Pharmacokinetics and Pharmacodynamics of Conventional-Dose vs Triple-Dose Oseltamivir in Severely Immunocompromised Children with Influenza

Francisco Bautista; Dan Engelhard; Carmelo Rizzari; Margarita Baka; Jesús Saavedra-Lozano; Eduardo Lopez-Medina; Clare Nasmyth-Miller; Jules Hernández-Sánchez; Stefan Sturm

doi:10.1093/ofid/ofz430

Pharmacokinetics and Pharmacodynamics of Conventional-Dose vs Triple-Dose Oseltamivir in Severely Immunocompromised Children with Influenza

Francisco Bautista
, Dan Engelhard
, Carmelo Rizzari
, Margarita Baka
, Jesús Saavedra-Lozano
, Eduardo Lopez-Medina
, Clare Nasmyth-Miller
, Jules Hernández-Sánchez
, Stefan Sturm

Research output: Contribution to journal › Article › peer-review

5 Citations (Scopus)

Abstract

This randomized phase 1b study evaluated the pharmacokinetics/pharmacodynamics of conventional-dose (30-75 mg twice daily [BID]) vs triple-dose (90-225 mg BID; weight-adjusted) oseltamivir for treatment of influenza in severely immunocompromised children <13 years. Oseltamivir carboxylate (OC) C_max and AUC_0-12h were ~2-fold higher with triple-dose vs conventional-dose oseltamivir. Increased dose/exposure of oseltamivir/OC did not improve virological outcomes or reduce viral resistance. Median time to cessation of viral shedding was similar with triple-dose and conventional-dose oseltamivir (150.7 vs 157.1 hours, respectively); median time to alleviation of baseline fever was longer with conventional-dose oseltamivir (28.4 vs 11.3 hours). No new safety signals were identified.

Original language	English
Article number	ofz430
Pages (from-to)	ofz430
Journal	Open Forum Infectious Diseases
Volume	6
Issue number	10
DOIs	https://doi.org/10.1093/ofid/ofz430
Publication status	Published - 1 Oct 2019
Externally published	Yes

Keywords

children
clinical trial
immunocompromised
influenza
oseltamivir

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10.1093/ofid/ofz430

Cite this

Bautista, F., Engelhard, D., Rizzari, C., Baka, M., Saavedra-Lozano, J., Lopez-Medina, E., Nasmyth-Miller, C., Hernández-Sánchez, J., & Sturm, S. (2019). Pharmacokinetics and Pharmacodynamics of Conventional-Dose vs Triple-Dose Oseltamivir in Severely Immunocompromised Children with Influenza. Open Forum Infectious Diseases, 6(10), ofz430. Article ofz430. https://doi.org/10.1093/ofid/ofz430

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title = "Pharmacokinetics and Pharmacodynamics of Conventional-Dose vs Triple-Dose Oseltamivir in Severely Immunocompromised Children with Influenza",

abstract = "This randomized phase 1b study evaluated the pharmacokinetics/pharmacodynamics of conventional-dose (30-75 mg twice daily [BID]) vs triple-dose (90-225 mg BID; weight-adjusted) oseltamivir for treatment of influenza in severely immunocompromised children <13 years. Oseltamivir carboxylate (OC) Cmax and AUC0-12h were \textasciitilde{}2-fold higher with triple-dose vs conventional-dose oseltamivir. Increased dose/exposure of oseltamivir/OC did not improve virological outcomes or reduce viral resistance. Median time to cessation of viral shedding was similar with triple-dose and conventional-dose oseltamivir (150.7 vs 157.1 hours, respectively); median time to alleviation of baseline fever was longer with conventional-dose oseltamivir (28.4 vs 11.3 hours). No new safety signals were identified.",

keywords = "children, clinical trial, immunocompromised, influenza, oseltamivir",

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Bautista, F, Engelhard, D, Rizzari, C, Baka, M, Saavedra-Lozano, J, Lopez-Medina, E, Nasmyth-Miller, C, Hernández-Sánchez, J & Sturm, S 2019, 'Pharmacokinetics and Pharmacodynamics of Conventional-Dose vs Triple-Dose Oseltamivir in Severely Immunocompromised Children with Influenza', Open Forum Infectious Diseases, vol. 6, no. 10, ofz430, pp. ofz430. https://doi.org/10.1093/ofid/ofz430

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AU - Bautista, Francisco

AU - Engelhard, Dan

AU - Rizzari, Carmelo

AU - Baka, Margarita

AU - Saavedra-Lozano, Jesús

AU - Lopez-Medina, Eduardo

AU - Nasmyth-Miller, Clare

AU - Hernández-Sánchez, Jules

AU - Sturm, Stefan

PY - 2019/10/1

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N2 - This randomized phase 1b study evaluated the pharmacokinetics/pharmacodynamics of conventional-dose (30-75 mg twice daily [BID]) vs triple-dose (90-225 mg BID; weight-adjusted) oseltamivir for treatment of influenza in severely immunocompromised children <13 years. Oseltamivir carboxylate (OC) Cmax and AUC0-12h were ~2-fold higher with triple-dose vs conventional-dose oseltamivir. Increased dose/exposure of oseltamivir/OC did not improve virological outcomes or reduce viral resistance. Median time to cessation of viral shedding was similar with triple-dose and conventional-dose oseltamivir (150.7 vs 157.1 hours, respectively); median time to alleviation of baseline fever was longer with conventional-dose oseltamivir (28.4 vs 11.3 hours). No new safety signals were identified.

AB - This randomized phase 1b study evaluated the pharmacokinetics/pharmacodynamics of conventional-dose (30-75 mg twice daily [BID]) vs triple-dose (90-225 mg BID; weight-adjusted) oseltamivir for treatment of influenza in severely immunocompromised children <13 years. Oseltamivir carboxylate (OC) Cmax and AUC0-12h were ~2-fold higher with triple-dose vs conventional-dose oseltamivir. Increased dose/exposure of oseltamivir/OC did not improve virological outcomes or reduce viral resistance. Median time to cessation of viral shedding was similar with triple-dose and conventional-dose oseltamivir (150.7 vs 157.1 hours, respectively); median time to alleviation of baseline fever was longer with conventional-dose oseltamivir (28.4 vs 11.3 hours). No new safety signals were identified.

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KW - clinical trial

KW - immunocompromised

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KW - oseltamivir

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ER -

Pharmacokinetics and Pharmacodynamics of Conventional-Dose vs Triple-Dose Oseltamivir in Severely Immunocompromised Children with Influenza

Abstract

Keywords

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