Favipiravir pharmacokinetics in COVID-19 patients with moderate to severe kidney dysfunction: Lessons learned for future use
There is limited information on favipiravir pharmacokinetics in critically ill patients and no studies on pharmacokinetics in patients with moderate and severe kidney dysfunction. The aim was to determine favipiravir pharmacokinetics (oral, 1,600 mg, q12h on day 1, then 600 mg, q12h for 4 days) in c...
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| Veröffentlicht in: | International journal of clinical pharmacology and therapeutics 2024-08 |
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| container_title | International journal of clinical pharmacology and therapeutics |
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| creator | Sürmelioğlu, Nursel Demirtürk, Esra Ateş Ayhan, Nazire Özel Yeşilyurt, Aysun Bayrakçi, Sinem Kaynak, Mustafa Sinan Özyılmaz, Ezgi Allegaert, Karel |
| description | There is limited information on favipiravir pharmacokinetics in critically ill patients and no studies on pharmacokinetics in patients with moderate and severe kidney dysfunction. The aim was to determine favipiravir pharmacokinetics (oral, 1,600 mg, q12h on day 1, then 600 mg, q12h for 4 days) in critically ill COVID-19 patients with kidney dysfunction and to compare those with observations reported in healthy adults.
In a descriptive study, blood samples taken from patients meeting the relevant criteria (estimated glomerular filtration rate |
| doi_str_mv | 10.5414/CP204496 |
| format | Article |
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In a descriptive study, blood samples taken from patients meeting the relevant criteria (estimated glomerular filtration rate < 60 mL/min) were collected and analyzed. Analysis of blood samples was done by high performance liquid chromatography (HPLC), and the maximal concentration (C
), the time of maximal concentration (t
), half-life (T
) and area under the curve (AUC
) of favipiravir were calculated (WinNonlin) and compared to reported data in healthy subjects after first administration.
Based on analysis of samples collected in 7 patients, the C
(29.99 vs. 64.5 µg/mL) of favipiravir was decreased, T
(5.8 vs. 4.8 hours) longer, t
delayed, while total exposure was lower (AUC
: 192.53 vs. 446.09 μg/mL) compared to reported data in healthy subjects after first administration. Exposure remained lower up to day 5.
In patients with kidney dysfunction related to COVID-19, favipiravir did not reach the expected exposure. This may be due to poorer and delayed absorption, and subsequent altered disposition. Population pharmacokinetic and mechanistic studies are needed to better explore the relevant covariates and to determine the optimal dose in these patients, as this drug is likely of relevance for other indications.</description><identifier>ISSN: 0946-1965</identifier><identifier>DOI: 10.5414/CP204496</identifier><identifier>PMID: 38920081</identifier><language>eng</language><publisher>Germany</publisher><ispartof>International journal of clinical pharmacology and therapeutics, 2024-08</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38920081$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sürmelioğlu, Nursel</creatorcontrib><creatorcontrib>Demirtürk, Esra</creatorcontrib><creatorcontrib>Ateş Ayhan, Nazire</creatorcontrib><creatorcontrib>Özel Yeşilyurt, Aysun</creatorcontrib><creatorcontrib>Bayrakçi, Sinem</creatorcontrib><creatorcontrib>Kaynak, Mustafa Sinan</creatorcontrib><creatorcontrib>Özyılmaz, Ezgi</creatorcontrib><creatorcontrib>Allegaert, Karel</creatorcontrib><title>Favipiravir pharmacokinetics in COVID-19 patients with moderate to severe kidney dysfunction: Lessons learned for future use</title><title>International journal of clinical pharmacology and therapeutics</title><addtitle>Int J Clin Pharmacol Ther</addtitle><description>There is limited information on favipiravir pharmacokinetics in critically ill patients and no studies on pharmacokinetics in patients with moderate and severe kidney dysfunction. The aim was to determine favipiravir pharmacokinetics (oral, 1,600 mg, q12h on day 1, then 600 mg, q12h for 4 days) in critically ill COVID-19 patients with kidney dysfunction and to compare those with observations reported in healthy adults.
In a descriptive study, blood samples taken from patients meeting the relevant criteria (estimated glomerular filtration rate < 60 mL/min) were collected and analyzed. Analysis of blood samples was done by high performance liquid chromatography (HPLC), and the maximal concentration (C
), the time of maximal concentration (t
), half-life (T
) and area under the curve (AUC
) of favipiravir were calculated (WinNonlin) and compared to reported data in healthy subjects after first administration.
Based on analysis of samples collected in 7 patients, the C
(29.99 vs. 64.5 µg/mL) of favipiravir was decreased, T
(5.8 vs. 4.8 hours) longer, t
delayed, while total exposure was lower (AUC
: 192.53 vs. 446.09 μg/mL) compared to reported data in healthy subjects after first administration. Exposure remained lower up to day 5.
In patients with kidney dysfunction related to COVID-19, favipiravir did not reach the expected exposure. This may be due to poorer and delayed absorption, and subsequent altered disposition. Population pharmacokinetic and mechanistic studies are needed to better explore the relevant covariates and to determine the optimal dose in these patients, as this drug is likely of relevance for other indications.</description><issn>0946-1965</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNo1kM1KAzEURrNQbK2CTyD3BUaTSSZp3Mn4VyjUhbotmeQOje1khiRTKfjwFtTNdzaHs_gIuWL0phJM3NavJRVCyxMypVrIgmlZTch5Sp-UllWl9BmZ8LkuKZ2zKfl-Mns_-HjcCMPGxM7YfusDZm8T-AD16mPxcIzAYLLHkBN8-byBrncYTUbIPSTcY0TYehfwAO6Q2jHY7PtwB0tMqQ8JdmhiQAdtH6Ed83jUx4QX5LQ1u4SXf5yR96fHt_qlWK6eF_X9shgYnedCMc1L4Thtna1sI5tWac2NYkojN04JJaVD6ZSzlFOKWDJsuSu5VYJZ2vAZuf7tDmPToVsP0XcmHtb_N_AfcJVeNg</recordid><startdate>20240801</startdate><enddate>20240801</enddate><creator>Sürmelioğlu, Nursel</creator><creator>Demirtürk, Esra</creator><creator>Ateş Ayhan, Nazire</creator><creator>Özel Yeşilyurt, Aysun</creator><creator>Bayrakçi, Sinem</creator><creator>Kaynak, Mustafa Sinan</creator><creator>Özyılmaz, Ezgi</creator><creator>Allegaert, Karel</creator><scope>NPM</scope></search><sort><creationdate>20240801</creationdate><title>Favipiravir pharmacokinetics in COVID-19 patients with moderate to severe kidney dysfunction: Lessons learned for future use</title><author>Sürmelioğlu, Nursel ; Demirtürk, Esra ; Ateş Ayhan, Nazire ; Özel Yeşilyurt, Aysun ; Bayrakçi, Sinem ; Kaynak, Mustafa Sinan ; Özyılmaz, Ezgi ; Allegaert, Karel</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p108t-719324d30fdc5cb6bf7993a7179e3ad74766de6d7dc0300ee21ef3d23c741c0b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sürmelioğlu, Nursel</creatorcontrib><creatorcontrib>Demirtürk, Esra</creatorcontrib><creatorcontrib>Ateş Ayhan, Nazire</creatorcontrib><creatorcontrib>Özel Yeşilyurt, Aysun</creatorcontrib><creatorcontrib>Bayrakçi, Sinem</creatorcontrib><creatorcontrib>Kaynak, Mustafa Sinan</creatorcontrib><creatorcontrib>Özyılmaz, Ezgi</creatorcontrib><creatorcontrib>Allegaert, Karel</creatorcontrib><collection>PubMed</collection><jtitle>International journal of clinical pharmacology and therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sürmelioğlu, Nursel</au><au>Demirtürk, Esra</au><au>Ateş Ayhan, Nazire</au><au>Özel Yeşilyurt, Aysun</au><au>Bayrakçi, Sinem</au><au>Kaynak, Mustafa Sinan</au><au>Özyılmaz, Ezgi</au><au>Allegaert, Karel</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Favipiravir pharmacokinetics in COVID-19 patients with moderate to severe kidney dysfunction: Lessons learned for future use</atitle><jtitle>International journal of clinical pharmacology and therapeutics</jtitle><addtitle>Int J Clin Pharmacol Ther</addtitle><date>2024-08-01</date><risdate>2024</risdate><issn>0946-1965</issn><abstract>There is limited information on favipiravir pharmacokinetics in critically ill patients and no studies on pharmacokinetics in patients with moderate and severe kidney dysfunction. The aim was to determine favipiravir pharmacokinetics (oral, 1,600 mg, q12h on day 1, then 600 mg, q12h for 4 days) in critically ill COVID-19 patients with kidney dysfunction and to compare those with observations reported in healthy adults.
In a descriptive study, blood samples taken from patients meeting the relevant criteria (estimated glomerular filtration rate < 60 mL/min) were collected and analyzed. Analysis of blood samples was done by high performance liquid chromatography (HPLC), and the maximal concentration (C
), the time of maximal concentration (t
), half-life (T
) and area under the curve (AUC
) of favipiravir were calculated (WinNonlin) and compared to reported data in healthy subjects after first administration.
Based on analysis of samples collected in 7 patients, the C
(29.99 vs. 64.5 µg/mL) of favipiravir was decreased, T
(5.8 vs. 4.8 hours) longer, t
delayed, while total exposure was lower (AUC
: 192.53 vs. 446.09 μg/mL) compared to reported data in healthy subjects after first administration. Exposure remained lower up to day 5.
In patients with kidney dysfunction related to COVID-19, favipiravir did not reach the expected exposure. This may be due to poorer and delayed absorption, and subsequent altered disposition. Population pharmacokinetic and mechanistic studies are needed to better explore the relevant covariates and to determine the optimal dose in these patients, as this drug is likely of relevance for other indications.</abstract><cop>Germany</cop><pmid>38920081</pmid><doi>10.5414/CP204496</doi></addata></record> |
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| source | Alma/SFX Local Collection |
| title | Favipiravir pharmacokinetics in COVID-19 patients with moderate to severe kidney dysfunction: Lessons learned for future use |
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