President Biden was diagnosed with COVID yesterday. He is vaccinated and double boosted, and his symptoms are said to be mild. Per CDC guidelines, he has begun taking Paxlovid, the anti-viral medication that reduces the risk of progression to severe disease. This seems a simple decision, but it isn’t for a number of reasons.
Paxlovid was shown to have impressive results in a pivotal trial of the unvaccinated. Even in this trial, when looking at the patients in the trial that already had evidence of antibodies to Sars-COV2, the benefit of Paxlovid was markedly attenuated. In the pivotal Paxlovid trial that lead to approval for widespread use, 98% of patients who had antibodies to COVID in their blood, who were given a placebo recovered from COVID.
Recent data from Pfizer, the manufacturer of Paxlovid, studied the use of Paxlovid in vaccinated individuals and found no statistically significant benefit in this population. The benefits in this population (that the President belongs to) are likely to be very, very small.
The President has non-valvular persistent atrial fibrillation, a condition that is associated with small clots forming in the heart and potentially causing a stroke. He takes apixaban, an anti-coagulant, to reduce his risk of stroke as a result. Apixaban is primarily metabolized in the liver by Cytochrome P450 3A4 (CYP3A4) so it can be eliminated by the body. One of the components of Paxlovid is ritonavir, a strong inhibitor of CYP3A4, which if taken with apixaban could significantly increase the levels of apixaban in the body. This would put patients on both medications at increased risk of bleeding. As a result, it is recommended to stop or reduce the dose of apixaban when Paxlovid is taken. In this particular case, President Biden’s physicians chose to stop apixaban completely per news reports, which does put him at an increased risk of having a stroke. The medical team is essentially saying that the small increase in the risk of stroke for the President of the United States is worth the reduction in risk of severe COVID that Paxlovid will provide.
If the news reports are accurate, it is interesting that the President’s physician chose to take him off of apixaban completely rather than reduce his dose of apixaban as is typically recommended. The president does have a history of brain aneurysms, but these were surgically addressed some time ago.
When you're asked as a cardiologist if it's ok to interrupt anticoagulation for a particular cardiac condition of a patient, the goal is generally to give some guidance about how risky that endeavor is. For a 79 y/o with persistent atrial fibrillation without any other major risk factors, the daily risk of stroke off of anticoagulation is very low, but an ischemic stroke in a 79 y/o would also be devastating. So the question turns frequently to why anticoagulation needs to be interrupted. Is it for an elective eye surgery that is relatively bloodless, or is it for a tumor in the brain? Bleeding into the brain is devastating, bleeding into the eye is bad, but not life threatening, and frequently can be controlled relatively easily. In the case of the President, his anticoagulation that protects him from having a stroke is being stopped per reports for 5 days so he can take Paxlovid. Remember, Pfizer noted no statistically significant difference in severe disease progression in vaccinated adults who got Paxlovid. So if Paxlovid is useful to the President, the benefit is at most exceedingly small. Given the stakes are potentially having a stroke, I'd probably recommend either not taking Paxlovid, or reducing the dose of apixaban to half if the medical team was adamant. Stopping completely? I wouldn't recommend it.
The medical team for the President are following the guidelines. But guidelines are best when interpreted by clinicians in the context of the particular patient. Hopefully, the political need to get the public health messaging right isn’t the primary motivation when dealing with the President’s health.
Anish Koka is a Cardiologist. Follow him on Twitter @anish_koka
Where are the irrefutable proofs that he:
1. Has been vaccinated; and
2. Has c19?
How come people don't "cross-examine" any claim made before they react anymore?
Dr. Koka
I remember early on with the Covid epidemic that some of the first fatalities that we saw at a hospital where I worked was with patients who had atrial fibrillation or severe coronary artery disease.
Covid also has a hyper-coagulation effect. It does seem very risky to stop coagulation of a geriatric patient with A-fib, especially with an infection that has severe hyper-coagulation effects.
I knew someone who was successfully treating patients with Covid hypoxia using hyperbaric oxygen therapy as an alternative to mechanical ventilation. One of his few unfortunate outcomes was a patient who had a pulmonary embolism despite HBOT having an anti-coagulation effect and the patient being on a heparin drip.