Pharmasset

[nazzareno]

I don't understand why Pharmasset is being so adored right now, especially by the market. From what I've read most of their trials have been very positive but also very small. I hope their meds are as good as the market makes it appear. Anyone know more?

[curiouslady1]

Many researchers have been at this for a long time and they can kinda tell when they're on to a good thing.  Know what I mean?  Sometimes not everything is made public all at once.  The only thing I can offer is that you could take a look at my journals if you really want to know more about it.  I am in a Pharmasset trial and am happy with it as are the people I have been able to find that are also in the trial.  But of course that is anecdotal. A new trial is recruiting currently with 2 of their more powerful drugs PSI 7977 and PSI 938. Both these drugs in the new trial have been fast tracked so the FDA must think they are on to something too.

[curiouslady1]

Recently there has been much arguing back and forth about the new all oral trials and interferon free treatments and I have spent a bit too much time on the net discussing it which I don't wish to do any more.  The only thing I can offer is that many people, investors, researchers, patients and even drug companies have been waiting for a medication that is easier on the system, clears the virus in a reasonable period of time and can be applied as an "omnibus" drug for all genotypes.  Pharmasset appears to be addressing these issues well as far as many are concerned.

[gonnabhepcfree]

I started an all oral on Aug 4 and was undetectable by Aug 11..My drugs were PSI 7977 (Pharmasset) and BMS 790052.  My Dr has another study ATOMIC which has had wonderful results.  My Dr is starting another Phamasset study in about two weeks called Quantum.they will be enrolling 450 nation or worldwide.  I could be wrong but early phase of study have less people to test the safety and efficacy before the open it up to such a large group.  

[SusieS2010]

You are absolutely right gonnabe. Te early studies are always quite small. The hard part is waiting to see what happens. The hepatitis community has been excited so many times about drugs in early trials only to have them pulled right before phase 3. Personally I don't get excited over any of them until they are close to approval.

I'm happy you are doing so well. I am actually going to Massachussetts to enter an interferon sparing trial with Ray Chung this fall. I don't know which drugs yet, but I am ready to get started.

[ninjamonkey]

How can you search for trials?

[ninjamonkey]

How can you search for trials?

[gonnabhepcfree]

www.clinicaltrials.gov...is one way.  google....Hepc clincial trials there are a few websites that lists ..what are you interested in and where do you live...

[Aaron57]

This link might interest you .. it has all chart of all the drugs in research as of June 2011 and the phases they are in ..

http://www.hcvdrugs.com/

Many "experimental" or drugs in development do not make through Phase 2 and Phase 3 .
The overall average is less than 50% of those started that do make it through all the trial phases ....

We have to be patient and know that with all the "new interest" and $$ in developing a high Tx average "cure" for HCV , Sometime in the future there is a real possibility that something will come along that will be our "silver bullet".

Cheers

[curiouslady1]

Great post Aaron.  Not completely up to date.  The Hoffman-LaRoche and last Pharmasset study are Phase II I believe.  I see that HepatitisCNewDrugResearch.com was taken down for some reason.  I hope it wasn't for all that abstract info that was posted precipitously.  

[ninjamonkey]

I'm in Texas not sure really I just wanted to look and study!

[UKgirl55]

I gonnabe...How have your side effects been on this trial? You're coming up on your 8 week VL soon, right? Please keep us posted. This is a very exciting trial you're on.

[burned74]

HCV advocate has a nicely laid out list of all the HCV drugs and where they are in clinical trials. It's updates 2 or 3 times a month.

[susan400]

Well, for those of us who are Protease Inh. resistant and also (like me)-now SOC null responders..., there needs to be something else.  I, for one, am thrilled that the researchers haven't given up on us.  My doctor, a major researcher in Hep C, told me that they are working on something for us Protease Inh failure patients and he has a folder of them already, waiting for when it gets to the right point in the all oral trial.  They're trying to get them to see that there needs to be a trial designed that will allow us, since we are resistant to the Protease Inh.  Susan400

[OdinLovesLife]

And another stunning thing about these new drugs is that so far they appear to have almost no side effects. No problems working while on treatment. If they aren't so harsh maybe there is a chance for people with other conditions to treat that can't do so now.

[nygirl7]

Please dont look to the market to tell you anything about a certain drug or treatment.  As we learned with experience from Vertex, these companies have a lot of different types of meds under review........so where you could look and think of the hep meds it could be spiking because of a MS med.  It really means nothing and the only thing that does is results and FDA approval.

I have been here many years and many of the very very promising drugs in latter stages of trial have flopped out much to the dismay of many of us.  You just can't tell what will happen eventually but judging using the market and PR work well.........wait for the trial data it will be more useful.

[curiouslady1]

Here is some interesting trial data when using some Pharmasset drugs in combination with Peg/inf/Riba from HCV advocate just posted in October newletter.

********

Pharmasset: 98% to 100% Cure Rates
—Alan Franciscus, Editor-in-Chief

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.
******

These results suggest that it is possible there is no need for the Peg/ing/Riba.  Operating on that assumption perhaps, the trials started some months after these (and therefore no SVR data available yet) are interferon free.  Some of the arms of the trials still use Ribaviron and some do not.  What seems to be coming out is that these drugs have few or no side effects during the treatment and that people with several different genotypes are seeing a rapid decline in VL within the first few weeks of treatment.  While there is not enough information out there to make definitive conclusions; it appears so far that, even with the addition of ifn, you will likely see drugs on the market in a few years which have fewer or no added side effects to SOC, which have a higher rate of cure than what is currently available and which are omnibus drugs, impartial to the genotype.  Nevertheless, many are still hoping for interferon free regimens.  Stay tuned.

[curiouslady1]

Oops, sorry.  Here is the url
http://hcvadvocate.org/news/newsLetter/2011/advocate1011.html

[UKgirl55]

Hi Susie! What is an interferon sparing trial?

[UKgirl55]

Hi gonnabe! I'm new to this forum, so not sure if I posted a reply back to you that you even saw. I mentioned the fact that your 8 week VL will be in soon and asked if that was right? Also, what are the side affects you've experienced on this trail?

[curiouslady1]

I cannot answer for gonna but I have had no substantial sides other than mild fatigue with this trial and I am on the same trial as she is.  Interferon-sparing or interferon-free is all oral medication since interferon is injected.  You may want to send gonna a private message so she can respond.  Sometimes members do not always continue to read the threads they have posted to.  

[gonnabhepcfree]

I have been tested every two weeks and am still undetectable.  the only side effect I have is some minor fatigue that comes and goes but has never stopped me from working and the only adjustment is really instead of walking 2 miles twice a day I now only do one two mile walk in the mornig.  

[gonnabhepcfree]

www.clinicaltrials.gov plug in NCT01435044 that number is for the Quantum study and they are recruiting in Austin Texas although they might not have actually started yet.

[UKgirl55]

Thank you for your reply. I didn't realize that interferon sparing was the same as all orals. I may have the chance of going on the new two PSI's. I saw that the four arms were something like...PSI 7977+PSI 938, PSI 7977+Riba, PSI 7477+PSI 938+Riba and of course the PSI 938 (monotherapy). I'm so happy to finally hear from those that are on the all orals. I was screened for the Gilead GS (four orals), but backed out after I heard about the GS-9190 problem. I'm now glad I did! I'm geno 1a, very high VL, treatment naive. 56 years old...SO ready to do something, but know how drug sensitive I am, so have been terrified to do the interferon.

[UKgirl55]

Love your screen name! What great news from you AND curiouslady. I'll be watching and waiting with baited breath! I could have been on this trial TWICE, but I was unsure! Sometimes you really need to take a leap of faith!