Episode 314: 313. Nirmatrelvir for Vaccinated or Unvaccinated Adult Outpatients with Covid-19

https://pubmed.ncbi.nlm.nih.gov/38598573/

In fully vaccinated adults with a risk factor or unvaccinated patients without a risk factor who have symptomatic COVID-19, does paxlovid--nirmatrelvir-ritonavir reduce the duration of symptoms or the likelihood of hospitalization?

Nirmatrelvir-ritonavir (Paxlovid) was shown in its initial randomized trial to reduce hospitalization and death in unvaccinated adults with at least one risk factor for severe disease when the ancestral variant of SARS-CoV-2 was predominant.

But it is important that drugs be evaluated in the correct target population patients who have been vaccinated or have the Omicron variant.

This industry-sponsored study enrolled 2 groups of patients: (1) fully vaccinated adults with symptomatic, confirmed infection with SARS-CoV-2 and at least one risk factor for severe disease,

(2) unvaccinated adults with a symptomatic infection but no risk factors

The onset of symptoms was within the past 5 days. Patients (N = 1296) were randomized to receive the standard 5-day course of nirmatrelvir-ritonavir or matching placebo.

the 1440 participants who were initially randomized There was no difference in duration of symptoms between groups, and no significant difference in the likelihood of hospitalization or death (0.8% vs 1.6% for placebo; difference -0.8%; 95% CI -2.0 to 0.4).