There is now a treatment option for those recently diagnosed with COVID-19, who are at risk of hospitalization and meet certain guidelines. Iroquois Memorial Hospital’s Pharmacy Director, Michael Sandsmark, discusses these groundbreaking treatments, and how they will benefit, not only patients, but healthcare as a whole.
Bamlanivimab and REGN-COV-2 are new outpatient infusion therapies. As Sandsmark explains, “These new treatments are Monoclonal Antibodies. Basically, our immune system naturally develops antibodies to combat viruses. These antibodies [Bamlanivimab and REGN-COV-2] are specific to COVID-19. So, it’s augmenting what your immune system creates on its own, by giving you those extra antibodies to help combat the COVID-19 virus. A lot of people have probably heard of the COVID-19 spike protein in the news. It recognizes the spike protein of COVID-19 and then prevents that spike protein from attaching to our cells and infecting us.” The goal of these monoclonal antibodies is to slow the progression of COVID-19 and prevent hospitalization.
There are certain protocols which need to be followed, in order for a patient to obtain this treatment. First, the patient needs to react fairly quickly. The monoclonal antibody treatments must be administered to the patient within ten days of testing positive for the COVID-19 virus and before the patient is hospitalized. So, as per usual, the second that someone starts showing symptoms or thinks they’ve come in contact with another individual that had COVID-19, it’s important to get tested right away. Next, there are certain “high risk qualifications” the patient has to meet, in order to receive the treatment. If these criteria (outlined in the figure below) are met, you may be prescribed one of these monoclonal antibody therapies by your primary care provider or an emergency room physician. After receiving the therapy, you would then be monitored for an hour and then sent home. As Sandsmark puts it, “It’s for outpatient use only, not for those already admitted in the hospital. We have patients that come to the ER, test positive for COVID-19 and then are sent home because they are not sick enough to be admitted. Now we can administer this drug, monitor the patient for an hour and then send them home. The goal of the drug is to prevent possible progression and lessen the overall severity of COVID-19 infection. These are patients that have tested positive with mild to moderate symptoms, but are at high risk. Some drugs have to be administered within hours of testing positive, this infusion is within 10 days, because we’re looking to prevent that steady decline over weeks, that we see in some patients.” It’s important to remember that Bamlanivimab and REGN-COV-2 are not cures, they just give your body assistance in fighting off COVID-19 so that your condition improves, rather than worsens.
As with any new treatments or vaccines, the safety and effectiveness is researched and evaluated by the manufacturer and the U.S. Food and Drug Administration (FDA) prior to approval. However, due to the unprecedented nature of the pandemic, the FDA has authorized emergency use of these therapies to a wider segment of the population. Early studies show the risk of subsequent hospitalization was lower in those receiving Bamlanivimab and REGN-COV-2 when compared to placebo. More facts on studies and results are presented in the figures below. The side effects of these treatments are minimal. “As with any drug there’s a risk of anaphylaxis – having an allergic reaction to it. So it’s an hour long infusion and then we watch them for an hour afterwards. As for other side effects, the rates are really low.”, says Sandsmark. In a resource from the FDA, “Frequently Asked Questions on the Emergency Use Authorization for Bamlanivimab”, the FDA stated, “The most commonly reported (in 2-4% of subjects) adverse events during these trials were nausea, diarrhea, dizziness, headache, pruritus, and vomiting. Clinical studies evaluating the safety of Bamlanivimab are ongoing, so it is possible all of the risks in using the drug to treat COVID-19 are not known at this time.” Although still being investigated, the outlook of Bamlanivimab and REGN-COV-2 looks promising. This is especially true when looking at the decline in hospitalizations we’ve seen already and the low chance of side effects.
In addition to all other information presented on Bamlinivimab and REGN-COV-2, Sandsmark feels it’s important to note, “If you get one of these monoclonal antibody treatments, it is advised to delay getting the COVID-19 vaccine for 90 days. It’s better if you wait, because you’re going to get a better immune response once the monoclonal antibodies have left your system. It would be rare to get COVID-19 again within those 90 days anyway.” Although you will have some natural immunity from already having COVID-19, it’s still important to get the vaccine once those 90 days have passed.
By this point we know the obvious benefits of Bamlanivimab and REGN-COV-2, which is people not severely declining as a result of COVID-19, giving them a better chance at fighting off this deadly virus. However, the benefits of these cutting-edge monoclonal antibody therapies don’t stop there. When asked why these new therapies were so groundbreaking, Michael Sandsmark stated, “Mainly because it can prevent that slow progression we’ve seen with COVID. A lot of times when people have tested positive, they stay at home for 4 or 5 days. Then they get short of breath and think ‘Oh, I’m just sick’. Next thing you know, it gets to be day 9 or 10, they show up in the ER and by that time they’ve got pneumonia and you’re scrambling to give them antibiotics, steroids, etc. This could prevent that potential severe progression. It also has the benefit of preventing those hospitalizations when hospitals are full, have limited resources, and everybody’s taxed to the max.” Healthcare heroes across the world have been tested and pushed to their limits this year. With countless hospitals at full capacity, shortages on supplies such as PPE, ventilation machines, etc., and now working to get vaccines out, the emergence of Bamlanivimab and REGN-COV-2 could give everyone the small break that’s been long overdue.
Even though these monoclonal antibody treatments are still being investigated, looking at what we know so far, Bamlanivimab and REGN-COV-2 are viable options when faced with the possible steady decline and hospitalization of COVID-19. Be sure to consult your physician when faced with the decision, and know that Iroquois Memorial Hospital is here to help if the time comes that you need these cutting-edge therapies. If you or a loved one needs to be tested for COVID-19, call the Iroquois Memorial Hospital Laboratory at 815.432.7795 to schedule an appointment and receive further instruction.