Oral Antiviral to Treat COVID-19
Date: 01/24/22
The U.S. Food and Drug Administration (FDA) recently approved an Emergency Use Authorization (EUA) for two agents for the treatment of coronavirus 2019 (COVID-19); Paxlovid® (nirmatrelvir tablets; ritonavir) and Lagevrio® (Molnupiravir).
Paxlovid (nirmatrelvir tablets; ritonavir) 150mg- 100 mg tablet:[i]
1. Paxlovid is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older, weighing at least 40 kg) who have positive results from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing and are at high risk of severe COVID-19, including hospitalizations or death.
a) Paxlovid is not recommended for use in patients who need to be hospitalized due to severe COVID-19, and is not approved for COVID-19 prevention as a pre-exposure or post-exposure prophylactic.
2. Start Paxlovid medication as soon as possible following a COVID-19 diagnosis and within 5 days of the commencement of symptoms. Nirmatrelvir 300 mg (two 150 mg tablets) and ritonavir 100 mg (one 100 mg tablet), administered combined by mouth twice daily for five days with or without food.
a) For moderate renal impairment (eGFR 30 to 60 mL/min), the dose is reduced to 150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet), given twice daily for five days.
b) Patients with severe renal impairment and severe hepatic impairment should not use Paxlovid.
3. When Paxlovid is used with other medications that are highly dependent on CYP3A, there is a risk of serious drug interactions. Avoid in combination with CYP3A4 substrates. For potential medication interactions, see the full prescribing information before and during treatment.
Lagevrio (molnupiravir) 200 mg capsule:[ii]
1. Lagevrio is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults (age 18 years and older) with positive results of SARS-CoV-2 viral testing who are at high risk of progressing to severe COVID-19, including hospitalization or death.
a) Lagevrio is not approved for COVID-19 prevention as a pre-exposure or post-exposure prophylactic and for the start of treatment in COVID-19 infected patients who require hospitalization.
2. Lagevrio 800 mg (four 200 mg capsules), administered by mouth every 12 hours for five days, with or without food as soon as possible after a COVID-19 diagnosis and within 5 days of the commencement of symptoms.
a) No dose adjustment in hepatic or renal dysfunction
3. Lagevrio should not be used during pregnancy, and is not recommend for use in patients under the age of 18 years due to the risk of affecting bone and cartilage formation. Avoid concomitant use with cladribine.
References
[i] Emergency Use Authorization for Paxlovid. New York, NY: Pfizer Labs Division of Pfizer Inc.; December 22,2021. https://www.fda.gov/media/155050/download Accessed January 16, 2022
[ii] Fact sheet for health care providers: Emergency use authorization for molnupiravir. Kenilworth, NJ: Merck & CO., INC.; 2021. https://www.fda.gov/media/155054/download Accessed January 16, 2022.