Is Paxlovid (nirmatrelvir/ritonavir) indicated for COVID-19 and what is the latest on its administration course?

From the Guidelines

Paxlovid (nirmatrelvir/ritonavir) is indicated for the treatment of COVID-19 in symptomatic patients with confirmed mild to moderate disease in the outpatient setting who are within 5 days of the onset of symptoms and at a high risk for progressing to severe disease.

Administration Course

• The treatment should be considered for patients who meet the above criteria, as stated in the practice points from the American College of Physicians 1.
• Nirmatrelvir–ritonavir combination therapy is supported for use in this patient population, with the goal of reducing the risk of progression to severe disease.
• The evidence suggests that nirmatrelvir–ritonavir combination therapy can be used to treat symptomatic patients with confirmed mild to moderate COVID-19 in the outpatient setting, as outlined in Practice Point 2 1.
• It is essential to note that the treatment should be initiated within 5 days of the onset of symptoms, and patients should be at a high risk for progressing to severe disease.
• The use of nirmatrelvir–ritonavir combination therapy is supported by the American College of Physicians, as stated in the living, rapid practice points from the American College of Physicians (version 2, update alert) 1.

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.

DOSAGE AND ADMINISTRATION PAXLOVID is nirmatrelvir tablets co-packaged with ritonavir tablets. Nirmatrelvir must be co-administered with ritonavir. • Initiate PAXLOVID treatment as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset. • Administer orally with or without food. • Dosage: 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet), with all 3 tablets taken together twice daily for 5 days.

Paxlovid (nirmatrelvir/ritonavir) is indicated for the treatment of mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19.

• The recommended administration course is 300 mg nirmatrelvir with 100 mg ritonavir, taken twice daily for 5 days.
• Treatment should be initiated as soon as possible after diagnosis and within 5 days of symptom onset 2.
• Dose reduction is recommended for patients with moderate renal impairment 2.
• Paxlovid is not recommended for patients with severe renal or hepatic impairment 2.

From the Research

Indication for COVID-19

• Paxlovid (nirmatrelvir/ritonavir) is indicated for patients with COVID-19 who are at risk for progression to severe disease due to the presence of one or more risk factors 3.
• The Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for early treatment with Paxlovid among persons with mild to moderate cases of COVID-19 who are at high risk for progression to severe disease 4.

Administration Course

• The standard treatment course for Paxlovid is a 5-day treatment course 4, 5.
• Paxlovid treatment within 10 days of onset can shorten the disease course of COVID-19 by reducing the viral load 5.
• However, recurrence of COVID-19 symptoms or a positive viral test result (COVID-19 rebound) 2-8 days after recovery or a negative SARS-CoV-2 test result among patients treated with Paxlovid has been documented 4, 6, 7.

Efficacy and Safety

• Paxlovid has been shown to reduce the risk for hospitalization and death among patients with mild to moderate COVID-19 who are at risk for progression to severe disease 4, 3.
• A study found that Paxlovid reduced the risk of hospitalization by 39% and reduced the risk of death by 61% 3.
• Paxlovid is effective and safe in treating COVID-19 with onset of more than five or even 10 days when patients have a high viral load 5.
• However, disparities in Paxlovid treatment rates imply that the benefit of Paxlovid's effectiveness is not equitably distributed 3.