【洛杉矶华人资讯网 记者Tracy】美西时间3月30日，截至美西时间3月30日早11点整，在美国境内确诊的新冠肺炎病例高达156,761例，死亡病例达2,848例，仅半日美国境内确诊人数高达13,066例。加州累计确诊病例6,452例，死亡病例133例，仅半日加州确诊病例达146例，新冠肺炎疫情在美国境内形势非常严峻。

由美国吉利德科学公司（Gilead Science Inc）开发的一种原意用于针对埃博拉病毒及呼吸道上皮细胞中SARS病毒和MERS病毒的药物瑞德西韦（Remdesivir），据今年的一项研究显示，这种药物是目前治疗新冠肺炎最理想的药物。


2020年1月31日权威医学期刊《新英格兰医学杂志》（NEJM）发表了一篇线上报告：详细阐述了美国首例新冠肺炎确诊病例的诊疗过程及临床表现。据报告显示：在患者住院的第7晚，该患者接受了瑞德西韦的静脉输液；第8天时，该患者的临床症状好转并改善，患者可以正常呼吸，氧饱和度恢复到94%--96%，除了干咳和流鼻涕外，已无其他症状。



瑞德西韦在治疗新冠肺炎上真的的有如此疗效吗？为什么该药仍未被广泛应用于治疗新冠肺炎？该药存在副作用吗？


就以上问题，本网记者特别采访一位熟悉瑞德西韦研制的博士研究员，以讨论该药对于治疗新冠肺炎的药效性。
1. 是什么让新冠病毒如此特别？有些人认为这种病毒是人为的，您怎么看?

· 这是一种全新的以前未出现过的病毒，而且传染力非常强；
· 在我看来，新冠病毒是一种天然病毒，并不是人为能制造的或者是实验室能构造的病毒。

2. 瑞德西韦在治疗新冠肺炎上，效果如何？这种药对治疗新冠肺炎有效吗?

· 研究发现，瑞德西韦对于治疗新冠肺炎有抗病毒活性，而且不仅仅是对新冠肺炎病毒，对于类似新冠肺炎的病毒，如SARS、MERS等病毒也有抗病毒活性；
· 在一像使用瑞德西韦来阻挡人体细胞中新冠病毒复制的研究中，显示瑞德西韦在阻挡了新冠病毒的复制。也就是说，在浓度为700nM时，瑞德西韦可以阻挡50%的病毒复制。换句话说，瑞德西韦对新冠病毒有真正的抗病毒活性；
· 除《新英格兰医学杂志》中描述的接受瑞德西韦输液的新冠肺炎确诊患者外，在美国和意大利也有报道类似的情况。

3. 瑞德西韦目前处于什么阶段?

· 目前瑞德西韦处于临床试验的后期阶段。在世界各地有几个关于瑞德西韦的三期临床试验。

4. 瑞德西韦未被广泛使用的主要原因是什么？

· 瑞德西韦还是在研药物，它在一些三期临床试验中得到了较好的研究结果，但FDA还没有三期临床试验的结果，该药物还未被批准上市，等研究结果出来时，FDA将决定是否批准瑞德西韦上市；
· 一种被广泛使用的药物的研发需要通过体外试验、动物实验、第一阶段的人体临床试验证明安全性，以及第二/第三阶段的大规模临床试验来证明有效性，再由研究员收集分析数据并提交申请FDA批准。

5. 您认为瑞德西韦何时能在美国市场被广泛使用?

· 据我所知，瑞德西韦第一个临床试验是在中国。该试验目前正在中国进行，但尚未完成，FDA需要看到试验的结果，才能进一步决定是否广泛使用瑞德西韦用于治疗新冠肺炎；
· 中国第一例瑞德西韦三期临床试验计划于4月27日完成。预计很快会知道试验结果并提交给FDA批准，由FDA决定瑞德西韦是否适合广泛使用，但是临床试验结果将于4月27日第三阶段试验结束后公布。


6. 3月24日，FDA批准瑞德西韦为孤儿药（Orphan drug），但两天后，3月26日，吉利德向FDA提交申请，要求取消孤儿药的称号。请问您的观点是?

· 孤儿药是指治疗罕见病的特效药(少于20万例)。孤儿药的市场需求非常低，在正常情况下，制药公司很难收回成本。这使得制药公司很难投入数百亿美元来研发这类药物。然而，为了给孤儿药提供激励，政府将给予孤儿药研发方优惠政策，如7年的市场排他性和50%的临床研究和试验税收抵免;
· 在正常情况下，一种药物的研发大约需要100亿美元，如果患者人数少于20万，或者药费不足以支付研发费用，那么就有机会申请孤儿药的认定;
· 一些消费者权益组织反对吉利德将瑞德西韦申请孤儿药，由于新冠肺炎是一种全球流行病，可能影响全世界20多万患者，因此，瑞德西韦可广泛使用。

7. 据世卫组织助理总干事布鲁斯·艾尔沃德（Bruce Aylward）说，瑞德西韦是世卫组织认为具有“真正疗效”的唯一药物。您同意这种说法吗?

· 我完全同意这个说法，这是完全基于科学数据得出的结论；
· 如果瑞德西韦对治疗新冠肺炎无效，后果堪忧。

8. 瑞德西韦对新冠肺炎患者有副作用吗?

· 瑞德西韦是一种安全药物，这是在80名患者的I期试验中得出的结论。在第一阶段的试验中，数据显示，瑞德西韦可以影响极少数患者的肝功能，有可能导致肝酶上升，但这种肝酶升高是可逆的，停药后患者肝酶水平会恢复正常。换句话说，患者可通过后天调理恢复。

English Version

【By Tracy】As of 11:00 am on March 30, 156,761 covid-19 cases and 2,848 deaths have been confirmed in the United States, and 13,066 cases have been confirmed in the United States in just half day. California has a total of 6,452 confirmed cases and 133 deaths, with 146 confirmed cases in only half day. COVID 19 become a very serious situation in the United States.

Remdesivir, a drug originally developed by Gilead Science Inc., is the most promising drug for treating COVID 19, according to a study found in 2020.



On January 31, 2020, the highly esteemed medical journal New England Journal of Medicine (NEJM) published an online paper detailing the diagnosis, treatment and clinical presentation of the first confirmed case of COVID 19 in the United States. According to the paper, on the seventh night of hospitalization, a patient received an intravenous infusion of Remdesivir. On day 8, this patient's clinical symptoms improved a lot, the patient was able to breathe normally, oxygen saturation returned to 94%--96%, and he had no symptoms except a dry cough and a runny nose.



Is Remdesivir really so effective in the treatment of COVID-19? Why is this drug still not widely used to treat covid-19? Does Remdesivir have any side effects?



We interviewed, a PhD researcher familiar with the discovery and development of Remdesivir, to discuss the drug's efficacy in the treatment of COVID - 19.

1. What makes the coronavirus so special? Some people consider this virus was humanmade, what’s your opinion on that?

• This is a brand-new virus that has not appeared before, and it is highly infectious;
• In my opinion and based on my readings, covid19 is a natural virus, and it is not man-made or constructed by laboratory.

2. How effective is Remdesivir on treating covid19? Will this drug work against covid19?

• Studies have found that Remdesivir has antiviral activity against covid-19, and also for viruses similar to covid19, such as SARS and MERS;
• In a study using Remdesivir to block covid-19 virus replication in human cells, it was shown that Remdesivir blocked the covid-19 virus from replicating. That is, at a concentration of 700nM, Remdesivir blocks 50% of the virus replication. In other words, it has a true antiviral activity for COVID-19.
• Except the confirmed COVID 19 patients who received the Remdesivir infusion described in the New England Journal of Medicine, there were other similar anecdotal reports in the US, Itally, and Check Republic.

3. At what stage does Remdesivir in currently?

• Currently, Remdesivir is in the late stage of clinical trial. There are several Phase III trials with remdesivir throughout the world.

4. What’s the major reason that Remdesivir still put in hold right now?

• Remdesivir is not on hold. It is vigorously studied in several Phase III clinical trials. FDA does not yet have the Phase III clinical trials results and the drug has not been approved on the market; Once the results are evaluated the FDA will decide to approve or not.
• The development of a drug for widespread use needs to go through in vitro experimentation, animal studies, Phase I human clinical trials demonstrate safety, and Phase II/III large-scale clinical trials to demonstrate efficacy. Such collected data are collected and analysed by researchers, and submitted to FDA for approval.

5. When will you think Remdesivir will be able to put into widely use in the US market?

• As far as I know, the first clinical trial of Remdesivir was in China. The trial is currently under way in China but has not yet been completed. FDA will need to see the results of the trial before it can make a further decision on whether or not to approve Remdesivir for the treatment of covid-19.
• The first Chinese Phase III clinical trial for remdesivir is scheduled to be completed by April 27. The results are expected to be available soon after that and be submitted to FDA for approval.
• It is up to the FDA to decide whether Remdesivir is suitable for widespread use, but the results of the clinical trial will be announced sometime after the completion of the Phase III trial scheduled for April 27.

6. On March 24, FDA approved Remdesivir as Orphan drug, but two days later, on March 26, Gilead has submitted a request to FDA to rescind the orphan drug designation. May Iask what’s your opinion on this matter?

• Orphan drugs refer to the specific drugs for the treatment of rare diseases (less than 200000 patients). The market demand for orphan drugs is very low, and it is difficult for pharmaceutical companies to recover the costs under normal circumstances. This makes it difficult for companies to invest the tens of billions of dollars needed to discover and develop such medicines. However, in order to offer incentives for orphan diseases, the government will give preferential policies for orphan diseases, such market exclusivity for 7 years and tax credit of 50% in clinical research and trials;
• Under normal circumstances, about $10 billion is needed to develop a drug, and if the number of patients is less than 200,000 or the drug fee is insufficient to cover the development cost, therefore there is an opportunity to apply for an orphan drug designation;
• Some consumer rights organizations objected Gilead’s application for Remdesivir as an orphan drug, since COVID - 19 is a global pandemic and likely to affect more than 200000 patients worldwide, so Remdesivir should be available for wide used.

7. According to WHO Assistant Director General Bruce Aylward, Remdesivir is the only drug that the organization considers having ‘real efficacy’. Do you agree on the statement?

• I totally agree with this statement, which is based entirely on scientific data;
• If Remdesivir fails to treat COVID-19, I will be very concern about the situation and the outcome of the pandemic.
8. Does Remdesivir has any side effects?

• Remdesivir is a safe drug as it was determined in Phase I in 80 patients. In Phase I it was discovered that Remdesivir can affect the liver function in a very small numbers of patients. Such rise of liver enzymes were reversible and levels returned to normal after stopping the medicine. In other words, the patient can recover through.



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