COVID-19 Therapeutics

COVID-19 cases can result in serious illness, hospitalizations and deaths. 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.

Important Updates

New and Notable: COVID-19 Therapeutics Announcements from the U.S. Administration for Strategic Preparedness and Response (ASPR)

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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 January 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.

On December 14, 2023, the Centers for Disease Control and Prevention (CDC) issued a Health Alert Network Health Advisory noting that antiviral medications against COVID-19 and influenza were underused, but are important to treat patients who are at high-risk of severe COVID-19 or influenza. As long as the patient has at least one symptom of COVID-19, regardless of its severity, antiviral therapy is recommended when started within 5-7 days of symptom onset. High-risk patients with COVID-19 have the potential to deteriorate quickly which is why early antiviral therapy is stressed.

COVID-19 Therapeutics Commercialization

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 December 29, 2023. It’s possible that changes to the commercialization process may occur.

Returning Excess Therapeutics

All therapeutic products are property of the United States Government (USG) and must be used in accordance with EUA guidance. 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. Non expired products, should not be destroyed.

If you seek to redistribute currently distributed products please fill out VDH's request to Redistribute Excess Therapeutics.

Regarding the drug Paxlovid (both standard and reduced dose packaging), partners and medical providers with EXCESS U.S. Government (USG) distributed, EUA-labeled product with a true expiration date of December 2023 or later are encouraged to return product through the Pfizer returns process to facilitate a credit to the USG. All returns should be completed so that the product is received by February 29, 2024. To return excess product, please do one of the following:

Go to the Paxlovid returns website at www.PaxlovidEUAreturns.com, or
Email PaxlovidEUAreturns@inmar.com and ask for information about how to return excess product, or
Call 877-740-6148 for assistance

Please note that any returned Paxlovid must be recorded in the Health Partner Ordering Portal (HPOP). Currently, there is no analogous returns process for USG credit for partners or medical providers who have excess Lagevrio.

Expiration Date Extensions

Several COVID-19 therapeutic products may have initial expiration dates approaching, however, many have received extensions. Please check the ASPR searchable expiry database before returning or disposing of any products.

Many lot numbers of Paxlovid (standard and reduced dose packaging) and Lagevrio have had expiration date extensions. The expiration date on the Paxlovid and Lagevrio packaging is likely NOT the TRUE product expiration date.

To determine the correct expiration date of a box of Paxlovid (standard or reduced dose), see Pfizer’s searchable expiration date database

Summary of COVID-19 Therapeutics


	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

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COVID-19 Therapeutics in Virginia