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Randomized Controlled Trial
. 2012 May;6(3):153-8.
doi: 10.1111/j.1750-2659.2011.00312.x. Epub 2011 Nov 26.

Clinical and virologic outcomes in patients with oseltamivir-resistant seasonal influenza A (H1N1) infections: results from a clinical trial

Nila J Dharan  1 , Alicia M Fry, Burney A Kieke, Laura Coleman, Jennifer Meece, Mary Vandermause, Larisa V Gubareva, Alexander I Klimov, Edward A Belongia
Affiliations
Randomized Controlled Trial

Clinical and virologic outcomes in patients with oseltamivir-resistant seasonal influenza A (H1N1) infections: results from a clinical trial

Nila J Dharan et al. Influenza Other Respir Viruses. 2012 May.

Abstract

Nineteen patients with oseltamivir-resistant seasonal influenza A (H1N1) infections were randomized to receive oseltamivir or placebo. Nasopharyngeal swabs were obtained, and clinical and virologic outcomes were compared, stratified by early or late treatment. Neuraminidase inhibition assay and pyrosequencing for H275Y confirmed resistance. Twelve (63%) patients received oseltamivir; 8 (67%) received late treatment. Seven (37%) patients received placebo; 6 (86%) presented >48 hours after onset. Time to 50% decrease in symptom severity, complete symptom resolution, and first negative culture were shortest among the early treatment group. While sample size prohibits a strong conclusion, future studies should evaluate for similar trends.

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Figures

Figure 1
Figure 1
Illness duration and virologic test results for 19 patients with oseltamivir‐resistant A (H1N1) infection. 1Influenza PCR was positive at enrollment, 1 day before randomization; culture was negative. 2Symptoms did not resolve by day 14.
Figure 2
Figure 2
Raw severity scores and percent change from baseline severity scores over time with trend lines by treatment group. Report zero is time of randomization. A. Raw severity scores for each individual. B. Smoothed severity scores by treatment group. C. Raw percent change from baseline severity score for each individual. D. Smoothed percent change from baseline severity score by treatment group.
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