Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.
Med Sci Monit. 2022 Jan 1;28:e935952. doi: 10.12659/MSM.935952.
On 4th November 2021, the first oral antiviral drug for COVID-19, molnupiravir (Lagevrio®), received full regulatory approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. Molnupiravir is an orally bioavailable antiviral drug for use at home when a SARS-CoV-2 test is positive. On 22nd December 2022, the FDA granted emergency use authorization (EUA) for the oral antiviral drug, nirmatrelvir/ritonavir (Paxlovid®) for adults and children with mild and moderate COVID-19 at increased risk of progression to severe COVID-19. These regulatory drug approvals come at a crucial time when new variants of concern of the SARS-CoV-2 virus are spreading rapidly. Although the FDA approved remdesivir (Veklury®) on 22nd October 2020 for use in adults and children for the treatment of COVID-19 requiring hospitalization, its use has been limited by the requirement for intravenous administration in a healthcare facility. The four FDA-approved therapeutic neutralizing monoclonal antibodies, imdevimab, bamlanivimab, etesevimab, and casirivimab are costly and also require medically-supervised intravenous administration. The availability of effective, low-cost oral antiviral drugs available in a community setting that can be used at an early stage of SARS-CoV-2 infection is now a priority in controlling COVID-19. An increasing number of repurposed antiviral drugs are currently under investigation or in the early stages of regulatory approval. This Editorial aims to present an update on the current status of orally bioavailable antiviral drug treatments for SARS-CoV-2 infection.
2021 年 11 月 4 日,首款用于 COVID-19 的口服抗病毒药物莫那比拉韦(Lagevrio®)获得英国药品和保健品管理局(MHRA)的全面监管批准。莫那比拉韦是一种可在家中使用的口服抗病毒药物,适用于 SARS-CoV-2 检测呈阳性的患者。2022 年 12 月 22 日,美国食品药品监督管理局(FDA)授予口服抗病毒药物奈玛特韦/利托那韦(Paxlovid®)紧急使用授权(EUA),用于有进展为重症 COVID-19风险增加的轻度和中度 COVID-19 成人和儿童。这些监管药物的批准正值 SARS-CoV-2 病毒的新关注变种迅速传播之际,这是一个关键时刻。尽管 FDA 于 2020 年 10 月 22 日批准瑞德西韦(Veklury®)用于需要住院治疗的 COVID-19 成人和儿童的治疗,但由于需要在医疗机构中进行静脉内给药,其使用受到限制。四种获得 FDA 批准的治疗性中和单克隆抗体,即 imdevimab、bamlanivimab、etesevimab 和 casirivimab,价格昂贵,并且也需要在医疗监督下进行静脉内给药。在社区环境中提供有效、低成本的口服抗病毒药物,可在 SARS-CoV-2 感染的早期阶段使用,这现在是控制 COVID-19 的优先事项。目前,越来越多的已重新定位的抗病毒药物正在进行调查或处于监管批准的早期阶段。本社论旨在介绍 SARS-CoV-2 感染口服生物利用抗病毒药物治疗的最新进展。