New Engl J Med
Novel oral antiviral reduces symptom duration in adults with mild-to-moderate COVID-19
Early administration of simnotrelvir plus ritonavir shortened the time to resolution of symptoms among adult patients with mild-to-moderate COVID-19 by approximately 1.5 days in this phase 2-3, double-blind, randomized, placebo-controlled trial. No evident safety concerns were found.
- A total of 1,208 patients were enrolled at 35 sites in China; 603 were assigned to receive simnotrelvir and 605 to receive placebo.
- Patients with mild-to-moderate COVID-19 and symptom onset within the past 3 days were randomized in a 1:1 ratio to receive 750 mg of simnotrelvir plus 100 mg of ritonavir or placebo twice daily for 5 days.
- Primary efficacy end point was the time to sustained resolution of symptoms, defined as the absence of 11 COVID-19-related symptoms for 2 consecutive days. Researchers also assessed safety and changes in viral load.
- Among patients in the modified intention-to-treat population who received the first dose of trial drug or placebo within 72 hours after symptom onset, the time to sustained resolution of symptoms was significantly shorter in the simnotrelvir group than in the placebo group (180.1 hours [95% confidence interval {CI}, 162.1-201.6] vs. 216.0 hours [95% CI, 203.4-228.1]; median difference, -35.8 hours [95% CI, -60.1 to -12.4]; P = 0.006).
- On day 5, the decrease in viral load from baseline was greater in the simnotrelvir group than in the placebo group (mean difference [±SE], -1.51±0.14 log10 copies per mL; 95% CI, -1.79 to -1.24).
- Incidence of adverse events during treatment was higher in the simnotrelvir group than in the placebo group (29.0% vs. 21.6%), but most were mild or moderate.
Source:
Cao B, et al. (2024, January 18). New Engl J Med. Oral Simnotrelvir for Adult Patients with Mild-to-Moderate Covid-19. https://pubmed.ncbi.nlm.nih.gov/38231624/