From the Guidelines
Paxlovid is recommended for adults and pediatric patients (12 years and older weighing at least 40 kg) with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, as supported by the most recent evidence from the American College of Physicians 1. The criteria for Paxlovid use include:
- Symptomatic patients with confirmed mild to moderate COVID-19
- Patients who are within 5 days of the onset of symptoms
- Patients who are at high risk for progressing to severe disease, including those with age 65 or older, obesity, diabetes, chronic kidney disease, immunosuppressive conditions, cardiovascular disease, chronic lung diseases, sickle cell disease, neurodevelopmental disorders, and active cancer The standard regimen is nirmatrelvir 300 mg (two 150 mg tablets) with ritonavir 100 mg (one tablet) taken together twice daily for 5 days, as outlined in the practice points from the American College of Physicians 1. Some key considerations for Paxlovid use include:
- Dose adjustment for moderate renal impairment (eGFR 30-60 mL/min)
- Avoidance in severe renal impairment (eGFR <30 mL/min) or severe hepatic impairment
- Careful evaluation of drug interactions, as ritonavir is a strong CYP3A inhibitor that can interact with many medications, including statins, anticoagulants, and immunosuppressants, as noted in the evidence from the American College of Physicians 1.
From the FDA Drug Label
PAXLOVID is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. The criteria for Paxlovid use for COVID-19 are:
- Mild-to-moderate COVID-19: Patients with mild-to-moderate COVID-19 symptoms.
- High risk for progression: Adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
- Initiation of treatment: Treatment should be initiated as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset 2. Key points:
- Paxlovid is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
- Patients with severe renal impairment (eGFR <30 mL/min) or severe hepatic impairment (Child-Pugh Class C) should not use Paxlovid 2.
From the Research
Criteria for Paxlovid Use for COVID-19
The following criteria are based on the available evidence:
- Paxlovid is granted an Emergency Use Authorization for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) 3
- Patients at high risk for severe COVID-19, including older patients, immunosuppressed patients, and patients with underlying neurological or cardiovascular disease, may benefit from Paxlovid treatment 3, 4
- Paxlovid is effective in reducing the risk of severe COVID-19 or mortality, with a significant decrease in hospitalization and all-cause mortality 3, 4
- The treatment should be started within 5 days of symptoms onset and given for 5 days' duration 5
- Paxlovid can be considered an effective therapeutic agent for treating patients with COVID-19, with a good safety profile 4, 6, 7
- The availability of different antiviral molecules, including Paxlovid, is a strong tool in changing the natural history of infection for frail persons, in which vaccination could be not sufficient for the prevention of severe COVID-19 6
Patient Selection
The following patient characteristics may be considered for Paxlovid use:
- Adults aged 18 years or older with first-ever positive test for severe acute respiratory syndrome coronavirus 2 3
- Patients with mild to moderate COVID-19 who are at risk for progression to severe disease 5
- Patients with underlying health conditions, such as neurological or cardiovascular disease 3
- Immunocompromised patients 3
Treatment Outcomes
The following treatment outcomes have been reported: