Vaccine, Gold Coast, Pfizer, General practitioner Antiviral game changer

Here, the merck, new medication called malnu pyravir now lets um just look at where we get this information. From now i dont like science by press release. We need science by peer reviewed literature, but we have this. We havent got it yet we will soon, but we havent got it yet. So weve got this. Basically, this press release from merck and ridgeback investigational oral antiviral, mulnu, purivia and great claims are made for it, and these do seem to be substantiated. Now we have to stress this is not substantiated by peer review yet, but a company like merc wouldnt, release this until they were fairly sure about what they were talking about. So lets look at what theyre saying so this is merck in combination with a another group called ridgeback who brought this out now. This is an oral antiviral. Now, of course, we have the monoclonal antibody therapies that are used at the moment, but the these can be given uh shortly after diagnosis in the first week of the illness, preferably preferably in the first day or two of the illness in the viral stage, before the Inflammatory problems have arisen why its still the virus thats the primary pathology, but they have to be given in hospital theyre expensive. They have to be given intravenously, whereas this is potentially a very simple, straightforward oral preparation, so its the first oral properly recognized anti viral. Now this is huge. I mean having worked in healthcare for for 40 years, weve always dreamed about an antiviral.

Now some antivirals did come out for herpes simplex virus like for cold sores, the acyclovir, and then semantic virus came out for uh against retroviruses. The the highly active antiretroviral therapy for hiv, but apart from that, we really dont have much in the way of antiviral therapists. So this is a big. This is a big step that this is now officially being officially recognized um, so its an oral um antiviral malnutrition. This is the code name for it. No one really, i dont know what they stand for theyre, just code names given by the pharmaceutical developers now theres a positive interim analysis of a phase three study. So what theyve done here is rather than let the study run for the whole duration. They were convinced by the results and theyve actually terminated the study, because the idea here is that, if something is very effective, it would be unethical to carry on giving people a placebo, which i i agree with, that makes sense now theyre saying significantly reduced risk of Hospitalizations or deaths, of course you welcome both during day one to five to twenty nine. What i mean by this is people were recruited and they were allowed to start the treatment if they were the first second, third, fourth or fifth day after they developed symptoms. So, in other words, this was in the viral phase of the illness. Itd be no good giving this in the second week because its an antiviral its got to be given early to reduce the viral load, to reduce the likelihood of the inflammatory complications that can cause death in this in severe illness and death.

In this condition, and then they followed the patients through for 29 days, which seems pretty reasonable, so its called the move out trial phase through three now they took at risk non hospitalized adults with mild to moderate covered 19.. This is who they recruited so its the global phase. Three randomized placebo, controlled, double blind, multi center study, excellent thats, the ideal clinical trial, and i strongly suspect that when we get the peer reviewed literature on this, this trial will have been impeccably carried out because theres, a big pharmaceutical companies involved and theres a lot of Money at stake and they will want to get it right, so its non hospitalized patients to prevent people getting hospitalized and it was carried out basically all over the place. All those countries so multi center international study that this is um research, really at its at its best, as they can coordinate eligibility criteria for the study who was allowed to get into it. Laboratory confirmed mild to moderate 19. Of course, all completely confirmed cases. Symptoms, onset within five days of study, randomization, so the first five days of the illness in the viral phase and all patients were required to have at least one risk factor, so one risk factor such as age, hypertension, obesity heart disease, lung disease, immunocompromised, something that would Make them more at risk more at risk of being hospitalized and the results are pretty good, basically, a fifty percent improvement. This is the mole period group, hospitalized or dead seven point: three percent of the patients remember: these are patients with at least one risk factor, in other words hospitalized or died 28 out of 385 patients.

No deaths in this group very good treated with more pervy mull nor pull over. Here you can tell antivirus. They got veer on the end. Um placebo group, completely randomized, of course. So this is. This is good. Stuff hospitalizations are dead 14.1. Getting on for double. That was 53 out of 3 7 7 patients and the probability that that result of rose by chance is p. Equals 0.012, in other words, theres only a very, very small, very, very small chance. This is a highly significant result that wouldnt arise by chance and um placebo group. Well, there was eight deaths in the placebo group, so pretty pretty convincing, actually about a 50 reduction in hospitalization and perhaps even more significant reduction in deaths as long as it was given in the first week of the illness, uh data monitoring committee on consultation with the Fda in the united states, recruitment to the study stopped early, which is good because it was working so well. Due to these positive results. Uh merck have applied for emergency use, authorization in the united states and all around the world, including the british authorities and the european medicines agency, and they are in consultation with many governments around the world and um are in consultation with governments that they havent yet made Agreements with so this is going to be a huge international, rollout im, pretty sure the approval is going to be given within a few weeks, and people will be taking this drug within a month.

So this it. This is happening pretty soon fda dependent of course, but of course, will the european medicines agency or the british regulatory authorities act first thats still possible because theyve um theyve been recruited into this as well. Now they evaluated data on 775 patients, which is a reasonable sample size. Now they were planning to recruit 1550 and they recruited 90 percent of that already when they paused it. Mondo provia reduced risk of hospitalizations and death across all key subgroups, which is important so different people with different risk factors, whether it was obesity, hypotension, heart disease, lung disease, renal disease, whatever it was, it was still effective at reducing hospitalizations, which is encouraging because it was Not affected by the timing of symptoms or the underlying risk factors, so it looks like it was working anytime in the first five days now were not sure about that, of course, because this is only this is all the information we have. The information we have here is pretty limited, as i say, its basically, a press release and ive just tried to get as much out of that and make as much sense of that as possible about 40 percent of patients had sequencing data to show them. What variant of the virus they have and multnomah demonstrated consistent, efficacy across viral variants, gamma delta and mu, and of course the mu is the one that might be somewhat vaccine resistant. The delta one is the one that we know, of course, is everywhere.

So looking like, the antiviral spectrum of properties is good across all of the variants equally, and that does make sense when we look at the way that this drug is working, um incidence of adverse events between groups. Now this is going to be critical. How safe is this drug going to be now? There was very limited data on this, but i think we can assume the fda and the regulatory orthodox have been given full information and from what we hear its going to be a reasonably safe drug. But lets look at what we uh know from the press: release incidents of adverse events in the more but more polarva group 35. But incidents of adverse events in the placebo are group 40, so not significant difference between the two groups. You can see why its so important to have two groups – drug related adverse events in the more peripheral group – 12 11 in the placebo group – in other words, these werent werent real. It was generated by the essentially by the mind of the individual, so um, basically again, not statistically significantly different subjects who discontinued the study therapy due to an adverse event. Well in the multiview group, 1.3 percent felt they had to discontinue taking the medication in the placebo group, 3.4 percent felt they had to discontinue uh. Taking the uh medication. Merck said, data shows monoprolivia is not uh capable of inducing genetic change in human cells. Now this is not from the press release, but the concern the concern is and im not too concerned about it myself, but its looking like its going to be okay, but the way this drug works is it interferes with the um, the rna replication of the virus And the some people are concerned that it could interfere with the viral replication over the dna replication rather in human cells, but merck here has said – and this is actually in what they said to reuters.

Rather than this press release. As merc said, data shows mongolo. Peruvia is not capable of inducing genetic change in human cells, so it messes up. The genetics of the viral cell kills the viral cell, but not the human cells. So, in other words, is this a silver bullet? Does it only kill the virus its looking? That way, but men enrolled in trials had to abstain from uh intercourse or agree to use contraception. They didnt want peoples sperm, fertilizing ovum when they were on this medication. No reason for that given, but this is just what we are. This is just what we know so far. Reuters report said women of child bearing age in the study could be pregnant, also had to use birth control now thats what they said. So i put the knot in there because i think theyve just missed it out. So basically, they dont want to give this to pregnant women, and this is not necessarily a warning sign it. This is just reasonable caution. Until more data is gathered, we can keep this out of the reproductive processes until more information is gathered, um about mercks effort to enable access to normal to approve it. If its granted emergency youth use authorization or approval which im expecting it will be fairly soon. Merc has been producing monopoly risk, in other words, theyre making a shed load of it, but if its not given approval theyll lose the money. Merck expects to produce 10 million courses of treatment by the end of 2021 10 million courses, which should be a good start.

Existing procurement agreement with the united states government they have and the agreement is, will supply approximately 1.7 million courses of monologue per year to the us government upon eau approval. Now, as i said, theres more background to talk about this now, but in this video were just talking about what we know from the press releases and other press sources, which is all we have at the moment and as ive said, that is encouraging. Now what they didnt seem to have space for in the press release was the cost um seven hundred dollars for a five day course. We believe, i think it works out at about 705, its two doses a day, so i guess thats working out about 70 dollars. A capsule and thats, based on 1.2 billion purchasing agreement from the united states government for 1.7 million 1.7 million treatment courses of malnour purvi. So, of course, is ten capsules, uh vd, two capsules a day for five days and thats going to cost seven hundred dollars. Of course, this is huge, huge potential income. Clearly other antiretrovirals are uh. Other sorry other other retroviral antiretrovirals we have. This is an antiviral. Uh starts growing advised to is not a retroviral. I misspoke there so other other antivirals are on their way from fizer and other companies, so this is just the first to be officially recognized so um, but not cheap, merck, uh, but news, maybe a getting better merc supply and purchase agreement with other governments worldwide thats Happening theyre also negotiating with other governments.

At the moment, people are going to be curing up for this stuff. I would imagine fairly soon plans to implement a tiered pricing approach based on world bank country income criteria. So its going to be cheaper for poorer countries, which is good company, has entered into none exclusive voluntary licensing agreement for multnoper with established drug manufacturers uh, particularly in india. Generic manufacturers to accelerate availability of monopoly in more than 100 lower middle income countries so lets hope they um come good on this boast, thats. What theyre saying so far also on this study, the most common risk factors um for poor disease outcome, included obesity. So these were kind of side effects really, but people with obesity didnt do so well in either category older age. Didnt do so well, diabetes, mellitus didnt do so well in heart disease. Didnt do so well, so nothing really new there, but it is interesting to sort of carry on with that data. Any extra evidence is always useful. Now this is um about monopoly now, so its investigational, its being investigated orally administered, not iv, the same as the monoclonal antibodies and its a form of uh ribonucleoside analog. So the ribo is the sugar part. The the these are, the the nucleic bases that make up the rna. So basically, what this does is it pretends to be one of these bases with its sugar, but it, but it actually um inhibits the replication of size coronavirus to ribonucleic acid, so its a bit its a bit like a sort of true.

As far as i know, i do we dont know a lot yet, but it seems to be a bit like a sort of a trojan horse, its like one of these ribonucleotides, but it actually isnt it actually goofs up messes up interferes with the whole process. Like i guess, i will call it an antagonistic effect, so it inhibits the replication of sars coronavirus ii thats the way it works, several pre clinical models of sarcoidovirus too and include so this looks like it could be effective for prophylaxis, preventing the infection. Early treatment of the infection and also reducing transmission, so it looks like it could have activity in those three areas. Theyre also conducting another story called move ahead, which is a global multi center randomized, dual blind control, placebo controls, phase 3 study, good and thats evaluating the efficacy and safety of multnomah periphery in preventing the spread of covered 19 within households. Well, that was the bitter that i found about the uh, the cost of this, the cost of the medication, the biden administration announcement, its actually uh its actually in there. Obviously i put the link there but uh here we are um on the 1.2 billion purchase agreement for the 1.7 million five day. Treatment causes of multnomah periphery, so uh not not remotely cheap but its uh, its the first one. So there we go um. Now, as i say, more critique of that at the moment, thats just a quick review of what we know – weve been waiting for anti virals for a long time.

Anti virals are potentially a complete game changer, because the the allergy i like to use is bubonic plague. You know the bubonic, the black death that first came to england in 1348 and theres been outbreaks. The plague of justinian back in classical times was um was was um the the same bacteria. You said yes in the pestis that causes the the black death and theres been outbreaks there. There was a big one in my country again in 1665, just before the great fire of london in 1666 and anyway so theres been outbreaks of this all the time and theres outbreaks as well. Every year in india, china quite a few places in the world, but its not a problem, because we treat it with antibiotics, its eminently treatable that cures the patients as long as we catch them early enough, theyre, nearly always cured if theyve become septic already, then theyre, Probably going to die, but as long as we catch it early enough, we treat these patients, but because we treat the patients we kill the bugs. Therefore, the bugs dont spread. So an antiviral really could be the um. An effective antiviral could really be the holy grail that, if properly implemented and distributed, um could halt this pandemic really quite quickly and, of course, shares in companies. Making antivirals have gone up and shares in some vaccine. Producers have gone down because if youve got brilliant antivirals, you might need less vaccines now, at the moment, of course, were encouraging the vaccination program.

This is going to be a useful additional weapon in the arsenal, reducing hospitalizations by getting on for 50, which is good news. As we await further data now, as i say more in antivirus later, but thats thats the news on that one for now so uh thank you for watching and antivirals are coming and they will be massively significant not only for this, but imagine we had a generic Antiviral that was really effective against all rna viruses. Then another rna pandemic came up, we could clobber it at source and the pandemic would never arise, and people are working very hard to recognize drugs that might be effective as antivirals and develop new antivirals as we speak. So this is promising and im hoping as weve said, is going to be implemented within the next few weeks.

What do you think?

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