Therapeutics Activity Against Emerging Variants
All products retain activity against most prevalent variant,BA.5 and there are currently no changes in authorization for use for any of the products.
Evusheld:
- Loses neutralization potency against BA.4.6 (confirmed)& potentially also against BF.7, BA.2.75.2 & BQ subvariants (preliminary); retains activity against BA.2.75*and BA.4
- Breakthrough infections are possible, advise patients to have a treatment plan in place and to seek timely medical attention if symptoms occur
- Evusheld Fact Sheet for Healthcare Providers
Paxlovid, Lagevrio, and Veklury:
- Expected to retain activity against all circulating variants based on preliminary data & sequence analysis
- Additional data pending
Bebtelovimab:
- Retains activity against BA.4.6, BA.2.75 and BA.4 (confirmed) & likely against BF.7 and BA.2.75.2 (preliminary); activity potentially impacted against BQ subvariants (preliminary)
- Additional data pending
- Bebtelovimab Fact Sheet for Healthcare Providers
Testing against emerging variants is ongoing for monoclonal antibodies currently not authorized for use (Regen-COV, bam/ete, sotrovimab).
Full statement from NIH here: Statement on Omicron Subvariants | COVID-19 Treatment Guidelines (nih.gov)
View prevalence of COVID-19 variants nationally here: CDC COVID Data Tracker: Variant Proportions
Additional findings:
Fact Sheet for Healthcare Providers: Emergency Use Authorization for Evusheld (fda.gov)
Evusheld Updates
FDA has updated the Evusheld Fact Sheets and released important information about risk of COVID-19 due to certain variants not neutralized by Evusheld. Evusheld is still recommended for use at this time.
Evusheld:
Key Points from the FDA
- EVUSHELD may be less effective at preventing COVID-19 because it does not neutralize all circulating variants. However:
- EVUSHELD has neutralizing activity against the most prevalent current SARS-CoV-2 viral variant/subvariant (Omicron BA.5)
- EVUSHELD has a long half-life (85 days) and is intended to protect against both current and future variants, and it is unknown what variants will be circulating in the future.
- EVUSHELD is currently the only authorized or approved product in the U.S. for pre-exposure prophylaxis of COVID-19 for individuals who may not mount an adequate immune response to COVID-19 vaccines or for whom vaccination is not recommended.
- FDA continues to recommend EVUSHELD as an appropriate COVID-19 prevention option, in combination with other preventative measures as appropriate (such as getting vaccinated and boosted)
Paxlovid Updates:
Recent updates to the NIH Clinical guidelines for Paxlovid include:
- Additional drug-drug interactions
- Information on viral rebound that may occur after Paxlovid other treatments or in patients with no treatment
- Updated data about variant susceptibility
On September 30, 2002, the FDA updated the Paxlovid Fact Sheet for Providers to include:
Bebtelovimab Replacement Program
On September 23rd, the bebtelovimab product replacement program went live in HPOP. A provider who has commercial supply and treats an under or uninsured patient with a purchased dose can request a replacement dose, at no charge, from a designated United States Government supply.
Provider site:
- Must have used all their USG supply acquired through the HHS distribution program
- Must have purchased commercial bebtelovimab
- Must attest to using a purchased dose for an under or uninsured patient
- May charge a reasonable administration fee - not to exceed the CMS-established administration fees - for bebtelovimab for that patient
- Please consider waiving or reducing the administration fee to be reasonable for the patient being treated
- May not charge the underinsured or uninsured patient for the cost of the bebtelovimab medication
Process:
- Make the request for the replacement in your HPOP account
- Complete the attestation
- Enter the lot number and expiration date of the purchased dose
- Replacement doses will be batched and processed once per week by the distributor
 To sign up for an HPOP account, please contact Therapeutics@dshs.texas.gov.
For additional questions about the replacement program, please visit Bebtelovimab (ASPR - scroll to bottom) or contact COVID19Therapeutics@HHS.gov
Evusheld and Lagevrio Minimum Order Quantity Change in HPOP
Beginning October 3rd, the minimum order quantity will decrease for Evusheld and Lagevrio.
-
12 cartons of Evusheld (equal to six patient courses)
- 15 patient courses of Lagevrio.
Reminder: Shelf-Life Extensions
Several products have initial expiration dates approaching, but many COVID-19 therapeutics have received extensions. Please check with the manufacturer before removing any products from the proper storage conditions.
See links below for detailed expiry information:
Please find an addition listing of expiration extensions from the FDA here.
Maintain all monoclonal antibodies under proper refrigerated temperatures, even if they are not currently authorized for use. It is expected that will be authorized again in the future for use against new strains of SARS-COV2.
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