Starting Sofosbuvir GS 5885

[Renee543]

Hi, I tried Teleprevir last year and failed. The Institute called me last week to see if I wanted to be in this new study for Sofosbuvir GS 5885. I have not been able to get much info on the net except from the Drug Co.
They have one slot open and I need to be there tomorrow for my bloodwork and EKG. Is there anyone on Med Help that is in this trial or anyone with any info that would help me make this decision. I was so dis-hearted when I could not stay in the Teleprevir study. It is Phase 3, either 12 or 24 weeks and either with or w/o Riba.  It starts next week. Thanks for any info. Reen

[HectorSF]

You can read all of our posts of our experience with Sofosbuvir and other drugs here.....http://www.medhelp.org/posts/Hepatitis-C/GS7977-Study-Patients-Here/show/1769198#post_8676147

This is THE trial to be in. This treatment, that if all goes well, with be the standard treatment for genotypes 1  2 or 3 years from now. To have the opportunity now, many infected people only wish they could be screened to get into this trial.

Once you do this treatment you will be happy you stopped the peg-INF + Ribavirin + Incivek. The side effects are minimal in comparison for the vast majority of us and you will be undetectable in a few weeks after starting the trial.

I am in a Sofosbuvir + Ribavirin trial on week 20 now and have been undetectable since week 2. I was a previous null-responder to interferon therapy.

Good luck with the screening!
Hector

[gerard11]

Run and get in the car do not stop until you get to where your trail begins. Camp out to make sure you get in. You have just won the lottery and you don't even know it.

[HectorSF]

Absolutely!!!

;-)

Hector

[rivll]

You have struck gold! Go for it.
http://hepatitiscnewdrugs.blogspot.com/2013/01/gileads-lead-nuc-sofosbuvir-anchoring.html

[katla]

Sounds pretty amazing to me...

"Gilead today announced full data from one cohort of the ongoing Phase 2 ELECTRON study examining a 12-week course of all-oral therapy with sofosbuvir, GS-5885 and ribavirin (RBV) among genotype 1 HCV patients who had previously failed to respond to an interferon...or “null responders.”

... Today’s announcement confirms that all nine patients (9/9) in this cohort achieved SVR4. "

http://hcvadvocate.blogspot.ca/search?q=sofosbuvir+results

[1swimmer]

Looks like you got your answer. Good luck.
C

[Renee543]

Thank you all so much for the positive comments. I am getting ready to go now. I am now excited to go. thank you

[dointime]

What I find interesting is that the trial is not excluding you because of your telaprevir experience.  Granted the Gilead drugs are not in the protease inhibitor class like telaprevir, but for a long time people who have had any DAA experience at all have been excluded from further DAA trials.  I guess that there's now so many people around with DAA experience that the drug companies can no longer afford to exclude this group from their trials.  So good news for people in your situation.  

dointime    

[rivll]

Are you speaking of a possible resistance issue?
According to my study Dr., it is not a concern.

[dointime]

hi rivll,

No I am just observing that when telaprevir failures first started coming through they couldn't find another trial that would take them, irrespective of any possible resistance issues.  That was upsetting for some people who really wanted to get on another trial but were completely excluded.  I am happy to see an improvement in this situation.

dointime

    

[katla]

Could you please post the clinical trial number - NCT if you have it. I looked up clinicaltrials.gov and there were a couple of trials with 5885/sofosbuvir/riba but it seemed like they were either for tx-naive or cirrhotics. I want the link or # to the trial that's accepting those who failed triple.

Thanks so much!!!

ps- How did the screening go?

[Willy50]

There are 2 cohorts in this trial for TX "experienced"  w/ a PI

one cohort/trial arm w/ 7997 & 5885  but NO riba
"        "        "           "        "      "     but WITH riba

http://clinicaltrials.gov/ct2/show/NCT01726517?term=Sofosbuvir%2C+5885&rank=1
======================

This trial should also have two 8 week arms for naives with and without RBV and a 12 week comparator.

This is a small trial; only 100 participants which I infer is 20/ arm.

willy

[Renee543]

I sent the nurse the question. From what she told me yesterday you can be in the trial for sure if your at either end of the spectrum, either naive or cirrhotic and if your blood work shows you are in between then you have to have a biopsy. (I haven't had one for 5 yrs). So I am not sure what the biopsy has to indicate. That is what I asked her and I will let you know as soon as I find out because now I am curious. I want to know what the biopsy has to be, close to cirrhotic, or close to stage one?

[can-do-man]

It seems one has to be cirrhotic, all treatment naive means is one has never treated before, it has nothing to do with your liver stage........ Best to you.


Criteria:

Cirrhosis determination; a liver biopsy may be required

[Willy50]

Renee, this is actually a trial I am currently trying to get into,
dubbed "Ion 1"

http://clinicaltrials.gov/ct2/show/study/NCT01701401?term=Sofosbuvir%2C+5885&rank=2&show_locs=Y#locn

Although they are running a separate and distinct trial w/ arms for PI experienced.....this trial does not list past PI experience as an exclusion rule.  So it appears that it could also be this.  It should be a good one, in my estimation.

willy

[can-do-man]

Isn't the trial your going for is for tx naive people?
------------------------------

The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of sofosbuvir/GS-5885 (FDC) with or without RBV administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.

[Willy50]

Dang.  That's right.  Coffee hasn't kicked in yet.

Renee's is possibly this one, dubbed "Ion 2".

http://beta.fool.com/jordobivona/2013/01/10/stellar-play-hepatitis-c-market-growth/21250/?aid=73027&ticker=BMY&source=eogyholnk0000001

"A second Phase 3 study for sofosbuvir/GS-5885, ION-2, is expected to begin screening patients in January 2013. This study will evaluate the fixed-dose combination, with RBV for 12 weeks and with and without RBV for 24 weeks of therapy, among 400 treatment-experienced genotype 1 HCV patients. "

===================

Good catch.  
willy

[Renee543]

This is the answer I got from the nurse for the study, when I asked her if you had to be either end of the spectrum to be included:

The study sponsor wants to be able to classify patients as either cirrhotic or non-cirrhotic.  If their blood test is not able to do that classification, then you would need a biopsy.  Both groups are able to be treated in this protocol

Hope this helpd.

[balagan51]

I am cirrhotic and a null responder with IFN.
I have chosen to NOT to participate in the Gilead Trial, even though I was accepted.
If you carefully read the results with the group I am in, the success rate is
1 in 10.

I am going back to be screened for the ABT triple therapy Trial as an alternate. I'm not sold that the Gilead TX is going to be the Gold Standard for future TX.

best of luck to all participating, but if you are unfortunate to have cirrhosis and are a G1 non CC I'd read the study results very carefully

[balagan51]

Plus. I dont like I dont being able to choose one of the 4 groups that are being studied. That is done randomly. So you dont know if you are going to recieve Ribo,get the high/ low dose of sofosbuvir, or be treated for 12 or 24 weeks.

With ABT study eeryone is getting the same protocal and the study group is international and with a much larger number of people. Unfortunately like i wrote I am being screened but as as an alternate. For myself with my staging, if I dont get in I will wait. I wont risk building resistence to inhibitors with the odds 1 in 10.. Again, for those in better shape with better numbers Gilead may be the trial for you and I am praying all participating clears

[Treadlightly]

Your comment is totally contrary to everything I have been reading. Not doubting you, just surprised. The lowest srv I have seen is around 20%. Can you elaborate on your condition. I am also G1. Original diagnosis: stage 3 cirrhosis, 4M viral count. Approximate duration of infection 35 years. One clinical trial thus far with a good response to Peg/Riba but could not complete the 48 weeks. Managed to last 16 weeks. No follow up.

[Treadlightly]

http://clinicaltrials.gov/ct2/show/NCT01701401
Hoping to qualify for this trial.

[Willy50]

You *could* be right, but 1) I am not so sure you are right and/or  2) if you are predicating your conclusions on small sample or apples to oranges comparisons.  
It is always useful to know where you are getting your information.  Can you provide a source, study w/ CT #,  article etc?

I am not sure which trials combined 7977 and 5885 together, both with and without Riba for 12 and 24 weeks.  Got a CT trial number?
  
Even this would not be enough for a conclusion; you would ALSO need to have a 1) meaningful number of participants as well as 2) them being cirrhotic and 3) you would need a breakdown of il-28 genotypes.

Perhaps this study has been done, but I am unaware of it.

It might be a useful comparison using a past 7977 and daclatasvir trial......  I believe that has or is starting to be revealed.

Regarding the original poster Renee...I am unaware of her staging, her genotype subtype (1a or 1b), nor do I know her il-28 genetic marker.

I believe you are correct; these will impact the results, but so far we don't really know what trial she is in.  Since I don't know the trials you reference it makes it impossible to compare.  I'm not sure anyone can assert as SVR rate as of yet.

So far, all I  have seen are positives but admittedly........
.... I have not seen the breakdowns of genotype subtypes, cirrhotic failure rate, and genetic marker.

I think I'll wait to see the data before commenting further.

thanks,
Willy

[Willy50]

By the way, I think it's great you are looking the trials over.
I like the looks of Abbott's phase 3 for cirrhotics;
ClinicalTrials.gov Identifier:
NCT01704755n
Basically, everything that has worked in the past (4 total compounds) in both 12 and 24 week treatments.

I see no comparator and I see no placebo.  That means no matter which arm you get into you will be in a good trial.

I have been shopping myself, but I'm a little less certain about one with placebo for naives;
ClinicalTrials.gov Identifier:
NCT01716585
This one has a variety of placebo.  

Every trial is different.  Every drug and drug combination is different each trial is different and we all start out with our own immune response as well as our own unique blend of HCV quasi-species.  I think we'll have a better idea of patterns in the near future.  Or, as you suggest, maybe we have some of the info now.

I am a CT and a G-1a so believe me.......I am very interested in compound/treatment response to particular groups.

willy