During times of limited availability of therapeutic mediations, it is essential that all prescribers apply ethical principles in determining eligibility of these medications. Medications should only be prescribed in bonified clinician-patient relationships. Additional information on ethical principles during scarce resource allocations can be obtained through MDHHS.
Antiviral medication is a treatment that kills a virus or suppresses its ability to replicate and, hence, inhibits its capability to multiply and reproduce. Vaccinations remain the best way to protect a person from COVID, and are a preventative measure to reduce severity of illness and risk of hospitalization or, even, death. Antivirals are prescribed after a person has tested positive for COVID-19 and within 5 days of symptom onset. Talk to a provider about your eligibility for antiviral treatment.
Monoclonal antibodies are laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance or mimic the immune system's attack on cells. Monoclonal antibodies are designed to block viral attachment and entry into human cells, thus neutralizing the virus. It is designed to limit viral replication and may be effective for the treatment of COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Monoclonal antibody treatment is for people who have tested positive for COVID-19 and have mild to moderate symptoms. When administered to non-hospitalized patients as soon as possible after positive viral testing for SARS-CoV-2 and within 7 days of symptom onset, monoclonal antibodies may reduce viral load, symptoms, and risk of hospitalizations and emergency room visits associated with COVID-19. Information reported by the manufacturers to the food and drug administration indicates that among high-risk symptomatic individuals, there is a 70% reduction in hospitalizations and deaths.
Bebtelovimab is currently the only authorized monoclonal antibody therapy given the prevalence of the Omicron BA.2 sub-variant.
On 12/08/2021, the FDA issued an Emergency Use Authorization (EUA) for the medication Evusheld (tixagevimab/cilgavimab).
Evusheld is a monoclonal antibody administered for pre-exposure prophylaxis to those who are either immunocompromised and unable to receive the COVID-19 vaccine or who are not expected to mount a response to the COVID-19 vaccination.
Designed to block viral attachment and entry into the cells, Evusheld is a long-acting monoclonal antibody (mAb) therapy used for pre-exposure prophylaxis (PrEP) of COVID-19 in adults and children >12 years and weighing at least 40kg. Only individuals who have immunocompromise due to a medical treatment or condition are eligible to receive this medication and the very few who are determined to be ineligible for additional vaccination because of a severe reaction to an earlier vaccination. Individuals who have received the COVID-19 vaccine must wait at least 2 weeks before receiving Evusheld.
Unlike other mAb medications used for COVID-19, Evusheld is not a treatment for COVID-19, it is only for PrEP (prevention). Evusheld is NOT a substitute for vaccination. Evusheld is not for those who have been exposed to COVID-19, and is not meant as a treatment for COVID-19.
Evusheld is only available by prescription and is administered via IM injection. The SARS-CoV-2 variants that will be circulating in the U.S. when Evusheld may need to be redosed are not known at this time and therefore repeat dosing recommendations cannot be made; the Fact Sheets will be revised with repeat dosing recommendations in the future when more data are available.
An emergency use authorization (EUA) was issued from the U.S. Food and Drug Administration (FDA) on Feb. 11, 2022, for the COVID-19 monoclonal antibody therapeutic bebtelovimab. The EUA allows healthcare providers to administer bebtelovimab for outpatient treatment of mild to moderate COVID-19 in adults and children age 12 years and older, who are at high risk for progressing to severe COVID-19 and/or hospitalization and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.
HHS will allocate patient courses of bebtelovimab on a recurring basis as product becomes available from the manufacturer. The initial 50,000 patient courses will be made available on Monday Feb. 14 to state and territorial health departments.
Bebtelovimab is used for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg):
death, and
accessible or clinically appropriate
Dosage and Administration
Contraindications
Drug Interactions
interactions with concomitant medications that are renally excreted or that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.
Pregnancy and Lactation
Pediatric Use
Patient Counseling Information
consistent with the "FACT SHEET FOR PATIENTS, PARENTS AND CAREGIVERS" and provide
them with a copy of this Fact Sheet prior to administration of bebtelovimab.
Additional information can be found at https://www.fda.gov/media/156152/download.
The Emergency Use Authorization for Sotrovimab has been paused as it did not demonstrate effectiveness against the BA.2 omicron sub-variant.
REGEN-COV is no longer being allocated following FDAs revised EUA limiting the use of REGEN-COV due to the omicron variant.
In a published article, REGEN-COV prevented symptomatic COVID-19 and asymptomatic SARS-CoV-2 infection in previously uninfected household contacts of infected persons. Among the participants who became infected, REGEN-COV reduced the duration of symptomatic disease and the duration of a high viral load.
Diminished potency and reduced neutralization against the Omicron variant has been demonstrated with the use of REGEN-COV.
Casirivimab + imdevimab has been granted expanded authorization for post-exposure prophylaxis in select high-risk adult and pediatric populations.
Bamlanivimab/etesevimab is no longer being allocated following FDAs revised EUA limiting the use of bamlanivimab + etesevimab due to the omicron variant.
Diminished potency and reduced neutralization against the Omicron variant has been demonstrated with the use of bamlanivimab/etesevimab.
Health care providers can use these tools to see what locations currently have COVID-19 therapeutics.
General
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