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Nirmatrelvir/Ritonavir Pfizer was evaluated in the pivotal EPIC-HR trial1EPIC-HR was a phase 2/3, randomised, double-blind, placebo-controlled study in nonhospitalised, symptomatic adults with SARS-CoV-2 with ≥1 risk factor for progression to severe disease (N=2246).Study Design1,2Patient 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
Study endpoints3Proportion 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 Nirmatrelvir/Ritonavir Pfizer in [market] 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 Diversity1,2
343 sites around the world
Region
41% from the U.S.
30% from Europe
12.3% from South America
9% from India
5% from Asia
0.6% from Africa
Sex
50.5% were male
49.5% were female
Ethnicity
72% were White
5% were Black
14% were Asian
45% were Hispanic or Latino
Median age
46 years, with 12.8% of participants being 65 years of age or older (n=268)
Baseline Demographics1,4
Demographics were balanced between the treatment arms
Median (SD) baseline viral load: 5.35 log10 copies/mL (0.00-9.16)
26% of subjects had a baseline viral load of >107 copies/mL
66% of subjects had onset of symptoms ≤3 days from initiation of study treatment
47% of subjects were serological negative at baseline
Only 6.25% 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 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. Hammond J, Leister-Tebbe H, Gardner A, et al. Oral nirmatrelvir for high-risk, nonhospitalized adults with COVID-19 [Supplementary Appendix]. N Eng J Med. 2022;386(15):1397-1408. 3. 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. 4. Nirmatrelvir/Ritonavir Pfizer Summary of Product Characteristics.Efficacy & Trial Design
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