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

[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
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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