Darunavir-cobicistat versus lopinavir-ritonavir in the treatment of COVID-19 infection (DOLCI): A multicenter observational study.

<h4>Background</h4>Coronavirus Disease 2019 (COVID-19) is an evolving pandemic that urged the need to investigate various antiviral therapies. This study was conducted to compare efficacy and safety outcomes of darunavir-cobicistat versus lopinavir-ritonavir in treating patients with COV...

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Main Authors: Eman Zeyad I Elmekaty, Rim Alibrahim, Rania Hassanin, Sitelbanat Eltaib, Ahmed Elsayed, Fatima Rustom, Mohamed Izham Mohamed Ibrahim, Mohammed Abu Khattab, Hussam Al Soub, Muna Al Maslamani, Abdullatif Al-Khal
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2022-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0267884
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author Eman Zeyad I Elmekaty
Rim Alibrahim
Rania Hassanin
Sitelbanat Eltaib
Ahmed Elsayed
Fatima Rustom
Mohamed Izham Mohamed Ibrahim
Mohammed Abu Khattab
Hussam Al Soub
Muna Al Maslamani
Abdullatif Al-Khal
author_facet Eman Zeyad I Elmekaty
Rim Alibrahim
Rania Hassanin
Sitelbanat Eltaib
Ahmed Elsayed
Fatima Rustom
Mohamed Izham Mohamed Ibrahim
Mohammed Abu Khattab
Hussam Al Soub
Muna Al Maslamani
Abdullatif Al-Khal
author_sort Eman Zeyad I Elmekaty
collection DOAJ
description <h4>Background</h4>Coronavirus Disease 2019 (COVID-19) is an evolving pandemic that urged the need to investigate various antiviral therapies. This study was conducted to compare efficacy and safety outcomes of darunavir-cobicistat versus lopinavir-ritonavir in treating patients with COVID-19 pneumonia.<h4>Methods and findings</h4>This retrospective, multicenter, observational study was conducted on adult patients hospitalized in one of the COVID-19 facilities in Qatar. Patients were included if they received darunavir-cobicistat or lopinavir-ritonavir for at least three days as part of their COVID-19 treatments. Data were collected from patients' electronic medical records. The primary outcome was a composite endpoint of time to clinical improvement and/or virological clearance. Descriptive and inferential statistics were used at alpha level of 0.05. A total of 400 patients was analyzed, of whom 100 received darunavir-cobicistat and 300 received lopinavir-ritonavir. Majority of patients were male (92.5%), with a mean (SD) time from symptoms onset to start of therapy of 7.57 days (4.89). Patients received lopinavir-ritonavir had significantly faster time to clinical improvement and/or virological clearance than patients received darunavir-cobicistat (4 days [IQR 3-7] vs. 6.5 days [IQR 4-12]; HR 1.345 [95%CI: 1.070-1.691], P = 0.011). Patients received lopinavir-ritonavir had significantly faster time to clinical improvement (5 days [IQR 3-8] vs. 8 days [IQR 4-13]; HR 1.520 (95%CI: 1.2-1.925), P = 0.000), and slower time to virological clearance than darunavir-cobicistat (25 days [IQR 15-33] vs. 21 days [IQR 12.8-30]; HR 0.772 (95%CI: 0.607-0.982), P = 0.035). No significant difference in the incidence or severity of adverse events between groups. The study was limited to its retrospective nature and the possibility of covariates, which was accounted for by multivariate analyses.<h4>Conclusion</h4>In patients with COVID-19 pneumonia, early treatment with lopinavir-ritonavir was associated with faster time to clinical improvement and/or virological clearance than darunavir-cobicistat. Future trials are warranted to confirm these findings.<h4>Trial registration</h4>ClinicalTrials.gov number, NCT04425382.
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spelling doaj.art-976326f21d284054b310b52b66d989242022-12-22T01:53:41ZengPublic Library of Science (PLoS)PLoS ONE1932-62032022-01-01175e026788410.1371/journal.pone.0267884Darunavir-cobicistat versus lopinavir-ritonavir in the treatment of COVID-19 infection (DOLCI): A multicenter observational study.Eman Zeyad I ElmekatyRim AlibrahimRania HassaninSitelbanat EltaibAhmed ElsayedFatima RustomMohamed Izham Mohamed IbrahimMohammed Abu KhattabHussam Al SoubMuna Al MaslamaniAbdullatif Al-Khal<h4>Background</h4>Coronavirus Disease 2019 (COVID-19) is an evolving pandemic that urged the need to investigate various antiviral therapies. This study was conducted to compare efficacy and safety outcomes of darunavir-cobicistat versus lopinavir-ritonavir in treating patients with COVID-19 pneumonia.<h4>Methods and findings</h4>This retrospective, multicenter, observational study was conducted on adult patients hospitalized in one of the COVID-19 facilities in Qatar. Patients were included if they received darunavir-cobicistat or lopinavir-ritonavir for at least three days as part of their COVID-19 treatments. Data were collected from patients' electronic medical records. The primary outcome was a composite endpoint of time to clinical improvement and/or virological clearance. Descriptive and inferential statistics were used at alpha level of 0.05. A total of 400 patients was analyzed, of whom 100 received darunavir-cobicistat and 300 received lopinavir-ritonavir. Majority of patients were male (92.5%), with a mean (SD) time from symptoms onset to start of therapy of 7.57 days (4.89). Patients received lopinavir-ritonavir had significantly faster time to clinical improvement and/or virological clearance than patients received darunavir-cobicistat (4 days [IQR 3-7] vs. 6.5 days [IQR 4-12]; HR 1.345 [95%CI: 1.070-1.691], P = 0.011). Patients received lopinavir-ritonavir had significantly faster time to clinical improvement (5 days [IQR 3-8] vs. 8 days [IQR 4-13]; HR 1.520 (95%CI: 1.2-1.925), P = 0.000), and slower time to virological clearance than darunavir-cobicistat (25 days [IQR 15-33] vs. 21 days [IQR 12.8-30]; HR 0.772 (95%CI: 0.607-0.982), P = 0.035). No significant difference in the incidence or severity of adverse events between groups. The study was limited to its retrospective nature and the possibility of covariates, which was accounted for by multivariate analyses.<h4>Conclusion</h4>In patients with COVID-19 pneumonia, early treatment with lopinavir-ritonavir was associated with faster time to clinical improvement and/or virological clearance than darunavir-cobicistat. Future trials are warranted to confirm these findings.<h4>Trial registration</h4>ClinicalTrials.gov number, NCT04425382.https://doi.org/10.1371/journal.pone.0267884
spellingShingle Eman Zeyad I Elmekaty
Rim Alibrahim
Rania Hassanin
Sitelbanat Eltaib
Ahmed Elsayed
Fatima Rustom
Mohamed Izham Mohamed Ibrahim
Mohammed Abu Khattab
Hussam Al Soub
Muna Al Maslamani
Abdullatif Al-Khal
Darunavir-cobicistat versus lopinavir-ritonavir in the treatment of COVID-19 infection (DOLCI): A multicenter observational study.
PLoS ONE
title Darunavir-cobicistat versus lopinavir-ritonavir in the treatment of COVID-19 infection (DOLCI): A multicenter observational study.
title_full Darunavir-cobicistat versus lopinavir-ritonavir in the treatment of COVID-19 infection (DOLCI): A multicenter observational study.
title_fullStr Darunavir-cobicistat versus lopinavir-ritonavir in the treatment of COVID-19 infection (DOLCI): A multicenter observational study.
title_full_unstemmed Darunavir-cobicistat versus lopinavir-ritonavir in the treatment of COVID-19 infection (DOLCI): A multicenter observational study.
title_short Darunavir-cobicistat versus lopinavir-ritonavir in the treatment of COVID-19 infection (DOLCI): A multicenter observational study.
title_sort darunavir cobicistat versus lopinavir ritonavir in the treatment of covid 19 infection dolci a multicenter observational study
url https://doi.org/10.1371/journal.pone.0267884
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