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523. Efficacy and Safety of Nirmatrelvir/Ritonavir for COVID-19 in Adolescents
BACKGROUND: Nirmatrelvir/ritonavir (n/r) is a currently 1 of 2 oral medications FDA-approved for treatment of COVID-19 in patients ≥ 12 years of age AND ≥ 40 kg. To date, dosing recommendations for adolescents are extrapolated primarily from adult studies. We conducted a retrospective study at a lar...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10677984/ http://dx.doi.org/10.1093/ofid/ofad500.592 |
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author | Lee, Kiriam Escobar Lee, Philip J Anosike, Brenda I |
author_facet | Lee, Kiriam Escobar Lee, Philip J Anosike, Brenda I |
author_sort | Lee, Kiriam Escobar |
collection | PubMed |
description | BACKGROUND: Nirmatrelvir/ritonavir (n/r) is a currently 1 of 2 oral medications FDA-approved for treatment of COVID-19 in patients ≥ 12 years of age AND ≥ 40 kg. To date, dosing recommendations for adolescents are extrapolated primarily from adult studies. We conducted a retrospective study at a large pediatric academic center to evaluate the efficacy and safety of n/r in adolescent patients. METHODS: Retrospective electronic chart review of adolescents ages 12-18 years diagnosed with COVID-19 between 1/1/2022 to 3/31/2022. We included those with laboratory confirmed COVID-19 by either PCR or rapid antigen, treated with n/r within 5 days of symptom onset. The primary endpoint was COVID-related hospital admissions, ER and/or outpatient visits within 30 days after completion of n/r. Our secondary endpoint was COVID-related adverse event(s) due to n/r. RESULTS: A total of 91 unique patients were prescribed n/r therapy; 1 was prescribed twice. All but 2 were ordered in the outpatient setting. 34.1% (29/85) had a BMI ≥ 30 kg/m2. Thirty-eight (41.8%) and 25 (27.5%) patients received 2 and 3 COVID-19 vaccines, respectively. Asthma (26/91, 28.6%) was the most common underlying condition; (16/91, 16.6%) were immunocompromised. Median time from initial COVID-19 positivity to n/r prescription was 0 days (range: 0-4). 2.2 % (2/90) of those who received outpatient prescriptions returned to the ER with COVID-19 like symptoms within 30 days. Another 2 different patients who were prescribed n/r inpatient expired at 28 and 48 days after completion of therapy. Only 2.2% (2) experienced an adverse event after completion of n/r. (Table 1) [Figure: see text] Demographic and outcome information of adolescent patients treated with nirmatrelvir/ritonavir for COVID-19 infection at a large pediatric academic medical center. CONCLUSION: Though limited, this single center study demonstrated low rates of COVID-related hospital admissions, ER and/or other outpatient visits as well as adverse events suggesting that n/r may be a safe and well tolerated by most adolescents diagnosed with COVID-19. Larger/prospective pediatric studies are still needed. DISCLOSURES: All Authors: No reported disclosures |
format | Online Article Text |
id | pubmed-10677984 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-106779842023-11-27 523. Efficacy and Safety of Nirmatrelvir/Ritonavir for COVID-19 in Adolescents Lee, Kiriam Escobar Lee, Philip J Anosike, Brenda I Open Forum Infect Dis Abstract BACKGROUND: Nirmatrelvir/ritonavir (n/r) is a currently 1 of 2 oral medications FDA-approved for treatment of COVID-19 in patients ≥ 12 years of age AND ≥ 40 kg. To date, dosing recommendations for adolescents are extrapolated primarily from adult studies. We conducted a retrospective study at a large pediatric academic center to evaluate the efficacy and safety of n/r in adolescent patients. METHODS: Retrospective electronic chart review of adolescents ages 12-18 years diagnosed with COVID-19 between 1/1/2022 to 3/31/2022. We included those with laboratory confirmed COVID-19 by either PCR or rapid antigen, treated with n/r within 5 days of symptom onset. The primary endpoint was COVID-related hospital admissions, ER and/or outpatient visits within 30 days after completion of n/r. Our secondary endpoint was COVID-related adverse event(s) due to n/r. RESULTS: A total of 91 unique patients were prescribed n/r therapy; 1 was prescribed twice. All but 2 were ordered in the outpatient setting. 34.1% (29/85) had a BMI ≥ 30 kg/m2. Thirty-eight (41.8%) and 25 (27.5%) patients received 2 and 3 COVID-19 vaccines, respectively. Asthma (26/91, 28.6%) was the most common underlying condition; (16/91, 16.6%) were immunocompromised. Median time from initial COVID-19 positivity to n/r prescription was 0 days (range: 0-4). 2.2 % (2/90) of those who received outpatient prescriptions returned to the ER with COVID-19 like symptoms within 30 days. Another 2 different patients who were prescribed n/r inpatient expired at 28 and 48 days after completion of therapy. Only 2.2% (2) experienced an adverse event after completion of n/r. (Table 1) [Figure: see text] Demographic and outcome information of adolescent patients treated with nirmatrelvir/ritonavir for COVID-19 infection at a large pediatric academic medical center. CONCLUSION: Though limited, this single center study demonstrated low rates of COVID-related hospital admissions, ER and/or other outpatient visits as well as adverse events suggesting that n/r may be a safe and well tolerated by most adolescents diagnosed with COVID-19. Larger/prospective pediatric studies are still needed. DISCLOSURES: All Authors: No reported disclosures Oxford University Press 2023-11-27 /pmc/articles/PMC10677984/ http://dx.doi.org/10.1093/ofid/ofad500.592 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Abstract Lee, Kiriam Escobar Lee, Philip J Anosike, Brenda I 523. Efficacy and Safety of Nirmatrelvir/Ritonavir for COVID-19 in Adolescents |
title | 523. Efficacy and Safety of Nirmatrelvir/Ritonavir for COVID-19 in Adolescents |
title_full | 523. Efficacy and Safety of Nirmatrelvir/Ritonavir for COVID-19 in Adolescents |
title_fullStr | 523. Efficacy and Safety of Nirmatrelvir/Ritonavir for COVID-19 in Adolescents |
title_full_unstemmed | 523. Efficacy and Safety of Nirmatrelvir/Ritonavir for COVID-19 in Adolescents |
title_short | 523. Efficacy and Safety of Nirmatrelvir/Ritonavir for COVID-19 in Adolescents |
title_sort | 523. efficacy and safety of nirmatrelvir/ritonavir for covid-19 in adolescents |
topic | Abstract |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10677984/ http://dx.doi.org/10.1093/ofid/ofad500.592 |
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