Neutrino study Psi-7977

[linda880]

Does anyone have information on the phase 3 Neutrino study for geno 1?  Pharmasset's webcast mentioned
it will be initiated in mid 2012.  I have high hopes of enrolling  Study drugs are Psi 7977 and ribaviran for 12 weeks.

Has anybody heard  more news on the specifics of this study?

Thanks to those of you that have answered my previous posts.  You're great!!  My GI doc wants me to start triple
therapy with incivek, but i am going to try and wait for this next study.  So far it appears 7977 drug is leading the
the way for the oral drugs.

[almawe]

Where do folk that have failed the tripple (l was on incivik for 4 weeks), am a 1a, fit with these new drugs?

[JeffK1947]

I hope you are doing well. I am being recruited for the Phase 3-7977 trial ("Neutrino") to begin in 2-3 weeks.  Can you tell me how you are doing and what side effects you have had? Thanks.

[Mari5116]

I'm in a trial with gs-7977 & riba.  I became UND at 6 weeks.  The trial is a roll-over from the Quantum trial and it is for 6 months.

[luigi790]

Hello, last week I met with the head of Mass General Hospital's Gastroenterology department in Boston to discuss PSI-7977.  He was extremely enthusiastic and positive regarding the clinical trial outcomes.  His word was that the drug will be available next year (2013) and that it's showing a 90% success rate for genotype ! and that's without interferon.  I'm very exciting about this treatment.  I was also pleased to find out that a stage 3 liver can revert to a stage 2 or even stage 1 once the Hep C is killed.  There's hope of a viable, reliable consistently successful Hep C cure in our very near future.  I think that's very exciting.

[katla]

oops- I realize that since Pharmassett's been taken over by Gilead this information may no longer be current.

It's still worth looking at the pdf if you haven't seen it yet.

[katla]

                  
"It was announced on Nov 1 that Pharmasset, INC would initiate three phase III studies of PSI- 7977 in combination with ribavirin, but WITHOUT interferon...........
....NEUTRINO:  280 HCV interferon-intolerant patients (all genotypes) – the study design will be based on the results from data when on-going studies are completed.  This study is expected to begin mid-2012."

http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html

It's on page 18.

I assume a lot of you saw this but I think it's really great information!

[linda880]

Thanks .  You guys are a big help.  I have been on clinicaltrials.gov numerous times, but they don't post trials untill they are ready to screen

[curiouslady1]

Marvelous Hector.  Thank you so much.  Couldn't find any links when I went to the web page.

[HectorSF]

Here is Gilead's plans for their HCV drugs in 2012 which PSI-7977 is a part of...
http://www.gilead.com/pdf/PharmassetSlides.pdf
-------------------------------------------------------------------------------------------------------
HCV: A Significant Unmet Medical Need

Over 12 Million Infected Individuals in Major Markets* with Fewer than 200,000 Treated per Year

* (US, EU-5, Japan, Australia, Austria, Brazil, Denmark, Finland, Greece, Ireland, Norway, Poland, Portugal, Sweden, Switzerland, Turkey, Canada)
------------------------------------------------------------------------------------------------------
♦A third Phase 3 study to be initiated in genotype 1 patients in 1H 12
♦Targeted U.S. FDA approval in 2014PSI
-------------------------------------------------------------------------------------------------------
PSI-7977: Pharmasset’sLead Pyrimidine Nucleotide Analogue

♦Excellent safety profile
    –250 patients at 8 weeks or more
    –1,500 patients by May 2014

♦High rates of cure in genotype 2/3
    –100% (10/10) with ribavirin
    –60% (6/10) without ribavirin

♦Studies in genotype 1 ongoing
    –Expecting Phase 2 SVR12 data early 2012

♦Multiple expanding data sets from studies in different patient populations


-------------------------------------------------------------------------------------------------------
2012 Key HCV Milestones

♦Initiate and integrate Pharmasset’sPhase 3 programs–GT 2/3 programs: no change–GT 1: Phase 2 data will determine strategy

♦Initiate clinical trial with PSI-7977 to define minimum treatment duration in GT 2/3 patients

♦Initiate multiple enabling drug-drug interaction studies with Gilead and Pharmasset assets

♦Explore combinations that exclude ribavirin

♦Initiate programs in pre-transplant and HIV co-infected populations

♦SVR data from Gilead’s all-oral Phase 2 Study 120 at EASL
---------------------------------------------------------------------------------------
Pharmasset and Gilead Combined HCV Efforts Position Us to Answer These Questions

♦High barrier to resistance/pan-genotypic compounds will be an important component for any all-oral regimen
   –Pharmasset’sPSI-7977 is the most advanced, pan-genotypic compound with a high barrier to resistance
   –Ongoing efforts at Gilead to identify other pan-genotypic compounds

♦Complementary portfolio accelerates potential for oral regimens
   –Includes direct acting antivirals with four different mechanismsin
Phase 2/3 clinical development
   –Potential to pursue different combinations to then answer the question of duration of treatment and necessity of ribavirin

♦Complementary portfolios cover a number of opportunities for
once-daily regimens
   –Potential for co-formulation
------------------------------------------------------------------------------------------------

Hector

[curiouslady1]

I just read my post and it does sound decidedly negative.  On a more positive note, some of the ongoing PSI 7977 studies such as part of Quantum and the earlier BMS.PSI study will be finishing dosing in February.  Perhaps there will be some more information on new trials then or shortly thereafter.  

[curiouslady1]

Linda, Pharmasset has been bought by Gilead Sciences.  Their web site has been taken down and they no longer exist except as a subsidiary of Gilead.  Unlike Pharmasset which was a small pharmaceutical company, there is little or no information forthcoming about upcoming trials posted on Gilead web page.  

They will only tell you to go to clinicaltrials.gov to get trial information.  When you do, if you type in PSI 7977 in the search box you can see what trials are currently recruiting and you can check the contacts to see if one is recruiting near you or in a surrounding state.  I see there are several but I don't know what their stage names are.  

It is not clear if and when GS will honor Pharmasset's plans as posted in the media and for investors.  Nor is it clear that they will have a similar business plan of publicly posting ongoing trials.  I have only heard that there is a plan to move ahead with recruitment of the BMS/PSI EXTENSION that has been in progress for some months.  I believe this is already listed under the ongoing trial.  

I was under the impression, and I would have to check some of the old links from my Medhelp journal, that most studies like Neutrino were awaiting outcomes of Quantum and other trials.  Since Quantum had a major reversal when PSI 938 was found to be toxic, I would think this trial and some others will be delayed.  Just my 2 bits.