Treatment consists of 4 x 200mg molunpiravir tabs (eg, 800 mg) twice daily for 5 days.
Molnupiravir appears to be a teratogen
Avoid in pregnancy.
Breastfeeding is not recommended until 4 days after conclusion of course.
Men are advised not to cause pregnancy for 3 months after use.
Both agents appear to be well tolerated.
The most common adverse effects are GI upset, malaise, and dizziness, which overlap with the symptoms of COVID.
Who should get these drugs?
Not accounting for scarcity or contraindications, the EUA approval indications are relatively broad:
Positive test for SARS-CoV-2
Symptomatic for 5 days or fewer
High risk for progression to severe disease
Does not require hospitalization
The goal is to avoid treating people who would do well regardless, and catch high risk patients in the viral replication phase of their illness, which presumably is when the drugs are effective, prior to the need for hospitalization.
Who is at high risk of progression? The CDC maintains a list of high risk conditions that predispose to severe illness from COVID. It is relatively broad and includes cancer, disease of any major organ (heart, lung, liver, kidney, brain), diabetes, mood disorders like depression, high BMI, pregnancy, smoking or other substance use.
Because these medications are currently scarce, New York State, for example, suggests reserving Paxlovid for patients who are moderately to severely immunocompromised, or, those that are unvaccinated, over 65, with at least 1 additional risk factor for severe illness.
The latest NIH guidelines recommend these therapies in order of preference: Paxlovid, sotrovimab, remdesivir, and finally molnupiravir.
glenn b. - January 6, 2022 2:22 PM
During supply shortages shouldn't we limit these to *unvaccinated* high-risk patients? The studies done on the unvaxxed. The already vaxxed should be considerated relatively low risk for hospitalization/death.
Reuben Strayer (@emupdates) - January 6, 2022 4:02 PM
That is what the New York State guidelines I mentioned recommend. Here are the prioritization criteria NYS has come up with:
Ryan A. - January 7, 2022 2:48 AM
As of this writing, whenever I click on the "full image" button I get an "access denied" error.
Reuben Strayer (@emupdates) - January 7, 2022 6:25 AM
tom f. - January 9, 2022 12:59 AM
Excellent review. Short, clear, concise, informative, Brooklyn-like.
Hope all is not too chaotic at Maimonides.
Ps; i finally caught covid last week
Ky H. - January 11, 2022 2:14 PM
Thank you for this update.
Michael O. - January 13, 2022 3:35 PM
There seems to be decent evidence for inhaled steroids in the treatment of COVID (including this https://www.thelancet.com/action/showPdf?pii=S0140-6736%2821%2901744-X). However this is prohibitive due to cost. I have been trying to think of ways to decrease cost for these therapies and realized that steroid nasal sprays are $10-20 at most pharmacy locations. The cap of these allows for a 18 gauge needle to pass through and facilitates capture of the liquid when pumped. When mixed with a saline bullet this nebulizes well.
For Fluticasone 50 mcg/spray it takes 1.1 mL to get about 440 mcg
For Budesonide 32 mcg/spray it takes 1.75 mL to get 800 mcg
Nebulizers are available online for $40 to $60. Fluticasone is less expensive OTC and requires less volume. A single bottle would allow BID dosing for 7 days meaning for about $50 a patient could use this completely OTC strategy and based on the data hopefully decrease ED visits and Hospitalizations.
Do you know if anyone is doing this? I'd love to hear the thoughts from the EM:RAP COVID and Pharm experts!
Mel H. - January 13, 2022 3:59 PM
Michael I will ask Sean Nordt and the team about it
Anand S. - January 13, 2022 4:03 PM
Seems like data on inhaled steroids is mostly in terms of reducing cough - small benefit. No real reduction in terms of hospitalization or other important outcomes. I think if the patient's cough is really bad, this is a reasonable intervention (costs aside)
Andrew A. - January 19, 2022 9:52 AM
With paxlovid and "non-recommended" drugs such as calcium channel blockers,warfarin etc can we reduce these drugs by say 1/2 or what is the recommendation. Obviously with warfarin following the INR. Also if dose reduction is the recommendation, how long after the 5 day course should the reduction be continued (additional 24 hrs????). The warning by not contraindicated meds don't give any guidance.
Reuben Strayer (@emupdates) - January 19, 2022 10:01 AM
Hi Andrew, this is one of several thorny issues for prescribers. There is no guidance I'm aware of and I doubt there will be any guidance that applies broadly–the decision to hold or reduce a drug dose is going to depend on the individual patient and drug. For example, discontinuing a statin is probably not a big problem but discontinuing warfarin potentially is, and might be best done in collaboration with the patient's other clinicians.