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Gilead Rollover Study
OC
Here is my history:
I was a Null Responder to Standard of Care back in 2002.

I was in this Clinical Trial (NCT01435226) and was considered a relapser, finished 10-17-12. I didn’t clear the virus at 2 weeks (baseline 11,100,000 to 65), so I went on the Rescue Study with 2 DAA’s, Ribavirin, & SOC. I cleared the virus at week 16, but went back and forth between undetected and <25 for most of the time. I was undetected at 48, but after 1 month the virus was back.

Here is a link to the thread that I posted, http://www.medhelp.org/posts/Hepatitis-C/Gilead-study-GS-US-248-0131---phase-2-all-oral/show/1610899?personal_page_id=2264261

I just got a call from the study coordinator saying that Gilead has a rollover study, that consists of GS-7977, Peg, Riba for 12 weeks that I can participate in.

I think I'm going to go for it, it’s my understanding that Gilead will only use the 7977 with Peg/Riba for Genotype 1’s.

What do you think?

peace
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I have heard of this study too and yes, I believe it is for gen.1 only.
I will look for the link but from what I read, it has shown to be a very effective treatment combination.
I would say, go for it.
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4670047 tn?1375734001
Now remember I don't know anything. But I'm so happy there's an offer on the table. This is great. :)      Kitty
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446474 tn?1446351282
What drugs did you take in your studies?
There were multiple arms and various placebos.

So you have never take Sofosbuvir (GS-7977)?

Sofosbuvir is highly effective with just Ribavirin so I would imagine it would be at least as effective if not more so with Peg-interferon.

I would go for it, as if you aren't undetectable by week 4 you know it won't work. Most of us on Sofosbuvir clear by week 2 or 3. It is only 12 weeks which even on peg-INF makes it much more tolerable than 24 or 48 weeks.

Good luck!
Hector
On week 30 of Sofosbuvir + Ribavirin. Hep C 1b, cirrhosis and liver cancer awaiting liver transplant. Undetectable since week 2.
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What were the DAA's you were on in the rescue?

I looked up the trial you were in, NS5A, non-nuc polymerase and  protease inhibitors and ribavirin, in one combo or another (with or without Riba or Togobuvir, the protease inhibitor).

You then went on rescue with 2 DAA's (the same or different?) and Peg-interferon and riba. And failed.

You have potentially been on a number of different classes of DAA and failed. Have you been checked for resistant mutations against any of the classes of DAA (protease, NS5A, non-nuc etc( that you were exposed to?

At this point it looks like the only promising class you were NOT expoded to was GS-7977 a nuc - polymerase inhibitor, but in the trial you mention, pairing it with Peg-IFN and riba,  this is not the ideal combination, and the Peg-INF / Riba failed to work in you before with 2 DAA's.....

I think you are best to wait this one out until you can show you have no resistance against a protease or NS5A, then treat with GS-7977 + GS-5885 and riba (maybe throw in another DAA in there if trials go that route).

Using sub-optimal treatments breeds resistant strains of the virus.

I am sorry to here of your bad fortune. My advice...Wait for a better trial.

Cheese
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OOOPS, I meant to say test to see if your are resistant to NS5A and protease then treat with GS-7977 and an NS5A or GS-7977 and a protease inhibitor,  (Or throw in another DAA AND riba  for good measure).
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Hector how long is your trial?  I noticed you said you are on  week 30. I was just curious if they keep you on Gilead trial meds until you get your tranx, or if there is a predetermined week that they stop treatment ? You are also undectable now.  H, I think about you all the time. There are so many people in Phx who have heard my story of my online friend Hector that has possibly saved my life ( depending on how my Gilead study goes!). Hang in there!!!
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446474 tn?1446351282
My trial, the first use of all oral treatment in cirrhotics, was supposed to be up to 24 weeks. Us candidates in the trial (with HCV and liver cancer awaiting transplant in the next 6 months) were expected to have transplants before we reached 24 weeks of treatment. So we would treat until the day of our transplant hoping to not have HCV recurrence in our new donor livers.

For me, my liver cancer has gotten unmanageable, so I am not eligible for a transplant and missed the 24 week window. Luckily, Gilead had a sub-study for us to continue treatment for up to another 24 weeks or until we get our transplants. I don't know how many of us of the original 50 people in the trial are in the sub-study, but I am sure it is a very small number.

I was a previous null responder to peg-INF and Ribavirin in 2008. With Sofosbuvir + Ribavirin I have been undetectable since week 2 of treatment. So for 28 weeks as of now.

For us awaiting transplant, we are in a different situation than the vast majority of folks treating their hep C. For us the goal is to suppress the virus for at least 4 weeks before transplant, as it has been shown that suppressing the virus for 4 weeks of more prevents recurrence of hepatitis C post transplant in most patients. So if you think about it, we don't have to worry about relapse which is why almost all people fail Sofosbuvir treatment.

So I should be hep C free if I can survive my cancer. So my and my doctor's challenge right now is to get a handle on my cancer so I can get a life saving transplant very soon.

Thanks for your well wishes and support I appreciate it.

Still hopeful and fighting the good fight.
Hector
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OC
On the trial I got all 4 of the meds, on the rescue study it was, gs-5885, gs-9451, & SOC...

No, I haven't been checked for resistant mutations.

peace
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OC
I didn't get a placebo, so I got all 4 drugs:

Tegobuvir
GS-5885
GS-9451
Ribavirin

After 2 weeks, they dropped the Tegobuvir and added the IFN for the rescue study.

I haven't had the GS-7977 yet.

I'm being told by the study coordinator that Gilead will only be prescribing the GS-7997 with PEG/Riba for Genotype 1's.

peace
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4670047 tn?1375734001
Keep us posted on your treatment status, if your going to or not. I wish you the best!!
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Um, I thought Gilead was working on Sofosbuvir (GS7977) Ledispavir (GS5885) with Ribavirin for Geno 1a??? I think on the ION trials? Perhaps they are not offering you that because nobody knows if treatment with an NS5A inhibitor like Ledispavir (GS5885) leads to resistance?

There are so many new INF-free treatments in the pipeline, but it seems not yet for HCV 1-a :-((  See the video at http://www.hivandhepatitis.com/hepatitis-c/hepatitis-c-topics/hcv-treatment/4052-croi-2013-advances-in-hepatitis-c-treatment-2013-video

If your liver is okay and you can live with being HCV+ a bit longer, I would wait, which is what I am doing after relapsing from GS5885, GS9541 (placebo) and INF/Rib. But I had a rotten time with INF, and the further out of the tx I get, the more I see how bad it was. Also, I'm reluctant to risk taking things on trials that create viral resistance and lock me out of tx options in the future when my liver might be much sicker than it is now.
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OC
From what I understand there is no cross resistance with the 7977.

I believe the ION trial is for treatment naive patients.

peace
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Hi OC,

I got offered the same trial as I had to quit the 9451/5885/INF/RBV due to resistance to either the 9451 or 5885.  I participate in the Registry study for monitoring and research.  I am thinking about this trial but want to get input from my hepatologist as she told me at my January appt that I need to get the most optimal tx the next time due to my being a non responder to INF/RBV in 2010 and then having the trial not work.  Being at Stage 3 fibrosis, I want to get cured as quickly as possible and want to make sure that the next tx is the one!  Will let you know what my hepatologist says when she gets back from vacation next week.It does sound like this is the tx that Gilead is going to push for Geno 1.
Best, jsf52
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OC
I was a non-resonder to SOC in 2002

I was a relapser on 9451/5885/INF/RBV in 2012

I've talked to 2 Hepatologists and they think it's a good option for me.

peace
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2135877 tn?1381864726
The ION-2 study is for null and partial responders.
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I am another one that was on the Gilead trial with two drugs and inf/rib. I went from 34 million to 100 but could not clear and at six months stopped. I was a non responder to two int/rib treatments.

I have been in a follow up resistence testing with Gilead and was told that 10 months later the resistence should have cleared. My doctor is getting this new trial but does not have the particulars yet so I have not been offered it but if I  I will do.  I have been told that 9777
Does not have any resistence and since I developed resistence to 5885 it is unlikely that I should go on that again and I know that is what Gilead will pair 9777 with if they do not use int/rib

Good luck to all and am so happy to hear Hector's good news.  

SVR to all.
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OC
hang in there, the 3rd time is the charm!

i'm getting screened on monday, that's what i'm hoping for?

peace
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OC
i was screened today, IFN 12 shots...uhh!!!

peace
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I looked for this study in clinical trials and could not find.  Is it just a select few
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OC
yes, you have to had been on certain gilead trials prior...

peace
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1835200 tn?1427463838
OC...best of luck. Please keep us posted.

For those reading I was also on this trail Gilead 9451/5885/interf/riba and failed. 1a, CT. Also treated previously with soc and failed. I am passing on this trail. I don't feel it is the optimal tx for me. I don't want to test the resistance thing on this one. Best of luck to all.
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OC
we're, the same genotype & phenotype, both failed SOC, i'm now considered a relapser from the gilead 9451/5885/interf/riba...i'm being told their is no cross resistance to worry about.

what is on the horizon that you're waiting for?

peace
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Definitely go for it.. I think it really could work this drug combo. I would if it were me!
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1835200 tn?1427463838
what is on the horizon that you're waiting for?

Lots of questions unanswered.

There are many new DAA being tested. Which one is for me?
Which combo?
Why would Gilead not offer 7977/5885 interf./riba to us? Gilead is offering non-responders this combo for folks that failed Incivek and Victrelis. ION-2.
There are massive relapse on 7977/riba with 12 weeks of tx. Will 24 weeks be the cure?
Do we still have resistant mutations lingering? I am in the registry study and they have been taking my blood for the past year.
Is Gilead just trying to get more data at our expense?
Will failure on this rollover exclude me from future 7977 trials with other DAA's?

I'm holding out for more data showing the most optimal tx before I treat again. There will be other trails.

Best of luck. I pray you succeed.
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Gilead can't offer you the trial with 7977+5885 because your previous trial had 5885 and you've probably developed resistance to 5885.  That's why they're only offering the 7977+riba.

Here's data on the Tx:

In NEUTRINO, 327 treatment-naïve HCV genotype 1, 4, 5 and 6 patients were treated for 12 weeks with sofosbuvir 400 mg once daily in combination with RBV (1,000 or 1,200 mg/day) and peg-IFN (180 μg/week). Seventeen percent of patients had compensated cirrhosis and 89 percent were infected with genotype 1. Among genotype 1 patients, 89 percent achieved SVR12. Of the 35 patients with genotypes 4, 5 or 6, 97 percent achieved SVR12. Among patients with cirrhosis at baseline, 80 percent achieved SVR12. All patients in this study became HCV RNA negative on treatment and relapse accounted for all virologic failures.

In FISSION, treatment-naïve HCV genotype 2 and 3 patients were randomized (1:1) to receive either 12 weeks of sofosbuvir 400 mg once daily plus RBV (1,000 or 1,200 mg/day) (n=256) or 24 weeks of peg-IFN (180 μg/week) plus RBV (800 mg/day) (n=243). Overall, 20 percent of patients had compensated cirrhosis (advanced liver disease) and 72 percent had genotype 3 infection.

The SVR12 rates in patients receiving sofosbuvir plus RBV were
97 percent for genotype 2 patients and
56 percent for genotype 3 patients.

You can read these under Hector's post in this thread:

http://www.medhelp.org/posts/Hepatitis-C/great-news/show/1928143

HepCat
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1835200 tn?1427463838
hepcat thanks, nothing new here. I'm waiting. Thanks for posting.
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OC
i've had 2 prominent hepatologists tell me this is a good option for me.

peace
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That's what I thought too. Good luck... Sofosbuvir is supposed to be good.. But only time will tell us.
All best on your journey... Hearts be with you.
Love
AliX
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OC
thanks, if all goes well, i start next friday 4-19-13.

peace
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From an earlier post:  >
In NEUTRINO, 327 treatment-naïve HCV genotype 1, 4, 5 and 6 patients were treated for 12 weeks with sofosbuvir 400 mg once daily in combination with RBV (1,000 or 1,200 mg/day) and peg-IFN (180 μg/week). Seventeen percent of patients had compensated cirrhosis and 89 percent were infected with genotype 1. Among genotype 1 patients, 89 percent achieved SVR12.  <

OK so here we see 89% of 327 (291 patients) had geno 1. Of those how many were genotype 1a or 1b? 1b is usually easier to cure. 1b generally do better than 1a's.
ALL of them were treatment niave. Treatment niaves tend to do MUCH better than relapsers and non-responders. Several studies have shown when it comes down to 1 or 2 DAA's with or without peg-riba, non-responders tend to do way worse than niaves! And 1b's do better than 1a's,  in general.

You ( OC )  have been on treatment with Peg/riba in the past at least TWICE and it failed to work for you. Peg-Riba failures do not do so well when retreated with peg-riba.
If you treat with 7977 and peg-riba and it fails because the 7977 needs the help of the peg-riba, (well, you do not seem to respond that great to peg-riba) then you put yourself at risk of relapse. If you relapse you will have been exposed to so many classes of DAA that you probably will not qualify for treatment (trials) for a long time.  

I would bring these facts up with the 2 hepatologists you are seeing and ask some serious questions.  It is your future on the line, not theirs.

Best wishes.

Cheese

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OC
both hepatologists know my exact history...

i'm not sure what is on the horizon from other manufacturers, but from what i understand gilead is only going to give genotype 1's the gs-7977 with peg/riba anyway.

peace
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This Feb/March 2013 Gilead started a trial in which genotype 1 peg-riba non-responders AND genotype 1  who failed a protease inhibitor are now being given 7977 with 5885 with-without riba.

I know a genotype 1a peg-riba null responder who failed telapervir, who is now in this study. They are on 7977 with 5885 and riba. UND at week 4.

So you see, Gilead IS treating genotype 1 with 7977 and 5885.  There will soon be Vertex and BMS in phase 2 trials with their polymerase and BMS-790052 (Daclastavir?)  and there will be other DAA combos coming out as well.

Cheese
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OC
let me clarify, when gilead goes to market with gs-7977, they will target genotype 1's with peg/riba...

i would prefer treating without peg, but right now i don't have that option...

i calculated that during my past 2 treatments, i injected IFN 93 times...

peace
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I see. Sad to hear we'll all (GT 1's) be missing out on gs-7977 and gs-5885.

http://www.medhelp.org/posts/Hepatitis-C/Expect-Sofosbuvir-end-of-2013/show/1917743
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OC
it's a tough call, i wish i had a crystal ball, i would certainly wait for a IFN free trial, that had good data for "1a relapsers", but who knows when that will be...

peace
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Sounds like you may be starting this trial tomorrow - good luck and God speed to getting a cure.  

I am going to pass on this trial - I spoke with my hepatologist and she said that since I have such a limited/non response to INF, that she is concerned that I may relapse after 12 weeks.  She wants to wait for the data to see if the 12 week timeframe will work for me as I am in the "hard to treat" group.  She also said that with all of the upcoming trials, there may be a combination of that would include 2 DAAs that may work better for me given my history.  Keeping faith for all of us!

Best, jsf52
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OC
thanks, i won't be starting until next week now...

peace
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I am going in next week to be screened for this trial. I was on the 5885 and 9541 plus SOC for six months but could not clear.  I went from 34 million to 80 by 12 weeks. No breakthroughs but built a resistence. I finished June last year.  In the registry for resistence. I am 1a CT.  So far I have been told very little chance of resistence on 7977. The worst that can happen is I do not clear.  I tolerated the trial pretty well last time.  As far as I have been told I would be available to treat in a year with 7977 and 5885 if this fails.  

Maybe when they release the results in a couple of weeks of previous non responders I will change my mind. The doctor said that with only RIBA and 7997 non responders had a 60% chance.  

If I am missing something please let me know so I can ask the right questions next week
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OC
now i'm going to start the following friday (4-26-13) because the drugs have not came in yet...

hopefully you will hear some news soon, so you can make a decision...

peace
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OC
make that next friday (5-3-13), gilead is having computer problems.
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How is it going. I start on weds the 22nd.  
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OC
so far so good

week 0 - 2,480,000 (baseline)
week 1 - 72

good luck to you!

peace
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4670047 tn?1375734001
Congrats OC, your going to win this time!!
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OC
thanks, i'm keeping my fingers crossed!
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Awesome news. So happy for you. Keep me posted and I will let you know how I do.  It took a few weeks In the last study before I got this low.
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Great news!  Keep us updated.  Will keep you in thoughts and prayers.
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OC
sounds good, keep us updated...
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OC
i will thanks, i appreciate it...

peace
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OC
week 0 - 2,480,000 (baseline)
week 1 - 72
week 2 - <25

peace
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4670047 tn?1375734001
Hallelujah!!
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Awesome.  That is great news.  Hopefully I will follow your lead. Two days in!
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Well got my first week results today

Baseline. 8,5 million
Week 1. 207

Not as low as you but heading in the right direction. Week 2 results next week.

Sides not that terrible besides the interferon sides two days after.

Trying to be cautiously optimistic!
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OC
great news, sounds like you're doing great so far...

my sides don't seem as bad this time around either.

i'm waiting for week 4 results anytime now.

peace
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OC
week 4 - undetected

peace
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4670047 tn?1375734001
Fantastic!!
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OC
yes, hopefully the 3rd time will be the charm!

peace
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So happy for you.  That's awesome news. I have this is it for you
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Congrats on the UND.  This is the best news!  Keeping prayers for SVR.
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5536514 tn?1373503602
Hi Hector.  I read your post and you really inspire me.  I stated this before (somewhere in this forum) but I have severe cirrhosis.   Will that lead to liver cancer.  Are there any symtons to watch for.  I have several people tell me I might need a transplant,  and others say they don't think I do need one and not to worry.  Gee how lucky they are to be psychic.  I may not understand all the numbers and such, but I do understand another human helping another.    Keep on trucking  bluebird305
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OC
thanks, i appreciate it!

peace
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OC
yes, great news, thanks for the prayers!

peace
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Wow am amazed at this drug.

Baseline 8.5 million
Week 1 207
Week 2 <25 detected

Hopefully like you at week 4 will be undetected.
Have never had this response before.  Of course I understand the proof will be in getting SVR.  Wishing everyone that
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OC
awesome results!

SVR forever...

peace
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1747881 tn?1358189534
Wishing you guys all the best with this trial, hopefully this is the one that does the trick, thanks for keeping your progress updated.
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Congrats on the great #s. Keeping you in prayers for UND and SVR.
Best, jsf52
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OC
no worries, thanks!
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OC
appreciate it!

peace
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Thanks. Will let you know how it goes. Early days yet so taking it one day at a time.
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Can you tell me what is the average time to wait for a liver transplant?  Just wondering...  
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Sorry to sound stupid, but what does DAA stand for?
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Well after an anxious two weeks waiting for my 4 week results. I
Am Undetected!  

In 13 years and now my 4th treatment I have never achieved this. Still a ways to go until I am certain I can maintain SvR.

Just did my 6 week blood work. Half way through the trial.

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4670047 tn?1375734001
That's just great news!!!!!:):)
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142526 tn?1397094272
Congrats on the UND. You're on your way to SVR! ;)

(It is agonizing waiting for lab results).
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You can do better than that Shesam,

Google :   DAA and HCV

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180992 tn?1383377657
DAA= Direct Acting Antivirals.  
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Congrats on the UND and future SVR.  Have a great and relaxing 4th.
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Thanks for the support praying for Svr for all and a successful treatment for all. Happy 4th
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OC
sweet!!!

happy 4th

peace
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When do you get your 6 week I should get mine next week or the week after. It seems to take two weeks to get results.
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OC
for some reason it's taking 2 weeks to get the results.

week 6 - undetected

peace
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Awesome so happy for you. Glad to know it takes as long for you two. My mind was saying delayed results meant bad news but turned out not to be true.  Trying to live in the present enjoy the good news and let go of any expectations.
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OC
thanks, yes, just letting in happen the ways it's gonna happen!

peace
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Still undetected at 6 weeks!  Just did my 8 week draw. Only 4 more weeks of treatment.
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OC
sweet!!!
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How are you doing must be nearing the end. I will finish on August 17 and then the three month wait to find out if it has worked. So far still undetected at 8 week blood draw.  Exhausted and but hopeful.
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OC
I was done on 7-25-13, awaiting my 12 week results.

I test at 4, 12, 24 weeks.

peace
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1747881 tn?1358189534
Congrats on finishing tx, wishing you all the best.
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OC
thanks!

peace
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Good for you. Keep me updated on your post results.  Fingers crossed
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OC
same for you!!!
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Did you get your 4 week post treatment results yet. I go in next Weds for mine. Will get the results 2 weeks later. Undected at 12 weeks
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  I'm keeping my fingers crossed, for you and OC!  All on here, fighting this, are in my prayers~ best wishes
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Thanks for the good wishes.
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OC
that's great!!!

i should get my 4 week post results any day now...

peace

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OC
thanks, greatly appreciated!!!

peace
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Best of luck on your results, it has been interesting following yours and 3xlucky journey in this thread
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OC
:-)
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Good luck on the test results - looking forward to hearing good news!
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Good luck on your test - looking forward to hearing  that you are SVR!
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OC
:-)
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OC
post week 4 - undetected

peace
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4670047 tn?1375734001
Aaahhhhh!!!!! NICE!!!   Happy for you OC!!    Kitty
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Great news!  Congrats - next step is SVR.
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OC
thanks!
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OC
thanks!
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Awesome news. I just got my 4 week post treatments results and am
Undetected!!!   Hard to not rejoice at the news but know I still have 5 months to go before reaching SVR.  The treatments are getting there. 4 treatments and first time Undected at all.  Good luck to you for the next tests
In 2 months.
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Congrats on the great news!  Will look for the SVR post.  Hoping that warriors like you and OC will open the door for all of us who have not responded with the triple and even quadruple combos like I had in a trial to get this tx  
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Thanks.  Hopefully it will work and everyone will have a choice. The next few months will show us. Good luck.
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OC
sweet!!!

i hear you there!

peace
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OC
hang in there!!!

peace
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1747881 tn?1358189534
"post week 4 - undetected"

Great news, congrats on the 4 wk post UND, now on to SVR

Wishing you all the best
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1815939 tn?1377995399
Congratulations to both of you on 4 weeks post Undetected. Now on to SVR!
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OC
thanks...:-)

peace
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OC
appreciated!!!

peace
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  Great news, I'm so glad to hear this :)   Are you two going to do a 12 month viral load test as well, before the 24 weeks?   On-ward to Svr!
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OC
they have me scheduled for post at:

4 weeks
12 weeks
24 weeks

peace
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Thanks. Hopefully it will work and set the stage for other
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Thanks. Fingers crossed for the next few
Tests.  
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Hope you are doing well. Any update? Went for my three month post treatment draw today. Will get results next week. The doctor told me they are seeing good results. Hope I am one of those that stays undetected but it is jot in my hands. Have faith.  But it seems as though there will be a drug combination that works for us all in sight. Exciting times unlike a few years ago.
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OC
post week 12 - undetected

i go back in january

good luck to you!!!

peace
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Congrats on the 12 week.  I just went for my annual registry labs today and the nurse at the site told me they are having good results with their patients in this trial.  I am hoping that it works for you.  It sounds like if they get good results from prior non responders, then this may become the treatment for folks like me.

Best,
jsf52
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1815939 tn?1377995399
Congratulations on 12 weeks post EOT UND status. Best of luck.
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Will keep thoughts and prayers for an undetected 12 week post.  I went for my annual registry labs today and the nurse at the trial site said that they are getting good results with this trial.  It sounds like if they get good results then it may become the next treatment for folks like me.

Best,
jsf52
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OC
thanks, hopefully this will work for everyone!

peace
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