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PAXLOVID was evaluated in the pivotal EPIC-HR trial1EPIC-HR was a phase 2/3, randomised, double-blind, placebo-controlled study in nonhospitalised, unvaccinated symptomatic adults with SARS-CoV-2 with ≥1 risk factor for progression to severe disease (N=2113).1,2Study Design1,3Patient inclusion criteria:
  • Unvaccinated
  • Adults ≥18 years of age
  • Confirmed SARS-CoV-2 positive
  • COVID-19 symptom onset of ≤5 days
  • No previous SARS-CoV-2 infection
  • ≥1 of the following characteristics/comorbidities associated with increased risk of developing severe COVID-19 illness:
    • ≥60 years of age
    • BMI >25 kg/m2
    • Cigarette smoking
    • Immunosuppresive disease (including HIV infections with CD4+ T cell count <200 mm3 in viral load <400 copies/mL)
    • Prolonged iatrogenic immunosuppressive
    • Hypertension
    • Chronic lung, cardiovascular, kidney, or sickle cell disease
    • Diabetes
    • Cancer
    • Neurodevelopmental disorders or other medically complex conditions
    • Medically related technological dependence
Study endpoints4Proportion of participants with a resting peripheral oxygen saturation ≥95% at Days 1 and 5.AE=adverse event; ICU=intensive care unit; PK=pharmacokinetics; RT-PCR=reverse-transcription polymerase chain reaction; SAE=serious adverse event; TEAE=treatment-emergent adverse event.
  • The key secondary analysis that informed the authorisation of PAXLOVID in Ireland was the percentage of relative risk reduction in hospitalisation or death in participants who were treated within 5 days of symptom onset
  • No patients had completed long-term follow-up at the time of this analysis (ie, through Week 24)
Patient Diversity2
      Sex
      • 51% were male
      • 49% were female 
      Ethnicity 
      • 71% were White
      • 4% were Black or African American
      • 15% were Asian
      • 41% were Hispanic or Latino
      Mean age
      • 45 years, with 12% of participants being 65 years of age or older
      Baseline Demographics2
      Demographics were balanced between the treatment arms
      • Mean (SD) baseline viral load: 4.71 log10 copies/mL (2.89)
      • 27% of subjects had a baseline viral load of >107 copies/mL 
      • 67% of subjects had onset of symptoms ≤3 days from initiation of study treatment
      • 49% of subjects were serological negative at baseline
      • 6.0% of subjects either received or were expected to receive COVID-19 therapeutic monoclonal antibody treatment at the time of randomisation and were excluded from the mITT and mITT1 analyses
      EXPLORE MORESafetySee the safety profile of PAXLOVID and learn how to report adverse events. Safety & tolerability LoadingReferences:
      1. Hammond J, Leister-Tebbe H, Gardner A, et al. Oral nirmatrelvir for high-risk, nonhospitalized adults with COVID-19. N Engl J Med. 2022;386(15):1397-1408.
      2. PAXLOVID Summary of Product Characteristics. https://www.medicines.ie/medicines/paxlovid-150-mg-100-mg-film-coated-tablets-35210/spc (Accessed October 2023).
      3. Hammond J, Leister-Tebbe H, Gardner A, et al. Oral nirmatrelvir for high-risk, nonhospitalized adults with COVID-19 [Supplementary Appendix]. N Engl J Med. 2022;386(15):1397-1408.
      4. Hammond J, Leister-Tebbe H, Gardner A, et al. Oral nirmatrelvir for high-risk, nonhospitalized adults with COVID-19 [Protocol]. N Engl J Med. 2022;386(15):1397-1408.
      Efficacy & Trial DesignPAXLOVID in ActionClick here Loading
      ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

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      PP-PAX-IRL-0175. October 2023

      Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
       

      Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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