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163305 tn?1333668571

Pharmasset: 98% to 100% Cure Rates


http://www.hcvadvocate.org/news/newsLetter/2011/advocate1011.html#1


Pharmasset: 98% to 100% Cure Rates

There are numerous HCV polymerase inhibitors in clinical development to treat chronic hepatitis C.  HCV polymerase inhibitors include three different types—nucleoside, nucleotide and non-nucleotide and they all work by preventing the hepatitis C virus from replicating or making more copies of itself.  Pharmasset has developed three different polymerase inhibitors—PSI-7977, PSI-938 and RG7128 (mericitabine).  In addition, Pharmasset is co-developing their polymerase inhibitors in collaboration with Genentech, Bristol-Myers Squibb and Tibotec.

PROTON STUDY
Various parts of the PROTON phase II study results were released this year.  In this study HCV treatment-naïve genotype 1, 2, and 3 patients were treated with PSI-7977 (400 mg QD – once-a-day), an HCV polymerase (nucleotide ) inhibitor given in combination with pegylated interferon and ribavirin for a total treatment duration of either 12 weeks for genotype 2 and 3 or 24 weeks for genotype 1.

GENOTYPES 2 & 3
In July the SVR data from the group of HCV genotype 2 and 3 treatment-naïve patients was released.  In this part of the study patients were treated for 12 weeks with the triple combination therapy—PSI-7977 (400 mg QD), pegylated interferon and ribavirin.  Twenty four out of twenty four (100%) of the patients who completed treatment became HCV RNA negative (lower level of detection (<12 IU/mL) 24 weeks after completion of therapy (viral cure).  Note:  one patient who only completed one-week of therapy dropped out and was lost to follow-up.  This patient was omitted from the study results.  

GENOTYPE 1
More results were released in September from another part of the PROTON study that treated HCV treatment-naïve genotype 1 patients.   In this part of the study the patients were treated with PSI-7977 (400 mg QD), pegylated interferon, and ribavirin for 12 weeks followed by an additional 12 weeks of pegylated interferon and ribavirin (without PSI-7977) for a total treatment duration of 24 weeks.  Of the available data 98% (43 out of 44 patients) were HCV RNA negative 12 weeks after the completion of therapy (SVR12). The final SVR results will be released later this year.

QUANTUM
One of the most exciting and promising studies that is being initiated this year is the QUANTUM study.   Please see the clinical trials column of this month’s HCV Advocate newsletter for more information about this interferon free study across all HCV genotypes.
35 Responses
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Avatar universal
I see none of your 1+post added much to the Op"s question...I guess we add only what we add sometimes ... analytically speaking :)
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Avatar universal
Thanks for the monitoring willy.
You have a real knack for creating order out of chaos.
We appreciate it a lot.

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Avatar universal
None of your 8+posts in this thread seem to address the subject of the thread or the study provided in the first post.  Analyze that.  : )
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Avatar universal
Commonality with hcv members and the stock market -  volatility.  I won't hedge my money on either.  :)
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Avatar universal
Frankly. I think a lot of the stock analysts have better fact checkers than some members.  : )
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Possibly a good spot for you to garner you facts then....

I am  a stock analyst....I think members here have a much better handle on HCV facts...
Will
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Avatar universal
I first started following the financial reports on drugs because they were the first to report.  Mark your calendar and watch how soon it takes hivandhepatitis.com to list the same sort of information as one finds *immediately* of the financial pages.

One of my favorite writers is Adam Feuerstein (with "thestreet.com)  Quite often one is able to read a good summary of drugs, sometimes even comparisons and some commentary.  If one is interested in a particular drug or groups of drugs the financial pages are an excellent resource.  To some extent one also does get some sense of how strong a drug/compound/ treatment is by how wall street responds to news of a study.  Many members are not able to weigh or understand studies and findings.

.......Personally, who cares about the third post and all of about 2 lines of copy?  For me it doesn't not detract from a thread.  Nor do I recall of any past complaints at MH.

I object a little to a thread being hijacked; made all about a very brief aside in the third post.  Why does that require so many responses that are decidedly off topic?  
Frankly. I think a lot of the stock analysts have better fact checkers than some members.  : )  I would not discount the financial pages as a useful source of information.  
You'll also note....... they are a lot less emotional.  : )

best,
Willy
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Avatar universal
And thanks to you too OrphanedHawk!
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Avatar universal
Thanks for the info Curious. It is stunning news that they are seriously trialling a single omnibus drug for a 12-week treatment with almost no side effects. More power to them and  a higher share price means a stronger company with the power to get the drugs to us!
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Avatar universal
Just keep sharing ANY good news that comes your way curiouslady because I for one LOVE to hear any ounce of it!! I think we all "got" what you were saying (at least I did). The PSI 7977 is the most exciting thing I've heard in six and a half years (since I was dx)!!

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Avatar universal
Thank you, you guys have been a true joy!!

Griz
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Avatar universal

Thats  a good sound  medical move. .. oh...don"t forget tho if the stock goes down ..to dose reduce :).....  lol
...
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Avatar universal
If this stock goes up like this again tomorrow, I'll be treating just as soon as I can get my hands on a bottle of that 7977.  I think I'll look in the dumpster behind the pharma labs for some throw away :)

Griz
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Avatar universal
Back at ya on that :)  
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Avatar universal
:)  Happy Thanksgiving Will
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Avatar universal
Btw..I am in the stock trade business..and the last thing I would consider when what to   or what not to treat with is ..the price of pharma shares.....

I won"t bother boring anyone here on stating , the machinations of manipulation of stocks...however how a drug may fair approx 5 years down the road is not a factor to be even looked at by a patient...

OH " invest in loving kindness"    well said  indeed   and I apologize for my off topic posts...just was hoping no-one was led to believe stocks had anything to do with efficacy...

Best to you while treating..
Will
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315996 tn?1429054229
Keep posting. I can scroll through it easily without my knee jerking.
Thank you very much. I found it interesting. You didn't need any excuses for doing it.
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Avatar universal
Hhere is a list of Pharma stocks that are volatile as of  this morning. Abbott,Achillion,Astra Zeneneca, Merck, Pharmasett,,Tibotec,Boehringer Ingelheim, BMS,Gilead,Anady"s,Pfizer,,Vertex....

All of the above currently are in the HCV  future drug business(as well as many other hundreds of medications)


Again...this info. is absolutely useless to a HCV patient considering treating..  only your doctor and your own research can determine what might be best insofar as medications to use or possibly to wait for...
Will
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163305 tn?1333668571
Thanks for the kind words.
The reason I posted this was to share the vision of interferon free treatment or even success rates of 98-100%. How cool is that?

I just started SOC so no, it isn't about me and I don't own any stocks in anything.
My only advise~ invest in loving kindness :)
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Avatar universal
Yes indeed.
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Avatar universal
BTW I am told that Biomed stocks are notoriously volatile.  Wow, just take a look at Vertex, another little Pharma, this morning.  Again, I fully support the point of view that has been expressed here.  However, it was seeing that jump that led me on a further hunt and it might do the same for others.  Let's not throw the baby out with the bathwater.  For myself, I look for good news while treating and the idea that they are putting a trial arm out there for GT 1 for a monotherapy for 12 weeks with one of the drugs I am treating with is very good news for me esp since I am not yet 12 weeks in.  
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Avatar universal
Will is not missing any point...no-one   and I repeat N0_one should ever make any treatment decisions based on the stock fluctuations of any drug company ...Ever
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Avatar universal
In some ways Will is correct but in some ways he may be missing the point.  Not everyone visiting this forum is able to understand the rather complex world of HCV.  It is in investors best interest to do just that.  It is very true that many things influence stock fluctuations and this should never be the only reason to treat or not to treat.  This association could be accidental. However, it is one more piece of information.  And in this case, there was a press release which coincided in time with the stock increase.   This is a small Pharma company which is focused on Hepatitis.  I think what is not apparent to many is that there is a lot of information that the general public, including this forum, is not privy to.  But one thing seems self evident, neither investors nor drug companies want to lose money and barring someone betting on a loss, it would appear to be company suicide to just randomly put a drug out there when there isn't a decent suspicion it will work.  I want to thank Orphanhawk for starting this thread.  She has no vested interest in that she is a transplant recipient and has already treated.  It seems she is solely wishing for better treatment in the future.  
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Avatar universal
Buyers our back in force into todays market, the way the market has been moving lately tomorrow they will be selling..... Like will said it doesn't mean a thing, so if it goe's down later or tomorrow are we to think the "investors" know of some bad news and we should panic?
Helpful - 0
Avatar universal
don't understand but 6% in 1 hr.
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Stock fluctuations on any drug in an early clinical trial has absolutely zero bearing on it"s proposed future success . Like all stocks the share price is manipulated by dozens of factors .
Your treatment regime should be only predicated on the your own in -depth research and the advice of a knowledgeable Hepatologist and paying no attention to stock fluctuations on the futures market of any drug company

Best to you on your future treatment..
Will
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