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In a recent study published in the New England Journal of Medicine, the antiviral combination pill Nirmatrelvir-Ritonavir demonstrated no significant difference in efficacy compared to a placebo in treating mild-to-moderate Covid-19. The researchers, led by Drs. Jennifer Hammond, Robert J. Fountaine, and James M. Rusnak, included both vaccinated and unvaccinated adults in their randomized trial.
The tested oral antiviral treatment, commonly known by its commercial name Paxlovid, was administered to patients who had tested positive for Covid-19, with symptoms onset within the previous five days. The trial consisted of 1296 participants, who logged detailed daily accounts of their specific symptoms from day one through day 28.
Importantly, the primary endpoint of the trial was not the eradication of the Covid-19 virus but rather the time to sustained alleviation of targeted symptoms. The median time taken for the disappearance of all Covid-19 symptoms was found to be virtually the same for the Nirmatrelvir-Ritonavir and placebo groups at 12 and 13 days, respectively.
“We found no significant difference between the time to sustained relief of symptoms in those treated with Nirmatrelvir-Ritonavir and those given a placebo,” said Dr. Hammond.
Despite these results, an agreement between Pfizer and the U.S. Department of Health and Human Services (HHS) ensures that access to Paxlovid will continue. The agreement extends till end-2024, with considerations for even uninsured individuals, under a ‘patient assistance program’. Under the agreement reached between Pfizer and the U.S. Department of Health and Human Services (HHS), individuals on Medicare, Medicaid, and those who are uninsured will continue to have access to Paxlovid free of charge through the end of 2024 via a patient assistance program.
Meanwhile, potential side effects were found to be relatively low in frequency and no more prevalent among patients taking the antiviral treatment compared to those taking the placebo. These included dysgeusia or a distortive taste sensation in 5.8% of the antiviral group, and diarrhea in 2.1%.
All members of the trial, including vaccinated and unvaccinated patients, will be monitored for up to 28 days post-trial to assess hospitalization rates and mortality.
- Drug Name: Nirmatrelvir-Ritonavir (Paxlovid)
- Type: Antiviral Treatment for Mild-to-Moderate Covid-19
- Trial Phase: 2 and 3
- Trial Participants: 1296 (Vaccinated and Unvaccinated)
- Median Time to Symptom Relief: 12 days (Nirmatrelvir-Ritonavir) vs. 13 days (Placebo)
References:
1: NEJM: Nirmatrelvir for Vaccinated or Unvaccinated Adult Outpatients with Covid-19
2: HHS and Pfizer Reach Agreement to Increase Patient Access to Paxlovid