Outpatient COVID-19 Treatments: Information for Healthcare Providers
Updated July 12, 2022
The U.S. Food and Drug Administration (FDA) has authorized several widely-available therapeutics to treat mild-to-moderate COVID-19 in people who are at high-risk for progressing to severe COVID-19, and to prevent infection in moderate to severely immunocompromised patients not expected to mount an adequate immune response to the COVID-19 vaccines. This webpage will help assist you in understanding which treatments might be beneficial for your patients.
On this page:
- What's new
- Therapeutic decision resources
- Overview of outpatient therapeutics
- Pre-exposure prophylaxis
- Distribution of therapeutics
- Other resources
- Webinars
- DHSS related links
What's new
Here are the most recent updates to this page:
- June 29: FDA recommends repeat dosing of Evusheld every six months if immunocompromised patients need ongoing protection
- June 16: New CDC COCA slideshow: What Clinicians Need to Know About Available Therapeutic Options for COVID-19
- June 14: Clinical Infectious Diseases study shows Paxlovid rebound is rare and generally mild.
- May 24: Public Health Alert Network (PHAN) COVID-19 Rebound After Paxlovid Treatment (PDF)
- May 12: Two new Paxlovid decision resources added: Paxlovid Patient Eligibility Screening Checklist Tool for Prescribers (PDF) and Management of Paxlovid Drug-Drug Interactions (PDF)
- April 25: Public Health Alert Network (PHAN) Updated Information on Availability and Use of Treatments for Outpatients (PDF)
Therapeutics decision resources
- ASPR: Therapeutics Decision Aid (PDF) A graphic guide to help providers decide which therapeutic options to offer (printable)
- DHSS: COVID-19 Oral Medication Order Form Aid (Word doc)
- University of Liverpool: COVID-19 Drug Interaction Checker
- University of Michigan: Management of Paxlovid Drug-Drug Interactions (PDF)
- FDA: Paxlovid Patient Eligibility Screening Checklist Tool for Prescribers (PDF)
- NIH: COVID-19 Treatment Guidelines
- IDSA: COVID-19 Treatment Guidelines
- CDC: Information for Healthcare Providers on Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19
- CDC: Who is Considered Moderately or Severely Immunocompromised?
Overview of outpatient therapeutics
The chart below provides an overview of eligibility criteria, routes of administration, and links to fact sheets for each drug. For more detail, please refer to the HHS side-by-side comparison of outpatient treatments for mild-moderate COVID-19 (PDF).
Paxlovid (Pfizer) | Remdesivir (Gilead) | Molnupiravir (Merck) | Bebtelovimab (Eli Lilly) |
|
---|---|---|---|---|
Age eligibility | 12+ |
All |
18+ |
12+ |
Initiate within # days of symptom onset | < 5 days |
< 7 days |
< 5 days |
< 7 days |
Mechanism of action | Viral protease inhibitor that halts viral replication. |
Nucleoside analog that halts viral replication |
Nucleoside analog that inhibits viral replication by viral mutagenesis |
Monoclonal antibody against spike protein; blocks viral entry. |
Route of administration | Oral |
IV |
Oral |
IV |
Duration of treatment | 5 days |
3 infusions over 3 days |
5 days |
One IV injection |
Clinical considerations (May want to note on prescription order as applicable) DHSS COVID-19 Oral Medication Order Form Aid (Word doc) |
High efficacy, |
High efficacy. FDA-approved. Determine eGFR, hepatic testing, and prothrombin time before therapy and during use as appropriate. Contraindicated for eGFR <30 mL/min. |
Lower efficacy. Not recommended for use in pregnancy, counsel on use of contraception |
Symptomatic improvement on Day 5 reduction in viral load vs. placebo. No direct comparison to other agents in trials. |
Links | Paxlovid: EUA fact sheet for healthcare providers, Paxlovid product website |
Remdesivir: Prescribing information (PDF), Remdesivir (VEKLURY) product website |
Molnupiravir: EUA fact sheet for healthcare providers , Molnupiravir product website |
Bebtelovimab: EUA fact sheet for healthcare providers, Bebtelovimab product website |
Note:
Paxlovid rebound: In a study of 483 high-risk patients treated with Paxlovid, 4 patients experienced a rebound, which was generally mild, at median of 9 days after treatment, and all resolved without additional COVID-19-directed therapy. The CDC advises that there is currently no evidence that additional treatment is needed for COVID-19 rebound.
The FDA has updated its authorizations for the following monoclonal antibody treatments: GlaxoSmithKline's sotrovimab; Lilly's bamlanivimab plus etesevimab; Regeneron's casirivimab plus imdevimab (REGEN-COV). FDA says these treatments are not currently authorized due to their inactivity against Omicron subvariants
Pre-Exposure Prophylaxis
Evusheld (tixagevimab/cilgavimab) is a long-acting monoclonal antibody therapy that has been authorized by the FDA under EUA for pre-exposure prophylaxis for COVID-19. It is only authorized for individuals (aged ≥12 years and weighing ≥88 lbs) who are not currently infected with or recently exposed to COVID-19, and only for individuals who are moderately to severely immunocompromised or cannot be fully vaccinated with any available COVID-19 vaccines.
Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.
This product is given by intramuscular injection every six months and may help prevent infection. For more information, read the NIH COVID-19 Treatment Guidelines Panel's statement on Evusheld.
In Alaska, Evusheld is available through nearly all infusions centers and clinics that care for the eligible patient populations.
Notes:
- On June 29, 2022, FDA revised the Evusheld Fact Sheet for Healthcare Providers to recommend repeat dosing every six months with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection.
- On February 24, 2022, the FDA increased the initial authorized dose of Evusheld to one injection of 300 mg of tixagevimab and 300 mg of cilgavimab. Patients who have already received the previously authorized dose (150 mg of tixagevimab and 150 mg of cilgavimab) should receive an additional dose of 150 mg of tixagevimab and 150 mg of cilgavimab as soon as possible to raise their monoclonal antibody levels to those expected for patients receiving the higher dose.
Distribution of therapeutics
Healthcare providers can find information about local availability of oral antiviral medications on the therapeutics locator map and therapeutics location data provided by the U.S. Department of Health and Human Services (HHS).
Information about monoclonal antibody infusion sites can be found on the HHS monoclonal antibody locator map as well as the National Infusion Center Association map.
Other resources
- AK PHAN: Updated Information on Availability and Use of Treatments for Outpatients with Mild to Moderate COVID-19 Who are at Increased Risk for Severe Outcomes of COVID-19 (PDF, April 25, 2022)
- DHSS: 3/18/22 Letter from DHSS to health care professionals and Tribal Partners regarding COVID-19 therapeutics
- HHS/ASPR: Therapeutics Locator Tool
A map of locations that have received COVID-19 therapeutics. VA, DOD, Tribal, and other federal facilities have received therapeutics but may not be included in this locator tool. - HHS/ASPR: Therapeutics Resources for Healthcare Professionals
- DHSS: Sick with COVID-19? You have treatment options flyer. (PDF) Providers are encouraged to use this flyer. It can be posted it in waiting rooms, shared with patients, and distributed to local organizations and public health partners.
Webinars
- CDC COCA Call (1/12/22): What Clinicians Need to Know About the New Oral Antiviral Medications
- Alaska Medical Provider ECHO (weekly)
- National Office Call Sessions: HHS / ASPR Allocation, Distribution, Administration of COVID-19 Therapeutics. Tuesdays and Thursdays 10:00-10:45 AM. Please email COVID19Therapeutics@HHS.gov to request Zoom links for these calls.
DHSS related links
- Resources for Health Care Professionals
- Treating COVID-19 at Home
- Treatments for Hospitalized Patients
- Hospital Support and Crisis Standards of Care
- Confidential Infectious Disease Report Form (PDF)
- Alaska Section of Epidemiology Guidance for COVID-19 Testing in Alaska (PDF)