A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.

Phase 3 Completed 228 enrolled Hoffmann-La Roche

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams \[mg\] to 75 mg twice daily orally \[po\], depending on age and weight) or double dose (60 mg-150 mg twice daily po depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.

Timeline

Start: 2008-02-04
Primary completion: 2017-05-02
Completion: 2017-05-02

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper Co-primary endpoints were safety/tolerability and viral resistance. PMID 31667696 ↗

paper Fewer patients experienced an adverse event (AE) in the conventional-dose group (50.5%) versus the double-dose group (59.1%). PMID 31667696 ↗

paper Fifteen patients had post-baseline resistance, more commonly in the conventional-dose group (n = 12) than in the double-dose group (n = 3). PMID 31667696 ↗

Publications

Mitha E, Krivan G, Jacobs F, Nagler A, Alrabaa S, Mykietiuk A, Kenwright A, Le Pogam S, Clinch B, Vareikiene L. Safety, Resistance, and Efficacy Results from a Phase IIIb Study of Conventional- and Double-Dose Oseltamivir Regimens for Treatment of Influenza in Immunocompromised Patients. Infect Dis Ther. 2019 Dec;8(4):613-626. doi: 10.1007/s40121-019-00271-8. Epub 2019 Oct 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oseltamivir	Small molecule	30 mg	Oral
Subject	Oseltamivir	Small molecule	60 mg	Oral
Subject	Oseltamivir	Small molecule	75 mg	Oral
Subject	Oseltamivir	Small molecule	150 mg	Oral