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Star33hcs

Pritelivir

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Star33hcs
can someone explain how much pritelivir will reduce viral shedding

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JHenry

https://jamanetwork.com/journals/jama/fullarticle/2593569

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asdfz

Is anyone in the US currently on Pritelivir??

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CHT
  • it is still not approved by FDA here in U.S.  However, there are (were?) clinical trials being conducted a few months back.  I'm not sure if they are on-going or if they were temporarily halted due to Covid19 pandemic.  The maker of Pritelivir (AiCuris) was offering to make the drug available to patients under certain circumstances.... I've asked my doctor if he would look into this option.... I'm waiting to hear back.

here is the link to the AiCuris "Early Access Program"   http://www.aicuris.com/134/Research-Development/Pritelivir-Early-Access.htm

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asdfz

Hi, I’m wondering because I want to ask my doctor for it tomorrow.  Do you know what your doctor had to submit or do you know anything about the process? 

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CHT

Unfortunately, I don't know yet whether my doctor has been successful in getting approval from AiCuris to get me on Pritelivir.  If you look at the link, the patient also has the option to contact AiCuris but, ultimately, your doctor has to get the approval first.  I believe you have to show that other anti-viral medications have not worked (such as acyclovir, famvir, valacyclovir, etc).  I believe you may also have to show that you are immunocompromised.  I will keep checking with my doctor and let you know what I find out.

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Kurdt01

You have to prove you're immune compromised because of a bone marrow transplant and or another disease/illness...or you have to prove you have a resistant strain...problem with that is nothing is resistant in a petri dish...doesn't matter if it doesn't work when you take it.

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asdfz

Wow, my doctor offered to try to submit me for the trial but I would rather wait until it’s approved. Any idea how long that will take? Thanks for your responses and help! 

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CHT

I'm not certain on how long it will take to finally get to through the Phase 3 trials and then approval by FDA (assuming the Phase 3 trials are successful). Typically it takes at least a couple of years to get from phase 2 to phase 3 and then FDA approval so, we won't likely see the drug available for prescription at your local pharmacy for a couple of years minimum.  Was your doctor trying to get you into the Phase 3 trial somewhere or was he/she trying to get you early access to pritelivir via the "early access" program?

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asdfz

He was willing to try to get me involved in the current phase 2 trial. Without additional details of side effects, I’m just not willing to participate in the trial.  

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iFdUp
8 hours ago, asdfz said:

He was willing to try to get me involved in the current phase 2 trial. Without additional details of side effects, I’m just not willing to participate in the trial.  

.... why? Its a phase 2.

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Graph14

Not to add fear but a while ago I had ask herpes specialist Terri Warren about its release in the US and she said that with certain animals it showed adverse effects on eyes. She normally participates with many clinical trials but I’m not sure where her stance is.

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WilsoInAus
6 hours ago, Star33hcs said:

but if that is true, they would not be allowing early access

Hey @Star33hcs that doesn’t quite follow. 
The drug is approved for use for small periods of time as a treatment for shingles in some countries. This enables some access for other purposes but only where the current circumstances outweighs the risks of complications. 
Long term use is not approved or recommended owing to animal issues involving eyes and skin abnormalities. 
No less an authority than Anna Wald was conducting the study on humans that was stopped owing to the emerging animal evidence. Terri  is a long term collaborator of Anna’s.

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CHT

Wilson... I did a quick online search and I'm not finding anything relating to either vision or dermal abnormalities relating to taking pritelivir.... can you please send link to these reports.  I'm looking into pritelivir through the "early access' program and want to be sure it is relatively safe before proceeding.    thank you!

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iFdUp
23 hours ago, Graph14 said:

Not to add fear but a while ago I had ask herpes specialist Terri Warren about its release in the US and she said that with certain animals it showed adverse effects on eyes. She normally participates with many clinical trials but I’m not sure where her stance is.

If you drink enough alcohol you will dissolve your eyes (probably not before organ failure). So you must understand that dosage control is important. 

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CHT

The information online is somewhat contradictory as it relates to any adverse side effects from pritelivir.  for example one report states:  "The study was terminated before all subjects had completed the entire treatment period for both drugs due to the US Food and Drug Administration (FDA) putting a hold on the drug’s clinical use because of skin and blood abnormalities that had presented in a concurrent animal trial. Dr. Wald noted that there have been no serious side effects in humans so far ."  So no serious side effects for humans (although the study seemed fairly limited in scope).  Another report stated:  "Treatment-emergency adverse events were reported in 62.3% of those in the pritelivir group and 69.2% of the valacyclovir group..."  so, apparently, adverse side-effects were actually slightly less than using valacyclovir.  It's also interesting to note that the FDA later provided fast-trac approval for moving pritelivir to phase 2 trials.... which is where the drug is currently.   I still cannot find any information relating to vision problems relating to pritelivir.  It still looks relatively positive for moving pritelivir forward....

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