COVID-19 Therapeutics
This webpage is for healthcare professionals and focuses on common antiviral treatments that can be used in the outpatient setting.
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. COVID-19 antiviral therapy has been shown to prevent worsening illness, and COVID-19-related hospitalizations and deaths. Drug therapy needs to be started quickly after the onset of symptoms. Use of these medications is considered a recommended practice for patients.
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On Monday, August 26, 2024, the FDA revised the Emergency Use Authorization for Pemgarda (pemivibart), which is indicated for pre-exposure prophylaxis against COVID-19 in people with moderate to severe immunocompromise. Per the update, the drug is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to 90%, based on available information including variant susceptibility to PEMGARDA and national variant frequencies. More information and resources about Pemgarda and its authorization are available on FDA’s website.
- According to the updated Pemgarda EUA Fact Sheet (see Section 12.4), it appears that Pemgarda may have reduced activity against the Omicron KP.3.1.1 variant
- National estimates of SARS-CoV-2 variant prevalences are on the CDC Nowcast website
- At this time, Pemgarda can still be used according to its EUA
- People with moderate to severe immunocompromise are encouraged to have a plan in place if they become ill with possible COVID-19
- Have rapid at-home COVID-19 tests available and test right away once symptoms begin
- Regardless of test result (positive or negative), contact medical provider promptly to discuss the situation.
- If test is positive for COVID-19, discuss starting Paxlovid promptly with provider
Summary Table of Food and Drug Administration (FDA) Approved and/or 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 (≥ 18 years) (Nirmatrelvir/ ritonavir) Paxlovid for children (ages 12 through 17) - under FDA EUA Paxlovid for patients with moderate renal impairment (reduced dose) | For treatment of mild-moderate COVID-19 in patients ≥ 12 years of age who are at increased risk for severe COVID-19 | 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 Fact Sheet • Renal dosing with Paxlovid | Within 5 days of symptoms starting |
Second Line Treatment | Remdesivir (Veklury) | For treatment of COVID-19 (inpatient or outpatient) | IV | • FDA approved for children and adults • 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 | Oral capsule | • 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 |
Antivrial medication | Use | How is it given? | Key highlights | When is it given? |
Pemivibart (Pemgarda) | COVID-19 pre-exposure prophylaxis (PrEP) | 60 minute IV infusion | • Drug is under FDA Emergency Use Authorization (EUA); it is not FDA approved • Drug is a monoclonal antibody •Indicated for: - People age ≥ 12 years -Weight ≥ 40 kg (~88 lbs) -People with moderate to severe immunocompromise -People who do not have COVID-19 or who have not been in recent contact with someone who has COVID-19 -People who are not expected to mount an adequate response to COVID-19 vaccination • Drug carries black box warning about risk of anaphylaxis • Be sure to consult before using drug EUA Fact Sheet • Drug is meant to be given over 60 minutes by IV infusion • Drug is NOT indicated for COVID-19 treatment • Drug is NOT indicated as a substitute for COVID-19 vaccine | Drug should be given at least TWO WEEKS after a person has had a COVID-19 vaccination Otherwise, the drug can be given anytime to a person who meets the EUA indication criteria |
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
- IDSA: Therapeutics
- University of Liverpool COVID-19 Drug Interaction Checker
Paxlovid (nirmatrelvir/ritonavir)
Lagevrio (Molnupiravir)
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