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In the EPIC-HR trial, PAXLOVID significantly reduced the risk of progression to severe COVID-191*PAXLOVID demonstrated ~86% relative risk reduction in hospitalisation or dealth compared with placebo (P<0.001)2,3

*EPIC-HR Trial Design: The safety and efficacy of PAXLOVID were evaluated in EPIC-HR (N=2113), a phase 2/3, randomised, double-blind, placebo-controlled study in nonhospitalised, unvaccinated, symptomatic adult participants with a laboratory-confirmed diagnoses of SARS CoV-2 infection at high risk for progression to severe disease. The primary endpoint assessed the proportion of participants with COVID-19–related hospitalisation or death from any cause through Day 28 when treated ≤3 days of symptom onset. The secondary endpoint similarly assessed patients treated ≤5 days of symptom onset.1,2 A full list of inclusion/exclusion criteria is available on clinicaltrials.gov.
 

a. The estimated cumulative proportion of participants hospitalised or death by Day 28 was calculated for each treatment group using the Kaplan-Meier method, where participants without hospitalisation and death status through Day 28 were censored at the time of study discontinuation.

As shown in the Clinical Study Report, PAXLOVID offered relief from muscle aches, shortness of breath, and headaches 3 days earlier than placebo3
Significant trial results across a broad patient population
  • PAXLOVID demonstrated significant efficacy across patient types regardless of baseline serology, time to symptom onset, age, diabetes, and weight1,2,3
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-coatedtablets-35210/spc (Accessed October 2023)
  3. Data on File. Pfizer Inc.; 2023.
  4. Goyal A, Reeves DB, Cardozo-Ojeda EF, Schiffer JT, Mayer BT. Viral load and contact heterogeneity predict SARS-CoV-2 transmission and super-spreading events. eLife. 2021;10:e63537.
Efficacy & Trial DesignPAXLOVID in ActionClick hereLoading
 
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.

 

Legal Category: S1A
Further information is available upon request

PP-PAX-IRL-0174. 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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