Hospitalized COVID-19 patients treated with the antiviral drug nirmatrelvir-ritonavir (Paxlovid) have a lower risk of death, intensive care unit (ICU) admission and need for ventilation than those receiving a combination of Paxlovid and the antiviral drug remdesivir (Veklury) or Veklury alone, according to a University of Hong Kong emulation trial. study suggests.
For the study, published yesterday in The Lancet Infectious Diseases, researchers analyzed electronic medical records from a weighted sample of adults hospitalized with COVID-19 who received Paxlovid plus Veklury (18,410 patients) or either drug alone (18,178 for Veklury, 18,287 for Paxlovid) within 5 days of hospitalization from March 16 to December 31, 2022.
The study period covered the prevalence of the SARS-CoV-2 omicron variant. The median follow-up was 84 days and the average age of participants was 75 years.
Both Veklury and Paxlovid are prescribed to patients with mild to moderate COVID-19 at risk for severe illness, but Paxlovid is not given to many hospitalized patients due to contraindications.
Risk of admission to ICU, need for ventilation.
Overall, 7,050 participants died from any cause (cumulative incidence, 12.9%; Veklury alone, 20.5%; Paxlovid alone, 4.2%; and combination therapy, 14.0%). There were also 3,688 ICU admissions or ventilations (cumulative incidence, 6.7%; Veklury alone, 11.2%; Paxlovid alone, 1.1%; and combination therapy, 7.9%).
The risk of death was lower in recipients of Paxlovid alone (hazard ratio (HR), 0.18; absolute risk reduction (ARR), –16.3%) or a combination of Veklury and Paxlovid (HR, 0.66; ARR, –6.5%) than in those who received Veklury alone.
Results were comparable for ICU admission or ventilation (Paxlovid alone HR, 0.09; ARR, -10.0% and combination therapy HR, 0.68; ARR, -3.2%). Relative to combination therapy, Paxlovid monotherapy was associated with a significantly lower risk of death (HR, 0.27; ARR, -9.8%) and ICU admission or ventilation (HR, 0.13; ARR, -6.8%).
Patients receiving Paxlovid alone had a significantly lower risk of heart attack, acute kidney injury, anemia, hyperglycemia, and abnormal blood clotting than those receiving Veklury alone. Patients receiving the combination treatment had a significantly lower risk of abnormal clotting than those receiving Veklury alone. The cumulative incidence of common adverse events such as ischemic stroke, rash, gastrointestinal symptoms, and hypoglycemia was similar regardless of treatment type.
Clear criteria are needed for the use of Paxlovid in the hospital
“Early initiation of nirmatrelvir-ritonavir monotherapy within 5 days of confirmed COVID-19 led to a significant decrease in the risk of all-cause mortality and a favorable safety profile,” the researchers wrote. “These benefits were consistent across different COVID-19 vaccination statuses, admission criteria, respiratory support modalities, and underlying comorbidities.”
“Randomized controlled trials are needed to support the validity of the current results and to investigate the efficacy and safety of combination therapy with nirmatrelvir-ritonavir and remdesivir or other antiviral combinations,” they concluded.
If nirmatrelvir-ritonavir is recommended as a therapy for the treatment of high-risk hospitalized patients with COVID-19, clear criteria should be established regarding its use, especially in terms of defining and identifying the target population.
On a related topic commentKarolina Akinosoglou, MD, PhD, and Charalambos Gogos, MD, PhD, both of the University of Patras in Greece, said the study findings could represent an opportunity to improve hospital COVID-19 treatment guidelines with the inclusion of Paxlovid.
“However, if nirmatrelvir-ritonavir is recommended as a therapy for high-risk hospitalized patients with COVID-19, then clear criteria should be established regarding its use, especially in terms of defining and identifying the target population,” they wrote.
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