This week it was announced that Eli Lilly’s Bamlanivimab (try saying that three times fast) antibody appears to significantly reduce the risk of getting sick with COVID-19.
The results were based on the ongoing BLAZE-2 clinical trial that has so far shown an 80% reduction in risk for COVID-19 in nursing home residents, and an overall 57% reduction among staff and residents.
The study is a collaboration between the National Institutes of Health (NIH), Eli Lilly, and the COVID-19 Prevention Network (CoVPN).
Bamlanivimab was the first antibody authorized by the FDA to treat COVID-19. The antibody received emergency use authorization (EUA) just before Thanksgiving after showing a significant decrease in the risk of hospitalization and death from COVID-19, but only if given in the early stages of illness and only in non-hospitalized patients.
The recently released data indicates the treatment can also help prevent people from getting sick in the first place. This could be a game changer for people with compromised immune systems and others who are at high risk but don’t yet have access to a vaccine. That’s a lot of us.
It was expected that after former president Trump was treated with a similar therapy manufactured by Regeneron, and sang its praises, there would be a mad rush by doctors and the public to get a similar treatment.
New data indicates the treatment can also help prevent people from getting sick in the first place. This could be a game changer for people with compromised immune systems and others who are at high risk but don’t yet have access to a vaccine. That’s a lot of us.
The federal government purchased more than a million doses for distribution, and Medicare will cover and pay for the treatment during the COVID crisis. That hasn’t been enough for doctors and patients to take advantage of this potentially life-saving treatment, however.
Healthcare systems are too overwhelmed with sick COVID-19 patients
Because the antibody is recommended to prevent and treat COVID-19, healthcare providers must have space and protective measures in place to treat sick patients without exposing others to COVID-19. They must also be willing to use their limited space, staff, and personal protective equipment, such as hard to find masks and gloves, to treat people who are not yet sick.
This comes at a time when overwhelmed and exhausted hospital staff are already dealing with a shortage time and beds as COVID-19 cases have spiked around the country since the holiday season, now reaching a record 3.3 million with over 39,500 deaths.
Unfortunately, underserved communities with low-resource hospitals and clinics, the hardest hit with COVID-19, are even less likely to provide patients access to the therapy.
Timing and eligibility must be just right for the new COVID-19 antibody treatment
Bamlanivimab is currently only available to individuals 65 years or older or those with specific high-risk factors, such as hypertension or asthma. Additionally, for those sick with COVID-19, symptoms must be mild to moderate. Patients who have been hospitalized or who need oxygen as a result of COVID-19 are not eligible to receive the treatment. This is because clinical trials did not show a benefit to patients with advanced symptoms, and studies suggest the treatment may even cause harm in more critically ill patients.
Complicating things is that a person who is sick must be treated within 10 days of the start of their symptoms. The sooner the better. That means there is little time between symptom onset, getting tested, receiving results, then scheduling and receiving treatment.
Unfortunately, it seems counterintuitive for people to seek out treatment when their symptoms are only mild to moderate. It’s been my experience with friends and family who became sick and were at high risk for complications, that people experience a sort of optimism bias. They think they’re less likely to experience a bad outcome than others in a similar situation and prefer to take the “wait and see” approach. Of course, by then the window of opportunity has likely closed.
COVID-19 antibody treatment requires IV infusion and staff time
Another hurdle is that the antibody therapy must be given through IV infusion. This can be time consuming. The infusion takes about an hour, with an hour of required observation afterwards.
Although rare, antibody infusion therapy carries a risk of an immune reaction. Healthcare providers must be prepared with medications on hand, be trained to recognize early symptoms of a potentially dangerous reaction, and have the ability to immediately activate the Emergency Medical System if necessary.
All of this might have been manageable under normal circumstances, however, the COVID pandemic has put immense pressures on health care staff. As a result, some hospitals and clinics have turned down the treatments.
At the recent Precision Medicine World Conference COVID-19 meeting, Dr. Anthony Fauci suggested that one solution might be to have dedicated infusion clinics for administering COVID-19 antibody therapies. There appear to be no plans for these in the near future, however.
People experience a sort of optimism bias. They think they’re less likely to experience a bad outcome than others in a similar situation and prefer to take the “wait and see” approach. Of course, by then the window of opportunity has likely closed.
Doctors and the public have been hesitant to use antibody treatments for COVID-19
COVID-19 antibody manufacturers, such as Eli Lilly, expected a mad rush leading to treatment shortages. That didn’t happen. In addition to concerns among doctors about limited staff and resources, news outlets have also reported hesitancy on the part of doctors to prescribe this and other antibody treatments that are is still in clinical trials. There are also doctors who still aren’t aware of the new treatment, or don’t know much about it.
Not all the news is grim, however. More and more providers appear to be using the antibody. Also, anecdotal evidence from news reports seem to indicate that health care providers who are administering the treatment are seeing similar benefits as those seen in the clinical trial.
Should you or a loved one get bamlanivimab therapy?
This is a lot of information to take in and data is just now coming in about bamlanivimab and other antibody therapies for COVID-19. Here are a few things to consider:
The FDA gave authorization for the use of bamlanivimab based on preliminary information from over 800 study participants that there appears to be a benefit to taking the treatment before being sick. They decided the risk of authorizing the treatment before the end of the clinical study outweighed the danger of high-risk people getting sick with COVID-19.
The safety profile of bamlanivimab is so far similar to that of the placebo arm. According to NIH’s Treatment Guidelines Panel there were two cases of severe reactions seen among the 850 participants who have received bamlanivimab as part of the study. Both stopped the therapy and have recovered after treatment.
That being said, the Guidelines Panel also stated that at this time, they could not recommend that bamlanivimab be given as standard of care treatment since the number of people it’s been tested on is still relatively small. They encourage healthcare providers to discuss participation in the clinical trial with their patients.
If you’re at increased risk for severe COVID-19, find out whether your doctor offers the treatment and be sure to discuss potential risks and benefits specific to you.
Wishing you health and wellness this year.
Curious about how to pronounce bamlanivimab? Check out the video below:
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Disclaimer: I am a biomedical scientist by training, and am not an expert in vaccines, infectious diseases, epidemiology, or drug development. Information about COVID-19 is constantly evolving. For the most reliable and up-to-date information, please talk to your doctor or visit the CDC or FDA website.