來看,molnupiravir可能會使新冠治療更易于管理。但出于實際原因(包括檢測和成本的需要),這種藥并不是萬能藥。這種藥的出現,并不會改變廣泛接種疫苗和其他公共衛生措施的迫切需求。
南曼杰·邦普斯是約翰霍普金斯大學醫學院(Johns Hopkins University School of Medicine)藥理學和分子科學系的教授和主任,她告訴我,molnupiravir是“工具箱中的一個重要補充工件”,可以幫助減少住院治療和死亡。但她同時補充說,疫苗接種“仍然是我們抗擊疫情的最有力工具”,因為其可以從源頭防止染病。
molnupiravir最有希望的作用之一,就是它有預防重癥病例的潛力,從而防止更多的死亡,讓人們遠離本已負擔過重的醫院。但一個問題便是,治療需要盡早開始:在默克公司的試驗中,藥物在出現癥狀的5天內就開始使用了。而在現實世界中,這將意味著在家中逐漸感到不適的患者,將需要盡快進行新冠檢測,因為很可能的是,需要陽性的核酸檢測結果才能獲得molnupiravir處方。這說起來容易,但做起來難——因為美國許多地區缺乏廣泛的、可輕易完成的檢測渠道,更不用說等待PCR檢測結果的漫長時間了。如果患者們不能盡早確診,那么molnupiravir可能就失去意義了。
“任何治療方法都有一個最佳效果的時間窗口。”邦普斯說,“我們需要更多地了解這種藥物,以及在臨床試驗之外它將如何在普通人群中發揮作用;但局限性依舊存在,疾病進展到一定程度后,它將無法起作用。”令人欣慰的是,10月6日,拜登政府承諾提供10億美元用于新冠家庭檢測,預計到12月,政府每月將提供2億次檢測,之后還將提供更多。
人們還對molnupiravir的價格表示擔憂——每個療程大約700美元,一些國家或將無法負擔。據Intercept報道,拜登政府已經以12億美元的價格從默克公司購買了170萬療程——這一價格相當于40倍的加成。默克公司表示,在其他國家,其將根據國民收入的不同對該藥物進行不同的定價,并計劃提供仿制藥。
對這種藥物持謹慎樂觀態度,并不是空穴來風:關于這種藥物的副作用、對接種疫苗者和孕婦的影響以及患者堅持5天療程之后的情況等等,仍有很多東西還有待了解。邦普斯還指出,“即使進行了治療,仍有發展成嚴重疾病的風險”。這就是疫苗接種和其他阻止新冠傳播的措施仍然至關重要的原因。“我們不能僅僅依靠對新冠的治療來抗擊疫情。”邦普斯說。
在上周試驗數據公布后,Moderna和BioNTech等疫苗制造商的股價下跌,而默克的股價上漲——人們對治療與疫苗的非此即彼的態度,著實令人不安。最有可能的解釋或許是,伊維菌素和羥氯喹等未經證實的治療方法在疫苗懷疑論者中很受歡迎。專家認為,如果molnupiravir獲得美國食藥監局批準,公共衛生部門必須向公眾的傳達信息是:治療和疫苗應該協同合作,而不是相互競爭。
正如邦普斯所說,治療構成了工具箱的重要部分,但接種疫苗仍然是我們擁有的最好的預防方法。(財富中文網)
編譯:楊二一
今天我們要談論的是人們期待已久的新冠藥物。
自疫情初期以來,研究人員一直在尋找一種可以輕松治療新冠病毒的抗病毒藥物。現在,molnupiravir似乎能滿足這種需求。這種藥物幾乎可以將新冠導致的住院和死亡風險降低50%。
該藥物由默克(Merck)制藥公司生產,該公司于10月1日公布了其令人興奮的試驗結果,股價由此大幅上漲,一些人稱其為“游戲規則顛覆者”。雖然目前已有針對新冠的治療方法,但都必須在醫院或臨床環境中通過靜脈滴注進行。與之不同的是,molnupiravir是藥片的形式,每天服用兩次,連續服用五天——這或使在家治療成為可能。
如果默克公司的研究結果符合同行審查,并獲得美國食品及藥物管理局批準,那么,從公共衛生的角度來看,molnupiravir可能會使新冠治療更易于管理。但出于實際原因(包括檢測和成本的需要),這種藥并不是萬能藥。這種藥的出現,并不會改變廣泛接種疫苗和其他公共衛生措施的迫切需求。
南曼杰·邦普斯是約翰霍普金斯大學醫學院(Johns Hopkins University School of Medicine)藥理學和分子科學系的教授和主任,她告訴我,molnupiravir是“工具箱中的一個重要補充工件”,可以幫助減少住院治療和死亡。但她同時補充說,疫苗接種“仍然是我們抗擊疫情的最有力工具”,因為其可以從源頭防止染病。
molnupiravir最有希望的作用之一,就是它有預防重癥病例的潛力,從而防止更多的死亡,讓人們遠離本已負擔過重的醫院。但一個問題便是,治療需要盡早開始:在默克公司的試驗中,藥物在出現癥狀的5天內就開始使用了。而在現實世界中,這將意味著在家中逐漸感到不適的患者,將需要盡快進行新冠檢測,因為很可能的是,需要陽性的核酸檢測結果才能獲得molnupiravir處方。這說起來容易,但做起來難——因為美國許多地區缺乏廣泛的、可輕易完成的檢測渠道,更不用說等待PCR檢測結果的漫長時間了。如果患者們不能盡早確診,那么molnupiravir可能就失去意義了。
“任何治療方法都有一個最佳效果的時間窗口。”邦普斯說,“我們需要更多地了解這種藥物,以及在臨床試驗之外它將如何在普通人群中發揮作用;但局限性依舊存在,疾病進展到一定程度后,它將無法起作用。”令人欣慰的是,10月6日,拜登政府承諾提供10億美元用于新冠家庭檢測,預計到12月,政府每月將提供2億次檢測,之后還將提供更多。
人們還對molnupiravir的價格表示擔憂——每個療程大約700美元,一些國家或將無法負擔。據Intercept報道,拜登政府已經以12億美元的價格從默克公司購買了170萬療程——這一價格相當于40倍的加成。默克公司表示,在其他國家,其將根據國民收入的不同對該藥物進行不同的定價,并計劃提供仿制藥。
對這種藥物持謹慎樂觀態度,并不是空穴來風:關于這種藥物的副作用、對接種疫苗者和孕婦的影響以及患者堅持5天療程之后的情況等等,仍有很多東西還有待了解。邦普斯還指出,“即使進行了治療,仍有發展成嚴重疾病的風險”。這就是疫苗接種和其他阻止新冠傳播的措施仍然至關重要的原因。“我們不能僅僅依靠對新冠的治療來抗擊疫情。”邦普斯說。
在上周試驗數據公布后,Moderna和BioNTech等疫苗制造商的股價下跌,而默克的股價上漲——人們對治療與疫苗的非此即彼的態度,著實令人不安。最有可能的解釋或許是,伊維菌素和羥氯喹等未經證實的治療方法在疫苗懷疑論者中很受歡迎。專家認為,如果molnupiravir獲得美國食藥監局批準,公共衛生部門必須向公眾的傳達信息是:治療和疫苗應該協同合作,而不是相互競爭。
正如邦普斯所說,治療構成了工具箱的重要部分,但接種疫苗仍然是我們擁有的最好的預防方法。(財富中文網)
編譯:楊二一
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.”