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Mechanism of Action DosingDosing InformationDose AdjustmentsDrug Interactions Trial Design & EfficacyTrial DesignEfficacySafety Profile & Tolerability  Support & ResourcesFrequently Asked QuestionsEducational ResourcesHCP Experience VideosNICE Guidance

Prescribing Information for ▼PAXLOVID (nirmatrelvir / ritonavir) here: Great Britain and Northern Ireland. Adverse event reporting information can be found at the bottom of the page. Please note, there are differences between the SmPC for Northern Ireland and the SmPC for Great Britain. Please refer to the appropriate SmPC depending on where you are based.

Paxlovid has a Conditional Marketing Authorisation in Great Britain. A Conditional Marketing Authorisation means that further evidence on this medicinal product is awaited. New information on this medicinal product will be reviewed when any relevant information of significance becomes available and at least every year and the product information will be updated as necessary.

For information tailored to where you are based, please select the appropriate tab below:

Great Britain

Northern Ireland

Tab Number 3

The Evaluation of Protease Inhibition for COVID-19 (EPIC-HR): A global clinical trial programme for nirmatrelvir / ritonavir1

Overview1,2
  • This phase 2/3, randomised, double-blind, placebo-controlled trial evaluated the efficacy, viral load, and safety associated with nirmatrelvir/ritonavir among non-hospitalised, symptomatic adults with COVID-19 who were at high risk for progression to severe disease1
  • The primary endpoint was the proportion of patients with COVID-19-related hospitalisation or death from any cause through Day 28 in the modified intend-to-treat (mITT) analysis set (all treated participants with onset of symptoms ≤3 days who had at least one post-baseline visit1
  • Patients were enrolled between 16th July and 9th December 2021.2
  • Data analysis set was updated after post hoc removal of data for 133 participants due to Good Clinical Practice quality issues.3


Randomisation was done using an interactive response technology system and stratified by geographic region and by receipt or expected receipt (based on investigator opinion) of COVID-19 monoclonal antibodies.2


The most frequently reported risk factors for progression to severe COVID-19 at baseline were:3

  • BMI ≥25 kg/m2 1692 patients (80.1%)
  • Current cigarette smoker 826 patients (39.1%)
  • Hypertension 671 patients (31.8%)
  • Diabetes mellitus 228 patients (10.8%)

Risk factors that were least represented in enrolled patients (<1%) included: chronic kidney disease, immunosuppressive disease, cancer, neurodevelopmental disorder, sickle cell disease, HIV infection, device dependence.3 

Study Design4,5

Patient inclusion criteria:4,5
  • >18 years of age
  • Confirmed SARS-CoV-2 infection as determined by RT-PCR within 5 days prior to randomisation
  • Initial onset of COVID-19 signs / symptoms within 5 days prior to the day of randomisation
  • At least one COVID-19 sign / symptom present at time of study entry
  • At least one condition or characteristic that is associated with an increased risk of developing severe COVID-19

COVID-19 signs / symptoms used for study entry: cough, shortness of breath or difficulty breathing, fever* or feeling feverish, chills or shivering, fatigue, muscle or body aches, diarrhoea, nausea, vomiting, headache, sore throat, stuffy or runny nose.

*Documented temperature >38°C (100.4°F).


Key patient exclusion criteria:4,5

  • Any previous SARS-CoV-2 infection or COVID-19 hospitalisation
  • Anticipated need for hospitalisation within 48 hours of randomisation
  • Pregnancy or breastfeeding
  • History of active liver disease
  • Moderate-to-severe renal impairment
  • Known HIV infection with a viral load >400 copies/mL
  • Suspected or confirmed active systemic infection other than COVID-19
  • Any comorbidity requiring hospitalisation and/or surgery or considered life-threatening ≤7 and ≤30 days, respectively, prior to study entry
  • History of hypersensitivity/other contraindication to any components of treatment
  • Other medical or psychiatric condition that may increase the risk of study participation or make the patient inappropriate for the study
Prohibited or concomitant therapies: COVID-19 vaccinations, convalescent COVID-19 plasma treatment, medications highly dependent on CYP3A4 for clearance and that may be clinically concerning at elevated plasma concentrations (during and through 4 days following treatment) and medications that are strong CYP3A4 inducers (≤28 days prior to and during treatment).

mITT Populations:3

Study Endpoints4 Adapted from protocol to Hammond et al 20224
Patient Diversity (Full Analysis Population)3

Median Age

  • 45 years (18.0-88.0) 
Sex
  • 50.6% Male (n=1069)
  • 49.4% Female (n=1044)
Ethnicity
  • 70.8% White (n=1496)
  • 4.2% Black (n=89)
  • 14.9% Asian (n=314)
  • 9.0% American Indian or Alaskan Native (n=191)
  • 0.1% Multiracial (n=3)
  • 0.9% Not reported/other/unknown (n=20)

Demographic and clinical characteristics of the patients (Full Analysis Population)3

Demographics were balanced between the treatment arms

Median (SD) baseline viral load: 

PAXLOVID: ~5.52 log10 copies/mL (0.00-9.16)
Placebo: ~5.39 log10 copies/mL (0.00-9.15)

Baseline viral load of ≥104 copies/mL
PAXLOVID: ~62% (n=654) of subjects
Placebo: ~61% (n=653) of subjects

Onset of symptoms ≤3 days from initiation of study treatment
PAXLOVID: ~69% (n=722) of subjects
Placebo: ~65% (n=696) of subjects

Serological negative at baseline
PAXLOVID: ~48% (n=505) of subjects
Placebo: ~50% (n=529) of subjects
 

Footnotes:
BMI, Body Mass Index; COVID-19, coronavirus disease 2019; HIV, human immunodeficiency virus; mITT, modified intent-to-treat (all treated subjects with onset of symptoms ≤3 days who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment); mITT 1, modified intent-to-treat (all treated subjects with onset of symptoms ≤5 days who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment); mITT 2, modified intent-to-treat (all treated subjects with onset of symptoms ≤5 days); mAb=monoclonal antibody; q12h, every 12 hours; RT-PCR, reverse-transcription polymerase chain reaction; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2

References:
1. PAXLOVID GB Summary of Product Characteristics. 
2. Hammond J, Leister-Tebbe H, Gardner A, et al. N Eng J Med. 2022; 386(15): 1397–1408.
3. Pfizer Data on File excerpts from Full Clinical Study Report for EPIC-HR and Core Data Sheet, February 2024
4. Protocol for: Hammond J, et al. N Engl J Med 2022; 386(15): 1397–1408.
5. Supplement to: Hammond J, et al. N Engl J Med 2022; 386(15): 1397–1408.

Trial Design & EfficacyEXPLORE MORESafety Profile & TolerabilityLearn more about the safety profile & tolerability of PAXLOVID.Learn moreLoadingBadge DosingKicker

Learn about PAXLOVID dosing and potential drug interactions before you prescribe.

Find out more

 See PAXLOVID in Action Learn about the mechanism of action of PAXLOVID.  Find out more Loading

The Evaluation of Protease Inhibition for COVID-19 (EPIC-HR): A global clinical trial programme for nirmatrelvir / ritonavir1

Overview1,2
  • This phase 2/3, randomised, double-blind, placebo-controlled trial evaluated the efficacy, viral load, and safety associated with nirmatrelvir/ritonavir among non-hospitalised, symptomatic adults with COVID-19 who were at high risk for progression to severe disease1
  • The primary endpoint was the proportion of patients with COVID-19-related hospitalisation or death from any cause through Day 28 in the modified intend-to-treat (mITT) analysis set (all treated participants with onset of symptoms ≤3 days who had at least one post-baseline visit1
  • Patients were enrolled between 16th July and 9th December 2021.2 During this period the predominant SAR-CoV-2 variant was Delta1
  • Data analysis set was updated after post hoc removal of data for 133 participants due to Good Clinical Practice quality issues.3


Randomisation was done using an interactive response technology system and stratified by geographic region and by receipt or expected receipt (based on investigator opinion) of COVID-19 monoclonal antibodies.2


The most frequently reported risk factors for progression to severe COVID-19 at baseline were:3

  • BMI ≥25 kg/m2 1692 patients (80.1%)
  • Current cigarette smoker 826 patients (39.1%)
  • Hypertension 671 patients (31.8%)
  • Diabetes mellitus 228 patients (10.8%)

Risk factors that were least represented in enrolled patients (<1%) included: chronic kidney disease, immunosuppressive disease, cancer, neurodevelopmental disorder, sickle cell disease, HIV infection, device dependence.3 

Study Design4,5

Patient inclusion criteria:4,5
  • >18 years of age
  • Confirmed SARS-CoV-2 infection as determined by RT-PCR within 5 days prior to randomisation
  • Initial onset of COVID-19 signs / symptoms within 5 days prior to the day of randomisation
  • At least one COVID-19 sign / symptom present at time of study entry
  • At least one condition or characteristic that is associated with an increased risk of developing severe COVID-19

COVID-19 signs / symptoms used for study entry: cough, shortness of breath or difficulty breathing, fever* or feeling feverish, chills or shivering, fatigue, muscle or body aches, diarrhoea, nausea, vomiting, headache, sore throat, stuffy or runny nose.

*Documented temperature >38°C (100.4°F).


Key patient exclusion criteria:4,5

  • Any previous SARS-CoV-2 infection or COVID-19 hospitalisation
  • Anticipated need for hospitalisation within 48 hours of randomisation
  • Pregnancy or breastfeeding
  • History of active liver disease
  • Moderate-to-severe renal impairment
  • Known HIV infection with a viral load >400 copies/mL
  • Suspected or confirmed active systemic infection other than COVID-19
  • Any comorbidity requiring hospitalisation and/or surgery or considered life-threatening ≤7 and ≤30 days, respectively, prior to study entry
  • History of hypersensitivity/other contraindication to any components of treatment
  • Other medical or psychiatric condition that may increase the risk of study participation or make the patient inappropriate for the study
Prohibited or concomitant therapies: COVID-19 vaccinations, convalescent COVID-19 plasma treatment, medications highly dependent on CYP3A4 for clearance and that may be clinically concerning at elevated plasma concentrations (during and through 4 days following treatment) and medications that are strong CYP3A4 inducers (≤28 days prior to and during treatment).

mITT Populations:1,3

Study Endpoints4 Adapted from protocol to Hammond et al 20224

No patients had completed long-term follow-up at the time of this analysis (i.e. through Week 24)1 Patient Diversity (Full Analysis Population)3

Median Age

  • 45 years (18.0-88.0) 
Sex
  • 50.6% Male (n=1069)
  • 49.4% Female (n=1044)
Ethnicity
  • 70.8% White (n=1496)
  • 4.2% Black (n=89)
  • 14.9% Asian (n=314)
  • 9.0% American Indian or Alaskan Native (n=191)
  • 0.1% Multiracial (n=3)
  • 0.9% Not reported/other/unknown (n=20)

Demographic and clinical characteristics of the patients (Full Analysis Population)3

Demographics were balanced between the treatment arms

Median (SD) baseline viral load: 

PAXLOVID: ~5.52 log10 copies/mL (0.00-9.16)
Placebo: ~5.39 log10 copies/mL (0.00-9.15)

Baseline viral load of ≥104 copies/mL
PAXLOVID: ~62% (n=654) of subjects
Placebo: ~61% (n=653) of subjects

Onset of symptoms ≤3 days from initiation of study treatment
PAXLOVID: ~69% (n=722) of subjects
Placebo: ~65% (n=696) of subjects

Serological negative at baseline
PAXLOVID: ~48% (n=505) of subjects
Placebo: ~50% (n=529) of subjects

For further details on baseline demographics, please see the NI SmPC. 

Footnotes:
BMI, Body Mass Index; COVID-19, coronavirus disease 2019; HIV, human immunodeficiency virus; mITT, modified intent-to-treat (all treated subjects with onset of symptoms ≤3 days who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment); mITT 1, modified intent-to-treat (all treated subjects with onset of symptoms ≤5 days who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment); mITT 2, modified intent-to-treat (all treated subjects with onset of symptoms ≤5 days); mAb=monoclonal antibody; q12h, every 12 hours; RT-PCR, reverse-transcription polymerase chain reaction; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2

References:
1. PAXLOVID® NI Summary of Product Characteristics. 
2. Hammond J, Leister-Tebbe H, Gardner A, et al. N Eng J Med. 2022; 386(15): 1397–1408.
3. Pfizer Data on File excerpts from Full Clinical Study Report for EPIC-HR and Core Data Sheet, February 2024
4. Protocol for: Hammond J, et al. N Engl J Med 2022; 386(15): 1397–1408.
5. Supplement to: Hammond J, et al. N Engl J Med 2022; 386(15): 1397–1408.

Trial Design & EfficacyEXPLORE MORESafety Profile & TolerabilityLearn more about the safety profile & tolerability of PAXLOVID.Learn moreLoadingBadge DosingKicker

Learn about PAXLOVID dosing and potential drug interactions before you prescribe.

Find out more

 See PAXLOVID in Action Learn about the mechanism of action of PAXLOVID.  Find out more Loading
PP-C1D-GBR-0189. February 2024

Adverse Events
 

Adverse Events should be reported. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/ or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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