Richmond DiBello Julia, Raziano Valerie T, Liu Xinyue, Puenpatom Amy, Peebles Kathryn, Khan Nazleen F, Hill Deanna D
Biostatistics and Research Decision Sciences (BARDS), Epidemiology, Merck & Co., Inc., Rahway, NJ, USA.
Center for Observational and Real-World Evidence (CORE), Merck & Co., Inc., Rahway, NJ, USA.
Infect Dis Ther. 2024 Jun;13(6):1177-1198. doi: 10.1007/s40121-024-00976-5. Epub 2024 May 14.
Molnupiravir (MOV) is an oral antiviral for the treatment of individuals with mild-to-moderate COVID-19 and at high risk of progression to severe disease. Our objective was to conduct a systematic literature review (SLR) of evidence on the effectiveness of MOV in reducing the risk of severe COVID-19 outcomes in real-world outpatient settings.
The SLR was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines and using pre-determined population, intervention, comparison, outcome, time, and study design inclusion criteria. Eligible studies were published between January 1, 2021, and March 10, 2023, and evaluated the real-world effectiveness of MOV compared to no treatment in reducing the risk of severe COVID-19 outcomes among outpatients ≥ 18 years of age with a laboratory-confirmed diagnosis of SARS-CoV-2 infection.
Nine studies from five countries were included in the review. The size of the MOV-treated group ranged from 359 to 7818 individuals. Omicron variants of SARS-CoV-2 were dominant in all study periods. Most studies noted differences in the baseline characteristics of the MOV-treated and untreated control groups, with the treated groups generally being older and with more comorbidities. Eight studies reported that treatment with MOV was associated with a significantly reduced risk of at least one severe COVID-19 outcome in at least one age group, with greater benefits consistently observed among older age groups.
In this SLR study, treatment with MOV was effective in reducing the risk of severe outcomes from COVID-19 caused by Omicron variants, especially for older individuals. Differences in the ages and baseline comorbidities of the MOV-treated and control groups may have led to underestimation of the effectiveness of MOV in many observational studies. Real-world studies published to date thus provide additional evidence supporting the continued benefits of MOV in non-hospitalized adults with COVID-19.
莫努匹韦（MOV）是一种口服抗病毒药物，用于治疗轻度至中度COVID-19且有进展为重症疾病高风险的个体。我们的目的是对莫努匹韦在真实世界门诊环境中降低重症COVID-19结局风险的有效性证据进行系统文献综述（SLR）。
该系统文献综述按照《系统评价与Meta分析优先报告项目2020》指南进行，并使用预先确定的人群、干预措施、对照、结局、时间和研究设计纳入标准。符合条件的研究发表于2021年1月1日至2023年3月10日之间，评估了莫努匹韦与未治疗相比在降低年龄≥18岁、实验室确诊感染SARS-CoV-2的门诊患者中重症COVID-19结局风险方面的真实世界有效性。
该综述纳入了来自五个国家的九项研究。接受莫努匹韦治疗的组规模从359人到7818人不等。在所有研究期间，SARS-CoV-2的奥密克戎变体占主导地位。大多数研究指出接受莫努匹韦治疗组和未治疗对照组的基线特征存在差异，治疗组通常年龄更大且合并症更多。八项研究报告称，在至少一个年龄组中，莫努匹韦治疗与至少一种重症COVID-19结局风险显著降低相关，在老年组中始终观察到更大益处。
在这项系统文献综述研究中，莫努匹韦治疗可有效降低由奥密克戎变体引起的COVID-19的重症结局风险，尤其是对老年人。接受莫努匹韦治疗组和对照组在年龄及基线合并症方面的差异可能导致在许多观察性研究中低估了莫努匹韦的有效性。因此，迄今为止发表的真实世界研究提供了额外证据，支持莫努匹韦对非住院COVID-19成人持续有益。
