From The People's Pharmacy 1st Oct 2021 and good news for immunocompromised patients like us.
" Today, the Merck company, together with Ridgeback Biotherapeutics, the company that originally developed molnupiravir, announced the results from a clinical trial. Independent experts monitoring the trial recommended it be stopped early because the results were so clear.
Molnupiravir cuts the risk for serious COVID-19 infection and hospitalization by about 50%. In this clinical trial, 775 unvaccinated people with confirmed cases of COVID-19 took either molnupiravir or a look-alike placebo pill. All of these volunteers had pre-existing conditions putting them at high risk for severe disease. In other words, they were obese or elderly. They started taking the medicine within five days of initial symptoms.
None of the people taking the drug died, but eight individuals in the placebo arm did. About 7 percent of those getting molnupiravir were hospitalized. Twice that many taking placebo pills were hospitalized or died. The safety monitors thought that made it unethical to continue the trial with people on placebo.
Laboratory research indicates that the drug is equally active against delta, gamma and other variants of SARS-CoV-2. Some scientists speculate it might even help protect people from other coronaviruses.
Merck and Ridgeback will be submitting the data and an application for emergency use application to the FDA. That is the same process that has been used for vaccines and the monoclonal antibodies. That puts it on an ultra-fast track for patient access.
The drug company has already started making pills. That’s a pretty clear indication that 1) Merck believes the medication is effective and 2) the FDA will grant EUA. The US government has already committed over $1 billion for the first pills that come off the production line.
To be maximally effective, most antiviral medications need to be taken at the very first sign of infection. That’s how antiviral drugs like Tamiflu (oseltamivir) work against influenza. If someone is exposed to the coronavirus, molnupiravir might be used preventively but research has not yet demonstrated such a tactic.
We have not yet seen the data about side effects with molnupiravir, so we don’t know how well people will tolerate this new medicine. Nonetheless, an oral drug against COVID-19 that is taken at home could be a real step forward in managing this pandemic."
Thank you Jackie, this is huge news today here in the states, however what you have said and provided for us here has now made clear for me certain details that had been confusing to me before. Thank you again.
I did read that 35% of trial participants had side effects, but what I read unfortunately didn't go into any specifics. I couldn't even offer that the 35% number was actually correct. Hopefully some more concrete and detailed information about that part will be coming very soon.
The fact of having a pill is a boon for us even if we are not able to be treated with it. The possibility of others getting treatment they would not otherwise get, gives us all a chance to avoid the virus and hopefully keeps the hospital population lower than has been happening.
I was referring to the trial exclusions which for me is an indicator that some of my current situations were not included in the tested ---application to those of us in treatment beginnings(at least) when platelets are low. Taking prohibited meds (prohibited for the trial efficacy, I'd assume.)
And for that matter, any of the situations that are excluded could be the situation for any one of us CLL or not.
Does that make sense to you? I didn't mean all CLLers, but the exclusions are applicable until we know better from clinical usage.
One course of Molnupiravir is 2 tablets a day for 5 days.
Price to US government approx $700 per course. If hospital costs are factored in, M is much less expensive than intravenous Ronapreve, but on average less effective if both drugs are given early in an infection. Subcutaneous R (available soon?) would narrow the $$ gap a bit.
Thanks Jackie. Overnight, I also added some details in a reply to an earlier post about molnupiravir. It has a link to Merck's press release and a New York Times article. It's good to see it's getting coverage around the globe. It's also gaining attention here in Australia. healthunlocked.com/cllsuppo...
i researched this and its still better to get monoclonal antibody cocktail for us than this pill if we have that option. monoclonal cocktail is 85% effective against severe disease and death, this pill is only 50%. but certainly it is good news!
I read that you can pursue both options simultaneously. Probably the card that would be played for us? The only downside is this type of option may further slow vaccination uptake in the population.
Not done in fully vaccinated people as far as I can see and why would they when that group are already almost certainly protected against severe disease and death unless they are severely immunocompromised.
More information from William Schaffner, MD, a professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, who helps explain what the new pill means in the fight against COVID-19, and what to watch for as it moves toward emergency use, in this Medpage Today podcast, Merck's COVID Pill Has Been Called a 'Game Changer' -- Is It?
— What molnupiravir can and cannot do in the fight against COVID-19
Schaffner: Well, it came about through the work of one of my colleagues right here at Vanderbilt, who was an expert in this whole field of coronaviruses, and COVID is a member of that virus family. And he was really concerned that someday we might have a rogue coronavirus, such as COVID, cause a pandemic.
And so he was looking in his laboratory for drugs that would interfere with the multiplication of the virus. And he found that it did. That led to further experiments in animals. And now when we have this pandemic in front of us, clinical trials were undertaken in people, volunteers. Now we have the documentation that this drug will actually work.
And so that data have now been submitted to the Food and Drug Administration, and they'll examine it very carefully and see whether they approve it for general use.
Marshall... I'm just so curious on why it's taken so long to get this treatment. Why maybe we weren't pushing for this treatment faster versus vaccination. We got those vaccines out in just about a year, right? Operation Warp Speed. If this could have stopped the virus from getting worse and lessen the strain on our hospital system, why weren't we putting more resources into this and why did it take longer to come about?
Schaffner: I think it's just a matter of how quickly the science can develop. The information, the science, was very, very mature, just waiting for a problem and that enabled people to develop the vaccine so rapidly. I mean, that was a world's record.
Here, the science was not quite as well developed. And so you had to do that before the FDA would allow those clinical trials in people to actually take place.
Marshall: Well, what about antiviral drug resistance?
Schaffner: We would have to see how well these viruses are able to develop resistance to the drug as they're widely used. Now, it doesn't always happen. You can use Tamiflu until the cows come home and that does not generate resistance in the influenza virus. Do we know exactly why that is? No. Are we happy that there's no resistance? Yes.
I don't think we can predict with assurance whether resistance to these drugs will develop in COVID virus. That's something we'll have to see as we start using it in the real world.
Marshall: What about with the different strains of COVID?
Schaffner: My understanding is that this drug will work on all the different variants of the COVID virus. And that makes sense because all these viruses multiply in exactly the same way.
Schaffner: Well, we have to remember, this is treatment. It's not prevention. So let's remember the fundamental way to get out of this pandemic is for all of us to get vaccinated. The fact that we might have some treatments, monoclonal antibodies and now this new drug, that's not a reason not to get vaccinated.
You know, Benjamin Franklin, all the way back to one of our founding fathers, reminded us an ounce of prevention is worth a pound of cure.
So, prevention is much better than requiring any sort of treatment. And there are "if's" around this treatment. You really have to have your diagnosis made quickly. You have to get to your healthcare provider quickly to get the prescription. And even if you were to take the medicine exactly for the full 5 days, remember, some people who take the medicine are still going to get sick. Who wants to risk that?
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