December 21, 2022
By Dr. Yadira Soler, MD on August 8, 2022
If you’ve kept up with the news and COVID-19 over the past year, you’ve likely heard the term Monoclonal Antibody Therapy (mAb), also referred to as Monoclonal Infusion Treatment. It’s an additional way of treating COVID-19 with the goal of preventing hospitalizations by reducing viral loads and lessening symptom severity.
mAb works by infusing COVID patients with laboratory produced substances that are similar to the ones our bodies would naturally make in response to infection. Mass-produced in a laboratory, monoclonal antibodies are designed to do a very specific job. They recognize the spike protein, or outer shell, of the Covid-19 virus, and then get to work. Blocking the virus that causes COVID-19 from attaching to human cells, mAbs make it more difficult for the virus to reproduce and cause more harm.
mAbs are for patients who have tested positive for COVID and show early symptoms because the key to success is starting early. When the treatment is started within 7 days of developing symptoms it can be very effective at treating mild to moderate COVID-19 infection among non-hospitalized patients.
At this time, the approved monoclonal antibody can be given to adults and pediatric patients (12 years of age and older weighing at least 40 kg): with positive results of direct SARS-CoV-2 viral testing, who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
Not all monoclonal antibodies work for all SARS-CoV-2 variants. However, one in particular, Bebtelovimab, developed by AbCellera and Eli Lilly, is proving effective against Omicron and its BA.2 subvariant. Bebtelovimab can be given to adults and pediatric patients (>12 years of age and weighing at least 40 kg) who test positive, present higher risks for progression to severe COVID-19, and for whom alternative FDA approved treatments aren’t accessible or appropriate. For example, the CDC considers patients with diabetes, cancer, COPD, obesity and more into this category.
When Bebtelovimab is appropriate, the single IV infusion is administered in a controlled setting where health care providers can monitor patients and treat any possible reactions.
Naturally, when something works, we wonder where else we can use it! Many patients ask about using mAb for post-exposure prevention. While there is no FDA-approved post-exposure prophylaxis, there is prevention for high risk patients who may be exposed in the future. On December 8, 2021, the FDA issued an Emergency Use Authorization (EUA) for a medication that does act as a pre-exposure prophylaxis (PrEP) of COVID-19. It’s called Evusheld (tixagevimab/cilgavimab) and it’s a long-acting mAb approved for use in adults and children >12 years, and weighing at least 40 kg (88 lbs.), with certain high-risk, immunocompromised conditions.
While we can’t always control exposure to COVID-19, preventing disease progression could prove to be our biggest weapon. Currently there is a study underway to determine if mAb therapy can reduce the number of patients who develop what many call “long COVID” or post-acute COVID-19 syndrome (PACS.) Long COVID is associated with significant morbidity, decreased quality of life, mental and behavioral health impact and healthcare cost. In a meta-analysis of studies of hospitalized COVID patients, 70% reported long covid symptoms after 60 days. The hope is that by defending against disease progression in the first place, early mAb therapy could significantly reduce the amount of people who suffer long term.
For more information about monoclonal antibody treatments for COVID-19 visit: https://covid-19-therapeutics-locator-dhhs.hub.arcgis.com/.