Q&A: Understanding treatment options for patients at high risk for severe COVID-19
Since 2020, COVID-19 has persisted as the third-leading cause of death in the United States.
Despite the emergence of new drugs and a better understanding of the disease, some confusion remains regarding the treatment of COVID-19. The relaxations of COVID-19 restrictions after multiple surges and variants of SARS-CoV-2 necessitates a comprehensive treatment plan for high-risk individuals.
Healio spoke with Vin Gupta, MD, MPA, a public health physician and professor at the University of Washington, to learn more about which patients qualify for COVID-19 treatment, how physicians should be caring for high-risk patients and how these patients have taken on more agency in their health care.
Healio: Who qualifies for treatment for COVID-19, and what exactly does “high risk” mean?
Gupta: This is a very important question. Typically, anybody who is aged 60 years and older. Just age alone will qualify or identify you as medically higher risk to potentially have a worse clinical outcome if you are exposed to COVID-19. Age or a significant underlying medical condition like poorly controlled diabetes, end stage renal disease requiring dialysis, cancer and things of that nature will make you high-risk. Chronic disease is a type of condition that, regardless of age, you're probably higher risk.
In some cases, it is black and white. If you have a cancer diagnosis, without question you are considered medically high risk. If that is not you and you are, for example, taking a few blood pressure medications, it's worth having a conversation with your medical provider to really better appreciate whether or not you'd benefit from something like Paxlovid (Pfizer) for COVID-19.
Ultimately, it is black and white if you are aged 60 years and older, you have a very clear immunocompromising medical condition like cancer, you're on chemotherapy or you're on a medication that diminishes your immune system response. If you're in the gray area and you don't know, you should discuss with your medical providers so you are prepared should you get COVID-19.
Healio: How can physicians quickly determine who is high risk?
Gupta: A clinician caring for a new patient needs to actively get to know that patient to understand their medical risks and their medical history. This is one of those things that if a provider is caring for a patient, it is on them to make sure that they understand very clearly what type of patient they are caring for to act appropriately. But the responsibility is also on the patient in this age that we live in. It is on the patient to empower themselves to make sure that their providers are fully aware of every diagnosis that they’ve been given and every medication that they are taking so that everybody is operating with the same information.
As a clinician myself, I do my best to make sure I know my patients. But the patient that I can give the best care to are those who are active and give me up-to-date information on their symptoms, medical status and anything else that may have happened recently that I may not be aware of so I can best optimize my therapy. Ultimately, it is on the patient to make sure that their providers are best informed.
Healio: If you decide to administer therapy, is there a window to start treatment? What does the evidence show regarding timing of treatment?
Gupta: Ideally, you want to start treatment as soon as possible after diagnosis of COVID-19 for somebody who's medically higher risk, regardless of their vaccine status. If you test positive, because you are medically higher risk, there's a chance you still may end up having a severe illness requiring hospitalization. It is vastly more likely if you are unvaccinated. If you are vaccinated, it is still possible. Either way, you want to get treatment as quickly as possible. The same day is perfect if that's possible. Logistically, that can be challenging given our medical system. Usually, there's some lags so ideally you want it within 72 hours of symptom onset. The time point is from start of symptoms if you're symptomatic.
The question is if you are asymptomatic, should you take Paxlovid or another therapy? That's where it's a little bit of a gray area. Technically, it's for people who are symptomatic with mild symptoms, not severe symptoms requiring hospitalization.
There are studies actively looking at whether or not treatment outside the 5-day treatment window would be appropriate or useful. I think this is going to be an area that we'll learn more about over time. However, right now, technically, we're not allowed to prescribe to someone with symptom onset out more than 5 days.
Healio: You mentioned Paxlovid. Are you recommending any other approved treatments to patients?
Gupta: In addition to Paxlovid, there is one treatment for somebody who's already diagnosed and symptomatic. It is called molnupiravir, developed by Merck. I don't offer that as often if at all because the data on that therapy relative to the data on Paxlovid is just not as strong. The molnupiravir data suggests that that medication was about 30% effective at reducing the risk for hospitalization if you're high risk and test positive with mild symptoms. In the case of Paxlovid, it had almost 90% risk reduction for hospitalization. All things being equal and given the knowledge we have right now, I want my patients to have the most effective therapy possible, and that's Paxlovid.
In terms of other therapies that exist, there are monoclonal antibodies; these IV infusions of premade antibodies that are effective at combating COVID-19, which have been used throughout the course of the pandemic with varying effectiveness. Omicron has changed how we think about those monoclonal antibodies. Currently, there are not any really effective therapies that exist in terms of monoclonal antibodies once you're diagnosed with COVID-19 because omicron has proven very clever at eliminating the effectiveness of the monoclonal antibody therapy.
There is one medication called evusheld (AstraZeneca). It is a prophylactic monoclonal antibody which may still be a great option for somebody who does not mount an appropriate antibody response to the vaccines, meaning that their immune system just does not respond to the vaccines the way somebody who is otherwise healthy responds. For those who are immunocompromised because of a condition like cancer or because of a medication, those individuals are likely to not get the same benefit from vaccines. This is where something like evusheld, a prophylactic antibody that helps give additional protection to somebody who's very immunocompromised, could be useful. This is for an individual who has not tested positive for COVID-19, who is not symptomatic and who is looking for additional protection to prevent infection. That still applies to omicron. So evusheld for prevention of infection for those that are immunocompromised is still very much something that I would highly recommend that individuals who are immunocompromised seek out and discuss with their medical provider regarding access as soon as possible. There is no reason why Paxlovid should not be administered to patients who were on evusheld. In terms of therapies, our toolkit right now is limited to these oral pills largely because omicron has negated the benefit of these monoclonal antibody therapies.
Healio: How can physicians help patients obtain treatment?
Gupta: I would recommend that patients go to the governmental website COVID.gov. When providers are trying to have a conversation with their patients about treatment, they should advise their patients, especially those at high risk, to plan about what they should do if they test positive for COVID-19 or become symptomatic and then test positive. COVID.gov is a good place to start. Identify places in your community that might have therapy like Paxlovid, or evusheld if you want to bolster your protection if you are high risk and have yet to test positive.
I recommend to everyone that if you consider yourself medically high risk because of your age or some underlying medical condition, go to COVID.gov and identify areas close to your home that might have something like Paxlovid so that you can make your provider aware. Then you and your provider can plan ahead. Each provider might have a different strategy as how to manage each individual patient but having that awareness is really important because I’ve seen some patients of mine or other providers be very proactive and actually guide the provider as to where supply exists. They have been very involved with their care or the care of their loved one. There is a lot of patient ownership right now. I ultimately think it’s a really good thing that patients are becoming more facile at navigating a complicated health system.
Healio: In terms of access, what are the barriers to getting treatment, and are there segments of the U.S. population that have a greater challenge?
Gupta: Awareness of therapy is still really low amongst patients. I think it's rising amongst providers. Often people just don't know about them and often that will be the case in more rural counties than in urban or suburban counties where there's probably a little bit more dissemination of this information and engagement with this information.
The fact of the matter is that supply is still very much constrained to pharmacies that have an urban footprint, both because of information dissemination and because of where the supplier for these medications exists.
There's going to be a lot of inequities as to who can and cannot and who will or will not seek out this therapy because of awareness and reasonable access. We're seeing that there's a lot of problems right now in terms of access because of geographic limitations. That's really impacting rural and suburban communities. I don’t think this has been proven yet, but I'm sure there's also a demographic component with communities of color, as they have throughout the pandemic suffered disproportionately from COVID-19. I'm sure our data will also bear out that the uptake of these medications is probably lower among communities of color compared with dominantly white communities. The typical population drivers that have explained discrepancies in COVID-19 burden will also help explain who is and is not benefiting from some of these therapies.