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Felina88

Pritelivir appears to still be kicking

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Felina88

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Hansje

Thank you for sharing. Another source of hope! Maybe a combination of Pritelivir and Theravax will make shedding even lower? Happy for the immunocompromized HSV patients, for them it is even more important than for many of us. Life and death. Hope it will be in the market soon!

 

Edited by Hansje

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Unrequited

"Of the 91 randomized participants, 561 completed both treatment periods. Analysis of a total of nearly 15,000 genital swabs showed HSV shedding of 2.4% during pritelivir treatment compared to 5.3% during valacyclovir treatment, meeting the primary endpoint with a p value of 0.012. Pritelivir also showed superior clinical characteristics with genital lesions of 1.9% of days versus 3.9% of days under valacyclovir treatment and pain of 4.0% of days versus 6.7% of days respectively. No differences in treatment-emergent adverse events were observed between the two treatments."

 

So just roughly twice as effective!

Edited by Unrequited

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Hansje

Twice is very nice! 

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Unrequited

So does anyone know where the oral pritelivir is in the trial phase? II / III ? and any indication of release? I do understand there were concerns about safety, but wasn't that in animal trials?

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Hansje

Text says FDA lifted the clinical hold partially for certain groups of patients. 

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@lw@ys
On ‎1‎/‎17‎/‎2017 at 2:33 PM, Unrequited said:

So does anyone know where the oral pritelivir is in the trial phase? II / III ? and any indication of release? I do understand there were concerns about safety, but wasn't that in animal trials?

"AiCuris Anti-infective Cures GmbH, a leading company in the discovery and development of drugs against infectious diseases, today announced the publication of results from a phase 2 clinical study evaluating the safety and efficacy of pritelivir"

That's the very first sentence.

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Gothic Beauty

They should fast-track it if it's passed phase 2. Phase 3 is just a larger scale of phase 2 anyways. This is good news though because even if they don't fast track it we only have to wait until the end of phase 3 for it to be on the market since phase 4 is kind of sort of watching how it works for the general public after it's released to market.

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Nietzsche

Just curious. When this hits the market why it will only be available for immunocompromised people? Because people who applied to the trails were only immunocompromised people? 

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Scooby2112
3 hours ago, Nietzsche said:

Just curious. When this hits the market why it will only be available for immunocompromised people? Because people who applied to the trails were only immunocompromised people? 

This is a common tactic to get drugs through development.  If you focus on a population at severe risk you can more easily prove that you are meeting or exceeding the current standard of care.  Recruiting patients in a do it die is often more acceptable since they may not have other options (drug resistance being one of the primary reasons).  Once in that population thy can expand to the overall population assuming no drug related adverse events are seen. 

Sometimes in phase three they will expand to a broader population (which really is the difference between phase 2 and 3.  Phase 3 tests a broader population looking for potential sub populations that may have impact or cross reactivity to other drugs/life style factors.  

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@lw@ys
11 hours ago, Scooby2112 said:

This is a common tactic to get drugs through development.  If you focus on a population at severe risk you can more easily prove that you are meeting or exceeding the current standard of care.  Recruiting patients in a do it die is often more acceptable since they may not have other options (drug resistance being one of the primary reasons).  Once in that population thy can expand to the overall population assuming no drug related adverse events are seen. 

Sometimes in phase three they will expand to a broader population (which really is the difference between phase 2 and 3.  Phase 3 tests a broader population looking for potential sub populations that may have impact or cross reactivity to other drugs/life style factors.  

This exactly what will happen.

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Voyager2

The original January 2017 post has a link that announced phase 2 results were available. It's now April 2018 and the aicuris website pipeline still shows pritelivir in a phase 2 trial. I hope there are no more glitches and that pritelivir is about ready to move to (or is already in) a phase 3 trial.

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Freefalling87

It was going to Phase 2 back in 2013 but that is when the FDA stepped in to put a halt to the study when it was discovered that the monkey's they had tested the drug on had internal bleeding. This year they got the green light to conduct their phase 2 study on the immunocompromised individuals.  

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Voyager2

The link provided by original poster felina88 references aicuris from January 17, 2017. A footnote says the original phase 2 trial started with 91 participants and was shut down by the FDA due to toxicity. It also says the hold was partially lifted in 2016. Then near the end of the article it says a second phase 2 trial with 156 participants was successfully completed and the results published. But it's confusing as to which phase 2 trial the headline refers to. My bet is that something was lost in the translation from German to English.

Maybe somebody should inquire about pritelivir's status.

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MikeHerp

My understanding is that the original phase 2 was discontinued.  there is now a phase 2 for immunocompromised patients.  It's been fast tracked, but results aren't due until 2019.

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Voyager2

That's good to hear. We already know it works better than acyclovir/valtrex.

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