In a recent Morbidity and Mortality Weekly Report (MMWR) Published on the US Centers for Disease Control and Prevention (US-CDC) website, researchers assessed the association between receiving a prescription for Paxlovid and hospitalization for coronavirus disease 2019 (COVID -19) over the next 30 days.
The actual evidence on the benefits of Paxlovid, by vaccination status, age group and underlying health conditions, is limited. This oral antiviral drug received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) on December 22, 2021. Since then, it has been used to treat adults with mild to moderate COVID-19 who are at increased risk for progression to serious disease.
About the study
In the present retrospective study, researchers analyzed records from Cosmos, a dataset with electronic health records (EHRs) of >160 million U.S. citizens ≥18 years old collected by Epic, a healthcare software company. They looked at the benefits of Paxlovid when given within five days of being diagnosed with COVID-19 within 30 days. Specifically, the researchers used a Cox proportional hazards model to assess the association between receiving a prescription for Paxlovid and hospitalization due to COVID-19 complications.
Study design considered age, sex, race/ethnicity, number of pre-existing health conditions, region of residence and social vulnerability index, history and infection to COVID-19 and vaccination status. The team repeated the primary analyzes after excluding telemedicine visits and hospitalized patients for two days after diagnosis. This helped them assess possible biases related to the severity of symptoms at the time of diagnosis. The CDC reviewed the study protocol, and the study adhered to applicable federal law and CDC policy.
Between April 1 and August 31, 2022, researchers identified 1,713,120 people ≥ 18 years of age with a diagnosis of COVID-19, of whom 699,848 (40.9%) met eligibility criteria for Paxlovid treatment, but 198,927 actually received Paxlovid within five days of diagnosis, i.e. ~28% of eligible people. Of these 198,927 people, 930 requested hospitalization; however, 4,299 people ineligible for Paxlovid treatment were also hospitalized. Of 5,229 people hospitalized with COVID-19, 3,311 (63.3%) were ≥ 65 years old and 930 received Paxlovid within five days of diagnosis.
Among Paxlovid recipients, 15% had documented prior SARS-CoV-2 infection and 68.8% had received more than two doses of the COVID-19 mRNA vaccine. They were also more likely to have a telehealth consultation (49.1%) than non-recipients. However, the prevalence of pre-existing health conditions was similar among Paxlovid recipients and non-recipients, with 92.4% having at least one underlying medical condition. Approximately 30.2% of Paxlovid recipients were immunocompromised and represented 9.4% of the study population. During the COVID-19-related hospitalization, 211 people died. Deaths in the Paxlovid recipient group were lower than those in the non-recipient group (0.01% versus 0.04%).
Paxlovid is a valuable anti-SARS-CoV-2 drug due to its ease of oral administration, short treatment duration, good safety profile and low resistance. Although under-prescribed for eligible people with COVID-19, it protected serious complications associated with COVID-19, with more pronounced benefits in adults aged 50-64 years and 18-49 years with or more pre-existing medical conditions, respectively.
The use of Paxlovid reduced the overall rate of hospitalization for COVID-19 by 51% in people with mild to moderate COVID-19. Clinical trial studies have shown that Paxlovid showed an 89% reduction in severe COVID-19 outcomes in unvaccinated people. The current real-world study has demonstrated that Paxlovid significantly decreases the risk of hospitalization in people who have had a previous vaccine-induced infection or immunity, even when Omicron subvariants are circulating in the United States.
Receiving Paxlovid was also associated with a lower rate of all-cause hospitalization, with an adjusted hazard ratio of 0.45. Overall, the authors emphasized the use of Paxlovid among eligible individuals to protect against COVID-19 hospitalizations regardless of vaccination status, particularly for the elderly and those with several pre-existing medical conditions.