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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

#181

Post by caeril »

AndrewBissell wrote: post #34

So an abbreviated trial in 775 people is considered sufficient to move forward with drug approval now?

I think we/they have to.

I'll don my tinfoil hat for a moment. A combination of initial vaccine effectiveness estimates having to be downgraded, and variants reducing effectiveness further, along with the infectiousness data of vaccinated carriers putting the herd immunity targets at risk have public health authorities scrambling for the next potential solution.

The data out of Israel and other places is damning. Not in the sense that anti-vaxxers would like, but in the sense that we are still nowhere near containing this thing.

We either need better vaccines, or drugs. So yes, epidemiological standards will relax in the face of a worldwide pandemic, to some extent.

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

#182

Post by Confiks »

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..

Keep in mind that any negative effects, even those unlikely to be caused by the medication, need to be reported as adverse effects. It allows for making a clean comparison between the placebo, and also makes it possible to retroactively relate effects that have been overlooked previously. For example, you want 'patient was hit by a car' as possible side effect, because the medication could make people drowsy.

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

#183

Post by cinntaile »

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...

It clearly states that clinical use should be carefully considered, so don't worry they're aware of its side-effects.

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

#184

Post by alistairSH »

alistairSH wrote: post #41
gfodor wrote: post #25

This is phenomenal news - I'm also curious how the various tribalist memes evolve. Will the vaccine maximalists who ridiculed "horse paste" when the data was still weak in part because a pill-based regime would undermine the message that vaccines ought to be mandatory embrace this much needed second tier therapeutic? Will the anti-vaxxers who will inevitably see this as the goal of a big pharma conspiracy covering up…

I probably fall into the "vaccine maximalist" category, having family who fall into high-risk categories (age, immune-compromised). This doesn't change my feelings. The existence of a treatment doesn't negate the importance of vaccination. It does make me hopeful that a return to normal may come sooner than later, as any new treatments reduce the risk of my family dying should they, despite their best efforts, become…

The existence of a treatment doesn't negate the importance of vaccination.

I never would have thought that statement was controversial in any way. I'd say the same thing for measles too.

But here we are. Humans are weird.

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

#185

Post by bshoemaker »

barbazoo wrote: post #167
bshoemaker wrote: post #164

Earlier quoted context omitted.

Is there any evidence they are? Otherwise, that sounds like a conspiracy theory itself.

Not that I know if. I'm a layman I know pretty much nothing in that field so I'm just having a hard time dismissing the whole Ivermectin thing. Especially now that Merck will make a boatload of money with their new drug. If I was Merck and I had a drug #1 that costs a few cents that might work and I can develop a new drug #2 that will cost $1000, then I'd probably not look into #1 much simply for financial reasons. T…

Sure, but you're suggesting that they are doing that without any evidence.

This is classic conspiracy theorist rhetoric, whether that's your intention or not.

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

#186

Post by ruaraidh »

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.

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

#187

Post by LurkingPenguin »

macintux wrote: post #171
LurkingPenguin wrote: post #72

Earlier quoted context omitted.

[flagged]

I’m definitely in the pro-vaccine, pro-mandate column, but both 1 and 3 from your list strike me as dubious given the information to this point. Certainly there’s been conflicting information on both.

Re-read my comment. I'm asking if anybody downvoting me can provide scientific evidence that those statements are true. Nobody has, because they're not.

Natural immunity is durable and robust, and vaccinated people can get infected and spread the virus. In fact, according to the Israeli data, vaccinated people are magnitudes of order more likely to get a Delta breakthrough infection than a person with natural immunity is to get reinfected with Delta.

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

#188

Post by kortex »

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…

The problem is that if the in-vitro studies are correct on their dose curves, then the majority of the human trials are at ineffective doses. This doesn't mean they must be wrong, but it's not a good look. If the studies were showing unequivocal benefit, we could overlook the dose curves. But the studies are still quite equivocal.

On the other hand, molnupirivir is a nucleoside polymerase inhibitor, with a slam-dunk mechanism of action, evidence of efficacy against a broad range of viruses, and increasingly compelling human safety profile.

I don't know if Merck is stalling but the ivermectin case is certainly less compelling.

https://www.science.org/content/blog-post/ivermectin-covid-1...

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

#189

Post by raphlinus »

barbazoo wrote: post #178
MisterBastahrd wrote: post #157

Earlier quoted context omitted.

There aren't any first-world countries using ivermectin to treat or prevent the spread of COVID. Because ivermectin is roundworm poison, not an antiviral. The countries were desperate to try ANYTHING, and it was the best they could get their hands on at the time. They were prompted to action because ivermectin affected COVID in lab experiments, not in actual cases, and the result of the use in those countries were th…

I'm curious to know if there are studies involving actual Covid-19 cases being treated with Ivermectin. If not, why? If yes, what are the results?

Yes, there are 14 studies that met the criteria for inclusion in the Cochrane review of Ivermectin. The results are mixed (some show a bit of improvement) but overall weak.

In addition, ACTIV-6 is a massive (15,000 participant) study that will study Ivermectin and two other repurposed medications. Because that study is large and rigorous, it will basically answer the question of whether Ivermectin works and how well.

[1]: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD...

[2]: https://dcri.org/activ-6-study/

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

#190

Post by kortex »

twofornone wrote: post #172
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…

>A concerning lack of safety data in the majority of studies. This is the part of Merck's statement that really rubs me the wrong way, and suggests to me that this communication was released with an agenda. The implication is that one of our safest, 60+ year old medications is suddenly potentially dangerous, and this press release is all too convenient when you consider that Merck was working on newer and more profit…

The dosing regime purported to be most effective against covid is way higher than the antiparasitic therapeutic window, so the safety history is not as applicable.
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