Remdesivir Use in Pediatric Patients with Acute SARS-CoV-2 Infection Is Safe and Well Tolerated
<b>Background/Objective:</b> Millions of children were infected with SARS-CoV-2, and a small proportion progressed to severe disease, especially those with underlying risk factors. Adult COVID-19 studies showed mortality benefits with Remdesivir. Data on Remdesivir use in pediatrics are...
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MDPI AG
2025-03-01
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| Online Access: | https://www.mdpi.com/2227-9067/12/3/331 |
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| author | Delma J. Nieves M. Tuan Tran Jasjit Singh Negar Ashouri Tricia Morphew Jennifer G. Lusk Felice C. Adler-Shohet Rachel Marano Stephanie Osborne Jennifer Strickland Antonio C. Arrieta |
| author_facet | Delma J. Nieves M. Tuan Tran Jasjit Singh Negar Ashouri Tricia Morphew Jennifer G. Lusk Felice C. Adler-Shohet Rachel Marano Stephanie Osborne Jennifer Strickland Antonio C. Arrieta |
| author_sort | Delma J. Nieves |
| collection | DOAJ |
| description | <b>Background/Objective:</b> Millions of children were infected with SARS-CoV-2, and a small proportion progressed to severe disease, especially those with underlying risk factors. Adult COVID-19 studies showed mortality benefits with Remdesivir. Data on Remdesivir use in pediatrics are limited. We report on the safety and tolerability of Remdesivir in pediatric patients seen at our institution. <b>Methods:</b> This was a retrospective cohort study of patients <19 years old with acute SARS-CoV-2 infection who received at least one dose of Remdesivir. Patients followed strict institutional guidelines for safety monitoring including standard clinical and laboratory daily observations. Demographics and underlying conditions were reported as averages; for laboratory values, linear regression was applied within a generalized linear mixed-effects model framework to evaluate the significance of changes in average levels over time. <b>Results:</b> We enrolled 318 patients with acute SARS-CoV2 infection from May 2020 to December 2022. In total, 53% were male, and the age range was distributed broadly. In total, 61% were school-aged children (28% 5–11 and 33% 12–18 years of age). In total, 62% of cases were Hispanic. The most common reasons for Remdesivir treatment included respiratory distress (201; 63%) and having high-risk underlying conditions (109; 34%). Therapy was completed as planned in 91% and discontinued early in 9%. Mean baseline, peak, and end of treatment values for AST were 57 (95% CI 53, 61), 79 (95% CI 73, 84) (<i>p</i> < 0.001), and 55 (51, 59) (<i>p</i> = 0.479); for ALT, they were 42 (38, 47), 59 (95% CI 52, 66) (<i>p</i> < 0.001), and 46 (95% CI 41, 52) (<i>p</i> = 0.054); and for bilirubin, they were 0.56 (95% CI 0.50, 0.62), 0.67 (95% CI 0.61, 0.74) (<i>p</i> < 0.001), and 0.44 (95% CI 0.40, 0.48) (<i>p</i> < 0.001), respectively. During Remdesivir treatment, we did not observe marrow suppression or renal toxicity. <b>Conclusions:</b> No clinically significant hematological or renal toxicity was noted. Mean liver enzymes increased modestly and returned to baseline without interrupting treatment. Remdesivir was well tolerated in patients <19 years old. |
| format | Article |
| id | doaj-art-7221e1694de54ee7a224b3ea0e1056c2 |
| institution | Kabale University |
| issn | 2227-9067 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | MDPI AG |
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| series | Children |
| spelling | doaj-art-7221e1694de54ee7a224b3ea0e1056c22025-08-20T03:43:37ZengMDPI AGChildren2227-90672025-03-0112333110.3390/children12030331Remdesivir Use in Pediatric Patients with Acute SARS-CoV-2 Infection Is Safe and Well ToleratedDelma J. Nieves0M. Tuan Tran1Jasjit Singh2Negar Ashouri3Tricia Morphew4Jennifer G. Lusk5Felice C. Adler-Shohet6Rachel Marano7Stephanie Osborne8Jennifer Strickland9Antonio C. Arrieta10Division of Infectious Diseases, Department of Pediatrics, CHOC Children’s Hospital, University of California, Orange, CA 92868, USADivision of Infectious Diseases, Department of Pharmacy, CHOC Children’s Hospital, Orange, CA 92868, USADivision of Infectious Diseases, Department of Pediatrics, CHOC Children’s Hospital, University of California, Orange, CA 92868, USADivision of Infectious Diseases, Department of Pediatrics, CHOC Children’s Hospital, University of California, Orange, CA 92868, USACHOC Research Institute, Orange, CA 92868, USADivision of Hospitalist Medicine, Department of Pediatrics, CHOC Children’s Hospital, University of California, Orange, CA 92868, USAHarbor-UCLA Medical Center, Torrance, CA 90509, USARady Children’s Hospital, University of California, San Diego, CA 92123, USACHOC Research Institute, Orange, CA 92868, USADivision of Infectious Diseases, CHOC Children’s Hospital, Orange, CA 92868, USADivision of Infectious Diseases, Department of Pediatrics, CHOC Children’s Hospital, University of California, Orange, CA 92868, USA<b>Background/Objective:</b> Millions of children were infected with SARS-CoV-2, and a small proportion progressed to severe disease, especially those with underlying risk factors. Adult COVID-19 studies showed mortality benefits with Remdesivir. Data on Remdesivir use in pediatrics are limited. We report on the safety and tolerability of Remdesivir in pediatric patients seen at our institution. <b>Methods:</b> This was a retrospective cohort study of patients <19 years old with acute SARS-CoV-2 infection who received at least one dose of Remdesivir. Patients followed strict institutional guidelines for safety monitoring including standard clinical and laboratory daily observations. Demographics and underlying conditions were reported as averages; for laboratory values, linear regression was applied within a generalized linear mixed-effects model framework to evaluate the significance of changes in average levels over time. <b>Results:</b> We enrolled 318 patients with acute SARS-CoV2 infection from May 2020 to December 2022. In total, 53% were male, and the age range was distributed broadly. In total, 61% were school-aged children (28% 5–11 and 33% 12–18 years of age). In total, 62% of cases were Hispanic. The most common reasons for Remdesivir treatment included respiratory distress (201; 63%) and having high-risk underlying conditions (109; 34%). Therapy was completed as planned in 91% and discontinued early in 9%. Mean baseline, peak, and end of treatment values for AST were 57 (95% CI 53, 61), 79 (95% CI 73, 84) (<i>p</i> < 0.001), and 55 (51, 59) (<i>p</i> = 0.479); for ALT, they were 42 (38, 47), 59 (95% CI 52, 66) (<i>p</i> < 0.001), and 46 (95% CI 41, 52) (<i>p</i> = 0.054); and for bilirubin, they were 0.56 (95% CI 0.50, 0.62), 0.67 (95% CI 0.61, 0.74) (<i>p</i> < 0.001), and 0.44 (95% CI 0.40, 0.48) (<i>p</i> < 0.001), respectively. During Remdesivir treatment, we did not observe marrow suppression or renal toxicity. <b>Conclusions:</b> No clinically significant hematological or renal toxicity was noted. Mean liver enzymes increased modestly and returned to baseline without interrupting treatment. Remdesivir was well tolerated in patients <19 years old.https://www.mdpi.com/2227-9067/12/3/331Remdesivirpediatric COVID-19SARS-CoV-2antiviral |
| spellingShingle | Delma J. Nieves M. Tuan Tran Jasjit Singh Negar Ashouri Tricia Morphew Jennifer G. Lusk Felice C. Adler-Shohet Rachel Marano Stephanie Osborne Jennifer Strickland Antonio C. Arrieta Remdesivir Use in Pediatric Patients with Acute SARS-CoV-2 Infection Is Safe and Well Tolerated Children Remdesivir pediatric COVID-19 SARS-CoV-2 antiviral |
| title | Remdesivir Use in Pediatric Patients with Acute SARS-CoV-2 Infection Is Safe and Well Tolerated |
| title_full | Remdesivir Use in Pediatric Patients with Acute SARS-CoV-2 Infection Is Safe and Well Tolerated |
| title_fullStr | Remdesivir Use in Pediatric Patients with Acute SARS-CoV-2 Infection Is Safe and Well Tolerated |
| title_full_unstemmed | Remdesivir Use in Pediatric Patients with Acute SARS-CoV-2 Infection Is Safe and Well Tolerated |
| title_short | Remdesivir Use in Pediatric Patients with Acute SARS-CoV-2 Infection Is Safe and Well Tolerated |
| title_sort | remdesivir use in pediatric patients with acute sars cov 2 infection is safe and well tolerated |
| topic | Remdesivir pediatric COVID-19 SARS-CoV-2 antiviral |
| url | https://www.mdpi.com/2227-9067/12/3/331 |
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