All oral study didn't work for me - looking for some advice.

[adamben101]

geno 1a.  infected for about 3 years.  biopsy stage 1 grade 1.
Started all oral Gilead trial
week 1-8 RIBA, protease, polymerase.  UND at week 1.  breakthrough week 6 or 7.
week 8 - added PEG in rescue arm.  Removed protease due to a few outlier complications with a few patients.
Now in week 12 and virus is slowly driving VL up.  No sides from anything.
My personal guess is the addition of PEG may have worked if they kept the protease in the mix.  No I feel very let down.  My guess is I'll be removed from the trial completely soon.

Any thoughts welcome.  Trying to find another Hepa for second opinion too.

Thanks!

[Willy50]

My thoughts?  It is all in the rear view mirror now but 2 things;

You MAY have made it IF you had the IFN earlier and IF the protease inhibitor had not been stopped, but I'm not sure anyone can promise you that.

This may also say something about either your starting quasi species or your own particular immune response.  I am a g-1a for instance, and I believe that they are seeing that 1a's may not respond as well as 1b's (all other things the same) to some PI's.  I'm not positive that is true but it gets back to the starting more resistant strains of virii, it means that unless ones innate immune response eliminates the virus quickly, 1a's may start out a little more resistant than 1b's; it's a *shorter drive* to resistance/ breakthrough.

What does this mean to you?  At this point it is a done deal.  You are probably done for a few years.  It's a drag, but not the end of the world.  Your more resistant strains will revert back to wild type in a period of 1.5 -3 years. (I would venture it may be different in different people).  There are tests which will adequately measure such reversions and measure quasi specie populations w/ assessments of what types of treatments will target certain virii populations.  This is kinda new and perhaps a little *grey area* but generally true i think.

There are many treatments being developed right now.  They will be more efficacious.  They will be more powerful and more specific to each type of need.  Once there was only really one type of TX; in the future I think you'll find there may be a variety of solutions.  

There may be a really tough treatment; ie right now there might be quad therapy in trials which could be used where one really had a tough case.  there may be certain protease or polymerase, or nuc mixes to provide the broad band coverage one needs to totally or finally decimate the virus.

There may be response guided solutions so that some people may treat less time based upon initial response, or mid course where the virus types are checked mid stream and an appropriate mix added.  There will be MANY approved drugs, all being tools which can be used to cure you.

There could be new drugs that work so well that all the painstaking effort will be eliminated.  They may work so well that the quality of doctoring won't be that important.

You've not been infected very long.  There are many people who have had this disease for decades without serious damage.  It looks as if you may have to wait a few years to re-treat, but I fully expect that you will get there.

Sorry for the outcome, but remember, one never knows; even quad therapy has it's failures.  Success was not assured and so IF I had advice, I would say forget about the "what if's".  They will avail you nothing at this point.  You will get there, just....not as soon as you had hoped.  It was worth the attempt and I would venture that there were many successes in the trial, so it was not a foolhardy choice you made to partake in the trial.

Still....sorry for the outcome.

best
willy

[willbb]

Nothing much to add to the good advice from Willy....would just say, like yourself  I too failed a trial experiment and also like you am fortunate to have minimal fibrosis and have  had HCV for 35 years years.
The future looks exceptionally bright with all that is in the pipeline.
Best to you..
Will

[nygirl7]

I'm very sorry adamben I know how much you were hoping this would be the magic ticket.  Hate this disease hate hate hate hate it.

[Dee1956]

Hi, like NYGirl7, I hate this disease, hate it, it has changed everything for me.  I have lost family over this virus and their ignorance.  All I can do is wish you the very best and try again.  Many people have treated more than once, twice etc.  I did a trial in 2008 was supposed to be the new gold, triple tx 16 weeks of trial and the rest up to 43 weeks with Peg and Riba. UND 4 weeks later and 2 weeks after that it was back.  It breaks your herat when you try to do everything you can and it comes back.  I wish you all the best.  As others told me, regroup, build yourself up and try again
Dee

[curiouslady1]

I had a hunch the rescue wasn't gonna do it for you Adam.  I am really sorry for how it all turned out for you.  You gave your liver a break for a few weeks though and that can't be a bad thing.   Now I suppose it is a matter of carefully figuring out what drugs you took and the resistances that go with them and what drugs you can take in the future.  Time to give your body and mind a rest from all of it.  Best of luck to you.

[his3707]

I am so disappointed that this has happened.  Thank goodness you will not have to wait years and years to try something new.   The researchers are going to find a way to get it all for every one.    SOON!  Take care and stay on top of it
Lydia  

[spectda]

Hi Adam-
I think Willy gave you very good advice. It's going to take a while to treat again especially since you have used two types of DAAs that have different resistance profiles. As we discussed you can try to treat privately if you can find a doctor that will increase the riba/interferon dose but honestly it may very well be futile at this point. Did you get another viral load result? What was it if you did?

I also agree that the future looks bright for you with little damage and a lot of great drugs on the horizon.
-Dave

[UKgirl55]

It would be crazy for me to say, try not to stress this because any one of us would! HOWEVER, there is such good news out of the liver conference this weekend and HONESTLY, I feel that you're going to kick this virus with the new drugs, which I'm guessing if all goes well will probably be on the market in 2 years.

I screened for the exact trial you did and backed out. I DO believe that if they'd kept the PI in there you would have cleared, but the 9190 was having AE with the IFN and it was best you didn't have it. The good news is that they didn't use the big gun....NUCLEOSIDE, which is the PSI-7977 and a couple of others. I just heard that the PSI is going into phase III. ALSO, in phase III is the cyclophilin (Deb 025)...think that's the number. The cyclophilin works indirectly on the RNA chain of the virus, so there are going to be so many options for you....in the not too distant future!!!

Like someone said....Look at it as giving your liver a little rest right now. Keep having a healthy lifestyle and you'll be ready for the next treatment. By the way...they're also screening for people that have failed a DAA (I believe)...so already they're looking at that sub group of people to treat.

[nowhine]

Isn't the GS 9190 Tegobuvir a polymearse inhibitor?

[adamben101]

yes tegobuvir is a polymerase

[adamben101]

Some great answers here.  Thanks, everyone.

[UKgirl55]

Oops, yes the 9190 is a polymerase, but it seemed to be the lead drug in this all oral combo. The 9451 was the PI and GS-5885 was an NS5A. It seemed to have all we were looking for (even the Riba), so I understand why you went for it.

[OC]

sorry to hear the study didn't work for you!!!

i'm currently in the following gilead trial, it maybe the same one as you?

Gilead Protocol Number: GS-US-248-0131
Clinical Trials Identifier: NCT01435226

peace

[belle19]

so sorry to hear that the study did not work for your.  my prayers are with you that some time in the future you will reach SVR thru another method.  best of luck to you.  belle

[Lifenet62]

Time IS on your side. Take a deep breathe, don't beat yourself up, thank God for guts and courage, and ride the wave. It's all gnarly now adamben. You will be fine and something bigger and better is on the way to you.  Always believe.