Remdesivir Use in Pediatric Patients for SARS-CoV-2 Treatment: Single Academic Center Study.

BACKGROUND: Millions of children in the United States have been infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), with many infections leading to hospitalization. For pediatric patients, especially younger children, treatment options are limited. Remdesivir has demonstrated a positive safety and efficacy profile in adults, but little data is published regarding remdesivir use in pediatric patients. Additional data for SARS-CoV-2 treatments in pediatric patients is required to prevent further SARS-CoV-2-related morbidity and mortality. At a single pediatric academic medical center, the safety and efficacy of remdesivir was evaluated. METHODS: A retrospective review of patients admitted to a pediatric academic medical center who received remdesivir over a 17-month period was completed. All pediatric patients who received at least 1 dose of remdesivir were included. Safety and efficacy were assessed using national organization's definitions of clinical improvement, bradycardia, hypertension, acute kidney injury and drug-induced liver injury. RESULTS: There were 48 pediatric patients included in this study with 29% of patients admitted to the pediatric intensive care unit. Less than one-third of patients received the full treatment course of remdesivir, with over half of patients not completing therapy due to symptomatic improvement or hospital discharge. Majority of patients required some level of supplemental oxygen support. The median World Health Organization score was consistent throughout all 5 days of therapy. No patients experienced significant bradycardia, hypertension, acute kidney injury, or drug-induced liver injury. CONCLUSIONS: Remdesivir may correlate with clinical stability or improvement and demonstrates safety when used in pediatric patients. A randomized controlled trial is needed to confirm these findings.

Nirmatrelvir‐ritonavir treatment of COVID‐19 in a high‐risk patient population: A retrospective observational study

Background Coronavirus disease 2019 (COVID‐19) is a highly contagious, airborne viral infection that can infect anyone. Those with certain underlying conditions may be at higher risk for infection to develop into a severe disease requiring hospitalization. This report summarizes use of nirmatrelvir‐ritonavir for the treatment of COVID‐19 in high‐risk patients at a single academic medical center through a pharmacist delegation protocol and demonstrates real‐world efficacy and safety of treatment. Methods This retrospective, single‐center, observational study analyzed all patients who received nirmatrelvir‐ritonavir ordered by a clinical pharmacist for treatment of COVID‐19 infection. The primary outcomes were safety and efficacy of nirmatrelvir‐ritonavir. Safety was evaluated by analyzing drug interaction management and adverse events. Efficacy was evaluated through hospitalization and death within 28 days of nirmatrelvir‐ritonavir use. Results Sixty patients were eligible for inclusion. No patients were hospitalized or died within 28 days after initiation of nirmatrelvir‐ritonavir. Pharmacists identified 101 drug interactions with 60% considered clinically significant, requiring modification of home medications. Adverse outcomes associated with the use of nirmatrelvir‐ritonavir were reported in 13 patients (21.7%). Conclusions A comprehensive program to mitigate drug interactions and prescribe nirmatrelvir‐ritonavir ensured timely access to COVID‐19 therapy, which may be associated with the prevention of hospitalization and death.

Nirmatrelvir-ritonavir treatment of COVID-19 in a high-risk patient population: A retrospective observational study.

Background: Coronavirus disease 2019 (COVID-19) is a highly contagious, airborne viral infection that can infect anyone. Those with certain underlying conditions may be at higher risk for infection to develop into a severe disease requiring hospitalization. This report summarizes use of nirmatrelvir-ritonavir for the treatment of COVID-19 in high-risk patients at a single academic medical center through a pharmacist delegation protocol and demonstrates real-world efficacy and safety of treatment. Methods: This retrospective, single-center, observational study analyzed all patients who received nirmatrelvir-ritonavir ordered by a clinical pharmacist for treatment of COVID-19 infection. The primary outcomes were safety and efficacy of nirmatrelvir-ritonavir. Safety was evaluated by analyzing drug interaction management and adverse events. Efficacy was evaluated through hospitalization and death within 28 days of nirmatrelvir-ritonavir use. Results: Sixty patients were eligible for inclusion. No patients were hospitalized or died within 28 days after initiation of nirmatrelvir-ritonavir. Pharmacists identified 101 drug interactions with 60% considered clinically significant, requiring modification of home medications. Adverse outcomes associated with the use of nirmatrelvir-ritonavir were reported in 13 patients (21.7%). Conclusions: A comprehensive program to mitigate drug interactions and prescribe nirmatrelvir-ritonavir ensured timely access to COVID-19 therapy, which may be associated with the prevention of hospitalization and death.