COVID-19 · Antivirals in outpatients
Nirmatrelvir for Vaccinated or Unvaccinated Adult Outpatients with Covid-19
| Design | Phase 2-3, randomised, double-blind, placebo-controlled trial |
|---|---|
| Treatment | Nirmatrelvir plus ritonavir |
| Control | Placebo |
| Population | 1288 vaccinated or unvaccinated adult outpatients with COVID-19 at standard risk |
| Follow-up | 28 days |
| Primary endpoint | Time to sustained alleviation of all COVID-19 signs and symptoms |
| Result | Median time to sustained alleviation of all targeted symptoms was 12 days with nirmatrelvir-ritonavir and 13 days with placebo (p=0.60). Hospitalisation for COVID-19 or death from any cause occurred in 5 of 654 (0.8%) versus 10 of 634 (1.6%) — difference -0.8 percentage points (95% CI -2.0 to 0.4). Adverse events were similar, 25.8% versus 24.1%. |
| Secondary endpoints | Hospitalisation or death, viral load |
The time to sustained alleviation of all signs and symptoms of Covid-19 did not differ significantly between participants who received nirmatrelvir-ritonavir and those who received placebo.
The trial authors, in the published abstract
The essential companion to EPIC-HR and the reason its 89% cannot be quoted alone. Same drug, different population — vaccinated, standard risk, later variants — and the benefit disappears. Antiviral efficacy in COVID-19 is a property of the patient as much as of the drug.
Hammond J, Fountaine RJ, Yunis C, et al. Nirmatrelvir for Vaccinated or Unvaccinated Adult Outpatients with Covid-19. N Engl J Med 2024 Apr 4;390(13):1186-1195.