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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Korean Academy of Medical Sciences 2023
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.
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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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