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Paxlovid (nirmatrelvir co-packaged with ritonavir)

A Preferred Oral Antiviral Drug to Treat COVID-19

Important Information About Paxlovid

Paxlovid (nirmatrelvir co-packaged with ritonavir) is an oral antiviral drug that should be initiated as soon as possible within 5 days of symptom onset. Paxlovid is available for patients by prescription only. Prescriptions can be obtained from your health care provider or through the Test to Treat program.

On May 25, 2023, FDA approved Pfizer’s application for Paxlovid to treat adults (18 years of age and older) with a current diagnosis of mild to moderate COVID-19 and who are at high risk for progression to severe COVID-19. At the same time, the FDA retained Emergency Use Authorization (EUA) for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with a current diagnosis of mild to moderate COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death. The EUA-labeled product – which contains the same tablets (nirmatrelvir tablets and ritonavir tablets) as the Paxlovid that is now FDA-approved – continues to be available from the federal government at no cost.

Please see the Eligibility Screening Checklist for additional details.

Paxlovid is available in two package presentations:

  1. Paxlovid Standard Dose that includes 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) taken together twice daily for 5 days.
  2. Paxlovid Reduced Dose is for people with moderate renal impairment (eGFR ≥ 30 mL/min to < 60 mL/min) that includes 150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet) taken together twice daily for 5 days. Paxlovid is not recommended for people with severe renal impairment (eGFR <30 mL/min).

Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended. There are known drug interactions with Paxlovid. See the Drug Interaction Checker for more information.

Emergency Use Authorization and Approval of Paxlovid

On May 25, 2023, Paxlovid received approval to treat adults with mild to moderate COVID-19 in eligible patients and retained the EUA for these patients as well as for children ages 12 and older weighing at least 40 kg (88 pounds).

Paxlovid received initial EUA on December 22, 2021 for the treatment of mild to moderate COVID-19 in eligible patients.

Distribution of Paxlovid

The Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) oversees the fair and equitable distribution of Paxlovid to jurisdiction health departments, pharmacy partners, Test to Treat sites, long-term care providers, and health centers funded by the Health Resources and Services Administration. This medication is provided with the EUA label for free by the U.S. government.

Jurisdiction health departments, pharmacy partners, and other central partners distribute product to dispensing sites across the nation, and the distributor ships product directly to sites, which include pharmacies, doctors’ offices, clinics, hospitals, urgent care centers, and local health departments.

Paxlovid FDA EUA Resources

Paxlovid

    

Paxlovid

Hello, I’m Dr. Colin Shepard. I serve as the CDC Liaison to the HHS Assistant Secretary for Preparedness and Response, also called ASPR. I want to talk about one of the therapeutics that can help people with COVID-19—Paxlovid.

What is Paxlovid?

Paxlovid is an oral antiviral used to help fight the coronavirus infection by stopping the coronavirus from replicating in the body. This lowers the viral load, reducing the chances of the illness progressing to more serious symptoms and hospitalization.

Who is eligible for Paxlovid?

Paxlovid is for adults and children 12 and older who are at high risk for developing serious symptoms of COVID-19 that may lead to hospitalization and/or death. For more information about who is at high risk, please see the resources provided in the description.

Paxlovid is for people who have a positive COVID-19 rapid or PCR test with mild to moderate symptoms and who are not in the hospital. It should be administered as early as possible but needs to be given within 5 days of symptom onset.

How is Paxlovid administered?

Paxlovid requires a prescription and is available through a pharmacy or health care clinic including Test to Treat locations where these antivirals are being distributed for use at home. Patients will take a combination of pills twice a day for 5 days.

What are the limitations of use of Paxlovid?

Paxlovid is not for everyone. There are serious drug interactions with some of the ingredients that need to be considered. Paxlovid is not recommended for patients with severe renal or hepatic impairment. It is not appropriate to start Paxlovid if you are already hospitalized for COVID-19.

Paxlovid is one of several COVID-19 therapeutic options. Watch the other Outpatient COVID-19 Therapeutics Videos in this series for more information. Visit us online at https://aspr.hhs.gov/COVID-19 and please see the resources linked in the description to learn more. You can connect with ASPR on social media platforms to stay up to date on our latest posts and information that we share. Please email any questions to COVID19therapeutics@hhs.gov.

Thank you for your time.

In this video, Colin Shepard, M.D., Centers for Disease Control and Prevention (CDC) liaison to ASPR, provides more information about the at home use of Paxlovid for treatment of COVID 19.

Paxlovid Frequently Asked Questions

Approval and Authorization

Eligibility

The benefit of a 5-day treatment course of Paxlovid was demonstrated in the clinical trial that supported the EUA. This study that among non-hospitalized, unvaccinated patients at high risk of progression to severe disease, treatment with Paxlovid reduced the risk of hospitalization or death by 88%.1

Observational data, including vaccinated patients, from Israel,2 Hong Kong,3 and the United States is consistent with benefit in high-risk patients:

  • 46% reduction in hospitalizations and deaths compared to the untreated2
  • 65% reduction in death compared to non-users3
  • 51% lower hospitalization rate within 30 days after diagnosis than those who were not prescribed Paxlovid4

References:

  1. Jennifer Hammond, et al. New Engl J Medicine. 2022;386(15):NEJMoa2118542. doi: 10.1056/nejmoa2118542
  2. Ronza Najjar-Debbiny, et al. Clinical Infectious Diseases, 2022; ciac443, https://doi.org/10.1093/cid/ciac443
  3. Carlos K.H. Wong, et al. Lancet Infectious Disease, 2022; doi: https://doi.org/10.1016/ S1473-3099(22)00507-2
  4. Melisa M. Shah, et al. MMWR. https://www.cdc.gov/mmwr/volumes/71/wr/mm7148e2.htm?s_cid=mm7148e2_w
  • Veklury (remdesivir) is a preferred antiviral medication for mild to moderate COVID-19. Veklury is given intravenously, once daily for 3 consecutive days.
  • Lagevrio (molnupiravir) (oral antiviral) is an alternative medication when preferred therapies authorized or approved by FDA are not clinically appropriate or available.

Testing and Prescriptions

Patients can receive a prescription for Paxlovid by three main ways: a health care provider, a Test to Treat site, or an authorized pharmacist.

  • An individual’s health care provider remains the best first option for assessment and prescribing for patients who have symptoms consistent with mild to moderate COVID-19.
  • For individuals who do not have timely access to their own health care provider, there are more than 2,700 Test to Treat sites where patients can get tested, assessed for COVID-19 therapeutic eligibility, and have their prescription filled. A Test to Treat call center is also available at 1-800-232-0233 (TTY 1-888-720-7489) to get help in English, Spanish, and more than 150 other languages. The Disability Information and Access Line (DIAL) is also available to specifically help people with disabilities access services. To get help, call 1-888-677-1199, Monday through Friday from 9 AM to 8 PM ET or email DIAL@usaginganddisability.org.
  • The FDA authorized pharmacists with access to a patient’s health care records to prescribe Paxlovid under certain conditions.

To fill a prescription, there are more than 40,000 locations nationwide available to provide oral antivirals, including Paxlovid.

No. Although FDA continues to recommend that authorized prescribers use direct SARS-CoV-2 viral testing to help diagnose COVID-19, FDA removed the requirement for positive test results effective on February 1, 2023. FDA recognizes that, in rare instances, individuals with a recent known exposure (e.g., a household contact with a positive direct SARS-CoV-2 viral test) who develop signs and symptoms consistent with COVID-19 may be diagnosed by an authorized prescriber as having COVID-19 even if they have a negative direct SARS-CoV-2 viral test result. In such instances, the authorized prescriber may determine that treatment with Paxlovid for COVID-19 is appropriate if the patient reports mild to moderate symptoms of COVID-19 and is at high-risk for progression to severe COVID-19, including hospitalization or death, and the terms and conditions of the authorization are met, as detailed in the Fact Sheet for Healthcare Providers.

Paxlovid continues to be distributed for free by the U.S. Government. There is currently ample supply of Paxlovid with no anticipated supply constraints. Paxlovid is available by prescription from more than 40,000 locations nationwide.

Paxlovid should be considered for any patient with symptoms consistent with mild to moderate COVID‑19 who meets the eligibility criteria.

For more information on how to order Paxlovid, visit the HHS Health Partners Ordering Portal website.

Patient Information