Department of Pharmacology, All India Institute of Medical Sciences-Bibinagar, Hyderabad, Telangana, 508126, India.
Department of Ophthalmology, All India Institute of Medical Sciences-Bibinagar, Hyderabad, Telangana, 508126, India.
Ir J Med Sci. 2023 Aug;192(4):1665-1678. doi: 10.1007/s11845-022-03139-y. Epub 2022 Sep 10.
Molnupiravir is an oral antiviral drug that received Emergency Use Authorization in three countries for the treatment of mild COVID-19. The aim of this systematic review was to find out the safety and efficacy of Molnupiravir in SARS-COV-2 infections.
The electronic databases such as PubMed, MedRxiv, BioRxiv, FDA, ClinicalTrials.Gov, ctri.nic.in and Google Scholar were searched for articles from January 2021 to March 2022 using the keywords such as "Molnupiravir", "COVID-19", "Oral antiviral pill", "MK-4482", "EIDD-280", "Efficacy" and "Safety". Details of published, unpublished with interim reports and ongoing studies of Molnupiravir in COVID-19 were retrieved, and a systematic review was performed.
A total of 6 articles and 18 ongoing trials data were collected. Out of these, data from 4 published and 2 unpublished with interim reports were extracted. After review of these studies, it was observed that the daily dose of 1600 mg Molnupiravir for 5 days was safe and tolerable with nausea, diarrhea and headache as the common adverse effects. The results also showed significant decrease in time to viral clearance with 800 mg twice daily in mild patients and reduction in the risk of hospitalization or death by 50% in non-hospitalized COVID-19 patients.
Evidence from clinical studies showed that Molnupiravir caused significant reduction in the risk of hospitalization or death in high-risk mild COVID-19 patients. Molnupiravir was also found to be well tolerated and safe without any major adverse events on short-term use. For confirmative use of this drug in mild-to-moderate COVID-19 disease, further studies are required in vaccinated COVID-19 patients and against emerging variants.
莫努匹韦是一种口服抗病毒药物,已在三个国家获得紧急使用授权,用于治疗轻度 COVID-19。本系统评价的目的是确定莫努匹韦在 SARS-CoV-2 感染中的安全性和疗效。
使用“Molnupiravir”、“COVID-19”、“口服抗病毒药物”、“MK-4482”、“EIDD-280”、“疗效”和“安全性”等关键词,检索 2021 年 1 月至 2022 年 3 月期间 PubMed、MedRxiv、BioRxiv、FDA、ClinicalTrials.Gov、ctri.nic.in 和 Google Scholar 等电子数据库中的文章。检索莫努匹韦在 COVID-19 中的已发表、未发表(有中期报告)和正在进行的研究的详细信息,并进行系统评价。
共收集了 6 篇文章和 18 项正在进行的试验数据。其中,提取了 4 篇已发表和 2 篇未发表(有中期报告)的数据。审查这些研究后发现,每日剂量为 1600mg 的莫努匹韦连续使用 5 天是安全且可耐受的,常见不良反应为恶心、腹泻和头痛。结果还表明,在轻症患者中,每日两次 800mg 剂量可显著缩短病毒清除时间,在未住院的 COVID-19 患者中可降低 50%的住院或死亡风险。
临床研究证据表明,莫努匹韦可显著降低高危轻症 COVID-19 患者的住院或死亡风险。短期使用莫努匹韦也具有良好的耐受性和安全性,无重大不良事件。为了在轻度至中度 COVID-19 疾病中更确认使用这种药物,还需要在接种 COVID-19 疫苗的患者中和针对新兴变异株进行进一步的研究。