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Grand Rounds

The ALIC4E RCT: Does Oseltamivir Lead to Shorter Recoveries for Patients with Flu-Like Symptoms?

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BACKGROUND AND PURPOSE:

  • Butler et al. (Lancet, 2019) investigated whether adding antiviral treatment oseltamivir (Tamiflu) to usual care for patients with influenza-like illness reduces time to recovery overall

METHODS:

  • Open-label, pragmatic, adaptive, randomized controlled trial (RCT)
    • Antivirals for influenza-Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE (ALIC4E)
  • Setting
    • 15 European countries
  • Participants
    • Patients ≥1 year |Influenza-like illness | Primary care setting
  • Interventions
    • Oseltamivir group: Oseltamivir added to usual care
      • Adults: 75 mg oral oseltamivir twice daily for 5 days
      • Pediatric doses used ofr children <13 years
    • Control group: Usual care
  • Influenza-like illness: Sudden onset of self-reported fever with
    • ≥1 respiratory symptom
      • Cough | Sore throat | Running or congested nose
    • And 1 systemic symptom
      • Headache | Muscle ache | Sweats or chills | Tiredness
    • Symptom duration of ≤72 h during flu season
  • Analysis
    • Oseltamivir benefit was assessed overall and in 36 prespecified subgroups defined by age, comorbidity, previous symptom duration, and symptom severity
    • Analysis was performed using a Bayesian primary analysis model
  • Primary outcome
    • Time to recovery (patient reported): Return to usual activities, with fever, headache, and muscle ache minor or absent

RESULTS:

  • 3,266 participants were recruited over three seasonal influenza seasons
  • Of those that the primary outcome could be determined
    • 1,533 were in the oseltamivir group | 1,562 were in the usual care group
    • 52% had PCR-confirmed influenza infection
  • Time to recovery was shorter in participants randomly assigned to oseltamivir
    • Overall: Hazard ratio (HR) 1.29 (95% Bayesian credible interval [BCrI] 1.20 to 1.39)
    • Similar benefit found in 30 of the 36 prespecified subgroups
  • Estimated absolute mean benefit
    • Overall
      • 1.02 days (95% BCrI 0.74 to 1.31)
    • <12 years of age, with less severe symptoms, no comorbidities, and shorter previous illness duration
      • 0.70 days (95% BCrI 0.30 to 1.20)
    • ≥65 years who had more severe illness, comorbidities, and longer previous illness duration
      • 3.20 days (95% BCrI 1.00 to 5.50)
  • Adverse events
    • Vomiting or nausea was increased in the oseltamivir group

CONCLUSION:

  • Overall, patients in the primary care setting with influenza-like symptoms recovered one day sooner using oseltamivir vs usual care
  • For older, sicker patients, oseltamivir resulted in faster recovery by 2 to 3 days
  • Benefit seen even when medication started after 48 hours and regardless of whether a patient tested positive for influenza

Learn More – Primary Sources:

Oseltamivir plus usual care versus usual care for influenza-like illness in primary care: an open-label, pragmatic, randomised controlled trial

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Related ObG Topics:

New 2019 / 2020 CDC Flu Vaccine Guidance: Updated Recommendations
CDC Guidelines on the Prevention and Control of Influenza in Pregnancy
Does Influenza Vaccination Actually Reduce or Prevent the Flu in Older Adults?
Does Flu Vaccine During Pregnancy Have Long Term Adverse Effects on Children?

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