Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia
Background. Few antiviral therapies have been studied in patients with coronavirus disease 2019 (COVID-19) and kidney impairment. Herein, the efficacy, safety, and pharmacokinetics of remdesivir, its metabolites, and sulfobutylether-β-cyclodextrin excipient were evaluated in hospitalized patients wi...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , |
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| Formato: | artículo |
| Fecha de publicación: | 2024 |
| País: | España |
| Recursos: | Universitat Autònoma de Barcelona |
| Repositorio: | Dipòsit Digital de Documents de la UAB |
| Idioma: | inglés |
| OAI Identifier: | oai:ddd.uab.cat:311092 |
| Acesso em linha: | https://ddd.uab.cat/record/311092 https://dx.doi.org/urn:doi:10.1093/cid/ciae333 |
| Access Level: | acceso abierto |
| Palavra-chave: | COVID-19 SARS-CoV-2 Kidney impairment Remdesivir |
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Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 PneumoniaA Randomized Clinical TrialSise, M.E.Santos, Jose RamonGoldman, J.D.Tuttle, K.R.Pedro Teixeira, J.Seibert, A.F.Koullias, Y.Llewellyn, J.Regan, S.Zhao, Y.Huang, H.Hyland, R.H.Osinusi, A.Winter, H.Humeniuk, R.Hulter, H.N.Gottlieb, R.L.Fusco, D.N.Birne, R.Stancampiano, F.F.Libertin, C.R.Small, C.B.Plate, M.McPhail, M.J.COVID-19SARS-CoV-2Kidney impairmentRemdesivirBackground. Few antiviral therapies have been studied in patients with coronavirus disease 2019 (COVID-19) and kidney impairment. Herein, the efficacy, safety, and pharmacokinetics of remdesivir, its metabolites, and sulfobutylether-β-cyclodextrin excipient were evaluated in hospitalized patients with COVID-19 and severe kidney impairment. Methods. In REDPINE, a phase 3, randomized, double-blind, placebo-controlled study, participants aged ≥12 years hospitalized for COVID-19 pneumonia with acute kidney injury, chronic kidney disease, or kidney failure were randomized 2:1 to receive intravenous remdesivir (200 mg on day 1; 100 mg daily up to day 5) or placebo (enrollment from March 2021 to March 2022). The primary efficacy end point was the composite of the all-cause mortality rate or invasive mechanical ventilation rate through day 29. Safety was evaluated through day 60. Results. Although enrollment concluded early, 243 participants were enrolled and treated (remdesivir, n = 163; placebo, n = 80). At baseline, 90 participants (37.0%) had acute kidney injury (remdesivir, n = 60; placebo, n = 30), 64 (26.3%) had chronic kidney disease (remdesivir, n = 44; placebo, n = 20), and 89 (36.6%) had kidney failure (remdesivir, n = 59; placebo, n = 30); and 31 (12.8%) were vaccinated against COVID-19. Composite all-cause mortality or invasive mechanical ventilation rates through day 29 were 29.4% and 32.5% in the remdesivir and placebo group, respectively (P =.61). Treatment-emergent adverse events were reported in 80.4% for remdesivir versus 77.5% for placebo, and serious adverse events in 50.3% versus 50.0%, respectively. Pharmacokinetic plasma exposure to remdesivir was not affected by kidney function. Conclusions. Although the study was underpowered, no significant difference in efficacy was observed between treatment groups. REDPINE demonstrated that remdesivir is safe in patients with COVID-19 and severe kidney impairment.Universitat Autònoma de Barcelona 22024-01-0120242024-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/311092https://dx.doi.org/urn:doi:10.1093/cid/ciae333reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.https://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:3110922026-06-06T12:50:31Z |
| dc.title.none.fl_str_mv |
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia A Randomized Clinical Trial |
| title |
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia |
| spellingShingle |
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia Sise, M.E. COVID-19 SARS-CoV-2 Kidney impairment Remdesivir |
| title_short |
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia |
| title_full |
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia |
| title_fullStr |
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia |
| title_full_unstemmed |
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia |
| title_sort |
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia |
| dc.creator.none.fl_str_mv |
Sise, M.E. Santos, Jose Ramon Goldman, J.D. Tuttle, K.R. Pedro Teixeira, J. Seibert, A.F. Koullias, Y. Llewellyn, J. Regan, S. Zhao, Y. Huang, H. Hyland, R.H. Osinusi, A. Winter, H. Humeniuk, R. Hulter, H.N. Gottlieb, R.L. Fusco, D.N. Birne, R. Stancampiano, F.F. Libertin, C.R. Small, C.B. Plate, M. McPhail, M.J. |
| author |
Sise, M.E. |
| author_facet |
Sise, M.E. Santos, Jose Ramon Goldman, J.D. Tuttle, K.R. Pedro Teixeira, J. Seibert, A.F. Koullias, Y. Llewellyn, J. Regan, S. Zhao, Y. Huang, H. Hyland, R.H. Osinusi, A. Winter, H. Humeniuk, R. Hulter, H.N. Gottlieb, R.L. Fusco, D.N. Birne, R. Stancampiano, F.F. Libertin, C.R. Small, C.B. Plate, M. McPhail, M.J. |
| author_role |
author |
| author2 |
Santos, Jose Ramon Goldman, J.D. Tuttle, K.R. Pedro Teixeira, J. Seibert, A.F. Koullias, Y. Llewellyn, J. Regan, S. Zhao, Y. Huang, H. Hyland, R.H. Osinusi, A. Winter, H. Humeniuk, R. Hulter, H.N. Gottlieb, R.L. Fusco, D.N. Birne, R. Stancampiano, F.F. Libertin, C.R. Small, C.B. Plate, M. McPhail, M.J. |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Universitat Autònoma de Barcelona |
| dc.subject.none.fl_str_mv |
COVID-19 SARS-CoV-2 Kidney impairment Remdesivir |
| topic |
COVID-19 SARS-CoV-2 Kidney impairment Remdesivir |
| description |
Background. Few antiviral therapies have been studied in patients with coronavirus disease 2019 (COVID-19) and kidney impairment. Herein, the efficacy, safety, and pharmacokinetics of remdesivir, its metabolites, and sulfobutylether-β-cyclodextrin excipient were evaluated in hospitalized patients with COVID-19 and severe kidney impairment. Methods. In REDPINE, a phase 3, randomized, double-blind, placebo-controlled study, participants aged ≥12 years hospitalized for COVID-19 pneumonia with acute kidney injury, chronic kidney disease, or kidney failure were randomized 2:1 to receive intravenous remdesivir (200 mg on day 1; 100 mg daily up to day 5) or placebo (enrollment from March 2021 to March 2022). The primary efficacy end point was the composite of the all-cause mortality rate or invasive mechanical ventilation rate through day 29. Safety was evaluated through day 60. Results. Although enrollment concluded early, 243 participants were enrolled and treated (remdesivir, n = 163; placebo, n = 80). At baseline, 90 participants (37.0%) had acute kidney injury (remdesivir, n = 60; placebo, n = 30), 64 (26.3%) had chronic kidney disease (remdesivir, n = 44; placebo, n = 20), and 89 (36.6%) had kidney failure (remdesivir, n = 59; placebo, n = 30); and 31 (12.8%) were vaccinated against COVID-19. Composite all-cause mortality or invasive mechanical ventilation rates through day 29 were 29.4% and 32.5% in the remdesivir and placebo group, respectively (P =.61). Treatment-emergent adverse events were reported in 80.4% for remdesivir versus 77.5% for placebo, and serious adverse events in 50.3% versus 50.0%, respectively. Pharmacokinetic plasma exposure to remdesivir was not affected by kidney function. Conclusions. Although the study was underpowered, no significant difference in efficacy was observed between treatment groups. REDPINE demonstrated that remdesivir is safe in patients with COVID-19 and severe kidney impairment. |
| publishDate |
2024 |
| dc.date.none.fl_str_mv |
2 2024-01-01 2024 2024-01-01 |
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Article http://purl.org/coar/resource_type/c_6501 VoR http://purl.org/coar/version/c_970fb48d4fbd8a85 |
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info:eu-repo/semantics/article |
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article |
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https://ddd.uab.cat/record/311092 https://dx.doi.org/urn:doi:10.1093/cid/ciae333 |
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https://ddd.uab.cat/record/311092 https://dx.doi.org/urn:doi:10.1093/cid/ciae333 |
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Inglés eng |
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Inglés |
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eng |
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open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by-nc-nd/4.0/ |
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info:eu-repo/semantics/openAccess |
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open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by-nc-nd/4.0/ |
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