The safety and efficacy of oral antiviral drug VV116 for treatment of COVID-19: A systematic review

Abstract: Medicine ® Systematic Review and Meta-Analysis The safety and efficacy of oral antiviral drug VV116 for treatment of COVID-19 wCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC1y0abggQZXdgGj2MwlZLeI= on 01/29/2024 A systematic review Ningkun Xiao, MDa,* , Xinlin Huang, MDa, Xiaotian Kang, Bachelorb, Wanli Zang, MDc, Bo Li, MDd, Sergey Kiselev, PhDa Abstract Background: Recent trials have highlighted the potential of oral antiviral VV116 in the treatment of patients with mild COVID- 19. However, no comprehensive studies have assessed the safety and efficacy of VV116. Therefore, we conducted a systematic review to assess the safety and efficacy of VV116. Methods: A comprehensive search was conducted on PubMed, Scopus, and Google Scholar websites, with a cutoff date of March 23, to identify pertinent studies. Results: The results from the 3 included studies indicated that no serious adverse events were reported in the VV116 experimental groups, which exhibited a 2.57-day faster time to viral shedding than the control group and demonstrated non-inferiority to the nirmatrelvir-ritonavir control group in alleviating major symptoms. Discussion: Collectively, available studies suggest a reliable safety and efficacy profile for VV116. However, the limited number of trials was insufficient for meta-analysis, and the included population consisted of younger individuals with mild and moderate symptoms, not encompassing the elderly who are severely affected by COVID-19. We hope that more studies will be conducted in the future to ensure that VV116 has a more reliable safety and efficacy profile in the clinical setting, especially in severe or critical patients. Abbreviations: AEs = adverse events, AUC = concentration-time curve, Cmax = the maximum measured plasma concentration, COVID-19 = corona virus disease 2019, NR = nirmatrelvir/ritonavir, PEDro = Physiotherapy Evidence Database scale, SARSCoV-2 = severe acute respiratory syndrome coronavirus 2. Keywords: COVID-19, oral antiviral drug, public health, vaccines, VV116 have high spike protein mutation rates. There is a higher probability of vaccine breakthrough rates and widespread escape from existing neutralizing antibodies,[8,9] more specifically, The BQ and XBB subvariants of SARS-CoV-2 Omicron are currently expanding rapidly, and BQ.1, BQ.1.1, XBB, and XBB.1 are the most resistant SARS-CoV-2 variations to date,[10] which poses a huge challenge to the immune protection of the majority of the population and a threat to worldwide health endeavors. Consequently, adjunct medications have become increasingly important for safeguarding global health. The U.S. Food and Drug Administration has approved 2 oral antiviral drugs for the treatment of mild to moderate COVID-19 outpatients at risk of progression to severe COVID-19: Pfizer’s PF-07321332 (nirmatrelvir/ritonavir, paxlovid)[11,12] and Merck’s