The trial met its primary and key secondary endpoints, making ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter 'ensitrelvir') the first antiviral agent to show both clinical symptom improvement and antiviral effect in a predominantly vaccinated population with Omicron infection regardless of risk factors.
The publication reports that treatment with once-daily ensitrelvir in the primary analysis population led to a statistically significant reduction in the time to resolution of five typical COVID-19 symptoms characteristic of Omicron (runny/stuffy nose, sore throat, cough, feeling hot or feverish, and low energy/tiredness1) versus placebo (p=0.04). The median time to symptom resolution was approximately one day shorter in the 125 mg ensitrelvir group versus placebo (approximately 7 days versus 8 days, respectively).1 Patients included in the primary analysis population were randomized less than 72 hours from symptom onset.1 More than 90% of patients had received two or more doses of the SARS-CoV-2 vaccine and patients were included regardless of risk factors for severe disease.1
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Key Secondary Endpoints
The study also met its two key secondary endpoints (primary analysis population), as previously presented at the Conference on Retroviruses and Opportunistic Infections 2023. The amount of viral RNA was significantly lower on Day 4 in the 125 mg ensitrelvir group compared with placebo (least squares mean change from baseline -2.48 log10 copies/mL versus -1.01 log10 copies/mL, p
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