Study provides more positive data for Paxlovid use in high-risk patients with COVID-19
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Key takeaways:
- Paxlovid significantly reduced times to sustained alleviation and resolution of COVID-19 illness.
- The treatment also resulted in fewer hospitalizations, ICU admissions and deaths.
Treatment with Paxlovid significantly reduced the duration and severity of SARS-CoV-2 infection among high-risk patients while also reducing health care utilization and severe outcomes, according to a study.
“We began this study because while it’s well known that severe cases of COVID-19 are associated with hospitalization and death, patients with less severe disease may experience COVID-19 symptoms that interfere with daily functioning and activities,” Jennifer Hammond, PhD, head of antiviral development at Pfizer Inc., told Healio.
“In addition to the key goal of preventing progression to severe disease, accelerating symptom recovery is a potential therapeutic goal as described in the National Institutes of Health therapeutic management guidelines for nonhospitalized patients, and is a particularly relevant efficacy outcome to patients given the declining rate of severe COVID-19,” Hammond said.
To assess the use of Paxlovid, Hammond and colleagues conducted a phase 2/3, double-blind, randomized study assessing oral Paxlovid vs. placebo at more than 300 sites in 21 countries.
The study included unvaccinated, high-risk adult patients with symptomatic COVID-19 who had not been hospitalized who were randomized 1:1 to receive the treatment or placebo every 12 hours for 5 days. The primary endpoints of the study were COVID-19-related hospitalization and all-cause death, while secondary endpoints included symptom duration and COVID-19-related medical visits.
In total, 1,966 patients were enrolled between July and December of 2021 and included in the final analysis. Of them, 977 received Paxlovid and 989 received placebo.
Overall, the analysis showed that Paxlovid “significantly reduced” times to sustained alleviation (13 vs. 15 days; HR = 1.27; P < 0.0001) and resolution through day 28 (16 vs. 19 days; HR = 1.2; P = 0.0022). Treatment with Paxlovid also reduced the number of COVID-19related medical visits by 64.3% and reduced the number of patients needing these visits (2.3% vs. 8.4%).
Among patients who required hospitalization, data showed those treated with Paxlovid had shorter stays (8.7 days per 100 patients vs. 76.6 days per 100 patients); none required ICU admission or mechanical ventilation; and all were discharged to their homes or under self-care, whereas in the placebo group, nine of the 63 hospitalized patients required ICU admission and four required mechanical ventilation.
A total of 54.7% of hospitalized patients who received placebo were discharged to home self-care. The rest, according to the study, were discharged home and required assistance, were transferred to a nursing or rehabilitation facility or died.
The data also showed that treatment with Paxlovid resulted in fewer deaths. Through week 24 of the study, no patients receiving Paxlovid died, whereas 15 deaths were reported among placebo-treated patients.
“These findings suggest that Paxlovid may reduce the COVID-19 burden in high-risk patients by reducing the duration and severity of symptoms and reducing the use of health care resources, particularly hospitalization and emergency room visits, which may reduce the burden of COVID-19 on health care systems during future waves of infection,” Hammond concluded.
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