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Real-World Effectiveness of Nirmatrelvir-Ritonavir and Its Acceptability in High-Risk COVID-19 Patients
BACKGROUND: Nirmatrelvir-ritonavir is highly effective in preventing severe coronavirus disease 2019 (COVID-19) in high-risk patients with mild-to-moderate severity. However, real-world performance data are limited, and the drug is not so acceptable to the COVID-19 patients at high risk who need it...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The Korean Academy of Medical Sciences
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10477076/ https://www.ncbi.nlm.nih.gov/pubmed/37667578 http://dx.doi.org/10.3346/jkms.2023.38.e272 |
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author | Kim, Min-Kyung Lee, Kyung-Shin Ham, Sin Young Choi, Youn Young Lee, Eunyoung Lee, Seungjae Lee, Bora Jeon, Jaehyun Chin, BumSik Kim, Yeonjae Kim, Gayeon Jang, Hee-Chang Choi, Jae-Phil Park, Sang-Won |
author_facet | Kim, Min-Kyung Lee, Kyung-Shin Ham, Sin Young Choi, Youn Young Lee, Eunyoung Lee, Seungjae Lee, Bora Jeon, Jaehyun Chin, BumSik Kim, Yeonjae Kim, Gayeon Jang, Hee-Chang Choi, Jae-Phil Park, Sang-Won |
author_sort | Kim, Min-Kyung |
collection | PubMed |
description | BACKGROUND: Nirmatrelvir-ritonavir is highly effective in preventing severe coronavirus disease 2019 (COVID-19) in high-risk patients with mild-to-moderate severity. However, real-world performance data are limited, and the drug is not so acceptable to the COVID-19 patients at high risk who need it in Korea. METHODS: To evaluate the effectiveness of nirmatrelvir-ritonavir, we conducted a propensity score-matched retrospective cohort study on patients with mild-to-moderate COVID-19 at high risk for a severe disease who were hospitalized at four hospitals in South Korea from February 2022 to April 2022. A total of 236 patients in the treatment group (administered nirmatrelvir-ritonavir) and 236 in the matched control group (supportive care only) were analyzed for the primary outcome, i.e., the time to oxygen support-free survival. The secondary outcome was a composite result of disease progression. The reason for not prescribing nirmatrelvir-ritonavir to the indicated patients was also investigated. RESULTS: The treatment group showed significantly longer oxygen support-free survival than the matched control group (adjusted hazard ratio [aHR], 0.07; 95% confidence interval [CI], 0.01–0.31; P < 0.001). Multivariate Cox regression analysis showed that age (aHR, 1.03; 95% CI, 1.00–1.07), National Early Warning Score-2 at admission (aHR, 1.36; 95% CI, 1.08–1.71), nirmatrelvir-ritonavir treatment, female sex (aHR, 0.37; 95% CI, 0.15–0.88), and time from symptom onset to admission (aHR, 0.67; 95% CI, 0.48–0.95) were significantly associated with oxygen therapy. However, none of the factors were related to the composite outcome. In the unmatched control group, 19.9% of 376 patients had documented explanations for nirmatrelvir-ritonavir non-prescription, and 44.0% of these were due to contraindication criteria. In the treatment group, 10.9% of patients discontinued the medication primarily because of adverse events (71.4%), with gastrointestinal symptoms being the most common (50.0%). CONCLUSION: Nirmatrelvir-ritonavir treatment significantly reduced oxygen therapy requirements in high-risk patients with COVID-19 during the omicron variant surge in South Korea. Physicians are encouraged to consider the active use of nirmatrelvir-ritonavir and to be watchful for gastrointestinal symptoms during medication. |
format | Online Article Text |
id | pubmed-10477076 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | The Korean Academy of Medical Sciences |
record_format | MEDLINE/PubMed |
spelling | pubmed-104770762023-09-06 Real-World Effectiveness of Nirmatrelvir-Ritonavir and Its Acceptability in High-Risk COVID-19 Patients Kim, Min-Kyung Lee, Kyung-Shin Ham, Sin Young Choi, Youn Young Lee, Eunyoung Lee, Seungjae Lee, Bora Jeon, Jaehyun Chin, BumSik Kim, Yeonjae Kim, Gayeon Jang, Hee-Chang Choi, Jae-Phil Park, Sang-Won J Korean Med Sci Original Article BACKGROUND: Nirmatrelvir-ritonavir is highly effective in preventing severe coronavirus disease 2019 (COVID-19) in high-risk patients with mild-to-moderate severity. However, real-world performance data are limited, and the drug is not so acceptable to the COVID-19 patients at high risk who need it in Korea. METHODS: To evaluate the effectiveness of nirmatrelvir-ritonavir, we conducted a propensity score-matched retrospective cohort study on patients with mild-to-moderate COVID-19 at high risk for a severe disease who were hospitalized at four hospitals in South Korea from February 2022 to April 2022. A total of 236 patients in the treatment group (administered nirmatrelvir-ritonavir) and 236 in the matched control group (supportive care only) were analyzed for the primary outcome, i.e., the time to oxygen support-free survival. The secondary outcome was a composite result of disease progression. The reason for not prescribing nirmatrelvir-ritonavir to the indicated patients was also investigated. RESULTS: The treatment group showed significantly longer oxygen support-free survival than the matched control group (adjusted hazard ratio [aHR], 0.07; 95% confidence interval [CI], 0.01–0.31; P < 0.001). Multivariate Cox regression analysis showed that age (aHR, 1.03; 95% CI, 1.00–1.07), National Early Warning Score-2 at admission (aHR, 1.36; 95% CI, 1.08–1.71), nirmatrelvir-ritonavir treatment, female sex (aHR, 0.37; 95% CI, 0.15–0.88), and time from symptom onset to admission (aHR, 0.67; 95% CI, 0.48–0.95) were significantly associated with oxygen therapy. However, none of the factors were related to the composite outcome. In the unmatched control group, 19.9% of 376 patients had documented explanations for nirmatrelvir-ritonavir non-prescription, and 44.0% of these were due to contraindication criteria. In the treatment group, 10.9% of patients discontinued the medication primarily because of adverse events (71.4%), with gastrointestinal symptoms being the most common (50.0%). CONCLUSION: Nirmatrelvir-ritonavir treatment significantly reduced oxygen therapy requirements in high-risk patients with COVID-19 during the omicron variant surge in South Korea. Physicians are encouraged to consider the active use of nirmatrelvir-ritonavir and to be watchful for gastrointestinal symptoms during medication. The Korean Academy of Medical Sciences 2023-08-09 /pmc/articles/PMC10477076/ /pubmed/37667578 http://dx.doi.org/10.3346/jkms.2023.38.e272 Text en © 2023 The Korean Academy of Medical Sciences. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Kim, Min-Kyung Lee, Kyung-Shin Ham, Sin Young Choi, Youn Young Lee, Eunyoung Lee, Seungjae Lee, Bora Jeon, Jaehyun Chin, BumSik Kim, Yeonjae Kim, Gayeon Jang, Hee-Chang Choi, Jae-Phil Park, Sang-Won Real-World Effectiveness of Nirmatrelvir-Ritonavir and Its Acceptability in High-Risk COVID-19 Patients |
title | Real-World Effectiveness of Nirmatrelvir-Ritonavir and Its Acceptability in High-Risk COVID-19 Patients |
title_full | Real-World Effectiveness of Nirmatrelvir-Ritonavir and Its Acceptability in High-Risk COVID-19 Patients |
title_fullStr | Real-World Effectiveness of Nirmatrelvir-Ritonavir and Its Acceptability in High-Risk COVID-19 Patients |
title_full_unstemmed | Real-World Effectiveness of Nirmatrelvir-Ritonavir and Its Acceptability in High-Risk COVID-19 Patients |
title_short | Real-World Effectiveness of Nirmatrelvir-Ritonavir and Its Acceptability in High-Risk COVID-19 Patients |
title_sort | real-world effectiveness of nirmatrelvir-ritonavir and its acceptability in high-risk covid-19 patients |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10477076/ https://www.ncbi.nlm.nih.gov/pubmed/37667578 http://dx.doi.org/10.3346/jkms.2023.38.e272 |
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