A study of over 100 thousand patients published in the New England Journal of Medicine on August 24, 2022, shows that oral protease inhibitor nirmatrelvir, used in combination with ritonavir under the brand name Paxlovid, offered no evidence of statistically reducing the rate of hospitalization from COVID among both treated and untreated patients 40 to 64 years of age.
According to the study’s conclusion, “Among patients 65 years of age or older, the rates of hospitalization and death due to Covid-19 were significantly lower among those who received nirmatrelvir than among those who did not. No evidence of benefit was found in younger adults.”
The study comprised of 109,254 patients of Clalit Health Services, the largest Israeli state-mandated health service in the country, that was conducted between January 9, 2022, and March 31, 2022. All patients eligible in the study were 40 years of age or older and were allowed to receive nirmatrelvir therapy during the omicron surge.
Among patients 65 years of age or older, the rate of hospitalization due to Covid-19 was 14.7 cases per 100,000 person-days among treated patients as compared with 58.9 cases per 100,000 person-days among untreated patients.
Among patients 40 to 64 years of age, the rate of hospitalization due to Covid-19 was 15.2 cases per 100,000 person-days among treated patients and 15.8 cases per 100,000 person-days among untreated patients
Nirmatrelvir effectiveness was notably higher (75% higher for reduced hospitalizations) among patients 65 years of age or older and among patients with current cancer or immunosuppression, according to the study. However, the drug’s uptake was significantly lower among patients with no previous SARS-CoV-2 immunity and within the Arab populations.
Adult patients between 40 and 64 years of age saw no statistical benefit to taking nirmatrelvir regardless of immunization status.
In December of 2021, the FDA authorized Pfizer’s Paxlovid for adults and children ages 12 and older with a positive COVID-19 test and early symptoms who face the highest risks of hospitalization. However earlier this year, a separate study of Paxlovid by Pfizer in healthy adults both vaccinated and unvaccinated, failed to show a significant benefit.
The FDA states that PAXLOVID is currently approved or authorized for conditional or emergency use in more than 60 countries across the globe to treat high-risk COVID-19 patients.
The Biden administration has spent more than $10 billion purchasing the drug and earlier this month, President Joe Biden experienced a COVID rebound after taking Paxlovid leaving many critics questioning its effectiveness.