Noninferiority established with respect to time to sustained clinical recovery for adults at high risk for progression
By Elana Gotkine HealthDay Reporter
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.
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.
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.
“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.
The study was funded by Vigonvita Life Sciences, the manufacturer of VV116.
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