為什么是瑞德西韋？一封來自吉利德CEODanielO’Day的公開信

　　當冠狀病毒的新聞首次出現時，吉利德立即開始了對瑞德西韋（Remdesivir）治療潛力的研究。我們對多種抗病毒藥物進行大量研究，其中，瑞德西韋是我們研究了很多年的一個藥物。瑞德西韋從未被批準使用，但是，根據我們到目前為止的了解，我們知道它可能有潛力治療新型冠狀病毒。從那時起，我們帶著最大的緊迫感和責任感努力工作，以確定瑞德西韋是否確實對新型冠狀病毒肺炎有效。

　　這種緊迫感來自于對患者迫切需求的認知以及沒有任何已批準治療方案的現狀。瑞德西韋是在研藥物，將其運往全球使用之前確保它是有效且安全的，這是責任。

　　這也是我們一直在以前所未有的速度入組患者參與臨床試驗的原因。與監管機構合作，明確瑞德西韋的安全性和有效性，對于未來可能讓更多患者獲得治療至關重要。有多項研究正在進行中，我們有望在接下來的幾周獲得初步數據。如果藥物獲得批準，我們將確保其可負擔性和可及性，讓有迫切需要的患者能夠用上瑞德西韋。

　　與此同時，我們還為不能參加臨床試驗的重癥患者提供了這一在研藥物。“同情用藥”程序通常只用于少數個例，但這一次的危機已突破常規，到目前為止，我們已向1000多名患者提供了瑞德西韋。這一程序由監管機構設計，要求必須對每個申請以個體為基礎逐一審評。通常情況下，這個程序可以很好地運行，因為申請數量很有限。但是，該系統無法支持和處理我們在新型冠狀病毒肺炎中遇到的巨大數量的申請。

　　為了解決這個問題，我們正在過渡到一種更加精簡、可持續的方式，即“擴大可及”方案。同情用藥程序將僅開放給兒童和孕婦患者，以將數量降低到系統可以應對的水平。通過擴大可及方案，醫院或醫生可以同時為多個重癥患者申請瑞德西韋的緊急用藥。雖然搭建站點網絡需要一些時間，但擴大可及的方式最終將可以加速讓更多患者緊急獲得藥物。截至昨天，美國的一些初始站點已經啟動并運行，預計在其他國家的站點也將很快啟動。

　　近些天來，許多人代表自己的朋友和親人向吉利德提出要求使用瑞德西韋。我非常能體會在那種處境中的感受。我們最近每天在新聞中看到數字和統計結果，但是，我們知道每一個數字背后都是一個真實的、令人心碎的關于人的故事。我知道，當我說“我們多么希望能夠幫助每一位有需要的患者”時，我代表著吉利德的每一位員工。現在，我們正在快速確立臨時的擴大可及方案，同時明確瑞德西韋的潛在安全性和有效性，并確定瑞德西韋對哪些患者可能有效。

　　瑞德西韋仍然是一種在研藥物，大家都在期待它可以被證明是一種安全、有效的治療方案，我們也正在基于這種預期做相應的計劃——與此同時，我們也在以合乎倫理道德且負責任的方式來確定結果是否如此。在這個過程中的每一步，我們會在公共衛生機構和生物倫理學家的指導下，結合我們數十年來為艾滋病病毒（HIV）和病毒性肝炎等疾病提供抗病毒治療方案的經驗來做出決定。

　　我們希望，通過與世界各地的許多團體合作，我們可以一起幫助新型冠狀病毒肺炎患者。我們知道情況是如此危急，迫切需要確定瑞德西韋是否是一種安全有效的治療方案。

　　我們掛念日以繼夜奮戰在抗擊流行病第一線的醫護人員，他們急需要有效的治療方案。我們知道全世界的患者和他們的家人都在等待。全體吉利德人正在全力以赴，懷著最大的緊迫感和關愛之心，和瑞德西韋一起，履行我們的責任。

　　在繼續努力推進上述工作的同時，我們也將及時提供最新進展信息，回應全球公眾對瑞德西韋的高度關注。

An Open Letter from our Chairman and CEO

Daniel O’Day

　　When the news of the coronavirus first emerged, Gilead immediately began to investigate the potential of remdesivir, a medicine we had been studying for many years as part of our extensive research in antivirals. Remdesivir had never been approved for use but based on what we had learned to date, we knew it might have potential with the novel coronavirus. Since then, we have been working with the greatest sense of urgency and responsibility to determine whether remdesivir does indeed work against COVID-19.

　　The urgency comes from knowing the desperate need among patients and the lack of any approved treatment. The responsibility is to ensure that remdesivir, an investigational medicine, is effective and safe before it is distributed for use worldwide.

　　This is why we have been working at unprecedented speed to enroll patients in clinical trials. Establishing the safety and efficacy of remdesivir, in partnership with regulatory authorities, is essential to potentially enabling the treatment of many more patients in the future. Multiple studies are ongoing, and we are on track to have initial data in the coming weeks. If it is approved, we will work to ensure affordability and access so that remdesivir is available to patients with the greatest need.

　　In the meantime, we have made the investigational medicine available for severely ill patients who cannot enroll in a trial. This “compassionate use” program is typically reserved for a small number of individual cases but there is nothing typical about this crisis and to date we have provided remdesivir to more than 1,000 patients. The program is designed by regulatory authorities in such a way that each application has to be reviewed on an individual basis. This works well when there is only a limited number of requests – as is normally the case – but the system cannot support and process the overwhelming number of applications we have seen with COVID-19.

　　To address this, we are transitioning to what should be a more streamlined, sustainable approach with “expanded access” programs. The compassionate use program will continue for children and pregnant women only, reducing the numbers to a level where the system can cope. With expanded access, hospitals or physicians can apply for emergency use of remdesivir for multiple severely ill patients at a time. While it will take some time to build a network of active sites, this approach will ultimately accelerate emergency access for more people. Initial sites in the United States are up and running as of yesterday, and it is expected that sites in additional countries will be activated soon.

　　In recent days, many people have reached out to Gilead to advocate for access to remdesivir on behalf of friends and loved ones. I can only imagine how it must feel to be in that situation. We are used to seeing numbers and statistics in the news on a daily basis but we all know that behind each of those numbers is a real and often heartbreaking human story. I know I speak for everyone at Gilead when I say how much we all wish we could help every patient in need. Today we are working at speed to establish the temporary expanded access programs, while at the same time establishing the potential safety and efficacy of remdesivir and determining for which patients remdesivir may have activity.

　　Remdesivir is still an investigational medicine. We are planning for the outcome we all hope for – that it will prove to be a safe, effective treatment – and in the meantime we are taking the ethical, responsible approach to determining whether that is the case. At each step of the way, our decisions are informed by guidance from public health authorities and bioethicists, and by our decades of experience in making antiviral treatments for diseases such as HIV and viral hepatitis.

　　We hope that, in partnership with many groups around the world, we can play a part in helping patients with this disease. We know how much is at stake and the urgent need to determine whether remdesivir will be a safe and effective treatment.

　　We think about the healthcare workers who are on the front lines of fighting this pandemic around the clock and the urgent need to equip them with a treatment. We know that patients and their families around the world are waiting. All of us at Gilead are doing everything we can to meet our responsibility with remdesivir, with the greatest sense of urgency and care.

　　As we continue with those efforts, we will provide updates on our progress as soon as information becomes available, recognizing the significant public interest in remdesivir around the world.