Paxlovid

• Paxlovid is not authorized for initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19.
• Paxlovid is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

Yes. State and territorial health departments can order product through the HHS Health Partners Ordering Portal. Dispensing sites began receiving product in December 2021.

Rebound, which is defined as experiencing recurrence of symptoms and/or SARS CoV-2 antigen positivity after initial resolution, has been observed not only among patients treated with Paxlovid but also occurs in patients receiving no treatment and in patients treated with other COVID-19 therapeutics.

Recent studies suggest patients experiencing rebound have an extremely low probability of developing severe COVID-19. Further studies on this phenomenon are ongoing.

Additional guidance on the management of patients experiencing rebound is available.

• Email any questions to COVID19therapeutics@hhs.gov.
• NIH Therapeutic Management of Non-hospitalized Adults With COVID-19
• FDA Fact Sheet for Health care Providers for Paxlovid (nirmatrelvir and ritonavir)
• Side-by-Side Outpatient Therapeutics Overview
• Therapeutics Clinical Implementation Guide
• COVID-19 Therapeutics Decision Aid

Paxlovid is for adults and children 12 and older who are at higher risk for developing serious COVID-19 disease that may lead to hospitalization and/or death. Paxlovid should be considered for any patients who meet the following criteria:

• Have a current diagnosis of mild to moderate COVID-19 & are within 5 days of symptom onset, AND
• Have one or more risk factors for severe COVID-19

The U.S. Food and Drug Administration’s (FDA) Paxlovid Patient Eligibility Screening Checklist Tool for Prescribers can be used to assess eligibility.

See the FDA’s Fact Sheet for Healthcare Providers for detailed information about Paxlovid.

Per the current CDC’s Interim Clinical Considerations for COVID-19 Treatment in Outpatient guidelines, risk factors include:

• Age 50 years or older, with risk increasing substantially at age ≥ 65 years
• Being unvaccinated or not being up to date on COVID-19 vaccinations
• Specific medical conditions and behaviors

For additional information, please see at NIH’s COVID-19 Treatment Guidelines: Clinical Spectrum of SARS-CoV-2 Infection.

The benefit of a 5-day treatment course of Paxlovid was demonstrated in the clinical trial that supported the Emergency Use Authorization (EUA). This study showed 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%.

Observational data, including vaccinated patients, from Israel,¹ Hong Kong,² and the United States is consistent with benefit in high-risk patients:

• 46% reduction in hospitalizations and deaths compared to the untreated¹
• 65% reduction in death compared to non-users²
• 51% lower hospitalization rate within 30 days after diagnosis than those who were not prescribed Paxlovid³

References:

1. Ronza Najjar-Debbiny et al. Clinical Infectious Diseases, 2022; ciac443, https://doi.org/10.1093/cid/ciac443
2. Carlos K.H. et al. Lancet Infectious Disease2022; doi: https://doi.org/10.1016/ S1473-3099(22)00507-2
3. Shah et al. MMWR https://www.cdc.gov/mmwr/volumes/71/wr/mm7148e2.htm?s_cid=mm7148e2_w

Drug-drug interactions are an important when considering whether to prescribe Paxlovid. Paxlovid may increase the concentration of concomitantly administered medications.

Despite its potential for drug-drug interactions, many commonly-used medications can be safely co-administered with Paxlovid. The prescriber should perform a thorough medication reconciliation, including over-the-counter medications and supplements, prior to prescribing Paxlovid.

FDA’s Paxlovid Patient Eligibility Screening Checklist Tool for Prescribers includes a helpful table with medications that interact with Paxlovid, and the recommended action for the prescriber.

• Veklury (remdesivir) is the other preferred treatment for mild to moderate COVID-19. Veklury is given intravenously, once daily for 3 consecutive days.
• Lagevrio (molnupiravir) (oral antiviral) is an alternative treatment when preferred therapies are not clinically appropriate or available.

Yes; a prescription from a qualified healthcare provider is required to be treated with Paxlovid.