Trial of BI201335.

[22hamilton]

I'm in a difficult position right now and unable to fully weigh the pros and cons of whats being offered to me. I have compensated cirrhosis-diagnosed 09, liver function reasonable at the moment. Have been classed as a non responder-gen1a after my last unsuccessful shot at treatment with SOC. My consultant is offering me a trial of BI201335+SOC in april, on the face of it I should be grabbing it with both hands I suppose but if this trial doesnt work am I going to be a rersistant non responder to an entire class of PIs. Thats a scary thought.

Any knowledge would be welcomed,what questions should I be asking my consultant prior to agreeing and enrolling.
Any ideas on what I can do to improve the possibility of achieving a SVR ?

Cheers
Paul

[22hamilton]

Thanks Hector,I realise my situation is very pressing but telaprevir and boceprevir have so far not been offered and who knows when they will be available in the uk. I am a complete null responder, BI201335 has been trialled on null responders already-some of whom were in the same position as me-age/cirrhosis etc.Seems response rate was 50+% at week 12.
It was quite a big trial with 280 people enrolled so theres something there.

Will update how things pan out.

Cheers and take care

Paul

[HectorSF]

Hi Paul.

Yes, this is a big decision. I would like to offer my point of view which may be to the contary to some of the advice have been getting. My point of view is based of my own experience treating when I was a compensated cirrhotic and now that I have decompensated and am looking at a liver transplant. Of course it is your life to live and ultimately your decision as to what is right for yourself.

Paul were you a Partial responder or a Null Responder?
Partial responder:  A person who had achieved a 2 log10 drop by week 12 but never became viral load undetectable by week 24 of a previous course of treatment
Null Responder:  A person who has less than a 2 log10 drop in viral load at the 12th week of treatment.

I agree you are correct in not wasting time with SOC again. According to the REALIZE study using Telaprevir previous Null Responders SVR rates were = 31%! vs.5% for those retreating with only SOC.
For Partial responders 57% vs.15% retreating with SOC.

Clearly no matter how you look at it the odds of SVR are greatly improved over SOC retreatment.

Maybe this has been discussed and I missed it...but why would you go into a trial with unknown odds of success (BI 201335, Boehringer Ingelheim Pharma) for cirrhotic "non responders" when it is known that Telaprevir and Boceprevir both have been shown to increase the the chances of SVR for non-responders who have cirrhosis?
Is it that you can not afford the new DAAs (Direct-Acting Antivirals) drugs for some reason?

Since you have compensated cirrhosis this may be that last treatment that you will get to try because you can decompensate at any time. No one can say when you might decompensate. After that you may find it extremely difficult to impossible to find a doctor to treat you with HCV meds when you are decompensated. I don't mean to be negative here, but are you aware the there is between a 5-10% that the treatment can cause your liver to fail? Therefore you should be in contact with a transplant center just in case. (I also treated when I was compensated and first had a transplant center monitoring my health during treatment. I was a non responder and am now decompensated and listed for transplant).

Yes, you are in a tough position for sure but on the flip side you are running out of time to treat. So the issue of failing treatment and becoming resistant meds should be less an issue for you. You still have a windows of opportunity. You need to use the time you have to give it at least one more try to clear yourself of the virus before you decompensate. And I would think you would want to give yourself the best odds of SVR that is available. Then you will know that you have done everything you possibly could before the final option of a transplant.

Good luck with this difficult decision.

Best of luck which ever way you go!!!
Hectorsf

[22hamilton]

Cheers, yes there will be a placebo arm and because its blind I wont know if I'm on the drug or placebo. So I guess one question would ne at what point would I find out.
Am sure there are lots of questions but at this point cant think of any.

Thanks anyway

paul

[willbb]

  One question you would ask,if you don"t already know about the trial...are you guaranteed the study drug  or is there a placebo arm.,as you would not want to take the chance of getting SOC again as a prior non-responder.

Good Luck

WILL

[desrt]

PROS:
1) Hey - drug trial! Free stuff! (Though maybe not that big a consideration in UK as in the States.)
2) Possibility of cure.

CONS:
1) Hey - drug trial! Possibility of unknown side effects.

Haven't heard of any protease inhibitor trial failure causing resistance to *all* PIs, though Susan400 getting stuck in a non-ribavirin arm of  a PI trial may have caused resistance. For that PI. For now.