From the Guidelines
Paxlovid is indicated for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who test positive for SARS-CoV-2 and are at high risk for progression to severe COVID-19, including hospitalization or death, as supported by the American College of Physicians in their living, rapid practice points from 2024 1.
Key Considerations
- Treatment should be initiated as soon as possible after diagnosis and within 5 days of symptom onset.
- The standard regimen consists of nirmatrelvir (300 mg) with ritonavir (100 mg) taken together twice daily for 5 days.
- High-risk factors include older age (especially over 65), obesity, diabetes, chronic kidney disease, immunosuppression, cardiovascular disease, chronic lung disease, and cancer.
- Paxlovid works by inhibiting the SARS-CoV-2 main protease, preventing viral replication.
- Dose adjustments are necessary for patients with moderate renal impairment (eGFR 30-60 mL/min), reducing nirmatrelvir to 150 mg while maintaining ritonavir at 100 mg twice daily.
- Paxlovid has significant drug interactions due to the ritonavir component, so a thorough medication review is essential before prescribing.
Practice Points
- Consider molnupiravir to treat symptomatic patients with confirmed mild to moderate COVID-19 in the outpatient setting who are within 5 days of the onset of symptoms and at a high risk for progressing to severe disease.
- Consider nirmatrelvir–ritonavir combination therapy to treat symptomatic patients with confirmed mild to moderate COVID-19 in the outpatient setting who are within 5 days of the onset of symptoms and at a high risk for progressing to severe disease.
- Do not use ivermectin to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting.
- Do not use sotrovimab to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting.
From the FDA Drug Label
PAXLOVID which includes nirmatrelvir, a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) main protease (Mpro: also referred to as 3CLpro or nsp5 protease) inhibitor, and ritonavir, an HIV-1 protease inhibitor and CYP3A inhibitor, 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. Initiate PAXLOVID treatment as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset.
Paxlovid is indicated for the treatment of mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19. Treatment should be initiated as soon as possible after diagnosis and within 5 days of symptom onset 2. Key points include:
- Indication: Treatment of mild-to-moderate COVID-19
- Patient population: Adults at high risk for progression to severe COVID-19
- Timing of treatment: As soon as possible after diagnosis and within 5 days of symptom onset
From the Research
Indications for Paxlovid Treatment
Paxlovid, an oral antiviral treatment, is indicated for adults with mild-to-moderate COVID-19 who are at increased risk for progression to severe illness 3. The treatment should be started within 5 days of symptom onset and given for 5 days' duration 4.
Patient Eligibility
Paxlovid is authorized for adults with mild-to-moderate COVID-19 who are at high risk for progression to severe illness, including those who are unvaccinated or have underlying health conditions 5, 6. The treatment is suitable for outpatient settings with asymptomatic or mild disease 6.
Benefits of Paxlovid Treatment
The benefits of Paxlovid treatment include:
- Reduced risk of hospitalization and death 3, 5, 6
- Lower viral load 5
- Reduced risk of severe COVID-19 5, 6
- Good safety profile with minimal adverse events 6, 7
Key Considerations
Key considerations for Paxlovid treatment include:
- The treatment should be started within 5 days of symptom onset 4
- The treatment is given for 5 days' duration 4
- Drug interactions are a major concern for nirmatrelvir-ritonavir, and prohibited prior or concomitant therapies include medications highly dependent on CYP3A4 for clearance and CYP3A4 inducers 5, 6