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

[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