COVID-19 Therapeutics in Virginia
This webpage is for health care professionals and focuses on common antiviral treatments that can be used in the outpatient setting.
COVID-19 can result in serious illness, hospitalization and death. In brief, COVID-19 therapeutics are indicated for symptomatic patients with mild to moderate COVID-19 who are at increased risk for progression to severe disease. Drug therapy needs to be started quickly after the onset of symptoms and use of these medications is considered a recommended practice for patients. COVID-19 antiviral therapy has been shown to prevent worsening illness, and COVID-19-related hospitalizations and deaths. More recent data has shown that the earlier antiviral therapy is started, the more effective it is.
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On March 22, 2024 the FDA granted an Emergency Use Authorization for the monoclonal antibody pemivibart (brand name Pemgarda) for COVID-19 pre-exposure prophylaxis. Pemgarda is indicated for use in people aged 12 years and older, who weigh at least 40 kg (approximately 88 lbs.), who are moderately to severely immunocompromised, and do not currently have COVID-19 or have had a recent exposure to someone infected with SARS-CoV-2. Pemgarda is not meant to be used in place of vaccination, and people who are immunocompromised are advised to stay up to date with COVID-19 vaccines.
For more information about Pemgarda, including an FDA black box warning, please see the resources available on the FDA’s Emergency Use Authorization webpage. Pemgarda is available only through the usual commercial marketplace; the federal government is not purchasing or distributing Pemgarda.
On February 29, 2024, the National Institutes of Health released its final update of the NIH COVID-19 Treatment Guidelines. Per NIH, this document will not be updated further, and the Treatment Guidelines website will remain available until August 16, 2024. A downloadable PDF version of the Guidelines (478 pages) will be available until August 16, 2024.
On January 29, 2024, the FDA announced that emergency use authorization-labeled (EUA) Paxlovid will no longer be authorized for emergency use after March 8, 2024. However, the Paxlovid EUA will continue to authorize emergency use of Paxlovid manufactured and labeled in accordance with the New Drug Application (NDA) (NDA-labeled Paxlovid) for the treatment of mild to moderate COVID-19 in children aged 12 through 17 years.
This revision is the next phase in the transition from the use of EUA-labeled Paxlovid to the use of NDA-labeled Paxlovid. The revised Paxlovid EUA states that:
- Paxlovid manufactured and labeled in accordance with the EUA currently in U.S. distribution will remain authorized for use through the labeled or extended expiration date or through March 8, 2024, whichever is earlier.
- Patients who have a prescription for Paxlovid will continue to receive either EUA-labeled or NDA-labeled Paxlovid through March 8, 2024.
Differences in EUA and NDA labeled packaging, along with answers to frequently asked questions can be found on the FDA webpage.
As of April 2024, three antiviral medications are FDA approved or authorized for the treatment of acute COVID-19. These include oral Paxlovid (nirmatrelvir with ritonavir), intravenous Veklury (remdesivir), and oral Lagevrio (molnupiravir). Please see the table under tab “Summary of COVID-19 Therapeutics” for more details about each medication.
Commercial Marketplace Ordering
The federal government completed the transition of the oral antiviral drugs Paxlovid (nirmatrelvir with ritonavir) and Lagevrio (molnupiravir) to the commercial marketplace. Non-U.S. Government entities (e.g., private pharmacies, medical practices) that wish to order these products must do so through the usual commercial marketplace. For more information about the commercialization transition, the U.S. Administration for Strategic Preparedness and Response (ASPR) published a guide online titled “Sunsetting the U.S. Government COVID-19 Therapeutics Distribution Program.” The guide’s most recent update was on April 10, 2024. The guide contains useful information about how to return unused Paxlovid and Lagevrio, and patient assistance programs for both medications. It’s possible that changes to the commercialization process may occur.
Returning Excess Therapeutics
All therapeutic products distributed by the United States Government (USG) are property of USG and must be used in accordance with EUA guidance, as applicable. Sites cannot donate products to entities outside the U.S. or for use outside the U.S. Any returned products will be destroyed as product integrity cannot be verified. Any sites that have “legacy” monoclonal antibody products (e.g., bamlanivimab/etesevimab [“Bam/Ete”], casirivimab/imdevimab [“REGEN-COV”], tixagevimab/cilgavimab [EVUSHELD], sotrovimab, or bebtelovimab) should dispose of the products by either returning them to the manufacturer or destroying the product locally in accordance with federal, state and local laws. It is very unlikely these monoclonal antibodies will be used therapeutically again.
Please note that any returned or locally destroyed EUA-labeled Paxlovid AND monoclonal antibody products must be recorded as disposed of in the Health Partner Ordering Portal (HPOP). The goal is for sites to zero out their inventory in HPOP, indicating to the USG that the product was used, unused and returned, destroyed locally, etc.
Expiration Date Extensions
Some lot numbers of Lagevrio have had expiration date extensions. The expiration date on the Lagevrio packaging is likely NOT the TRUE product expiration date. Please see this ASPR website for extended Lagevrio expiration dates.
Summary Table of Food and Drug Administration (FDA) Authorized Treatments for High-Risk Patients
Antiviral Medication | Use | How is it given? | Key Highlights | When is it given? | |
First line treatment | Paxlovid for Adults (Nirmatrelvir/ ritonavir) Paxlovid EUA (Children) | For treatment of mild-moderate COVID-19 in patients ≥ 12 years of age who are at increased risk for severe COVID-19 | By oral tablets | • Paxlovid has many potential drug-drug interactions • Need complete medication list from patient • Suggest use University of Liverpool drug interaction checker • Consult Paxlovid prescribing information and/or EUA • Renal dosing with Paxlovid | Within 5 days of symptoms starting |
Second Line Treatment | Remdesivir (Veklury) | For treatment of COVID-19 (inpatient or outpatient) | IV | • Must be administered over 3 consecutive days | Within 7 days of symptoms starting |
Third line Treatment | Molnupiravir (Lagevrio) | For treatment of mild-moderate COVID-19 in adults (≥ 18 years of age). Medical providers are strongly encouraged to consult prescribing information before using the medication | By oral tablets | • Lagevrio continues to be under an FDA EUA (EUA Fact Sheet) • Be sure to review EUA Fact Sheet before prescribing. There are mandatory requirements for administration of this drug • Only authorized for use in adults • Per EUA, Lagevrio is a drug of last resort | Within 5 days of symptoms starting |
According to the National Institutes of Health (NIH) COVID-19 Treatment GuidelinesCOVID-19 Treatment Guidelines
Patients who are uninsured or underinsured can access medical care, including COVID-19 treatment. To find treatment:
- Treatment Locator (search for Test to Treat sites)
- Local Health Department
- Federally Qualified Health Center (FQHC)
- Free Clinic
Patient assistance programs are available to help lower out-of-pocket costs for COVID-19 treatment medications:
Therapeutics Guidelines
- CDC Interim Clinical Considerations for COVID-19 Treatment in Outpatients
- VDH Variant and Therapeutics
- NIH: COVID-19 Treatment Guidelines
- IDSA: Therapeutics
- University of Liverpool COVID-19 Drug Interaction Checker
Paxlovid (nirmatrelvir/ritonavir)
Lagevrio (Molnupiravir)
Page Last Updated: April 29, 2024
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