Comparative Analysis of Neuropsychiatric Adverse Reactions Associated with Remdesivir and Nirmatrelvir/Ritonavir in COVID-19 Treatment: Insights from EudraVigilance Data DOI Open Access

Aliteia-Maria Pacnejer,

M.E. Negru, Anca Maria Arseniu

et al.

Journal of Clinical Medicine, Journal Year: 2025, Volume and Issue: 14(6), P. 1886 - 1886

Published: March 11, 2025

Remdesivir (RDV) and nirmatrelvir/ritonavir (NMVr) are among the most widely used antivirals in treatment of COVID-19, aiming to reduce disease severity progression. Adverse neuropsychiatric effects, such as anxiety, sleep disturbances, movement disorders, have emerged significant concerns associated with these treatments. To better understand safety profiles RDV NMVr, this study performs a pharmacovigilance analysis individual case reports (ICSRs) from EudraVigilance (EV) database. Objectives: This evaluates risk adverse events NMVr. Comparisons other antiviral drugs, including darunavir, sofosbuvir, ribavirin, tenofovir, ritonavir, sotrovimab, also performed develop comprehensive understanding profiles. Methods: A retrospective ICSRs submitted EV until 7 July 2024, data extraction on 12 was conducted. Demographic characteristics (age, sex, geographic region, reporter type) were included descriptive analysis. Disproportionality using reporting odds ratio (ROR) 95% confidence intervals (CI) compare drug reaction (ADRs) frequencies across 27 system organ classes (SOCs), emphasis “Nervous disorders” “Psychiatric disorders. Results: The total number significantly higher for NMVr (n = 8078) compared 3934). Nervous disorders accounted 3.07% 17.31% reports, while psychiatric represented 0.92% ADRs reported 60) 3.61% 672). On hand, showed lower frequency headache (ROR: 0.1057; CI: 0.0676–0.1653). Conclusions: presents than RDV, underscoring need enhanced monitoring, particularly patients preexisting central nervous (CNS) conditions. These findings contribute optimizing informing clinical decision making.

Language: Английский

Comparative Analysis of Neuropsychiatric Adverse Reactions Associated with Remdesivir and Nirmatrelvir/Ritonavir in COVID-19 Treatment: Insights from EudraVigilance Data DOI Open Access

Aliteia-Maria Pacnejer,

M.E. Negru, Anca Maria Arseniu

et al.

Journal of Clinical Medicine, Journal Year: 2025, Volume and Issue: 14(6), P. 1886 - 1886

Published: March 11, 2025

Remdesivir (RDV) and nirmatrelvir/ritonavir (NMVr) are among the most widely used antivirals in treatment of COVID-19, aiming to reduce disease severity progression. Adverse neuropsychiatric effects, such as anxiety, sleep disturbances, movement disorders, have emerged significant concerns associated with these treatments. To better understand safety profiles RDV NMVr, this study performs a pharmacovigilance analysis individual case reports (ICSRs) from EudraVigilance (EV) database. Objectives: This evaluates risk adverse events NMVr. Comparisons other antiviral drugs, including darunavir, sofosbuvir, ribavirin, tenofovir, ritonavir, sotrovimab, also performed develop comprehensive understanding profiles. Methods: A retrospective ICSRs submitted EV until 7 July 2024, data extraction on 12 was conducted. Demographic characteristics (age, sex, geographic region, reporter type) were included descriptive analysis. Disproportionality using reporting odds ratio (ROR) 95% confidence intervals (CI) compare drug reaction (ADRs) frequencies across 27 system organ classes (SOCs), emphasis “Nervous disorders” “Psychiatric disorders. Results: The total number significantly higher for NMVr (n = 8078) compared 3934). Nervous disorders accounted 3.07% 17.31% reports, while psychiatric represented 0.92% ADRs reported 60) 3.61% 672). On hand, showed lower frequency headache (ROR: 0.1057; CI: 0.0676–0.1653). Conclusions: presents than RDV, underscoring need enhanced monitoring, particularly patients preexisting central nervous (CNS) conditions. These findings contribute optimizing informing clinical decision making.

Language: Английский

Citations

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