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Controversy surrounds recent papers on use of neuraminidase inhibitors for influenza
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In response to a recent review recommending that guidance on using neuraminidase inhibitors be reviewed based on the small benefit compared with the risk of harm, the Infectious Disease Society of America released an official statement to address any confusion with regard to these drugs.
“IDSA continues to recommend the use of neuraminidase inhibitors for treatment of influenza. The recent Cochrane Review evaluated published and previously unpublished data from randomized clinical trials largely in healthy outpatients with mild illness,” the statement read.
The statement also highlighted that the Cochrane analysis included patients with both influenza virus infection as well as patients with influenza-like illness.
Previous clinical trials of oseltamivir (Tamiflu, Genentech) used to treat influenza indicated the drug increased the risk of nausea and vomiting by about 4% in adults and 5% in children. In prevention trials, oseltamivir increased the risk of headaches, psychiatric disturbances, and renal events. Oseltamivir also did not prevention influenza transmission, according to results of the systematic review published in BMJ.
BMJ reported similar findings were for zanamivir (Relenza, GlaxoSmithKline), which led to alleviation of symptoms in adults but not children. However, the risk of pneumonia was not reduced and the effect on pneumonia in children was not significant. No significant effects on otitis media or sinusitis were found among adults and children. However, there was a small effect on bronchitis among adults but not children. Reduction in the risk of complications of influenza, hospital admission or death were not evident with zanamivir use, according to the authors of the systematic review also published in BMJ.
“Given the specific antiviral activity against influenza viruses of neuraminidase inhibitors, this analytic approach underestimates neuraminidase inhibitors treatment efficacy,” according to the statement.
In addition, the randomized clinical trials of neuraminidase inhibitor treatment in ambulatory patients with mild illness do not inform clinical practice regarding treatment of patients with severe illness or individuals at higher risk for influenza complications. No placebo-controlled randomized clinical trials are available for neuraminidase inhibitor treatment of hospitalized influenza patients, according to IDSA.
“Therefore, evidence from the many observational studies of hospitalized seasonal and pandemic 2009 H1N1 influenza patients should be considered, despite the limitations of observational studies compared to randomized clinical trials,” the statement read.
The IDSA continues to recommend the use of neuraminidase inhibitors for treatment of influenza, and endorses the CDC statement that current antiviral recommendations for influenza remain unchanged. Similar recommendations for antiviral therapy are an integral part of the AAP Annual Policy Statement on Influenza from the Committee on Infectious Diseases.
The IDSA also recommends that clinicians start antiviral treatment with oral oseltamivir as soon as possible for any hospitalized patient with suspected or confirmed influenza and for any patient with suspected or confirmed influenza who has severe or progressive illness.
Regarding stockpiling, the IDSA said it supports stockpiling of antiviral agents for pandemic influenza preparedness and research on novel influenza therapeutics, including antivirals and immunotherapy. See the full IDSA statement for more information.
For more information:
AAP. AAP News 2013; 34:10-1.
Heneghan CJ. BMJ. 2014;doi:10.1136/bmj.g2547.
Jefferson T. BMJ. 2014;doi:10.1136/bmj.g2545.
Jefferson T. Cochrane Libr. 2014;doi:10.1002/14651858.CD002965.pub4.
Disclosure: See the studies for the full list of disclosures.
Perspective
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Theodore C. Eickhoff, MD
The Cochrane group, with its rigid insistence on relying only on double-blinded and appropriately controlled field trials as acceptable evidence, is well known for nay-saying much of what we do in the practice of infectious disease and preventive medicine. Their views on the efficacy of influenza vaccine and pneumococcal polysaccharide vaccine (none) are well known. Their report on neuraminidase inhibitors has been widely publicized during the past several weeks. Both the CDC and the IDSA have issued statements that reaffirmed their previous recommendations for the use of oseltamivir and zanamivir, although they did not directly rebut the Cochrane Library report.
We would not do well, however, to simply dismiss the Cochrane report as meaningless. Rather, it should stimulate both CDC and IDSA to take a long and critical look at the quality of the data supporting their current recommendations. It might be appropriate to appoint an independent review group within IDSA to do this, in a fashion similar to the independent review group appointed several years ago to review the IDSA recommendations on the treatment of Lyme disease.
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