COVID-19 Therapeutics 

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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 a monoclonal antibody allocation every week and an oral antiviral allocation every two weeks. This website is designed to provide brief background material on the state-allocated therapeutics and identify administration or distribution site locations.

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 or post-exposure prophylaxis of COVID-19

Monoclonal antibody treatments are available for people who test positive for COVID-19, have experienced symptom onset in the last 10 days, and are not hospitalized, but who are at high risk of developing severe COVID-19. A full description of the clinical indications is included in the Emergency Use Authorization for the available product, sotrovimab.

The following medical conditions or other factors may place adults and pediatric patients (age 12-17 years and weighing at least 40 kg) at higher risk for severe COVID-19:

 

  • Older age (≥65 years of age)
  • Obesity or being overweight (adults with BMI > 25 kg/m, or if age 12-17, have BMI ≥ 85th percentile for their age and gender based on CDC growth charts)
  • Pregnancy
  • Chronic kidney disease
  • Diabetes
  • Immunosuppressive disease or immunosuppressive treatment
  • Cardiovascular disease (including congenital heart disease) or hypertension
  • Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
  • Sickle cell disease
  • Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
  • Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19))

 

Other medical conditions or factors (for example, race or ethnicity) may place individual patients at high risk for severe COVID-19. Authorization of monoclonal antibody therapy under the EUAs is not limited to the medical conditions or factors listed above. For more information on medical conditions and factors associated with increased risk, see the CDC’s website. Healthcare providers should consider the benefit-risk ratio for individual patients. 

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 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).

 

Recent updates regarding the monoclonal antibody treatments

On January 24, 2022, the FDA updated the Emergency Use Authorization (EUA) fact sheets for bamlanivimab and etesevimab and casirivimab and imdevimab. FDA now says these two treatments not currently authorized for use anywhere in the U.S., due to the prevalence of Omicron. The National Institutes of Health (NIH) updated its clinical guidelines to  recommend against the use of bamlanivimab plus etesevimab and casirivimab plus imdevimab (REGEN-COV) at this time. HHS/ASPR is asking sites to keep their existing supplies on hand and await further guidance on inventory management.  Please see the FDA press announcement for additional information.

The Assistant Secretary for Preparedness and Response Public Health Emergency COVID-19 Therapeutics sites provides updates on the distribution of these therapeutics.

The National Institutes of Health has published the following statements:

December 30, 2021: The COVID-19 Treatment Guidelines Panel's Statement on Therapies for High-Risk, Nonhospitalized Patients With Mild to Moderate COVID-19

Monoclonal Antibody Therapy Administration Sites

These outpatient treatments are administered intravenously (IV) at hospitals, outpatient infusion centers, and doctors' offices. Patients must qualify for a monoclonal antibody treatment and have a doctor’s referral. IV administration requires a single infusion administered over an hour or less. IV administration are followed by one hour of monitoring. 

Please visit the following sites to search for an infusion or injection site:

Monoclonal antibody resources

Oral antivirals

Two oral COVID-19 antiviral medications for non-hospitalized patients at high risk for progression to severe COVID-19 recently 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 two weeks. 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 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. 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.

 

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 The COVID-19 Treatment Guidelines Panel’s Statement on Potential Drug-Drug Interactions Between Ritonavir-Boosted Nirmatrelvir (Paxlovid) and Concomitant Medications.

 

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.

-     Molnupiravir Fact Sheet for Healthcare Providers

-     Molnupiravir Fact Sheet for Patients and Caregivers

-     FDA Molnupiravir Checklist Tool for Prescribers: https://www.fda.gov/media/155118/download

Updated: 12/01/21

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).

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).