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?

[coeric]

thanks for the update on your trial. hopefully it will not take longer than 5 years for an interferon sparing treatment to get approval.  i am currently on triple therapy.
blessings
eric

[attagrl]

Thanks! We're pretty happy about it. :D

[UKgirl55]

still figuring out this site, so only just realized what you meant about your journals. thanks....they're great!

[UKgirl55]

How awesome that your mom is in the same trial and doing as well! WOW!!

[susan400]

I'm excited about the Pharmassett news. I can't wait to jump on board when it gets to the phase/place in the trials for null responders (and hopefully allowing previous Prot.Failure patients).  Susan400

[UKgirl55]

I am so excited about this particular trial you are on. Such good news to hear that others are also experiencing the same thing! Pharmassett's PSI 7977 is one amazing drug! I know someone very special to me that's on PSI 7977+SOC and she's having the same amazing outcome. Thank you all for being so brave and for taking the first BIG step!!

[curiouslady1]

Just a footnote to this thread as I had mentioned in another.  I was informed today that all six participants at our site in this BMS/Pharmasset all oral experimental trial had RVR and I know of two others in other states as well for a total of 8 that I know of achieving RVR.  The energy that attagrl speaks of is not idiosyncratic to her either.  I have posted several times about feeling much better in just a short period of time.  It appears those undergoing studies with the oral drugs in combo with the SOC (trials done at an earlier point in time have a very high percentage of SVR . . . something over 90% and up to 100% which is already a better finding than what is on the market now. . . check web sites in my journals).   Those of us in the all oral trials will have to wait a while longer before we can proclaim that good news of SVR interferon free.    

[attagrl]

Thought I'd jump in since I'm also in the same trial as curious and gonnab. I'm 35, started with a viral load around 3.7million, and was undetected by my week 3 visit; just got my week 6 results yesterday and still undetected! The first week or two I had some significant fatigue and headaches, but since then I've experienced ZERO side effects and am even training for a half-marathon in two weeks. I also do karate and I won my sparring division last weekend at a big tournament, so kicking some literal butt along with HCV's. ;)

I feel blessed to be a part of this exciting study and even more, my mom is also a participant and is undetected as well!

[curiouslady1]

Actually, there are several people that are members of medhelp forum on all oral medication trials which involve meds put out by Pharmasset.  Not all of them are posting to the list and some want to maintain their privacy I believe.  The people that I know are all doing very well but it is too early for anyone to say that their undetectable status has been sustained for 6 months following treatment.  You are correct that this is a leap of faith that we have all made.  For myself, the alternative was far worse than either staying infected or getting into a trial with drugs I felt comfortable with.  FYI I am 64, 40 year infection, was high VL.  You may want to check people's journals and notes and prior posts and get a sense of the site and the information on it.    

[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!

[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.

[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.

[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.  

[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.  

[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?

[UKgirl55]

Hi Susie! What is an interferon sparing trial?

[curiouslady1]

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

[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.

[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.

[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.

[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

[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.

[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.

[ninjamonkey]

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