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Pritelivir: At Last


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Corporate Announcement Excerpt,   "Internal development program Pritelivir – Phase 2 trial ongoing, AiCuris to conduct Phase 3 pivotal trial in Acyclovir resistant HSV infections in im

Nonsense dude.  New meds are approved all the time.  Cancer research has gone from hopeless in the 1960s to actually a lot of people now being able to survive cancer because of increasingly better sol

A couple of thoughts that we need to continue to stress: Big pharma does NOT profit from Valtrex today. Once upon a time they did but Valtrex has been off patent for years which is why Valtrex

It was mentioned here and there that this is available now through somewhere? Does anyone know how we can purchase these? I looked through Everywhere on this site and all the search results and couldn’t find any direct links to sites that have this? How are people getting this?

Thanks for your help!

 

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On 12/10/2019 at 6:46 AM, LemonOne9 said:

Awesome. If all goes well when might this realistically be available for purchase?

who knows... but just estimating, if the phase 3 is really happening in 2020, it will likely occur later in the year since phase 2 ends in march... it will probably run deep into 2021, possibly until early 2022 since there's usually thousands of participants in phase 3 as opposed to hundreds like in phase 2. Since its under fast track designation, the approval would come soon afterwards. Aicuris is a veteran company and has been anticipating this moment for decades so their supply chain is on point... it would likey be sold within a few months of approval. If all goes as planned i dont see any reason why it would take more than 2-3 years before you could get your hands on it. Possibly sooner if you live in the U.S.... where off-brand perscriptions are very legal and extremely common.

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22 hours ago, alextheman said:

Even if its out,how long until is actually affordable?

Hard telling, but there could be programs a available to get it cheaper if you don’t have insurance and can show a need. Where there’s a will there’s a way....let’s just hope it makes it and is effective as we’re all hoping.

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Seems to me the length of a phase 3 trial would depend on whether it is a prophylactic or a therapeutic vaccine. Recall the GSK prophylactic vaccine began a phase 3 trial in 2002 with 8000+ patients, but was stopped in 2010 when it didn't protect well enough. Genocea's therapeutic vaccine began a one year phase 2 trial with 132 patients in November 2015 but the program was cancelled in 2017 because it didn't work quite well enough.

If the antiviral Pritelivir begins a phase 3 trial with, say, 8000 patients in 2020, I would think they'd know within 6 months to a year how well it's suppressing outbreaks and shedding (either it does or it doesn't). If it works as well as we're expecting, it might be approved in 2021. An announcement of positive results along the way would make headlines and finally give us real hope.     

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Sorry, I should have looked up the length of the phase 3 trial for the antiviral med, acyclovir. That one would have been more than 30 years ago and probably not fast tracked, so this one might be a bit shorter. Too lazy to look it up now.

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46 minutes ago, deanjones said:

It looks like you can already purchase this.  But is this just another stronger version of valtrex?  If so, I am not really interested.

You clearly didn't read anything about pritelivir.

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On 12/15/2019 at 6:39 AM, Voyager2 said:

Seems to me the length of a phase 3 trial would depend on whether it is a prophylactic or a therapeutic vaccine. Recall the GSK prophylactic vaccine began a phase 3 trial in 2002 with 8000+ patients, but was stopped in 2010 when it didn't protect well enough. Genocea's therapeutic vaccine began a one year phase 2 trial with 132 patients in November 2015 but the program was cancelled in 2017 because it didn't work quite well enough.

If the antiviral Pritelivir begins a phase 3 trial with, say, 8000 patients in 2020, I would think they'd know within 6 months to a year how well it's suppressing outbreaks and shedding (either it does or it doesn't). If it works as well as we're expecting, it might be approved in 2021. An announcement of positive results along the way would make headlines and finally give us real hope.     

Oh my, I hope they don't need 8,000 patients.  I get the sense they had trouble getting the few hundred for phase 2. I talked to a doctor at Emory that was aware of the trial and he stated they didn't have any patients in the trial yet. Remember testing is being conducted on people who are immunocompromised where acyclovir doesn't work for them but instead must take Foscarnet, which has many side effects.  Basically people where HSV has run amuck because there's nothing to stop it!  From what I read, phase 3 usually has 1,000 - 3,000 patients.  Anyways, I hope it's closer to 1,000 since finding these patients to participate seems to be a difficult task. Fingers crossed that word has gotten out and more people who fit the profile will participate.

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@TCBH, right you are! The word "immunocompromised" changes everything, like "fast track." Since this med is needed so badly, somebody's going to have to just say at some point, "Okay, we've managed to get X recruits in Y months, let's go for it!" So we'll have to wait and see. Maybe "clinicaltrials.gov" will switch status from "recruiting" to "closed to recruiting" when they start testing. 

@deanjones, Pritelivir is better than Valtrex (by 1/2?) and uses a completely different mechanism, meaning we can probably use both at the same time, to get a better overall effect. If we also get a monoclonal antibody shot periodically (when approved), then outbreaks and shedding might be close to zero.

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6 hours ago, Voyager2 said:

@TCBH, right you are! The word "immunocompromised" changes everything, like "fast track." Since this med is needed so badly, somebody's going to have to just say at some point, "Okay, we've managed to get X recruits in Y months, let's go for it!" So we'll have to wait and see. Maybe "clinicaltrials.gov" will switch status from "recruiting" to "closed to recruiting" when they start testing. 

@deanjones, Pritelivir is better than Valtrex (by 1/2?) and uses a completely different mechanism, meaning we can probably use both at the same time, to get a better overall effect. If we also get a monoclonal antibody shot periodically (when approved), then outbreaks and shedding might be close to zero.

I've thought about this and wondered about the difficulty in employing a cocktail / the costs involved with a trifecta approach. 

I don't believe for HSV that we could reach the same level of affordability as ART.

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LightafterDarkness

A couple of thoughts that we need to continue to stress:

  • Big pharma does NOT profit from Valtrex today. Once upon a time they did but Valtrex has been off patent for years which is why Valtrex is affordable and cheap. If we are taking about $$$ as a motivation (and lets be clear its one of several) then big pharma has every incentive to introduce a more effective medication that they then can charge a premium. I have never understood this big pharma wants to keep us on Valtrex forever....it holds no water.
  • List of location recruiting + contact info can be seen at the bottom of this page: https://clinicaltrials.gov/ct2/show/NCT03073967
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On 12/22/2019 at 10:50 AM, LightafterDarkness said:

A couple of thoughts that we need to continue to stress:

  • Big pharma does NOT profit from Valtrex today. Once upon a time they did but Valtrex has been off patent for years which is why Valtrex is affordable and cheap. If we are taking about $$$ as a motivation (and lets be clear its one of several) then big pharma has every incentive to introduce a more effective medication that they then can charge a premium. I have never understood this big pharma wants to keep us on Valtrex forever....it holds no water.

Yep.  Also, why would other "big pharma" companies collude so that GSK continues to enjoy revenues from valtrex.  If other companies can develop a better or different remedy, then they would be the one that profits and maybe people wouldn't even buy valtrex anymore.  This "conspiracy theory" makes little sense. 

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The valtrex patent barely expired ten years ago.  Nothing new was allowed before that.
 

Once we get pritlivir, you won’t see another treatment for ten to twenty years. That profit model will be protected. Forget about crispr, they won’t let it go mainstream.

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3 hours ago, Mikeike3 said:

The valtrex patent barely expired ten years ago.  Nothing new was allowed before that.
 

Once we get pritlivir, you won’t see another treatment for ten to twenty years. That profit model will be protected. Forget about crispr, they won’t let it go mainstream.

Thats not how patents work. 

You cant patent against progress, only against use of mechanisms. The methods and tecnhiques of editing are vastly different from drugs. 

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7 minutes ago, iFdUp said:

Thats not how patents work. 

You cant patent against progress, only against use of mechanisms. The methods and tecnhiques of editing are vastly different from drugs. 

You can use federal regulators to slow progress, stonewall, and also make things hard to get

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Image result for stephen hahn fda

There have been a number of changes lately in the head of the FDA. 

Currently it is Stephen Hahn, someone with a cancer research background and practicum in the real world medical field. 

The most notable member in the past while was Scott Gottlieb. Gottlieb was known to be a forward thinking individual, he was in support of advancing gene therapy into medical trials. 

https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-peter-marks-md-phd-director-center-biologics

Have faith in those appointed to the head of the FDA under your current government, they have all been outstanding people since 2016. You can see this if you google either Stephen Hahn or Scott Gottlieb, go to their wiki and go up through Gottlieb's successors to Hahn. 
 



The FDA is being backed up by the government and pushed to accelerate efforts with regard to things like HIV. 

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35 minutes ago, iFdUp said:

Image result for stephen hahn fda

There have been a number of changes lately in the head of the FDA. 

Currently it is Stephen Hahn, someone with a cancer research background and practicum in the real world medical field. 

The most notable member in the past while was Scott Gottlieb. Gottlieb was known to be a forward thinking individual, he was in support of advancing gene therapy into medical trials. 

https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-peter-marks-md-phd-director-center-biologics

Have faith in those appointed to the head of the FDA under your current government, they have all been outstanding people since 2016. You can see this if you google either Stephen Hahn or Scott Gottlieb, go to their wiki and go up through Gottlieb's successors to Hahn. 
 



The FDA is being backed up by the government and pushed to accelerate efforts with regard to things like HIV. 

If you’re defending gottlieb you must work there. Look at what they did to kratom. Google Zantac cancer link. They don’t regulate much unless it impacts pharm profits.

i can share more evidence of gsk and Merck crap.

Edited by Mikeike3
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