Factors associated with non-persistence to oral and inhaled antiviral therapies for seasonal influenza: a secondary analysis of a double-blind, multicentre, randomised clinical trial

Abstract

ObjectivesWe aimed to evaluate and compare non-adherence to oral and inhaled antiviral therapies prescribed of a randomised clinical trial in outpatients with influenza A infection.DesignA parallel, three-arm, double-blinded trial randomly allocated antiviral therapies twice daily for 5 days: (1) oral oseltamivir plus inhaled zanamivir (arm OZ); (2) oseltamivir plus inhaled placebo (arm Opz); or (3) oral placebo plus inhaled zanamivir (arm poZ). Analysis of non-adherence was a secondary objective of the trial.SettingsOutpatients were enrolled by 145 general practitioners throughout France during the 2008–2009 seasonal influenza epidemics.ParticipantsA total of 541 adults presenting with influenza-like illness for less than 36 hours.Primary outcomesNon-persistence, the time between inclusion and the last dose treated as a failure time, was used as the primary endpoint.ResultsThe proportions of patients who persisted on treatment until the end of prescription were estimated at 85.73% (±3.28%) for the oral route and 82.73% (±3.44%) for the inhaled route. Based on multivariable models, non-persistence was associated with a PCR confirmation of influenza for both the oral (HR=0.54, p=0.010) and inhaled (HR=0.59, p=0.018) drugs and antibiotic coprescriptions (HR=2.07, p=0.007; and HR=1.88, p=0.017, respectively) and active combination treatment (HR=1.71, p=0.035; and HR=1.58, p=0.035, respectively). The hazard of non-persistence of the inhaled therapy was increased compared with that of the oral therapy (HR=1.23, p=0.043).ConclusionIn addition to the clinical and virological profiles of influenza infection, non-persistence may have been influenced by an active combination and the route of administration.RCT registration numberNCT00799760. This is a post-result analysis.

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“…Among the series of antivirals, there are various dosage forms for administration. Oral oseltamivir and inhaled zanamivir are required twice daily for 5 consecutive days, and adherence-which is an important factor of successful therapy-could influence the success of treatment [9]. Peramivir can be used intravenously once daily or repeated administration.…”

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“…However, nonadherence to therapy affects the outcome, and the route of administration may influence compliance with influenza therapies. 6 For example, oseltamivir must be administered for 5 days, potentially resulting in poor adherence; the recommended dose of inhaled zanamivir or laninamivir may not be delivered in young children and those with respiratory symptoms, 7 and peramivir must be administered intravenously. To improve adherence, there is a medical need for anti-influenza drugs that are safe, well tolerated, and can be easily administered as a single dose to children.…”

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“…The role of patient adherence in successful antiviral treatment for influenza should not be underestimated; route of administration, specifically oral in preference to inhalation, appears to drive patient adherence to a certain degree. 87 For this reason, oral treatment may be preferable to inhalation during the influenza season. A single-dose treatment option makes "directly observed therapy" possible for the entire treatment course.…”