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

[rivll]

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.

[mzkity]

Now remember I don't know anything. But I'm so happy there's an offer on the table. This is great. :)      Kitty

[HectorSF]

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.

[Cheesegrater]

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

[Cheesegrater]

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).

[gerard11]

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!!!

[HectorSF]

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

[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

[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

[mzkity]

Keep us posted on your treatment status, if your going to or not. I wish you the best!!

[Tekelcat]

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.

[OC]

From what I understand there is no cross resistance with the 7977.

I believe the ION trial is for treatment naive patients.

peace

[jsf52]

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

[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

[Eki1]

The ION-2 study is for null and partial responders.

[3xlucky]

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.

[OC]

hang in there, the 3rd time is the charm!

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

peace

[OC]

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

peace

[3xlucky]

I looked for this study in clinical trials and could not find.  Is it just a select few

[OC]

yes, you have to had been on certain gilead trials prior...

peace

[nowhine]

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.

[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

[alico222]

Definitely go for it.. I think it really could work this drug combo. I would if it were me!

[nowhine]

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.