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.

[curiouslady1]

Yes.  It looks good.  Even with interferon added, treatments that are being developed now have been getting higher SVR rates and less additional side effects from the newer drugs.

[Mary4now]

Oh Happy Day,

[EyesofBlue55]

Sounds good 2 me especially with less side effects!!!!!

[kirk8]

Ya, It’s coming.  Question is, Who will be able to afford it?  Sounds to good to be true, but I believe it.  Question is, will it cost a Half Million. I’m sure it will at first and people will die because they can’t afford it.  Drug companions are all heartless bastards, looking out for the bottom line.  But they are the only hope we have.  I give them my money.  They promise me life.  They better deliver or I won’t be around to know!!!

[curiouslady1]

Wow.  This stock is taking off this morning.  It is up 6% since market opened an hour ago.  Probably because of this news.  

http://investor.pharmasset.com/releasedetail.cfm?ReleaseID=613039

[willbb]

This side of the forum is for folks to get medical questions answered and to share support of each other,,as by the rules of membership set out by MH.
It is not a daily stock ticker ,about how some drug company is doing on the exchange market.

Stock prices go up and down all the time and has no bearing on our futures.
Will

[curiouslady1]

The material I posted was regarding the opening up of new arms in a treatment trial willbb.  Perhaps I should have made that clearer in the introduction to the post.  Nevertheless, anyone who clicks on the link can find out about it.  Sometimes using the investor articles is the fastest and maybe only way to find out that some of the studies are changing and that others have a chance of getting into a trial.  Many people who are treatment experienced have been asking about an opportunity with all oral treatment.  That is why I post here and frequently regarding this topic.  I have been asked to do so.  

[willbb]

Posting about possible new HCV trials opening up may be helpful to some .. however your post stating :

" Wow.  This stock is taking off this morning.  It is up 6% since market opened an hour ago.  Probably because of this news."...........is totally irrelevant .

[his3707]

Hey, it's Columbus Day!  

[curiouslady1]

I'm really sorry.  I think Electron recruits only in NZ now.  I do know someone who is in AU who might be eligible.  But at least it gives people an idea of what is going on.  What I got from it is that they believe that a monotherapy (one pill PSI 7977) for only 12 weeks for GT 1 might actually do the job!! Apparently Gilead is opening up some trials too.  I am not sure if FDA needs to be involved if the study is done overseas but I know that some approvals need to take place.  The go-to person at my university research center indicates that there is a good hunch that the research hypothesis will be upheld when they put it out there like that.  Apparently investors think so, that's my point.  Just one more note about this subject. This is not just about promoting one company.  It is about promoting research that brings us into a new age and a new paradigm.  There will be a number of companies jumping on to this bandwagon.  For the purposes of this list, it is about giving people a taste of what the future might be like.  Hopefully,  this will give those on this list greater hope . . . even those who are treatment experienced and null or partial responders or interferon resistant/unable/ intolerant.  

[grizwald]

I am a null responder and have been wondering and researching to try and decide whether to treat now with triple treatment or wait.  Lots of medical jargon I don't understand but 6% in 1 hr. is exciting and warrants closer investigation.  I am familiar with 7977 938 and 128 having read about them this past weekend.  when you find news like this please keep it coming.

Bless You curiouslady1,

Griz

[willbb]

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

[can-do-man]

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?

[curiouslady1]

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.  

[willbb]

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

[curiouslady1]

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.  

[lynda607]

Yes indeed.

[orphanedhawk]

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 :)

[willbb]

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

[scratchinghead]

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.

[willbb]

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

[curiouslady1]

:)  Happy Thanksgiving Will

[willbb]

Back at ya on that :)  

[grizwald]

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

[willbb]

Thats  a good sound  medical move. .. oh...don"t forget tho if the stock goes down ..to dose reduce :).....  lol
...

[grizwald]

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

Griz

[UKgirl55]

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)!!

[OdinLovesLife]

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!

[OdinLovesLife]

And thanks to you too OrphanedHawk!

[Willy50]

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

[willbb]

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

[lynda607]

Commonality with hcv members and the stock market -  volatility.  I won't hedge my money on either.  :)

[Willy50]

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.  : )

[willbb]

Thanks for the monitoring willy.
You have a real knack for creating order out of chaos.
We appreciate it a lot.

[willbb]

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 :)