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: firstname.lastname@example.org.
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.
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