What's the alternative for those who are at high risk of being hospitalized or experiencing permanent damage from covid? Until there is a clear alternative, this drug probably isn't going anywhere.
Despite the phrasing of this title there's always been a better alternative and the problems were well known. Paxlovid is better in every way and it was approved for sars-cov-2 first.
Molnupiravir should never have been approved for sars-cov-2 caused covid-19 for out patient use. It was never given except in the context of supervised hospital care for other viral diseases. There's an argument that it could've been approved for this limiting situation but out-patient use was and is absurd.
Clinical data supporting this EUA are based on data from 1,433 randomized subjects in the Phase 3 MOVe-OUT trial (NCT04575597). MOVe-OUT is a randomized, placebo-controlled, double-blind clinical trial studying LAGEVRIO for the treatment of non-hospitalized patients with mild-to-moderate COVID-19 who are at risk for progressing to severe COVID-19 and/or hospitalization. Eligible subjects were 18 years of age and older and had one or more pre-defined risk factors for disease progression: over 60 years of age, diabetes, obesity (BMI ≥30), chronic kidney disease, serious heart conditions, chronic obstructive pulmonary disease, or active cancer.
>On December 22, 2021, the FDA issued an EUA for emergency use of PAXLOVID for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg)...
And from your linked document,
>LAGEVRIO™ (molnupiravir) capsules, for oral use Original EUA Authorized Date: 12/23/2021
Paxlovid was approved 1 day before molnupiravir. Everything I said was true.
I think you're confused. What I am complaining about is that it was used for out patients for sars-cov-2 infection leading to covid-19. We both agree that happened and I am saying that is bad and unprecedented usage outside of supervised hospital care.
Molnupiravir was never given except in the context of supervised hospital care for other viral diseases. And your link does not disprove that. My knowledge about Molnupiravir is not direct, but only from the research I, and others on IRC did, back in 2021. It is much harder to research this now with all the sars-cov-2 studies improperly using the drug muddying the results. But I assure you, your search will be 99% in-patient usage for other viral diseases. This usage is weird. And it was available only after paxolovid was approved.
Right, the Phase 3 MOVe-OUT trial (NCT04575597) was done in outpatients prior to approval, so to say it was never used in outpatients prior to approval is not accurate. Use in hospitalized patients may have been the focus of research with molnupiravir before the MOVe-OUT trial, but that does not prove that molnupiravir should not be used in an outpatient setting.
That's uselessly pedantic. Yes, the approved out patient usage for sar-cov-2 emergency was out patient in testing too. How could it be otherwise?
But it was never used as an out patient drug in prior studies or FDA approvals for other viral infections. I'm starting to think you aren't debating in good faith...
Paxlovid apparently has interactions with a large number of relatively common medications, Molnupiravir does not (and one would hope it is only being used in cases where paxlovid is unavailable).
> Sarah Otto, an evolutionary biologist at the University of British Columbia in Vancouver, Canada, says the paper is another blow to the continued use of molnupiravir. She notes that a large-scale UK study found that the drug had no effect on hospitalizations or deaths
I read the article and my point still stands. Put yourself in the shoes of the patient (who largely drives their own care for these situations). You get covid, you go into the dr with a cough and say "dr, this is getting bad, and I'm obese and scared!"
The dr goes, "well, we have this drug that was proven to be slightly effective in double blind placebo controlled trials. It has no adverse side-effects. But a large scale study showed it might not actually be effective. Would you like to try that?"
The patient, who is probably on medicare or hit their deductible, is going to say yes give me that shit.
People have been saying this same thing about the over-prescription of antibiotics for ages but nothing has changed.
Might I say the unsayable with not too scared to lose weight?
Perhaps doctors should be ignoring the pride of their patients and telling them, after 3 years, to take their health seriously instead of waiting for the grim reaper to knock on their door? Doctors are also able to prescribe weight loss drugs, surgeries, and generally tell people what they really need to hear so we might ask why the problem persists. Maybe it's because they don't listen to advice they don't want to hear. From [1]:
> The researchers found that disagreement between GPs and patients increased with patients' excess weight and was particularly pronounced for advice given by GPs on weight and lifestyle issues. Overweight patients were more likely to disagree with their GP regarding advice given on weight loss (odds ratio, 10.7), advice given on doing more physical activity (odds ratio, 1.9), and nutritional advice (odds ratio, 2.9) compared with patients with a "normal" body mass index.
I'm not suggesting doctors be rude, and, as that study points out, if doctors are taking such steps and obese patients ignore them and it harms the relationship then should we not be considering other things to push them?
Some people propose sugar taxes and the like but I think that still pushes responsibility away from the main cause of the problem, which is the person. Obese people should pay higher taxes and/or insurance fees that are then mitigated by efforts such as slimming classes, gym attendance etc.
Or, we can continue to allow a section of society to risk their own health and mortality while putting enormous strain and cost on the health service and thus risking everyone's health and mortality. Arguing about a drug that most of them wouldn't need if they weren't obese seems a bit like rearranging deck chairs on the Titanic to me, even if they do need rearranging.
>There are 636 drugs known to interact with Paxlovid (nirmatrelvir/ritonavir), along with 5 disease interactions, and 2 alcohol/food interactions. Of the total drug interactions, 236 are major, 360 are moderate, and 40 are minor.
Of these interactions, several are with: statins, blood thinners, hormonal birth controls, and other heart medications. The exact high-risk population who is taking these drugs, have potential interactions with paxlovid. That wipes out a significant portion of the general population from eligibility.
636 interactions sounds impressive.
But almost any drug that’s been around for a while (like Ritonavir has) will have hundreds of interactions listed.
Drug interaction databases aren’t complete nonsense, but you should take them with a huge grain of salt.
The vast majority of those interactions won’t prevent a physician from prescribing Paxlovid, and for most of the rest there are either alternatives or patients can lower dosages or stop taking them for the duration of treatment.
For better or worse, I'm fairly certain statins do prevent drs from prescribing paxlovid on occasion. Happened to a family member. Tons of high risk / older Americans are on statins.
There are statins that can be taken with Paxlovid. The general recommendations are to either to stop taking them 12 hours before through a few days after treatment or switch temporarily to one of the statins that can be take with Paxlovid.
I agree that in an ideal world, drs would recommend your course of action. I am not debating that statins can be stopped and paxlovid taken, with statins resumed after the disease has run its course. that doesnt change the fact that doctors will still hesitate to prescribe paxlovid if their patient is on statins. This could be for a number of reasons - but consider for a second that up to 55% of seniors are already noncompliant in listening to their drs and taking their medication.
When you are asking a patient to stop taking a drug that they have habitually taken for potentially decades, and they have shown hesitancy or inability to comply in the past, maybe prescribing a drug with a potentially serious interaction isnt the best course of action.
Your argument has now went from: significant portion of the population aren't eligible, to: doctors might hesitate to prescribe it to old people because old people can't follow instructions.
We were talking about a hypothetical situation where someone is scared because they high risk.
The Doctor can A--tell that person to change their medication (they don't have to stop statins, not all statins can't be taken with Paxlovid) for 2 weeks and take Paxlovid.
Or B they can take Molnupiravir, which worst case doesn't do much, and best case is much less effective than Paxlovid. Also Molnupiravir has mutagenic effects (which granted probably aren't as much of a concern for someone 65+).
Molnupiravir was approved based on early data that showed it was much more effective than it has proven to be, and at a time when Paxlovid production hadn't ramped up yet.
It very likely wouldn't be approved if it were being evaluated today.
Based on it's potential to produce more variants, and it's not widely studied mutagenic effects, keeping it around because some doctors might hesitate to prescribe Paxlovid to a subset of old people seems less than ideal.
No, my argument is still that a significant portion of the population is ineligible. The anecdote above is just to help you understand a large piece of that ineligibility. If you want to understand that ineligibility yourself, feel free to take the fda checklist and add the populations within each exclusion and see how many tens of millions of people that is:
https://www.fda.gov/media/158165/download
Or better yet, a N100 or equivalent half-face respirator, which will likely be more comfortable because of the soft elastomeric seal, as well as being more effective.
