opinions regarding treatment options

[viaduk]

I met with Dr. Jacobson  on Friday and am mulling over the different options that he presented to me. I would appreciate your opinions.  First, some background:  

Dx with HCV 1990, biopsy showed mild inflammation. I treated with monotherapy and was considered a nonresponder (no viral load test back then, but LFTs were unchanged).  Had another biopsy 1999, which showed early stage cirrhosis. I was able to get into the 2000/2001 phase 3 trial of peg/riba and responded quickly and became undetected at 12 weeks.  I remained undetected throughout the  rest of the trial (which was 48 weeks), but had significant sides, required neupogen, and had to stop work. I remained undetected for 2 months post tx (monthly testing), but became detectable at the third month blood draw. Tried maintenance tx with pegasys, but had to stop due to sides and no clinical response after 3 months.

Fast forward to the present... enlarged spleen, portal hypertension, varices banded 4 times and currently no varices noted. I am generally well compensated, MELD stable at around 10, am working and generally hanging in.  I saw Dr. Jacobson on Friday, liked him and am planning to become his patient, and was hoping of getting into a clinical trial.   He posed the following options:  1) daily infergen/riba. 2) Perhaps get into the trial of omega interferon/riba  with a "dura" capsule that is inserted under the skin at 3 months intervals and provides the medication without the need for injections.  3) Extend tx to 72 weeks. 4) Wait for a trial of PI (hopefully Vetex) that includes nonresponders and relapsers.   The only possible exclusion from the trials could be platelets below 100k and psoriasis.

Anyway, sorry for the long post. I have been lurking around here for a little while and have been  impressed by the kind and helpful folks here.  Thank you

[mremeet]

I'd add Alinia into your option list, might be something to look into. Also consider dosing riba and/or IFN above normally prescribed levels during the initial portion of treatment (although psoriasis and low platelets might make that option tough). Otherwise it looks like you've been pretty good options. And it sounds like you really had it on the ropes back in '01, I'd perceive that as a positive sign you could do so again, except this time nail your SVR.

[dointime]

This only points I'd like to make about a trial are:
1.  Make sure that they'd allow neupogen.
2.  Be clear on what happens if you are in the control group, ie. you don't want to treat all over again with a regimen that you know didn't work for you last time.

Good luck,
dointime.

[jmjm530]

As you probably know, Dr. J. is one of the best, so I assume he endorsed all four options or else he wouldn't have given them to you.

Everything being equal, I'd choose the Telaprevir trial option, but personally I'd want more info on which trial, how long it would be until I got in, and the likelihood of exculsion because of platelets and psoriasis plus Dr. J's opinion on whether your condition allows that projected wait.

If you decide to treat outside of trial, 72 week seems reasonable, but I'd also add increasing the riba dose if you can tolerate and also discussing with Dr. J. the idea of pre-dosing riba for 2-3 weeks prior to tx, as FlGuy did. I'd also ask about double-dosing until UND per the Dieterich video on the Clinical Options web site, with weekly viral load tests. Lastly, let's throw in the Alinia like Mre says -- nothing proven yet but the side effect profile seems OK and you probably want as much edge as possible.

Anyway, that's what I would run by Dr. J. if in your shoes and then I'd heavily lean on his opinion, as he is "the man" or at least one of a select group of them. BTW don't think you have to be concerned about the riba in terms of psoriasis. The problem is primarily the interferon. Depending on how bad you have it, consider the biologic Enbrel, or at least get hold of a good derm prior to treatment. Enbrel has some plusses and minuses and actually was trialed once for Hep C. I'm sure Dr. J. can add some on that score.

-- Jim

[jmjm530]

Forgot to mention that you should try and get weekly viral load tests to gauge your viral response as accuratly as possible which might allowing some tweaking of meds  -- one way or the other -- if necessary.

[viaduk]

Thanks for the replies.  I would also lean towards the Telaprevir trial option, but at this point there is no telling when they will allow relapsers into the trial.  Dr. J. said that all options seem reasonable, as I have been pretty well compensated for over 8 years, but he seemed to lean towards the omega trial. I did ask about "rescue" drugs and they said that they would be allowed. I'll have to wait and see if I am eligible for that trial, but another year of treatment with what may be similar odds is a depressing thought.  I don't think I can handle 72 weeks, but I didn't think I'd last through the 48 last time and I managed to.

Anyway, thanks for the helpful ideas.  I will mention the Alinia to him, though I don't think they'd allow that in the omega trial, and I'll also check out enbrel.

[Andiamo1]

Isn't enbrel an immune system suppressant?

[jmjm530]

Yes.  Enbrel was suggested to me initially by one doctor, cautioned by another, but both said to take it if my psoriasis got worse and threatened to take me off treatment as can often happen. I don't know the extent of Viaduk's psoriasis or how it was affected in the past on tx. Of interest is that Enbrel had been trialed as both an adjunct to HCV therapy and as an antifibrotic in the past although haven't heard any follow-ups.
http://dermatology.cdlib.org/127/reviews/psoriasis/cecchi.html