COVID-19 Therapeutics 

 

How to find and access COVID-19 therapeutics information video

Background

At various times during the COVID-19 pandemic, Montana DPHHS has been involved in the distribution of scarce therapeutics purchased by the federal government. Currently, the state receives monoclonal antibody and oral antiviral allocations every week. This website is designed to provide brief background material on the state-allocated therapeutics and identify administration or distribution site locations. Facilities interested in offering the state-allocated COVID-19 therapeutics should email margaret.cook-shimanek@mt.gov for additional information.

On April 1, 2022, the National Institutes of Health updated the Therapeutic Management of Nonhospitalized Adults with COVID-19, which provides recommendations for the COVID-19 medications that can be used as treatment for nonhospitalized patients with mild to moderate COVID-19 who are high risk of progressing to severe disease.

Monoclonal antibody therapy

What is monoclonal antibody therapy?

Our bodies naturally make antibodies to fight infection. Monoclonal antibodies are like the antibodies your body makes to fight other viruses, but they are made in a lab and are designed to target the coronavirus spike protein. When the antibodies bind to the spike protein, they block the virus from entering your body’s cells. This keeps the virus from spreading to more of your cells and can help those who are at higher-risk of being hospitalized with COVID-19. 

Getting vaccinated is the best way to prevent COVID-19 and the monoclonal antibody treatments are not a substitute for vaccination.

Monoclonal antibody products for treatment of COVID-19

Monoclonal antibody treatments are available for people who test positive for COVID-19, have experienced symptom onset in the last 7 days, and are not hospitalized, but who are at high risk of developing severe COVID-19. Monoclonal antibody treatments are not authorized for use in patients who are hospitalized due to COVID-19, in those who require oxygen therapy due to COVID-19, or in those who require an increase in baseline oxygen flow rate due to COVID-19 (e.g., for those on chronic oxygen therapy due to an underlying non-COVID-19 related comorbidity).

Monoclonal antibody products

Sotrovimab

On March 25th, the FDA announced sotrovimab is not authorized for use in regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant and updated the product Fact Sheet to reflect this restriction. The Centers for Disease Control and Prevention (CDC) Nowcast data from April 5, 2022, estimates that the proportion of COVID-19 cases caused by the Omicron BA.2 variant is above 50% is all Health and Human Services (HHS) U.S. regions. Data included in the health care provider fact sheet show the authorized dose of sotrovimab is unlikely to be effective against the BA.2 subvariant. Due to these data, sotrovimab is not authorized in any U.S. state or territory at this time.

Healthcare providers should use one of the other COVID-19 medications for treatment in eligible populations that are expected to retain activity with omicron BA.2, as below.

Bebtelovimab

This Lilly monoclonal antibody product received EUA on Friday, February 11th. Bebtelovimab is an investigational medicine used for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]):

  • with positive results of direct SARS-CoV-2 viral testing, and
  • who are at high risk for progression to severe COVID-19, including hospitalization or death, and
  • for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate.

Bebtelovimab is administered as an intravenous injection within 7 days of symptom onset. There is limited known information about the safety and effectiveness of using bebtelovimab for the treatment of mild-to-moderate COVID-19.

 

Monoclonal antibody product for pre-exposure prophylaxis of COVID-19

Evusheld (AZD7442) is tixagevimab and cilgavimab, which are neutralizing IgG1 monoclonal antibodies that bind to distinct, non-overlapping epitopes within the receptor binding domain of the spike protein of SARS-CoV2. Evusheld is authorized for the pre-exposure prophylaxis of adults and certain pediatric individuals with immune compromised systems and thus are not expected to mount an adequate immune response following vaccination, or for whom vaccination is not indicated due to health conditions or a history of severe allergic reactions. The EUA states Evusheld (AZD7442) is not a substitute for vaccination.

The FDA issued an EUA for the emergency use of the unapproved product Evusheld (tixagevimab co-packaged with cilgavimab) for the pre-exposure prophylaxis of COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg):

  • Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2; and
    • Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination; or
    • For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s).

 

On February 24, 2022, the U.S. Food and Drug Administration (FDA) announced a modification to the Emergency Use Authorization (EUA) for AstraZeneca’s COVID-19 medication Evusheld. The modification involves a change to the dosing regimen. Evusheld now should be administered as an initial dose of 600 mg (300 mg of tixagevimab and 300 mg of cilgavimab) administered as two separate consecutive intramuscular injections. Individuals who received the previously authorized initial 300 mg dose (150 mg of tixagevimab and 150 mg of cilgavimab) should receive a second Evusheld dose, with dosing dependent on the timing of initial administration.

  • Initial dose ≤ 3 months prior: 150 mg of tixagevimab and 150 mg of cilgavimab
  • Initial dose > 3 months prior: 300 mg of tixagevimab and 300 mg of cilgavimab

Recommendations regarding repeat dosing will be made when more data are available to determine the appropriate timing.

Oral antivirals

Two oral COVID-19 antiviral medications for non-hospitalized patients at high risk for progression to severe COVID-19 have received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). DPHHS is working with the Federal Retail Pharmacy Program to distribute these therapeutics across the state and expects to receive allocations of these products every week. The current federal pharmacy partners in Montana include Albertsons, Cardinal Health, CVS, Topco, Walgreens, and Wal-Mart. DPHHS will have some flexibility in offering to specific pharmacy sites as well as not all Montana counties have access to one of the federal partners. The oral antivirals described below may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which the oral antivirals belong (i.e., anti-infectives). Both EUAs direct readers to the Centers for Disease Control and Prevention People with Certain Medical Conditions for information on medical conditions and factors associated with increased risk for progression to severe COVID-19 and state the healthcare providers should consider the benefit-risk for an individual patient.

Both oral antivirals must be initiated within 5 days of symptom onset. A test-to-treat model is an ideal strategy for the oral antiviral products, given the short window between symptom onset and treatment required by the EUA. Federal HHS has recently created the Test to Treat program, which provides fast access to the oral antiviral products through co-located testing, evaluation, and treatment. Please visit the HHS Test to Treat webpage for sites in Montana.

Oral antiviral products

PAXLOVID

Paxlovid (Pfizer product) received EUA on December 22, 2021. Paxlovid is comprised of nirmatrelvir, a SARS-CoV-2 main protease inhibitor, co-packaged with ritonavir, an HIV-1 protease inhibitor and CYP3A inhibitor. Ritonavir, which has no activity against SARS-CoV-2 on its own, is included to inhibit the CYP3A-mediated metabolism of nirmatrelvir and consequently increase nirmatrelvir plasma concentrations to levels anticipated to inhibit SARS-CoV-2 replication.

Paxlovid received EUA 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) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

The EUA Fact Sheet for Healthcare Providers includes important information on potential drug interactions, drug resistance, and special dosing considerations for individuals with moderate renal impairment. Healthcare providers should carefully review the EUA prior to prescribing this medication. Additionally, the National Institutes of Health has published Ritonavir-Boosted Nirmatrelvir (Paxlovid), which includes important information on potential drug interactions.

 

MOLNUPIRAVIR

Molnupiravir (Merck product) received EUA on December 23, 2021. Molnupiravir is a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis.

Molnupiravir may only be used for the treatment of mild-to-moderate COVID-19 in adults:

  • With positive results of direct SARS-CoV-2 viral testing, and
  • Who are at high-risk for progression to severe COVID-19, including hospitalization or death, and
  • For whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate.

 

The EUA Fact Sheet for Healthcare Providers includes important information on the use of this product in individuals of reproductive age with childbearing potential. Molnupiravir is not recommended for use during pregnancy. Molnupiravir is not authorized for use in patients less than 18 years of age because it may affect bone and cartilage growth. Healthcare providers should carefully review the EUA prior to prescribing this medication.

COVID Therapeutics Treatment Sites

Updated: 03/03/2022

Patients must qualify and have a doctor’s referral. They should not show up to a treatment site without an appointment. Product availability may change based on access to the monoclonal antibody products and demand. Potential recipients should contact the site before presenting for treatment.  Please note that this website discusses therapeutics distributed as a part of the state-led allocation and may not reflect all treatment sites in the state. Sites involved in a direct federal allocation are not included on this map, as that allocation occurs independent of the state (e.g., Veterans Affairs or Indian Health Service).

Please visit the HHS COVID-19 Therapeutics Locator at https://covid-19-therapeutics-locator-dhhs.hub.arcgis.com/ for the most up to date distribution sites and product inventories.

Download Monoclonal Antibody Treatment Sites for a printable list of treatment locations.  Please note that this list only includes therapeutics distributed as a part of the state-led allocation and may not reflect all treatment sites in the state. Sites involved in a direct federal allocation are not included on this list, as that allocation occurs independent of the state (e.g., Veterans Affairs or Indian Health Service).