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So what’s in play for USA and Europe !???


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On 30.09.2020 at 15:37, Nath said:

Mam nadzieję, że pritelvir pojawi się w 2021 roku, ponieważ potrzebuję czegoś silniejszego niż Valacyclovir, aby powstrzymać moje nieustanne epidemie.

Nath kiepsko z twoją nadzieją czarno to widzę. O ile patrzyłem sprawdź sam clinical trials Priteliviru. Badanie Priteliviru kończy fazę 2 w maju 2021 roku.Gdzie jeszcze faza 3 może 2024 rok to bym się zgodził. Też bym chciał żeby zatwierdzili Pritelivir za rok.

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Right now, Pritelivir is supposed to be for immunocompromised people, but for those of us who need SOMETHING now, withholding it seems unnecessarily cruel.

Just looked at the aicuris website  and they have an interesting "Expanded Access Program" (EAP) that will allow people to purchase pritelivir tablets. I drilled down and found you have to have your doc (GP, GYNO, UROLOGIST, whatever) agree that you have "tried everything" and need this medication. Then you both contact aicuris, they question you, and then send you the tablets. It is still in a phase 2 trial so they can't market it just now. Let's hope the phase 3 trial doesn't drag on for 5 years.

Since a half billion people have this,  you'd think the powers that be would move a bit faster.

A company in Japan is selling their version right now. Some in the hive have purchased them.   

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Please note that the "Early Access Program" will only make Pritelivir available to those that are immunocompromised (i.e., HIV positive, chemotherapy, etc).  I went through the entire EAP process with "My Tomorrows" and my primary care doctor did his part too.... he explained that my HSV2 has somehow become acyclovir-resistant and therefore outbreaks are uncontrolled.  It looked promising.... however, because I am immunocompetent, they denied me access to Pritelivir.  It was very disappointing to say the least!  Even my doctor started to believe access to the drug might be made available but, no such luck.  He was almost as disappointed as I was because we've run out of options for controlling the outbreaks.  All I can hope for now is that Pritelivir hits the market soon (and it's affordable)!

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If it's in a phase 2 trial, it must have passed a phase 1 safety trial, and it just seems to me that if it's safe for people who are immunocompromised, it sure ought to be safe for everybody else. Would love to talk to the people who made these "rules." It's outrageous that they denied you access. Hopefully they will eventually rethink this and do the right thing. At least the drug is making progress through the pipeline. Once it hits the market, I'd bet you can get your hands on it, with your doctor's help.

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I do agree that these restrictions are awful and probably the people that are corresponding at the "Early Access Program" do not even know what are the risks of having excessive outbreaks. They just apply a rule that someone else has decided, without even knowing the situation of extreme cases. My impression is that they give it only to immunocompromised + ACV resistant because in those cases it's impossible to suppress the replication with a common drug (like if ACV is that efficient, anyway!) and the immunocompromised condition can't control the spread of the infection to other parts of the body (and on this point there is still a very wrong misconception in most of the doctors).

Unluckily people are just numbers to the health system: they are costs, and in case of infectious diseases, they are a risk of a further spread of infection among the population. As long as costs can be controlled and the infection doesn't cause a serious treat to the population, they don't act with emergency. This is what we have seen with Covid.

What apparently they haven't realized is that badly symptomatic herpes can cause multiple symptoms that are hard to diagnose and correlate to herpes and that they are not efficiently reduced by ACV. This means that people will ask for multiple specialistic exams, which will not manage to give a precise diagnosis and therapy. A more potent inhibitor could reduce these costs; if it managed to keep such symptoms under control, it would be clear that they are caused by herpes, without the need of multiple blood exams, swabs and so on.

That's a very simple concept and it's even supported for many diseases by doctors: if the treatment reduces the symptoms, then the cause can be attributed to the condition that has been treated. And it should be also quite evident that ACV is very weak and cannot be used in that way; otherwise the herpetic keratitis would not be such an economic burden nowadays.

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I wish somehow those of us with acyclovir-resistance, as determined by a physician, but still immunocompetent could band together and push Aicuris (manufacturer of Pritelivir) to re-consider the early access to the drug.  It's our only hope for getting outbreaks under control until there is a cure.... it's a quality of life issue for so many people worldwide.... Aicuris already knows the drug is safe and it has been given "fast track" status by the FDA here in the US (drug is still in Phase 2 trial).... if Aicuris can show compassion to those with compromised immune systems by making Pritelivir available why can they not show compassion to those with acyclovir-resistance who have no other options at this time?  Maybe this will become an option in 2021 but, I'm not holding my breath.

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On 12/2/2020 at 10:50 AM, CHT said:

I wish somehow those of us with acyclovir-resistance, as determined by a physician, but still immunocompetent could band together and push Aicuris (manufacturer of Pritelivir) to re-consider the early access to the drug.  It's our only hope for getting outbreaks under control until there is a cure.... it's a quality of life issue for so many people worldwide.... Aicuris already knows the drug is safe and it has been given "fast track" status by the FDA here in the US (drug is still in Phase 2 trial).... if Aicuris can show compassion to those with compromised immune systems by making Pritelivir available why can they not show compassion to those with acyclovir-resistance who have no other options at this time?  Maybe this will become an option in 2021 but, I'm not holding my breath.

Did you get tested for aciyclovir resistance?  Just curious.  If you did and they still denied, that seems ridiculous.  They might as well you have to be practically dying to get access.

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Yes.... I was working with an Infectious Disease doctor that strongly suspected acyclovir-resistance and he ran the needed tests (involved swabbing during an outbreak) however, the results were "inconclusive" due to not getting to the outbreak during the short window where the outbreak provides enough viral matter to test.  Yet, this doctor as well as my Primary care doctor are still working under the assumption I have acyclovir-resistance based on the constant outbreaks even while on daily suppressive Valacyclovir (and have tried daily famvir).  My Primary doctor spoke with the "My Tomorrows" representative and explained in detail that he is treating me as having acyclovir-resistance however, per the protocol, you must be immunocompromised.... which I am not.  So, the answer was "sorry but, no"  .... no option to try Pritelivir at this time.  So unbelievably disappointing... my doctor was also very perplexed as to the decision.

 

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So ACV resistance is done by swabbing a lesion, doing a viral culture and testing the effect of ACV on it?

It seems rather complex, considering that in case of resistance there is probably a mixed population of strains (one that is not resistant, and the mutated one).

I've always thought that no one really knows how widespread the resistance is, because no one tests it extensively.

When I report to my doctors that I still experience symptoms even under suppressive therapy, they ignore it and they keep prescribing it. Even if I suggest that perhaps this therapy is not so effective for me, they won't comment.

One thing that is astonishing in your experience is that this initiative by "My tomorrows" is against resistance. Not only they denied access to you, but they do not even propose to actively monitor cases of development of resistance by requesting more informations/exams. This again shows that no one really knows how widespread herpes infections are and how widespread resistance is.

The point is: are the number of people affected by resistance increasing over the years to predict that in a certain amount of years the current medications will become totally useless?

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My limited understanding is that acyclovir-resistance is actually increasing.  The doctor from "My Tomorrows"  who spoke with me and my doctor (she was located in Amsterdam) acknowledged that they realize there are many people with what is considered resistance however, the current Phase 2 FDA trial for Pritelivir is aimed solely at those with documented compromised immune systems and therefore, they have no option to make the drug available to any one with non-compromised immune systems.  It was very cut and dry on that point unfortunately.  

As for the ACV-resistance testing.... according to my infectious disease doctor that took the swab, there are only a limited number of labs that can test for ACV resistance (I believe my sample was shipped to the Mayo clinic in Minnesota).... in hindsight, it was all sot of a waste of time (and insurance money) since it was not only "inconclusive" but, ultimately, even if resistance was proven via the lab result, there was/is nothing my doctor can prescribe other than acyclovir drugs (I actually switched from valacylovir to famvir after the test just to see if there might be a difference.... there was no difference).  The sad reality is that I am stuck with the situation, like so many others who have suspected/known ACV resistance... we anxiously await Pritelivir hitting the market so we can give it a try.  I have recently also expended a great deal of time trying a variety of supplements in a desperate attempt to try to get the outbreaks under control (with some limited success) but that's a whole other topic!

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I remember that there was another member here that had similar problems and she uses a different drug that is approved not for HSV, but for other herpes viruses. It is more expensive but effective also on HSV.

I do not remember the name of the drug.

The other thing that someone can always try (I don't see any risk in that) is ordering a box of amenalief and see if it suppresses the symptoms; it's always better if you talk to a doctor, in case you choose such options. The only problem is that it is expensive and I'm not sure that the insurance would refund that. I know that sometimes insurances agree on a refunding, maybe partial, if there are no alternative treatments. This at least happens when you go to a private doctor, because doctors that are conventioned with the insurance didn't find a solution.

Thanks for sharing your experience! As I believed, resistance to herpesviruses has really 0 priority worldwide..

Edited by hk81
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Thanks for your suggestions.... I've heard a little about Amenalief and will look into it further.  I will see if my doctor has any opinion.  I have heard it is quite expensive but, as you mentioned, perhaps my health insurance provider would help offset the cost.  What I'd also like to do is find a new Infectious Disease doctor who has some level of specialization with HSV.... the problem right now is that many infectious disease doctors are understandably very busy with Covid matters so, my HSV problem will not get much attention at this time.  If you happen to remember the name of the other drug you heard about, I would very much appreciate hearing back from you.... I'm willing to try just about anything that might work!  Thanks again!

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