吉利德對瑞德西韋在中國的臨床實驗之聲明 Gilead 20200423

【縛雞之見】

4/22，WHO「手殘」洩漏Remsivir臨床試驗「失敗」的消息。Gilead發表聲明，說明試驗過程始末。

首先，WHO無權發佈民間公司的消息。這要做，是侵害商業利益，有刑責的。不知WHO為何撈過界？

其次，從Gilead說明知道：這是漫長臨床試驗過程中的一環。因為樣本數不足而無統計意義，與成功或失敗無關。

WHO再一次出現奇怪的行徑。

Gilead Sciences Statement on Data From Remdesivir Study in Patients With Severe COVID-19 in China    Gilead Sciences 20200423  Taimocracy翻譯

Foster City, Calif., April 23, 2020 – Gilead Sciences today issued the following statement from Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences:

“Today, information from the first clinical study evaluating the investigational antiviral remdesivir in patients with severe COVID-19 disease in China was prematurely posted on the World Health Organization website.  This information has since been removed, as the study investigators did not provide permission for the publication of the results.  Furthermore, we believe the post included inappropriate characterizations of the study.  The study was terminated early due to low enrollment and, as a result, it was underpowered to enable statistically meaningful conclusions.  As such, the study results are inconclusive, though trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease.  We understand the available data have been submitted for peer-reviewed publication, which will provide more detailed information from this study in the near future.

「今天，來自第一個在進行中國重度COVID-19疾病患者臨床研究的抗病毒藥物瑞德西韋(Remdesivir)的消息，被過早發佈在WHO網站上。此訊息已被刪除，因為研究調查人員未授權允許（WHO）發布結果。此外，我們認為該消息包含該研究的不適當特徵。由於樣本數量低該研究提前終止，它不足以得出具有統計學意義的結論。儘管數據趨勢表明瑞德西韋具有潛在的益處，尤其是在疾病早期接受治療的患者中，但研究結果尚無定論。我們了解已將可用數據提交給同儕審查出版物，在不久的將來提供此研究的更多詳細資訊。

The results of this trial in China, along with those of the compassionate use cohort of more critically ill patients published on April 10, add to a growing but still inconclusive body of evidence for remdesivir.  Remdesivir is an unapproved investigational product, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet known.  There are multiple ongoing Phase 3 studies that are designed to provide the additional data needed to determine the potential for remdesivir as a treatment for COVID-19.  These studies will help inform whom to treat, when to treat and how long to treat with remdesivir.  The studies are either fully enrolled for the primary analysis or on track to fully enroll in the near future.

在中國這項試驗結果，以及4月10日所發表，針對更多危重症病人富同情心使用者的研究結果，為瑞德西韋提供越來越多，但尚無定論的證據。瑞德西韋是未經批准的研究產品，目前尚不知道瑞德西韋治療COVID-19的安全性和有效性。進行中的多個3期研究，旨在提供確定瑞德西韋作為COVID-19治療藥物的潛力所需的其他數據。這些研究將有助於理解瑞德西韋治療對象，治療時間和治療時間。這些研究已全部招募進行初期分析，或者有望在不久的將來全面招募。

We expect to share results at the end of this month from our open-label study of remdesivir in patients with severe COVID-19 disease.  This randomized clinical trial is fully enrolled and will compare treatment outcomes and safety following 5 or 10 days of remdesivir treatment.  We expect data at the end of May from our open-label study in patients with moderate disease that is studying 5 or 10 days of remdesivir versus standard of care.  We also anticipate data at the end of May from NIAID’s double-blind, placebo-controlled study of remdesivir in patients across a range of disease severity.

我們期望在本（4）月底分享瑞德西韋在重度COVID-19疾病患者中的開放性研究結果。這項隨機分派臨床試驗已全面招募，將比較瑞德西韋治療5或10天後的結果和安全性。我們希望在5月底，從我們的開放性研究中，獲得關於中度疾病患者在研究瑞德西韋相對於標準的5或10天治療的數據。我們還預計美國「國家過敏和傳染病研究機構」在5月底將針對各種疾病嚴重程度的患者，對瑞德西韋進行雙盲、安慰劑對照研究的數據。

We appreciate the work done by the investigators in China and the continuing efforts of our colleagues and partners around the world to help inform our understanding of remdesivir’s potential as a treatment for this devastating illness.  The incredible collaboration across the global health community to respond to COVID19 has resulted in the rapid generation of data that move us toward understanding the natural history of COVID-19 infections and add to the understanding of the potential role of remdesivir in the treatment of this disease.”

我們感謝中國研究人員所做的工作，以及全球同事和合作夥伴的不懈努力，以幫助我們了解瑞德西韋治療這種毀滅性疾病的潛力。 全球衛生界在應對COVID19方面進行了令人難以置信的合作，從而迅速產生了數據。這些數據使我們更了解COVID-19感染的自然病史方向，並加深了對瑞德西韋在治療該疾病中的潛在作用的了解。”

Forward-Looking Statement

This statement 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 clinical trials involving remdesivir and the possibility that Gilead 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 Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the U.S. Securities and Exchange Commission.  All forwardlooking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

本聲明包括1995年《私人證券訴訟改革法案》所定義，有關風險，不確定性和其他因素的影響的前瞻性聲明。瑞德西韋是一種研究藥物，尚未在全球任何地方獲得許可或批准，且尚未證明其對任何使用（包括治療COVID-19）的安全性或有效性。涉及瑞德西韋的臨床試驗，可能會出現不利的結果，也可能無法在當前預期的時限內（或根本無法）完成一項或多項此類試驗。此外，Gilead可能會做出策略性決定，中止瑞德西韋的開發，或者FDA和其他監管機構可能不批准瑞德西韋，並且任何市場許可（如果獲得批准）都可能對其使用產生重大限制。結果，瑞德西韋可能永遠不會成功地商業化。除歷史事實的陳述外，所有其他陳述均應視為前瞻性陳述。這些風險，不確定性和其他因素可能導致實際結果與前瞻性聲明中提及的結果存在重大差異。讀者應謹慎，不要依賴這些前瞻性陳述。這些風險和其他風險，在Gilead截至2019年12月31日的年度10-K表年度報告中有詳細說明，該報告已提交給美國證券交易委員會。所有前瞻性陳述均基於Gilead當前可用的資訊，並且Gilead不承擔更新任何此類前瞻性陳述的義務。