2/21/22
COVID Variants and Drug Susceptibility - A Moving Target?
Over time, the SARS-CoV-2 virus continues to evolve. The recent surge of the Omicron variant (BA.1.1) appears to be slowing. However, a subvariant with additional mutations, BA.2, appears to be rising in other parts of the world.
This Omicron subvariant, BA.2, has been demonstrated to be more infectious compared to the highly transmissible BA.1.1. It is not clear yet if this will lead to increased hospitalizations and morbidity.
Vaccination (with boosters) and natural infection with Omicron BA.1.1 appear to be protective against this subvariant. Antiviral therapies such as Paxlovid, molnupiravir, and remdesivir also appears to be effective against BA.2. However, evidence is arising that some of the monoclonal antibodies, particularly sotrovimab, may be less effective against BA.2. As such, treatment recommendations may be adjusted as we learn more about this subvariant.
The CDC has made public a number of tools for monitoring the COVID pandemic. You can track the proportions of variants in the United States and particular geographic regions here: https://covid.cdc.gov/covid-data-tracker/#variant-proportions.
The NIH maintains a website with the reported in vitro activity of the available therapeutics against the COVID variants here: https://opendata.ncats.nih.gov/variant/activity.
1/20/2022
Evusheld
Evusheld (tixagivimab-cilgavimab) is a monoclonal antibody cocktail that has received FDA Emergency Use Authorization for pre-exposure prophylaxis in certain high risk persons for severe COVID-19.
Unlike the other COVID monoclonal antibodies that have received FDA EUAs for the treatment of mild-moderate COVID-19, Evusheld is approved for use in high risk persons who are not infected with SARS-CoV-2. Evusheld has demonstrated in vitro activity against the known SARS-CoV-2 variants (https://opendata.ncats.nih.gov/variant/activity). In the PROVENT clinical trial, Evusheld reduced the incidence of SARS-CoV-2 symptomatic disease by 77% and offered protection for six months.
Evusheld is to be used as an adjunct to vaccination, not as a substitute to vaccination. All patients should be encouraged to get vaccinated against SARS-CoV2, including getting a booster shot.
At Stony Brook, patients with at least one of the following are eligible for Evusheld:
- Receiving active treatment for solid tumors and hematologic malignancies.
- Received a solid organ transplant and are taking immunosuppressive therapy.
- Received a chimeric antigen receptor T cell therapy or a hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy).
- Have a moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome).
- Have advanced or untreated HIV infection (defined as people with HIV and CD4 T lymphocyte cell counts <200/mm3, a history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV).
- Are receiving active treatment with high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents that are classified as severely immunosuppressive, tumor-necrosis blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B cell-depleting agents).
Eligible patients interested in getting Evusheld will need to demonstrate proof of COVID vaccination and have a recent negative SARS-CoV-2 test.
Please go to the Stony Brook Antimicrobial Stewardship home page to find the instructions and order forms for Evusheld.
FDA Fact Sheet: https://www.fda.gov/media/154701/download
Other COVID Treatment Information
[Updated] COVID Oral Treatments FAQ
Stony Brook Medicine COVID Therapeutics Guidelines
- Note that due to national shortages of effective monoclonal antibodies against the Omicron variant, use is limited to specific high risk persons. Please refer to the main page for up to date information on institutional policy.
