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Safety and Tolerability of Double-Dose and Duration Oseltamivir Regimens in Patients with H1N1pdm09

Cupelli, Lisa PhD*; Bailony, Mohammed MD; Burgess, Tracy MSc; Dutkowski, Regina PhD§

Infectious Diseases in Clinical Practice: July 2014 - Volume 22 - Issue 4 - p 229–231
doi: 10.1097/IPC.0000000000000126
Original Articles

Background: A novel influenza A/H1N1 virus (H1N1pmd09) emerged in April 2009. To address concerns about the suitability of standard oseltamivir regimens for controlling the virus, a randomized trial was initiated to explore virologic responses to standard and nonstandard regimens in patients infected with H1N1pdm09.

Methods: Patients aged 1 year and older with influenza-like illness and a positive rapid test result for influenza A were eligible for enrollment. Adults received 75 mg or 150 mg of oseltamivir twice daily for 5 or 10 days; children received weight-based unit-dose equivalents. Assessments included viral shedding and resistance testing; symptoms were recorded in patients’ diaries and adverse events (AEs) were recorded during patient visits.

Results: When the pandemic was declared over, the study was closed prematurely and therefore did not meet its recruitment target. A total of 102 patients were enrolled, with 101 included in the safety population and 70 in the intent-to-treat infected population. The sample size prevented meaningful evaluation of virologic responses to the investigational regimens. No resistant viruses were isolated at baseline, and treatment-emergent resistance was detected in 2 (3.2%) of 63 patients with positive virology test results. All of the regimens were generally well tolerated, with most on-treatment AEs considered unrelated or remotely related to treatment. No serious AEs or deaths were reported.

Conclusions: In the current study, treatment-emergent resistance was uncommon and all of the oseltamivir regimens were well tolerated in children and adults.

From the *Hoffmann-La Roche, Inc, Nutley, NJ; †Bailony Pediatrics, National City, CA; ‡Genentech, Inc, South San Francisco, CA and §d3 Limited, Hong Kong, China.

Correspondence to: Tracy Burgess, MSc, Genentech, Inc, 1 DNA Way, South San Francisco, CA; E-mail: burgess.tracy@gene.com.

T Burgess, L Cupelli, and R Dutkowski are current or former employees of the Roche Group and hold or have held stock options with the Roche Group. M Bailony is an employee of Bailony Pediatrics, which received funding from Roche for the conduct of this study (NCT01032837).

This study was sponsored by Roche. Support for third-party writing assistance for this article was provided by Roche.

Supplemental digital content is available for this article. Direct URL citation appears in the printed text and is provided in the HTML and PDF versions of this article on the journal’s Web site (www.infectdis.com).

© 2014 by Lippincott Williams & Wilkins.