has anyone taken boceprevire through clinical trial?

[wtgb]

Hi -I am a 41 y/o female genotype 1a.  viral load 199,000 with mild elevated liver enzymes.  fibroscan (which I don't put much weight in) and biopsy (which I do agree is the gold standard) both have shown recent progression from (0-3).  I am really thinking of participating in a clinical trial with boceprevire and/or teleprevir.  I am very concerned about long term affects as I have never had any symptoms from the hep c except for worry.  I often wonder "if its not broken why try to fix it".  I would love to hear from anyone who has experience with any of these clinical trials.  It would be the standard tx plus boceprevir.

[newleaf09]

I was in the Boceprevir trial for naives.  That trial had a response-guided arm that allowed early responders to have a possibility of randomizing out of the trial at 28 weeks and I was one who did randomize out at 28.  The boceprevir whomps both hgb and neutrophils but I think that what it does to you as far as side effects is also related to how strongly you respond and develop side effects in relationship to the interferon.

My hgb did not get low until several months into the trial.  I think that if you cleared early on the boceprevir and it was a few more months until your hgb dropped enough to need a dose reduction of riba (that's one of the arms in the new boceprevir/procrit trial on clinicaltrials.gov) that you would probably be fine with the reduced riba.  Boceprevir is looking like a great drug.  A freind in the teleprevir trial who had her riba reduced for a good while when she was on teleprevir also had good results.  I say go for it if it's a possibility for you.

Your VL is under 200,000 (that's excellent), you are at stage 3 fibrosis.  Time to do something

[WriteItDown]

OK, wtgb, what you need to do is get the details of this trial -- how long it is, what the dosages are, what the stopping criteria are, etc. when and how much they will dose-reduce the riba.  But it sounds potentially very good! Phase III is very desirable.

If it is a trial where you are guaranteed to get the Boceprevir for the standard treatment length (I would personally hope for the shorter period, 24 - 28 weeks, though some people prefer to be cautious and do 48), and they don't lower the riba too soon, I would absolutely say DO IT.  That would be a great deal for you and Boceprevir has had overall excellent results.

Please post more details when you know them.

About the treatment itself, it can be very difficult.  My husband is currently in his 16th week of a trial with a different protease inhibitor.  He's been lucky and is doing well, doesn't have as bad sx as many people, but he is very tired and feels somewhat sick quite a bit of the time.  Do you have help with your kids, a good situation work-wise, support from family and friends?  All these things will help you a lot.  But I do agree that, if you've progressed from Stage 0 to Stage 3 (did I get that right?)  you definitely need to think very seriously about treatment, as I can see you are, and a trial with Boceprevir would be a dream come true for many folks.

If you do a search on here for Boceprevir you'll get a lot of hits and can read a lot about others who have been on this drug.

[wtgb]

Thank you for welcoming me to the forum.  I am very overwhelmed yet excited at the opportunity to posssibly clear hep c.  I have two young children and often worry about the path hep c may take me.

I am happy to share my experiences/story with anyone it may help.

In response to "writeitdowns' interest in  a boceprevire trial for treatment naive pts Ihave found a phase three clinical trial with boceprevire in the philadelphia area. the trial is not blind to either pt or physicain regarding the boceprevire(the docs are very positive and excited about boceprevire) it is a trial to determine the best way to treat the highly potential  side affect of anemia.  treatment of the anemia is randomized to two options.  One being to treat it with procrit and the other is to decrease the dose of ribavarin.  

Thanks again for the support!  

[WriteItDown]

My feeling is that if you want to treat, and can find a good trial with one of the protease inhibitors, that that would provide you a better chance of clearing, and do it faster, than SOC.

I didn't know there was a Boceprevir trial available now for treatment-naive patients -- do you know the details of the trial?

There are a bunch of people here who have cleared on Boceprevir -- I am sure they will chime in and give you good advice.  Best of luck!

[Marcia2202]

I very much agree with the statement 'if it's not broken why try to fix it'.

The problem it that if one has HCV 'it is broken'.

There are quite a few here who have been or are in clinical trials with either Telaprevir or Boceprevir. If I'm not mistaken, they have all had positive results so far.

Personally I treated for 32 weeks, extended treatment for geno 3a, and am now SVR. I had a hard time during treatment, but it was definitely well worth it. I am now HCV free and can go on with my life without having a life threatening illness.

[Bill1954]

Hi there,

Yes, there are a number of Boceprevir trial folks here; give them a bit to respond.

I did the Standard Of Care (IFN/Ribavirin) twice, and am now SVR (cured), so the stuff does work, at least for many of us.

In my opinion, it was well worth the trouble. My liver enzymes are now down in the teens; and I continue to test undetectable for virus, using very sensitive assay methods.

Welcome to the discussion group, by the way,

Bill