Pharmacokinetics and Pharmacodynamics of Conventional-Dose vs Triple-Dose Oseltamivir in Severely Immunocompromised Children With Influenza-Reference-Cited by-同舟云学术

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

Published:2019-10-01 Issue:10 Volume:6 Page:
ISSN:2328-8957
Container-title:Open Forum Infectious Diseases
language:en
Short-container-title:

Author:

Bautista Francisco¹,Engelhard Dan²,Rizzari Carmelo³,Baka Margarita⁴,Saavedra-Lozano Jesús⁵,Lopez-Medina Eduardo⁶,Nasmyth-Miller Clare⁷,Hernández-Sánchez Jules⁷,Sturm Stefan⁸

Affiliation:

1. Pediatric Hematology, Oncology and Stem Cell Transplantation Department, Hospital Infantil Universitario Niño Jesús, Madrid, Spain

2. Department of Pediatrics, Hadassah-Hebrew University Medical Center, Jerusalem, Israel

3. Pediatric Hematology-Oncology Unit, Department of Pediatrics, MBBM Foundation, ASST-Monza, University of Milano-Bicocca, Monza, Italy

4. Department of Pediatric Oncology, Aglaia Kyriakou Children’s Hospital, Athens, Greece

5. Infectious Disease Unit, Department of Pediatrics, Hospital General Universitario Gregorio Marañón, Madrid, Spain

6. Department of Pediatrics, Universidad del Valle, Centro Médico Imbanaco and Centro de Estudios en Infectología Pediátrica, Cali, Colombia

7. Roche Products Ltd, Welwyn Garden City, UK

8. Roche Innovation Center Basel, Roche Pharmaceutical Research and Early Development, Basel, Switzerland

Abstract

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 ~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.

Funder

F. Hoffmann-La Roche Ltd.

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Oncology

Link

http://academic.oup.com/ofid/article-pdf/6/10/ofz430/33599133/ofz430.pdf

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