Clinical Trials questions

[tkflex36]

Hey everyone,
I've been trying to get into a trial for the last year, sent all my records and was told to just wait and eventually I'd get called. So meanwhile I was prescribed sof/riba 24 wks from gi(I'm a 3a) and long story short never could get ins to ok it, even with support path. So last week I get a call that a trial is starting in early dec and it's with gilliad meds for either 8 or 12 wks and did I want in. Of course I said yes, but since then I can't find any info on this trial in clinicaltrials.gov  or the university of Penns website. I think it might be the Polaris-2 with sof/vel or sof/vel/gs-9857. But not sure, what's everyones thoughts on trials and the new gilliad combo and the new gs-9857?

[KimInTheForest]

Hi tkflex. And welcome! I also could not find any such trial as you describe on clinicaltrials.gov. I searched for "genotype 3" as you probably did too. I found several that are currently recruiting or not-yet recruiting. But none with 8-week and 12-week arms.

I was also geno 3a, and I was cured this summer in a clinical trial of 12 weeks of Harvoni+ribavirin. I would NOT have been covered for any of the new direct-acting antivirals where I live in Canada unless I first tried interferon, which I had refused for 20 years. So clinical trial was the ONLY way for me to get the new drugs into my body at the time, and get cured. (The market for low-cost overseas generics had not yet opened up.)

Consequently, I am a fan of clinical trials if the drugs are not readily available to you by other means. Some trials are better than others in terms of your likelihood of being cured. Mine was very good in that regard. But even if you aren't cured in your trial (because you were given a placebo or shorter duration), most trials have a policy of letting you take the full course of drugs afterwards so you can get cured (unless you have become resistant). A question worth asking, if you go forward with your trial opportunity.

Another good thing about trials is that you tend to be more closely monitored in a trial than under normal prescription conditions. Quite possibly weekly blood draws. And of course you are entitled to have copies of all your lab results.

good luck!
kim

[tkflex36]

Kim,
I just heard back from Penn, the trial number on clinicaltrials.government is ntc02607800. The drugs used will be sof/vel for 12 weeks or sof/vel/gs9857 for 8 weeks. She said I will know on day 1 which of the tx arms I will be on. She also said she hopes to have me in for screening next week. If everything goes right I'll actually be taking the first dose within 30 days. I'm so excited to finally be able to put this dragon down for good! Just an FYI this is a worldwide phase 3 trial and they are looking for many people of all Genos, as thsee meds were made to treat them all, in a short time. Maybe u could spread the word, since I don't know how to navigate this site that well.
Much love,
TK

[beto]

tkflex36,

Always great when things line up in life.  You are on your way.  Trust that this is your time and I am sure you know how lucky you are.  I wish you the very best and look forward to your progress and hearing all of the great news to come.  SVR...the promise land.  Peace...

[KimInTheForest]

That's great news, TK. Good luck to you on the trial!

kim