Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19

新冠病毒(COVID-19)最新消息：美国食品药品监督管理局(FDA) 首次授权通过口服抗病毒药物来治疗新冠肺炎

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.

今天，辉瑞公司的新冠口服药Paxlovid获得了美国食品药品监督管理局的紧急使用授权(EUA)（Paxlovid由Nirmatrelvir片和利托那韦片组成，为口服的复方制剂），用于治疗新冠检测呈阳性的、患轻中度新冠肺炎且很有可能发展为重症新冠肺炎的成人和儿童（12岁及以上，体重至少40公斤或约88磅）。一旦病情发展为重症，患者则面临着住院甚至死亡。Paxlovid为处方药，应尽快在确诊感染新冠肺炎后开始服用，并应在症状出现后的五天内开始服用。

“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”

美国食品药品监督管理局的药物评估与研究中心主任、医学博士Patrizia Cavazzoni说：“今天，美国食品药品监督管理局批准首个用于治疗新冠肺炎的口服抗病毒药物，这是抗击新冠全球大流行的重大举措。随着新冠新变体的出现，这一授权为在疫情全球流行的关键时刻抗击新冠病毒提供了一种新的工具，并有望使得重症新冠肺炎的高风险病人更容易接受到抗病毒治疗。”

Paxlovid is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19. Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended. The FDA has approved one vaccine and authorized others to prevent COVID-19 and serious clinical outcomes associated with a COVID-19 infection, including hospitalization and death. The FDA urges the public to get vaccinated and receive a booster if eligible. Learn more about FDA-approved or -authorized COVID-19 vaccines.

Paxlovid未被授权用于对 COVID-19 暴露前或暴露后的预防，也未被授权对需要住院的新冠肺炎危重症患者进行治疗。对于适合接种新冠疫苗和新冠疫苗加强针的个体来说，Paxlovid并不能替代疫苗接种。美国食品药品监督管理局已经批准了一款疫苗，并授权其他种类的疫苗，以预防新冠肺炎和与新冠肺炎感染相关的严重临床后果，包括住院和死亡。美国食品药品监督管理局敦促公众接种疫苗，并在符合条件的情况下接种加强针。阅读下文，以了解更多关于美国食品药品监督管理局批准或授权的新冠疫苗的情况。

Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations. Paxlovid is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days, for a total of 30 tablets. Paxlovid is not authorized for use for longer than five consecutive days.

Paxlovid由Nirmatrelvir和利托那韦组成，前者抑制SARS-CoV-2蛋白，阻止病毒复制，后者减缓前者的分解，帮助前者以较高浓度的状态在体内停留更长时间。Paxlovid一次口服三片（两片Nirmatrelvir和一片利托那韦），每日两次，连续五天，一盒共30片。 Paxlovid 未被授权连续使用 5 天以上。

The issuance of an EUA is different than an FDA approval. In determining whether to issue an EUA, the FDA evaluates the totality of scientific evidence available and carefully balances any known or potential risks with any known or potential benefits of the product. Based on the FDA’s review of the totality of the scientific evidence available, the agency has determined that it is reasonable to believe that Paxlovid may be effective for the treatment of mild-to-moderate COVID-19 in authorized patients. The agency has also determined that the known and potential benefits of Paxlovid, when used consistent with the terms and conditions of the authorization, outweigh the known and potential risks of the product. There are no adequate, approved and available alternatives to Paxlovid for the treatment of COVID-19.

紧急使用授权（EUA）的签发不同于美国食品药品监督管理局的批准。在决定是否签发紧急使用授权时，美国食品药品监督管理局要评估所有可用的科学证据，并仔细平衡产品任何已知的或潜在的风险与益处。基于美国食品药品监督管理局对所有可用科学证据的审查，该局已经确定，有理由相信Paxlovid在符合使用条件的轻中度新冠肺炎患者的治疗中可能有效。美国食品药品监督管理局还确定，在符合授权条款和条件的情况下使用Paxlovid，其已知和潜在的好处超过了风险。对于治疗COVID-19，没有合格的、经批准的和可用的Paxlovid的替代品。

The primary data supporting this EUA for Paxlovid are from EPIC-HR, a randomized, double-blind, placebo-controlled clinical trial studying Paxlovid for the treatment of non-hospitalized symptomatic adults with a laboratory confirmed diagnosis of SARS-CoV-2 infection. Patients were adults 18 years of age and older with a prespecified risk factor for progression to severe disease or were 60 years and older regardless of prespecified chronic medical conditions. All patients had not received a COVID-19 vaccine and had not been previously infected with COVID-19. The main outcome measured in the trial was the proportion of people who were hospitalized due to COVID-19 or died due to any cause during 28 days of follow-up. Paxlovid significantly reduced the proportion of people with COVID-19 related hospitalization or death from any cause by 88% compared to placebo among patients treated within five days of symptom onset and who did not receive COVID-19 therapeutic monoclonal antibody treatment. In this analysis, 1,039 patients had received Paxlovid, and 1,046 patients had received placebo and among these patients, 0.8% who received Paxlovid were hospitalized or died during 28 days of follow-up compared to 6% of the patients who received placebo. The safety and effectiveness of Paxlovid for the treatment of COVID-19 continue to be evaluated.

支持Paxlovid获得紧急使用授权的主要数据来自EPIC-HR，EPIC-HR是一项随机、双盲、安慰剂对照临床试验，研究Paxlovid对新冠病毒检测呈阳性的、未住院、有症状且18岁及以上的成人的治疗情况。患者是 18 岁及以上的成年人，他们未患新冠前的身体状况使其病情很有可能发展为重症。也有 60 岁及以上的患者，其既往病史不予考虑。所有患者均未接种过新冠疫苗，且此前未感染过新冠病毒。该试验测量的主要结果是在28天的随访中，因新冠肺炎住院或因任何原因死亡的人群比例。与安慰剂组的患者，即在症状发作五天内接受安慰剂治疗且未接受新冠肺炎单克隆抗体治疗的患者相比，服用Paxlovid使得与新冠病毒相关的住院或因任何原因死亡的风险显著降低了88%。在这项分析中，1039名患者接受了Paxlovid治疗，1046名患者接受了安慰剂治疗。在这些患者中，0.8%接受Paxlovid治疗的患者在28天的随访期间住院或死亡，而这一数字在安慰剂组为6%。Paxlovid治疗新冠肺炎的安全性和有效性仍在继续评估中。

Possible side effects of Paxlovid include impaired sense of taste, diarrhea, high blood pressure and muscle aches. Using Paxlovid at the same time as certain other drugs may result in potentially significant drug interactions. Using Paxlovid in people with uncontrolled or undiagnosed HIV-1 infection may lead to HIV-1 drug resistance. Ritonavir may cause liver damage, so caution should be exercised when giving Paxlovid to patients with preexisting liver diseases, liver enzyme abnormalities or liver inflammation.

Paxlovid可能的副作用包括味觉受损、腹泻、高血压和肌肉疼痛。与某些其他药物同时使用Paxlovid可能导致潜在的显著药物相互作用。感染了HIV-1但病情未得到控制或还未诊断为HIV-1的人群使用Paxlovid可能导致HIV-1耐药性。利托那韦可能会引起肝脏损害，因此对既往有肝病、肝酶异常或肝脏炎症的患者在服用Paxlovid时应谨慎。

Because Paxlovid works, in part, by inhibiting a group of enzymes that break down certain drugs, Paxlovid is contraindicated with certain drugs that are highly dependent on those enzymes for metabolism and for which elevated concentrations of certain drugs are associated with serious and/or life-threatening reactions. Paxlovid is also contraindicated with drugs that, conversely, strongly induce those same enzymes, leading to the faster breakdown of nirmatrelvir or ritonavir, as reduced concentrations of nirmatrelvir or ritonavir may be associated with potentially losing virologic response and developing viral resistance. Paxlovid cannot be started immediately after discontinuing such medications because the effects of those medications remain after discontinuation. For a complete list of drugs that should not be taken in combination with Paxlovid, see the fact sheet for healthcare providers.

由于Paxlovid部分地通过抑制一组分解某些药物的酶而起作用，因此Paxlovid禁与某些药物同时服用，这些药物高度依赖于Paxlovid所分解的酶进行代谢。并且，某些药物的浓度升高会引发严重和/或威胁生命的身体反应。Paxlovid 也禁止与反方向强烈诱导相同酶的药物一起使用，这会导致nirmatrelvir或利托那韦更快分解，因为nirmatrelvir或利托那韦的浓度降低可能与潜在的病毒学应答丧失和产生病毒耐药性有关。在停用上述药物后，不能立即开始使用Paxlovid，因为停药后，这些药物的效果仍然存在。有关不应与Paxlovid合用的药物的完整清单，请参见医疗保健提供者的概况介绍。

Paxlovid is not recommended in patients with severe kidney or severe liver impairment. In patients with moderate renal impairment, a reduced Paxlovid dose is needed. Patients with kidney or liver problems should discuss with their healthcare provider whether Paxlovid is right for them.

不推荐严重肾脏或严重肝脏损害的患者不使用Paxlovid。对于中度肾功能损害的患者，需要减少Paxlovid的剂量。有肾脏或肝脏问题的患者应该与他们的医疗保健提供者讨论Paxlovid是否适合他们。

Under the EUA, fact sheets that provide important information about using Paxlovid in the treatment of COVID-19 as authorized must be made available to healthcare providers and to patients and caregivers. These fact sheets include dosing instructions, potential side effects, drug interactions and information about who is able to prescribe Paxlovid.

在紧急使用授权的情况下，必须向医疗保健提供者、患者和护理人员提供关于经授权使用Paxlovid治疗新冠肺炎的重要信息的概况介绍。这些概况介绍包括剂量说明、潜在副作用、药物相互作用以及关于谁能开Paxlovid处方的信息。

Paxlovid EUA Letter of Authorization

Paxlovid紧急使用授权授权书

Frequently Asked Questions on the Emergency Use Authorization for Paxlovid

关于Paxlovid紧急使用授权的常见问题

Emergency Use Authorization: Drugs and Non-Vaccine Biological Products

紧急使用授权：药品和非疫苗生物制品

Coronavirus Disease (COVID-19)

新冠肺炎(COVID-19)

Coronavirus Treatment Acceleration Program (CTAP)

冠状病毒治疗加速计划(CTAP)

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