Nirmatrelvir/Ritonavir Pfizer

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In the EPIC-HR trial, Nirmatrelvir/Ritonavir Pfizer significantly reduced the risk of progression to severe
COVID-191In high-risk patients who received treatment ≤5 days from symptom onset, Nirmatrelvir/Ritonavir Pfizer demonstratedCOVID-19-Related Hospitalisation or Death From Any Cause Through Day 282EPIC-HR Trial Design: The safety and efficacy of Nirmatrelvir/Ritonavir Pfizer were evaluated (2,246 participants), a phase 2/3, randomised, double-blind, placebo-controlled study in non-hospitalised, 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. These data present the results of the primary analysis for data collected up to December 2021.1

Safety & Tolerability: During the EPIC-HR trial, comparable rates of adverse events were observed between the Nirmatrelvir/Ritonavir Pfizer and placebo groups e.g. Dysgeusia 5.6% vs 0.3%; Diarrhoea 3.1% vs 1.6% respectively. Discontinuation rates due to AEs were low and consistent with placebo.1
COVID-19–related hospitalisation or death from any cause through Day 28
  Nirmatrelvir/Ritonavir Pfizer
N=1039		 Placebo
N=1046
n=patients with events (%) 8 (0.77%) 66 (6.31%)
Absolute risk reduction to placebo [95% CI], % P<0.001 -5.62 (-7.21, -4.03) N/A
All-cause mortality through Day 28, % 0 12 (1.15%)
As shown in the Clinical Study Report, Nirmatrelvir/Ritonavir Pfizer offered relief from muscle aches, shortness of breath, and headaches 3 days earlier than placebo2Early treatment with Nirmatrelvir/Ritonavir Pfizer can help reduce peak viral load1The Nirmatrelvir/Ritonavir Pfizer arm of the trial demonstrated
  • Decrease in viral load could be linked to a decrease in virus transmission3
Find out more about the viral load secondary endpointAs a secondary endpoint of the EPIC-HR trial, the SARS-CoV-2 viral loads at baseline and Day 5 were evaluated for 1574 patients. After accounting for baseline viral load, geographic region, and serology status, Nirmatrelvir/Ritonavir Pfizer reduced load by approximately 10-fold relative to placebo when treatment was initiated within 3 days of symptom onset.1Significant trial results across a broad patient population
  • Nirmatrelvir/Ritonavir Pfizer demonstrated significant efficacy across patient types regardless of baseline serology, time to symptom onset, age, diabetes, and weight1
  • Learn more about the characteristics and diversity of the patients included in the EPIC-HR trial
EXPLORE MORE Safety

See the safety profile of Nirmatrelvir/Ritonavir Pfizer

 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. Data on File. Pfizer Inc.; 2022. 3. 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 Design

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