Noninferiority established with respect to time to sustained clinical recovery for adults at high risk for progression<\/p>\n<\/h3>\n
By Elana Gotkine HealthDay Reporter<\/b><\/p>\n
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FRIDAY, Jan. 6, 2023 (HealthDay News) — VV116 is noninferior to nirmatrelvir-ritonavir with respect to time to sustained clinical recovery for adults with mild-to-moderate COVID-19 at risk for progression, according to a study published online Dec. 28 in the New England Journal of Medicine<\/em>.<\/em><\/p>\n Zhujun Cao, M.D., Ph.D., from the Shanghai Institute of Virology, and colleagues conducted a phase 3, noninferiority trial during the outbreak caused by the B.1.1.529 (omicron) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Symptomatic adults with mild-to-moderate COVID-19 and a high risk for progression were randomly assigned to five days of VV116 or nirmatrelvir-ritonavir (384 and 387 patients, respectively). Sustained clinical recovery through day 28 was examined as the primary end point.<\/p>\n The researchers found that in the primary analysis, the noninferiority of VV116 to nirmatrelvir-ritonavir was established with respect to the time to sustained clinical recovery (hazard ratio, 1.17) and was maintained in the final analysis (median, four versus five days; hazard ratio, 1.17). In the final analysis, there was no significant difference observed between the groups in the time to sustained symptom resolution (score of 0 for each of 11 COVID-19-related target symptoms for two consecutive days) or to a first negative SARS-CoV-2 test. There were no deaths or progression to severe COVID-19 reported by day 28 for participants in either group.<\/p>\n “This noninferiority in efficacy was seen in the full analysis population, the per-protocol population, and in participants who started treatment within five days after symptom onset,” the authors write.<\/p>\n The study was funded by Vigonvita Life Sciences, the manufacturer of VV116.<\/p>\n