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Editor, Senior Moderator
BMJ Open. 2017 Jul 10;7(7):e014546. doi: 10.1136/bmjopen-2016-014546.
[h=1]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.[/h] Flicoteaux R[SUP]1,[/SUP][SUP]2[/SUP], Protopopescu C[SUP]3,[/SUP][SUP]4[/SUP], Tibi A[SUP]5[/SUP], Blanchon T[SUP]6[/SUP], Werf SV[SUP]7[/SUP], Duval X[SUP]1[/SUP], Mosnier A[SUP]8[/SUP], Charlois-Ou C[SUP]1[/SUP], Lina B[SUP]9,[/SUP][SUP]10[/SUP], Leport C[SUP]1[/SUP], Chevret S[SUP]2[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]OBJECTIVES:[/h] We 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.
[h=4]DESIGN:[/h] A 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.
[h=4]SETTINGS:[/h] Outpatients were enrolled by 145 general practitioners throughout France during the 2008-2009 seasonal influenza epidemics.
[h=4]PARTICIPANTS:[/h] A total of 541 adults presenting with influenza-like illness for less than 36 hours.
[h=4]PRIMARY OUTCOMES:[/h] Non-persistence, the time between inclusion and the last dose treated as a failure time, was used as the primary endpoint.
[h=4]RESULTS:[/h] The 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).
[h=4]CONCLUSION:[/h] In 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.
[h=4]RCT REGISTRATION NUMBER:[/h] NCT00799760. This is a post-result analysis.
? Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
[h=4]KEYWORDS:[/h] Antiviral Agents; Controlled Clinical Trials; Human Influenza; Medication Non-Adherence; Randomized
PMID: 28698321 DOI: 10.1136/bmjopen-2016-014546
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[h=1]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.[/h] Flicoteaux R[SUP]1,[/SUP][SUP]2[/SUP], Protopopescu C[SUP]3,[/SUP][SUP]4[/SUP], Tibi A[SUP]5[/SUP], Blanchon T[SUP]6[/SUP], Werf SV[SUP]7[/SUP], Duval X[SUP]1[/SUP], Mosnier A[SUP]8[/SUP], Charlois-Ou C[SUP]1[/SUP], Lina B[SUP]9,[/SUP][SUP]10[/SUP], Leport C[SUP]1[/SUP], Chevret S[SUP]2[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]OBJECTIVES:[/h] We 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.
[h=4]DESIGN:[/h] A 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.
[h=4]SETTINGS:[/h] Outpatients were enrolled by 145 general practitioners throughout France during the 2008-2009 seasonal influenza epidemics.
[h=4]PARTICIPANTS:[/h] A total of 541 adults presenting with influenza-like illness for less than 36 hours.
[h=4]PRIMARY OUTCOMES:[/h] Non-persistence, the time between inclusion and the last dose treated as a failure time, was used as the primary endpoint.
[h=4]RESULTS:[/h] The 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).
[h=4]CONCLUSION:[/h] In 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.
[h=4]RCT REGISTRATION NUMBER:[/h] NCT00799760. This is a post-result analysis.
? Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
[h=4]KEYWORDS:[/h] Antiviral Agents; Controlled Clinical Trials; Human Influenza; Medication Non-Adherence; Randomized
PMID: 28698321 DOI: 10.1136/bmjopen-2016-014546
Free full text