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
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'abstract': '<jats:sec><jats:title>Background:</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods:</jats:title><jats:p>A comprehensive '
'search was conducted on PubMed, Scopus, and Google Scholar websites, with a cutoff date of '
'March 23, to identify pertinent '
'studies.</jats:p></jats:sec><jats:sec><jats:title>Results:</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Discussion:</jats:title><jats:p>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.</jats:p></jats:sec>',
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