Although many people who contract COVID-19 are asymptomatic or minimally symptomatic, an alarming number of others are still becoming acutely ill and dying from the virus. COVID-19 monoclonal antibody therapy increases the survival rate for these high-risk individuals. In fact, COVID-19 antibody treatments reduce hospitalizations and death in those aged 12 and older by 50% to 70%.
In order to qualify for COVID-19 antibody treatment, patients must receive the treatment within 10 days of symptom onset, demonstrate mild to moderate disease—in general, feeling well enough to be at home versus being admitted to the hospital. They also must have a confirmed positive COVID-19 test and be classified as high risk in at least one category. Common high-risk criteria include age, overweight or obesity; high blood pressure; pregnancy; heart, lung, or chronic kidney disease; diabetes; and compromised immune system.
The key is to receive COVID-19 antibody treatment as soon as possible after symptom onset. Most patients are symptomatic for at least a full week before they become severely ill and are admitted to the hospital. This is a window of opportunity for high-risk patients to lower their risk significantly of becoming severely ill from COVID or succumbing to it. In addition, it is an opportunity to lessen the strain on our local hospital staff.
Monoclonal antibody therapy isn’t a new treatment within the medical field; the U.S. Food and Drug Administration approved the first drug in this class in 1986.
Antibodies since have been widely used to treat cancer and autoimmune diseases such as rheumatoid arthritis and Crohn’s disease. A few examples include Humira to treat arthritis, Herceptin to treat breast cancer, and immunotherapy products, such as Keytruda or Opdivo, to treat a multitude of cancers. There are currently over 100 FDA-approved monoclonal antibodies in the U.S.
Three monoclonal antibody treatments have been authorized for emergency use by the FDA for the treatment of COVID-19. REGEN-COV consists of two antibodies, casirivimab plus imdevimab. This drug cocktail was approved first. It has the highest current production and the most robust data. Moreover, REGEN-COV is the most well-known due to Donald Trump receiving the therapy during his presidency. The final phase of a recent REGEN-COV trial showed a 71% reduction in hospitalizations or death and demonstrated a shortened duration of COVID symptoms by four days.
The distribution of another drug cocktail, bamlanivimab plus etesevimab, was paused in June because of concerns about the reduced efficacy with COVID-19 variants. As of Sept. 2, the use and distribution of these monoclonal antibodies has been resumed throughout the U.S. According to available data, bamlanivimab plus etesevimab may be less effective than REGEN-COV but is a viable option if REGEN-COV is unavailable.
Finally, sotrovimab was the latest to be authorized for emergency use in May of this year. Of the three available COVID-19 antibody treatments, sotrovimab has the least amount of data and history of use.
Although the first COVID-19 antibody treatment was authorized for emergency use approximately one year ago, availability has been severely limited to the general public based on many factors. Manufacturers cannot keep up with demand. Allocation of COVID-19 antibodies are based on the number of reported COVID-19 positive cases and drug utilization within each state and individual health care organizations.
Beyond supply and demand issues, high-risk individuals are waiting too long to seek treatment. During the first week of their illness, many patients don’t feel sick enough to contact their health care providers. Logistically, if they wait until day seven to seek treatment, they may not receive it before the 10-day window closes.
Additionally, many people are unaware of COVID-19 antibody therapy, so they do not address the treatment option with their health care provider.
Each patient needs to evaluate the risks and benefits to determine if COVID-19 antibody treatment is right for them. There is a very small risk of severe allergic reaction. Local reactions surrounding the IV site or sites that the medications are injected is common. In addition, long-term risks of the antibody treatment and impact on the body’s ability to fight off future COVID infections is unknown.
The World Health Organization recently updated its recommendations on COVID-19 antibody therapy to include patients with severe or critical illness who have not mounted an antibody response. The FDA is considering emergency authorization for these patients because of a 15% decreased risk of death. While this idea is promising, early treatment before development of severe illness and hospitalization is preferred.
Aside from antibody therapy, antivirals are also being used to treat COVID-19. Remdesivir is FDA approved to treat patients who are severely ill and hospitalized due to COVID-19. It is given intravenously daily for up to 10 days. It shortens recovery time by an average of five days.
The pharmaceutical company Merck plans to seek emergency use authorization from the FDA for molnupiravir, an antiviral COVID-19 pill that is taken twice a day for five days. It will essentially be the “Tamiflu” of COVID-19. Data from Merck’s recent phase 3 clinical trial suggests a 50% decrease in hospitalization and death with this therapy. The effectiveness is not as robust as the antibody therapy REGEN-COV, but it is appealing, as it will not require administration by nursing staff at a COVID-19 treatment site.
My practice is currently prescribing COVID-19 antibody therapy in both Washington and Idaho. With 15 years of experience prescribing antibody therapies and the accompanying medications for cancer patients, I have taken on the role as a COVID-19 antibody prescriber.
Every day that passes from the onset of symptoms that a high-risk individual is not prescribed COVID-19 antibody therapy, the odds of accessing treatment decreases. Individuals considering antibody therapy can visit the eVillageHealth website at www.evillagehealth.com where they can review the requirements for antibody treatment. Those who qualify should contact their primary care provider without delay.
Jessica Blackwell, who has 20 years of experience in health care, is the owner of eVillageHealth, a primary care practice currently accepting new patients from Washington and Idaho. She can be reached at 509.960.6527 or through her website at www.evillagehealth.com.
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