The treatment landscape for COVID-19 has dramatically changed in the last few weeks primarily for the better. On December 22, 2021, the US Food and Drug Administration issued a EUA for Pfizer’s antiviral pill, Paxlovid the first treatment for COVID-19 that can be taken by mouth.
The drug was authorized for the treatment of mild to moderate COVID-19 in adults and children >11 years of age “with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.”
Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations. Paxlovid is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together by mouth twice daily for five days.
Paxlovid looks to be very effective. In a randomized controlled trial in non-hospitalized unvaccinated symptomatic patients with confirmed SARS-CoV-2 it reduced the proportion of people with COVID-19 related hospitalization or death from any cause by 88% compared to placebo among patients treated within five days of symptom onset.
Fact sheets regarding dosing, side effects and drug interactions (of which there are many) are available for healthcare providers and to patients and caregivers.
Pavloxid has rapidly become the outpatient treatment of choice as the NIH updated their COVID-19 guidelines on December 30, 2021 to state:
The Panel’s current outpatient treatment recommendations are as follows (in order of preference):
- Paxlovid (nirmatrelvir 300 mg plus ritonavir 100 mg) orally twice daily for 5 days
- Sotrovimab 500 mg, administered as a single intravenous (IV) infusion
- Remdesivir 200 mg IV on Day 1, followed by remdesivir 100 mg IV on Days 2 and 3
- Molnupiravir 800 mg orally twice daily for 5 days
Molnupiravir, Merck’s antiviral pill, was approved December 24 but as it was less effective in trials than paxlovid it was placed fourth on the preference list after the intravenous monoclonal antibody sotrovimab and the IV antiviral remdesivir.
For a good discussion comparing Paxlovid to Molnupiravir I recommend Josh Bloom’s article at the American Council on Science and Health.
Treatments That Now Appear Not Promising
In a December 16 update, the NIH recommended against using convalescent plasma and flovoxamine, previously promising treatments, but with more recent disappointing trial results:
- The Panel recommends against the use of COVID-19 convalescent plasma for the treatment of COVID-19 in hospitalized patients without impaired humoral immunity.
- There is insufficient evidence for the Panel to recommend either for or against the use of COVID-19 convalescent plasma for the treatment of COVID-19 in:
- Nonhospitalized patients without impaired humoral immunity; and
- Nonhospitalized or hospitalized patients with impaired humoral immunity.
Based on the current evidence, the Panel continues to find that there is insufficient evidence to recommend either for or against the use of fluvoxamine for the treatment of nonhospitalized patients with COVID-19.
The New York Times has a frequently updated document (The Coronavirus Drug and Treatment Tracker) which gives a concise summary of the background, development and supporting trials for each of the many proposed treatments>
It puts them into the following categories
Of note, ivermectin and hydroxychloroquine, drugs that continue to have passionate advocates are appropriately in the NOT PROMISING category because the preponderance of scientific evidence does not support their efficacy. Now that we have a proven oral treatment, hopefully, the use of these drugs to treat COVID-19 or as chemoprophylaxis for COVID-19 will cease.
Monoclonal Antibodies (the mabs) Rise and Fall
Regeneron’s REGEN-COV was a very promising monoclonal antibody treatment that seems less effective against the Omicron variant and thus has fallen out of favor.
The monoclonal antibody developed by GSK, sotrovimab on the contrary has shown effectiveness against Omicron which accounts for its position in second place on the outpatient treatment priority list.
After the discovery of the Omicron variant, GSK announced that experiments on cells suggest that sotrovimab will remain effective against it. With Regeneron and Lilly’s compounds performing poorly against Omicron, the Biden administration began scrambling to get more doses of sotrovimab. GSK is expected in January 2022 to deliver 300,000 more doses to the United States.Per
Are you at High Risk? Do you Qualify for Treatment?
Who among us is at sufficiently high risk that we should take these drugs to prevent hospitalization due to COVID-19?. It depends on age and if you, like me, are >65 years of age you don’t need any other factors. here’s the HHS chart breaking it down
Note that obesity defined as a BMI >35 makes you high risk independent of age. There are some conditions I don’t think should be considered high risk on here, namely hypertension and asthma. There are also incredibly vague conditions like “heart or circulatory disease.” I tell my stable coronary disease patients without heart failure they are not a high risk for serious COVID-19.
If you click on the little red button at the bottom (mab treatment locator) and answer a few questions to determine your risk it will show facilities close to you that may be able to give you monoclonal antibodies
The supply of Paxlovid will be limited for a while. Apparently, some Walgreens have a small amount. Clearly, these early doses should be prioritized to the most high-risk patients. This government site lists COVID-19 therapeutics available in the community.
I have only discussed outpatient treatments in this post. The inpatient treatment options are also much improved but a lot more complicated. The NY Times article goes over them in detail. It is also likely that what I have written today will be substantially different a week from now as science advances in the crusade against COVID-19.
Sanguinely Yours,
-ACP
12 thoughts on “Tracking the New Outpatient Treatments For COVID-19 in Early 2022: We Have an Effective Pill!”
does it matter whether or not you are vaccinated and boosted , re the choice to treat the high-risk patients or not wit these new meds ? given the excellent protection of vaccination against hospitalization and death, and the relatively benign nature of Omicron, why give them these additional meds? i would think the meds should be reserved for those who REFUSE vaccination ? thoughts?
gpokmd,
You make a great point which does not appear to have been addressed by CDC/NIH/FDA. If we take two individuals of the same age with identical comorbidities/high risk factors clearly the vaccinated individual is at much lower risk for developing severe COVID19 requiring hospitalization/death.
It is interesting in light of this that 1) unvaccinated state is not listed as high risk factor 2) the unvaccinated may be less likely to accept the pill
From NY Times…”There is also a risk that Americans most in need of the pills will refuse them, just as they have spurned vaccines. About half of unvaccinated adults polled by Morning Consult said they would not take F.D.A.-authorized antiviral pills if they got sick with Covid.”
Dr. P
What’s the over/under that the new EAU pills will be just as ineffective and unsafe as the EAU “vaccinations”?
Pfwag,
The manner in which your question is posed suggests you would be an individual like the ones I mentioned in my reply to gpokmd: Unvaccinated, therefore higher risk for serious complications of COVID and also reluctant to take proven effective pills.
These are the people filling our ERS and hospitals right now
Dr. P
I have sone information indicating this drug is not the best for those taking BP MEDS-
-and Eliquis for a- fib.
I have seen information that the interactions of the Pfizer treatment are especially serious for afib medications – can you discuss this? Thanks!
David,
Ritonavir, the component of paxlovid which functions as a booster, is known to strongly inhibit the metabolizing enzyme CYP3A. The drug interactions are with other drugs which are metabolized by CYP3A.
There are a lot of cardiac drugs on the NIH list (https://www.covid19treatmentguidelines.nih.gov/therapies/statement-on-paxlovid-drug-drug-interactions/) This includes the antiarrhythmics amiodarone, dronedarone,flecainide, propafenone, disopyramide, quinidine. These are used to maintain SR in patients with afib,. . The blood thinner rivaroxaban (Xarelto) which is indicated to prevent stroke in afib patients is on the list but Eliquis is not.
Certainly, if you are on any drug on this list your physician should know that and make adjustments accordingly.
Dr P
Thanks! I’m currently on one of those antiarrhythmics and a rate control drug as well. So this is a red flag for me. I’m planning to continue to lie low and get any additional boosters. But I’m wondering if some kind of treatment recommendations will become available, such as cutting back on the antiarrhythmics for the five days and “riding it out” if necessary, or the relative risk/reward involved.
David,
Every patient is unique with afib. For some of my patients the approach you describe makes sense. For others likely not. The topic is sufficiently complicated that I may be stimulated to write a post outlying strategies based on the drugs involved.
Dr P
Flecainide is also on the no-go list. No luck me.
So, if an oldster such as myself gets some nasty variant or other and finds that Paxlovid is available, do I risk arrhythmia or do I risk ICU and possible death?
Ah, but Paxlovid is going to be rare for a while. Ordering millions is not the same as receiving them.
https://www.science.org/content/blog-post/making-paxlovid
Thank you for another timely update TSC. To answer the question that everyone will be asking after the ask if they can get the treatment: $529 per course.
Dan,
good to know. Hopefully insurance will cover the majority.
Dr P