A brand new examine within the New England Journal of Drugs means that, for these absolutely vaccinated in opposition to COVID-19 however having no less than one danger issue for extreme COVID, the antiviral drug Paxlovid did little to scale back symptom length, however specialists warning the findings may not apply to older sufferers.
The part 2/3 trial of 1,296 individuals randomly assigned in a 1:1 ratio to obtain nirmatrelvir–ritonavir (Paxlovid) or placebo each 12 hours for five days inside 5 days of COVID-19 symptom onset. A complete of 654 individuals took Paxlovid, and 634 individuals took the placebo.
The examine was performed from July 2021 to July 2022.
Included within the examine have been sufferers who have been absolutely vaccinated and who had no less than one danger issue for extreme illness, in addition to sufferers with out such danger elements who had by no means been vaccinated in opposition to COVID-19, or had not been vaccinated inside the earlier yr.
No vital between-group distinction
The most typical danger elements famous have been weight problems, smoking, and hypertension, and solely 2% of individuals had coronary heart or lung circumstances that predisposed them for extreme COVID-19 infections.
Members recorded each day symptom severity on a 4-point scale (0, absent; 1, gentle; 2, reasonable; 3, extreme), and the included signs have been cough, shortness of breath or issue respiration, feeling feverish, chills or shivering, muscle or physique aches, diarrhea, nausea, vomiting, headache, sore throat, and stuffy or runny nostril.
The first finish level was sustained symptom alleviation, outlined as the primary of 4 consecutive days throughout which all signs that had been scored as reasonable or extreme and as gentle or absent at baseline have been scored as gentle or absent and as absent, respectively, the authors stated.
“The median time to sustained alleviation of all focused indicators and signs of COVID-19 was 12 days within the nirmatrelvir–ritonavir group and 13 days within the placebo group (P=0.60),” the authors wrote.
A secondary finish level was COVID-19–associated hospitalization or dying from any trigger by day 28 of the trial. 5 individuals (0.8%) within the nirmatrelvir–ritonavir group and 10 (1.6%) within the placebo group have been hospitalized for COVID, or died from any trigger by day 28.
“The outcomes with respect to the numbers of Covid-19–associated hospitalizations and deaths from any trigger on this trial, though not vital, are in line with and supported by latest real-world knowledge,“ the authors wrote.
Findings may not apply to older sufferers
The trial was notable for together with youthful individuals: The median age was 42 years, and solely 5% have been 65 years of age or older.
Michael Osterholm, PhD, MPH, director of the College of Minnesota’s Middle for Infectious Illness Analysis and Coverage (CIDRAP), writer of CIDRAP Information, cautioned that the examine’s younger participant inhabitants modified how danger was outlined within the examine, “Can we actually say an unvaccinated 18-year-old has the identical danger issue as a vaccinated 89-year-old? I do not suppose so.“ Osterholm stated right this moment in right this moment’s episode of the Osterholm Replace podcast.
Can we actually say an unvaccinated 18-year-old has the identical danger issue as a vaccinated 89-year-old?
“We have to keep away from overgeneralizing the findings to older, high-risk populations,“ Osterholm stated. For these folks, Paxlovid continues to be a helpful first-line remedy.
In an editorial on the examine, Rajesh T. Gandhi, MD, and Martin Hirsch, MD, wrote, “As with many medical interventions, there’s prone to be a gradient of profit for nirmatrelvir–ritonavir, with the sufferers at highest danger for development probably to derive the best profit.”
Gandhi and Hirsch stated longer-term research on Paxlovid are warranted, to see the extent to which the drug gives safety in opposition to lengthy COVID.