期刊
OPEN FORUM INFECTIOUS DISEASES
卷 6, 期 10, 页码 -出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/ofid/ofz430
关键词
children; clinical trial; immunocompromised; influenza; oseltamivir
资金
- F. Hoffmann-La Roche Ltd.
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 similar to 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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