Nirmatrelvir-ritonavir is Restricted: High-risk* outpatients > 12 years of age weighing at least 40kg with mild-moderate COVID-19, Laboratory or home test confirmed COVID-19, Symptom onset ≤ 5 days  

For outpatient use only

• • Note: Not a substitute or alternative to vaccination against COVID-19
  • Note: if patients are hospitalized after starting treatment, we recommend to stop therapy due to potential for drug-drug interactions and lack of known benefit
• Patients must meet EUA criteria: for the treatment of mild-moderate COVID-19 in adults and pediatric patients (age 12 years and older and weighing at least 40kg) with positive COVID-19 testing and high risk of progression to severe COVID-19*
  • *High risk for progression to severe disease: older (age > 60 years), diabetes, overweight (BMI >25), chronic lung disease (including asthma), chronic kidney disease, current smoker, immunosuppressive disease or immunosuppressive treatment, cardiovascular disease, hypertension, sickle cell disease, neurodevelopmental disorders, active cancer, medically-related technological dependence
• Inclusion criteria
  • Laboratory confirmed COVID-19
  • Symptom onset ≤ 5 days
  • Mild-moderate COVID-19 symptoms
  • Age ≥ 12 years old weighing > 40kg
  • Unvaccinated for COVID-19**
  • High risk for progression to severe disease
  • Exclusion criteria
    • Previous SARS-CoV-2 infection**
    • Current hospitalization for COVID-19
    • Severe hepatic impairment
    • Moderate to severe renal impairment (eGFR < 30 mL/min) or ESRD
    • Known human immunodeficiency virus (HIV) infection with a viral load greater than 400 copies/mL or taking prohibited medications for HIV treatment***
    • Suspected or confirmed concurrent active systemic infection other than COVID-19
    • Has received or is expected to receive monoclonal antibody treatment or convalescent COVID-19 plasma
    • Pregnancy or breastfeeding ****
    • Use of any medications or substances highly dependent on CYP3A4 for clearance or strong inducers of CYP3A4 due to drug-drug interactions

Combining outpatient COVID-19 therapeutics is not currently recommended

**Note: benefit of Paxlovid is unknown in vaccinated or previously infected patients

***Consider HIV testing in high-risk patients, balance risk of potential development of HIV resistance with delaying therapy

**** Safety and efficacy data in pregnant and lactating women is lacking but the Society for Maternal-Fetal Medicine supports the use of Paxlovid in pregnant women with COVID-19 who meet clinical qualifications 

See Ambulatory COVID Therapeutic Guidance

See Ambulatory COVID Treatment Order Form

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