The U.S. government recently advised those with COVID-19 and at risk for serious complications to ask their health care provider about one of the monoclonal antibody therapies authorized by the U.S. Food and Drug Administration in November for emergency use.
The outpatient therapies, Eli Lilly’s bamlanivimab and Regeneron’s casirivimab and imdevimab (REGEN-COV2), contain laboratory-made antibodies designed to mimic the body’s immune system and block the virus that causes COVID-19 from infecting cells. President Donald Trump was given REGEN-COV2 when he tested positive in October. The therapy’s potential for lessening the severity of the disease was widely promoted at the time, but the federal government has seen little demand for the doses it has stockpiled.
Baystate Medical Center’s Chief Medical Officer, Dr. Doug Salvador, who trained in infectious diseases at Beth Israel Deaconess Medical Center in Boston and serves as chief quality officer of Baystate Health, was asked about the therapies and why they have not been more widely used.
What do you think of United States Secretary of Health and Human Services Alex Azar’s advice during a recent press conference to people 65 and over with underlying medical conditions who test positive for COVID-19 to ask their health care provider why they are not being given one of the antibody therapies?
I think that patients with newly diagnosed COVID should discuss monoclonal antibodies as a treatment option. Not all patients will qualify based on the indications for the drug. Some patients will hear about the drug and choose not to take it because this treatment is still experimental and not the recommended standard of care for all patients. Some, after hearing all of the information and understanding their options will opt for the treatment. That is why we have worked to make it available to the people of Western Massachusetts.
There was much interest at the time in these laboratory-produced antibodies designed to block the virus’ ability to infect cells, but apparently much of the government’s 300,000 doses of each drug has not been administered. What happened? Studies have shown the drugs not to be effective in hospitalized patients whose complications require oxygen therapy, but is there still not enough evidence of their effectiveness for infected patients at high risk for complications?
Unfortunately, there is very limited data on the effectiveness of monoclonal antibodies at this time. As far as published data from clinical trials, there is information from fewer than 1,000 patients who have received the drug. The available data indicates that the drug may prevent emergency room visits and hospitalizations in patients with mild symptoms of COVID when given early in the disease course. We have no long-term safety data and no data has been published from Phase 3 trials yet. We have a lot more to learn about whether or not these drugs work and in which patients. The initial data are promising, but definitely inconclusive.
How much of a challenge is presented by the fact that these drugs have to be given fairly early on to COVID-positive patients at high risk for complications for providers in terms of identifying patients and prescribing the drugs as well as the fact the drugs have to be infused intravenously in an outpatient setting?
The way the antibodies work tells us that they are likely to be most effective very early in the infection. This poses a massive challenge for patients, physicians, and the health system. There are many places in the country where people can get a test and wait days for the result. We have done better than that in most of Massachusetts, but there are still so many steps from getting a diagnosis to completing an infusion. It involves identifying patients with early infections, talking to them to see if they qualify based on their age, body mass index, and health conditions, having an in-depth conversation about the pros and cons of taking the drug and getting to a decision. After this, they have to be scheduled for an available slot at one of the relatively few infusion centers in the state, and finally make arrangements to safety get to the infusion center.
Has your hospital/providers been involved in the drugs being prescribed and administered to patients?
Baystate Health is one of two health systems in Western Massachusetts, along with Berkshire Health that began infusing monoclonal antibodies shortly after they were made available by the commonwealth.
If so, what results have been seen?
We have been able to successfully infuse almost 50 patients in less than a month. We’ve learned how to manage the complex steps I described and it has been done safely. We have seen only a few minor reactions to the infusions.
What advice would you offer providers in prescribing these drugs? Do you see them as an effective form of treatment for infected patients at high risk?
For any providers interested in offering these infusions, I would recommend bringing together a team of people to plan ahead. They should include nurses, pharmacists, people who run clinics or infusion centers, and infectious diseases experts. The group will have to reach out to local primary care physicians and testing centers and open up lines of referral. It is very important to have expert communicators to spend time with patients to explain the pros and cons in what we call a ‘shared decision-making’ process. Because this is not yet the standard of care, we want to make sure that patients get all the information and make the decision that is best for them. The group needs to think about how to safely get patients to the clinic because every patient receiving the infusion will have COVID infection and can spread it to others.
We don’t yet know if this is an effective treatment. There is promising preliminary data and we are all hopeful that this will prevent people with early mild illness from deteriorating and needing to be in the hospital.
What advice would you give patients who might be eligible for these therapies?
I’d tell patients to take the time to understand the possible benefits of getting this drug, but also the potential side effects like allergic reaction. Ask questions about it. Understand that this drug is still experimental.