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Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent

merck.com

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Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent

#221

Post by linuxftw »

rory wrote: post #86
lsternlicht wrote: post #43

Phase 3 trial was stopped on a positive interim analysis by DSMB and in consultation with FDA Interim analysis was performed on approximately half of the total enrolled patients (775 of the 1550). Trial included many delta and other variant patients ————— Efficacy • ~50% reduction in hospitalization (14.1% PBO vs 7.3% drug) • 100% reduction in deaths (8 PBO vs 0 drug) ————— Safety • fewer adverse reactions in the dru…

Is 40% adverse reaction to a placebo typical? Really makes me wonder how many "side effects" are in our heads..

That depends. In the case of vaccines, the placebo is often all the ingredients of a vaccines minus the biological component, or in other cases, an already approved vaccine is used as the placebo.

So, it's probably a poorly controlled study, or garbage results, or both.

Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent

#222

Post by mywittyname »

ruaraidh wrote: post #186
barbazoo wrote: post #162

Disclaimer: I'm not promoting Ivermectin here, don't get me wrong. I just want to cover my bases as this announcement is definitely going to be used by people to support their conspiracy theory. Earlier this year Merck the manufacturer of Ivermectin issued this [0] statement saying that Ivermectin isn't useful for preventing/treating Covid-19 and people shouldn't take it. Some people explained that with the fact that…

How could Merck stall those studies? Ivermectin is widely available, you don't need to get Merck's permission to use it in a study.

The FDA isn't immune to the same kind of corruption/conflicts of interest that impacts other federal agencies.

Scott Gottlieb worked at the FDA at a high level, before leaving for a stint in the private sector which included being a partner in a VC fund which invested in many medical startups. He left that to become the commissioner of the FDA under the previous administration. Gottlieb is currently on the board of Pfizer, and has relationships with several other companies in the pharma space.

It's not insane to think this person still has sway with people who are working within the FDA and are considering a move to the private sector.

Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent

#223

Post by linuxftw »

matt_heimer wrote: post #199
loeg wrote: post #9

Earlier quoted context omitted.

The trial was on non-hospitalized patients, because you can't test impact on hospitalization risk with patients that are already hospitalized. But given the supposed mechanism of action, I don't think there's any reason to believe it would not also be an effective therapy for hospitalized patients.

This drug is an antiviral and isn't the Covid viral load already on the decline by the time that most people are hospitalized? See Fig 2 from https://www.bmj.com/content/371/bmj.m3862 . Its the other issues like the inflammatory cytokine response, tissue damage, and secondary infections that cause the poor outcomes in most hospitalized patients. So you'd need to take any antiviral early on. I think they said within 5…

It makes one wonder why they administer remdesivir and other similar drugs to hospitalized patients.

Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent

#224

Post by dougmwne »

EricE wrote: post #219
helloguillecl wrote: post #150

Earlier quoted context omitted.

Would you mind to share which antibody treatment were you able to get for your father? I would be useful for the rest of us if we ever find ourselves in this situation again.

There are actually a multitude of treatments beyond waiting for thing to get bad enough that you need to go to the hospital: https://aapsonline.org/covidpatientguide/ This is also worth a watch: https://www.youtube.com/watch?v=QAHi3lX3oGM

To anyone seeing this link please beware. The linked PDF recommends several treatments that have insufficient evidence of being safe or effective, such as Ivermectin and Hydroxychloroquine. The only pre-hospitalization treatment currently recommend by the NIH with strong evidence is Monoclonal antibodies. Other previously recommended treatments such as steroids and Remdesivir have weak or conflicting evidence. Steroids are still recommended in a hospital setting.

I'm sure many of us are familiar with sources of statical bias and issues such as multiple testing error. These things apply to clinical trials just as much as email subject line testing. That is why it is important to focus care on treatments that have strong evidence and continuing to study new treatments with insufficient evidence. Politics should not determine treatment, evidence should.

Please see the NIH pages on current covid care recommendations, which also include pages on treatments with insufficient evidence, their theorized mechanism and the state of research.

https://www.covid19treatmentguidelines.nih.gov/management/cl...

Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent

#225

Post by b9a2cab5 »

photochemsyn wrote: post #179
jrockway wrote: post #107

Earlier quoted context omitted.

I don't think investing money necessarily transfers the ownership of things bought with that money to the investor. The government could put in their contract "we get all your drugs that you invent" if they wanted that. But this would be like startup VCs getting 100% of your company, or your bank getting the appreciation on your house when you sell it, etc. They could ask for those things, and you could say no... and…

I think a better option is for the pharmaceutical corporations themselves to reduce both their advertising budget and their shareholder dividends and pour those funds into their own independently financed research institutes (see Bell Labs for the model followed in the past). The best way to encourage them to do this is to eliminate exclusive licensing of inventions financed even in part by the taxpayer, i.e. NIH, NS…

Where is the motivation for Merck to pour funds into a drug they don't get any return on?

And if the government is doing this R&D instead of pharma cos, what is their motivation to perform? If you're a government apparatchik making decisions about what drugs to invest into R&D for, what penalty and upside do you get for being wrong/right? Getting fired or getting a promotion? That's hardly motivating at all.

Your proposal has terrible incentives for everyone all around and would certainly reduce innovation in the long run.

Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent

#227

Post by sterlind »

AndrewBissell wrote: post #92
DominikPeters wrote: post #58

I enjoyed this article explaining in more detail how the drug works, though much of it goes over my head: https://www.nature.com/articles/s41594-021-00657-8 Briefly, it causes the copying process of viral RNA to go wrong by increasing the number of G-to-A and C-to-U mutations. A potential worry is that such mutations will also increase in places where we don't want them, such as in host DNA, but apparently at least f…

Seems like a lot of added potential risk for anyone at low odds of being hospitalized for Covid. https://pesquisa.bvsalud.org/global-literature-on-novel-coro...

Full text here it's not trivial to find [1].

This study doesn't show that molnupiravir (rNHC) is genotoxic at levels effective for treating covid. Dosage of 1µm reduced COVID+ cells by 15x, while 3µm removed the infection entirely. [2] 1µm and even 3µm dosing didn't lead to any statistically significant genotoxicity, only 10µm showed effects [3].

The authors know this, because their conclusion is that the risk of genotoxicity "might not be zero." They have not demonstrated that therapeutic doses cause any statistically significant increase in mutations.

1. https://academic.oup.com/jid/article/224/3/415/6272009?login...

2. https://academic.oup.com/view-large/figure/283696469/jiab247...

3. https://oup.silverchair-cdn.com/oup/backfile/Content_public/...

Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent

#228

Post by guilhas »

ceejayoz wrote: post #125
vixen99 wrote: post #118

Earlier quoted context omitted.

No, that is incorrect. The FDA Only renewed emergency use authorization for Pfizer; Approval was for BioNTech’s Comirnaty with additional safety studies required (until 2027). It's currently not available in the US.

False. https://www.reuters.com/article/factcheck-fda-pfizer/fact-ch... > The FDA state that Comirnaty has the same formulation as the EUA-approved (Emergency Use Authorization) Pfizer vaccine and is interchangeable (here). Their website says: “Providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed…

"Reuters is seeking comment on the legal specificities of the FDA approval and will update the check in due course."

How convenient. Pfizer states that both vaccines are legally different. Meaning even with the same formula 'Pfizer' vaccine has no liability for compensation claims, 'Comirnaty' has but it is not being supplied

Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent

#229

Post by blacksqr »

EricE wrote: post #219
helloguillecl wrote: post #150

Earlier quoted context omitted.

Would you mind to share which antibody treatment were you able to get for your father? I would be useful for the rest of us if we ever find ourselves in this situation again.

There are actually a multitude of treatments beyond waiting for thing to get bad enough that you need to go to the hospital: https://aapsonline.org/covidpatientguide/ This is also worth a watch: https://www.youtube.com/watch?v=QAHi3lX3oGM

Document link goes to AAPS web site.

Wikipedia: "The Association of American Physicians and Surgeons (AAPS) is a politically conservative non-profit association that promotes medical disinformation, such as HIV/AIDS denialism, the abortion-breast cancer hypothesis, vaccine and autism connections, and homosexuality reducing life expectancy."

Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent

#230

Post by _3u10 »

jeltz wrote: post #154
_3u10 wrote: post #30

Earlier quoted context omitted.

Precisely. Also congrats on having sane politicians. Sweden has 10x the hospitalization rates of many countries that still have mandates, thus it is a political question, not a medical one.

What countries? Show me the data. Edit: Deleting most of my post since Sweden does not track hospitalizations, only ICU admissions so I compared incorrectly. Here is the graph for ICU, judge for yoruselves if there are any with a 1/10 of Sweden's numbers. https://ourworldindata.org/grapher/weekly-icu-admissions-cov...

I misspoke, it was deaths, not hospitalizations. Norway has 1/10th the deaths per capita of Sweden. Canada has 1/2 of what Sweden has, and we are still have mandates and restrictions.
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