R7128 Trial begins tomorrow

[DragonSlayer45]

I will begin the Roche/Pharmasett trial for polymerase inhibitor R7128 tomorrow. I am in the genotype 1 treatment naive arm that will be getting 1000mg of R7128 (or placebo) along with pegasys and copegus. There is a 1 in 5 chance of getting the placebo. Regardless you will still be getting the SOC.

This trial will give all 3 drugs for 4 weeks and then just peg and riba for the next 4 with the option of continuing an additional 40 weeks of SOC.

I am excited to be in this trial but I am also nervous about the drugs at the same time. I will let everyone know how it all shakes out for me.  I am hoping that I get the trial drug and not the placebo.

[DragonSlayer45]

Thanks I appreciate it.

[Marcia2202]

Am a bit late on this one... I am wishing you all the best with the trial!

Marcia

[DragonSlayer45]

I apologize for not answering you but I was at the hospital when I responded and really did not have a lot of time. To answer your question, No it will not replace interferon. As of now the only FDA approved drugs for HCV are pegylated interferon and ribavarin. All of the experimental drugs that are in trials whether they are polymerase, protease, or helicase inhibitors are being given with peg and riba as a triple therapy. So far there has not been anything that can rid the virus alone. maybe some day in the future there will be something that is more user friendly than the conventional medicine but that day has not arrived yet.

Having said that what they are finding is they get much higher response rates with some of these newer drugs. It takes many years even when fast tracked to get a new drug approved. i hope that answers your question.

[rita863]

Mr. Lucky ~ i dont think it replace interferon,  but i am not sure,you may want to look at the links above that others have posted, it will give you more information.
I am sure when DSlayer can post he will, he has just started the TX and is getting blood drawn every hour or so and he will be there overnight to start the TX.

peace
rita

[mr.lucky66]

I being ignored and am asking if this drug will replace interfueron?

[DragonSlayer45]

Thanks Buddy!!!! I had to stop posting they were coming in haha

[DragonSlayer45]

Thanks for the well wishes from everyone and I will keep everyone posted.

To Fl Gator,

The trial did not end abruptly. It was a phase 1 trial and only lasted 4 weeks. The person from this study site is still clear I believe and is doing the SOC so those results won't be posted for a while since the trial was in November 07

[rita863]

hey we are with you in spirit!! hang in there buddy!

peace
rita

[DragonSlayer45]

Yes that is the trial and I will post results as they come in, including my sides etc. shhhh I am posting from the hospital hehe. I am just sitting here getting blood drawn every hour and the computer was sitting here all alone sooooooo. Thanks

[fretboard]

Allright were all hoping you do well with zero sx's, stay safe and get back to us for the true lowdown on how you're feeling etc.  I've read nothing but positive on this one, so much luck to you.  
God Bless

[mr.lucky66]

is this the drug that will replace interfueron?

[GSDgirl]

Good Luck.  I am curious to read about the results.

Denise

[n49]

Best of luck.. I hope it works !!!

[nersayner]

oh so good luck, keep us posted!

[Trish77]

DS45, is this the study you're in?

http://clinicaltrials.gov/ct2/show/NCT00382798?term=r7128&rank=1

Here's some background on this for others .. interesting.

http://www.hivandhepatitis.com/hep_c/news/2007/091407_a.html

Please post details.....this particular drug I find very promising so far.  Seems the adverse affects are very minimal.  The trials are in early phases yet however looks good so far.

Good luck to you and will look forward to the results of this.

Trish

[IAmTheWalrus]

Good luck! I am anxious to see how the new polymerase inhibitors work out. They seem to have a lot of hope. Keep the forum posted.

Best to you,
Brent

[Fl_Gator]

Good luck to you....please post often. I am very interested in the new treatments. I read good things about it last year. That it rivals VX950. The R7128 study that started last November was stopped abruptly...do you know anything about it?

here is some good news...have you seen this?

http://www.pharmasset.com/download/VRUS-R7128-HCVDrugDiscovery-CHI-042828.pdf

[mr.lucky66]

Is this the drug that is supposed to replace Interfueron?

[willing]

ds: best wishes on the upcoming battle ; those 4/5 odds seem pretty good. And yes, please share details on enrollment, protocol, tests, etc. I think quite a few of us will be interested.

dointime: did you ever hear back about access to your sequence data ?

[dointime]

Exciting stuff Dragon.  I believe you are the first on the forum to maybe get R7128.  I am really looking forward to your reports on this trial.  Thank you,

dointime