Boceprevir Trial failed

[Keith_2008]

Just to let some of you know that I have been on the Boceprevir trial for 5 months and I did not clear the virus. I quit as a result of the fact I was unable to get to undetectable limits in a time frame that I thought would achieve SVR. My last blood test came up at around 60 VL with only a 30 point drop from the month before. So it just goes to show you that no matter what you take. This ain't no wonder drug but I still think it helps more people than it hurts. I suffered headaches, Muscle aches, coughing from the interferon, fatigue and rashes just to name a few side effects. My doctor says I will have to wait until 2011 to try and treatment again.

[GreatBird]

Which version of the trial are you on? I was under the impression that they would pull people at 12 weeks if they were not UND.

Are you sure you had the boceprevir and not the placebo? In the trial I'm on (tx naive phase 3) they do not unblind until 28 weeks. I think.

[Keith_2008]

The drug company does not really tell you what arm you are in otherwise it would not be a blind study. So I can't answer that question. I was in the 3rd phase of the trial. I believe that I was actually getting the Boceprevir and not the placebo. I did seem to have some minor side effects with the Boceprevir that leads me to believe that is what I was getting. If I was on Placebo I would feel no difference in side effects right?

They do not pull people from the study at week 12. The drug company will keep you in until week 24 and if you undetectable they will keep treating you and if you are detectable they will stop treatment if you are getting the Boceprevir and will begin treatment with Boceprevir if you were getting the Placebo.

If my memory serves me correctly I think you were in this study and quit after just a couple of weeks of treatment. Is that correct?

[GreatBird]

I am in the boceprevir trial. Just did shot #18. I'm tx naive. Did go UND between weeks 9 and 10. I don't know what arm I'm in either--but I do know I'm getting the drug.

I've had sx from the peg, the riba, and the boceprevir. Not always easy to tell, but that aftertaste from the boceprevir is unmistakeable. Did you have that too?

So sorry it did not work out for you!

[can-do-man]

Sorry to hear, i'm in the relapser trial with boceprevir, if your in the tx naive trial what are you comparing your sx effects to? My first tx was just SOC and i really don't see much difference in my sides with the boceprevir. Most everybody has sx effects from tx.

While this trial i'm in is also double blinded its pretty clear i'm getting the real thing as i was und 2 weeks after starting the boceprevir. Your tx sounds like my first tx with just soc as i just did go und by 24 weeks.

With your Doctors comment about waiting till 2011 to tx again it sounds like he thinks you were also getting the placebo sense thats when these new drugs should hit the market and IF you were getting the real thing you wouldn't be able to tx again with these pi's. At least at this time.

Hang in there and best to you.

Cando

[smaug48]

Sorry to hear that you didn't clear.  At least you will get another shot at taking that dragon down.  Hope you start feeling better soon.

smaug

[GreatBird]

Actually, if we don't get the PI and do get the placebo, they are supposed to offer to roll us into treating with the real thing.

[can-do-man]

Yes same as the relapser trial, but if one was to quit the trial early would that still stand? I know the relapser trial is totally different then the naive trial and i'm not up on how it works, but in the relapser trial i was told if i would quit early i would not be able to be in the provide study. Its a mute point with me but i do know i had to comply with their rules to get in the rollover if needed........ Hope all is well with you.

cando

[Isobella]

Sorry to hear the trial didn't work out well for you.

I am also in a double blinded trial and I was absolutely sure, no doubt in my mind I was on the real drug based on the sx I had for the first 12 weeks of triple therapy.

Imagine my surprise at the 24 week point when I was told I had to continue for the full 48 weeks.  So technically, the only thing we can be sure of is that if they keep us going, we are UND.

Bottom line.....we're blinded.  We won't know what we were taking until they unblind us.  Hopefully you will be able to get into a rollover if you were in fact on a placebo.

On behalf of future tx'ers...I want to thank you for taking part in this trial =)

I wish you well

Isobella

[fretboard]

Sorry to hear that the trial didn't work for you.  good luck

[Rockerforlife]

IM also so sorry to hear you were pulled out of the trial,as you all know im in the Boceprevir relapser double blinded trial and i cleared 2 weeks after taking the BOC and am still clear today...just did shot  24,i may be stopping at week 36...depending which arm im in.so 12 more shots dont sound too bad....but if im in the other arm.im only at the halfway mark of 48 weks....i know im getiing the real BOC because i cleared so fast...in my previous TX with SOC...i dint clear until after wk 12...ant the taste is pretty strange...i get the taste when i wake up in the mornings...its weird...my tonge and mouth tastes awful bit my lips taste like a sweet taste almost...has anyone experienced the bad taste and the sweet lip thing???

[Keith_2008]

I'm not sure how many people here have had successful treatment with Boceprevir but it would be interesting to know. Right now I know that there were about 4 of us that started treatment around the same time and Rockerforlife is the only one who has had some success with it. If there are others out there who have had successful treatment with Boceprevir I would like to hear from you.

I am not really sure I was ever getting the Boceprevir. I originally thought I was but can't be certain anymore and toward the end of treatment I felt like maybe I really never was getting the Boceprevir. The doctors seem to think I was not getting the Boceprevir.

Another question is when a drug company share's their data for success rate of 74% does that include the people like myself who drop out or just the people who stayed in for treatment and failed. It seems to me if you did not include the people who dropped out that the data would not be accurate as most people who drop out of the study is because they failed to reach undetectable levels of viral loads within a certain time frame that would achieve SRV levels. It would change the success rate quite dramatically if that were the case and with the knowledge I have now it seems to me that the success rate stated is higher than it actually is and that may be due to the way the data is collected.

[can-do-man]

I'm 2 weeks behind rocker, I am a geno 1 who also has cirrhosis, so i'm one of the hardest to tx. My first tx i was a slow responder under soc. Treated a total of 86 weeks and relapsed. This time with boceprevir i am a RVR.

Fretboard who post here was also a RVR with boceprevir but do to personal reasons had to stop tx. (i think do to work issues).

There was also another responder that had to end tx early, don't recall her name.

Bill1028 is the only one i recall that was forced to stop but he was getting the placebo and will be put in the provide study and given the real drug

To me thats sounds like a petty good track record

Wishing you the best going forward and understand your decision to end it sense if you were only getting soc as a late responder you would have needed to extend tx to have a better chance for svr. But these trials don't allow this.

[can-do-man]

Also greatbird seems to be responding well to boceprevir and had cleared early.

[fretboard]

Yes there was a couple of us who had to drop off early.  I was down to 188, I think that's how low I was in my 5th week after only taking the boceprevir for 3 or 4 days but I was never UND.  I had a couple of health issues going on and the jerk at work just pushed me into throwing in the towel.

I had a bx in 11/08 with zero fibrosis and grade 2, right before I started the trial.  One of the biggest problems I ran into was depression which I plan to revisit at a later date.  Also, I am almost always anemic so I hope to change that thru exercise and eating better.  Unfortunately I am always in pain due to a back injury and with the HepC my back just kills me so of course I plan on trying tx again once I can get my health up to par.  thx cando

[Rockerforlife]

I am starting to notice that my leg muscles get fatigued and the bottoms of my feet hurt if i stand for a long time...i went for a bike ride today and i sure felt my legs...im surprised  i made it this far with losing it....and i was workn 50 hour weeks at my last job....12 more shot and i will find out if im done

[StormRider]

Hi Keith,

Sorry to hear that you didn't reach UND, I probably would have done the same as you and try another day if I didn't reach UND after five months. I am also participating in the BOC trial for naives. Friday I started my 24th week, started the same day as "sweet lips". I also had RVR and reached UND at week six. This entire ordeal has not been easy and can't wait until it comes to an end, I'm hoping to stop at week 28. All the best to you!

[Keith_2008]

Thanks to all that posted. I think it helps to keep us periodically up to date with certain study's so we know if they are working or not. Also it helps others to understand what to expect from their treatment and how many people are having success or not.

[nygirl7]

IF you were getting the real thing you wouldn't be able to tx again with these pi's

That is a little promising - since it does sound like you were not getting the real BOC at least there is a good chance that you will succeed next time when it's not a trial and you do actually get it.

I think you were wise to stop now and wait for another day and a better chance.  Why go through all the hell and beat your body up even more right now for low odds when certainly they will be better next time.

Smart man.

[GreatBird]

Is there any chance they will still take you for the rollover? (This is assuming that you were getting the placebo.)

[susan400]

Gosh, Keith, that's too bad, but from a personal perspective, I've give just about anything to be eligible to be in that trial and I wasn't allowed to be in it!   It's too bad that they didn't give me your slot!    ......

Take care of yourself with your regroup and with your waiting time.

Susan400

[Keith_2008]

I don't think they can give me the rollover because I have already stopped treatment. I will have to wait until 2011 to treat again. I could have stayed in the program but even my doctors were getting to a point where they were concerned about whether or not I would obtain undetectable levels of VL. I would have had to stay in the program for another 8 weeks before I could have gone into the rollover and that is only if I was getting the placebo and not the Boceprevir. Had I actually been getting the Boceprevir then they would have just stopped treatment right then and there. The problem is that it drags out the treatment time and forces the patient to take the drugs longer than required because you are not getting the real drug Boceprevir. I don't like the idea that they use the SOC treatment as an arm of the Boceprevir program because they already know what the data is on that and repeating the same study over and over again just doesn't make sense. If people are willing to take the Boceprevir than they should give them the best chance possible and treat right away with the Boceprevir as opposed to making some patients wait until week 28. When I spoke to my doctor about this issue he told me the FDA makes them do this.

[Keith_2008]

If you can't get into the study which is closed now then maybe you should wait until 2011 when you can get these drugs.

As to taking my slot comment you made. One never really knows if you get into this trial that you will actually be provided with the real Boceprevir or the Placebo. The reality is that you could join the study and only receive the Soc treatment. I was in this study group for 17 weeks and was still getting detectable levels of viral load. I quit because of the detectable levels and the toll it was taking on my body after being on treatment for 17 weeks. My treatment failed and had I stayed on treatment for even longer, which would have taken a greater toll on my body then I might have still failed because the longer it takes to get to undetectable levels the lower your chances of clearing the virus. I think I gave adequate time to reach undetectable levels and just did not get to where I need to be in the right time frame. Had I reached the undetectable levels of VL. I would have continued in the program for several more months to obtain SVR. But for you to tell me you should have got my slot because my slot failed. Know one knows who's going to fail or who's going to succeed. One also does not know if they are going to get the real drug or not. The fact that I failed does not mean that you should have got my slot. The fact of the matter is that maybe you would have failed too. Does that mean that someone else you have got your slot? It's the wrong thing to say to someone and I hope you see my point of view. I would not say this to someone who just came off of a failed treatment.

[susan400]

I am sorry if that came across that way.  I didn't mean to imply that I should have gotten your slot because you "failed" treatment.  I just meant that I would have liked to have had the chance to get 'a slot' at taking the Boceprevir in that trial.  I, personally, hate to use that term "failed" when it comes to describing having to stop TX.  Maybe you aren't aware that I've had that unfortunate end of my 10 treatments without ever having gained an 'undetected' status.  So, right now, I'm in a waiting mode for anything that will come up to give me another chance at viral clearance.  But, I'm not just spending all my time sitting around thinking about the Hep C and whining about not clearing.  I'm out living my life, enjoying this time that I have off of treatment.  For some reason, I guess I was under the impression that you were just dropping out of the trial of your own choice and not that you were dropped from the trial, or that you had 'failed'.  I totally apologize and I hope that you will forgive my remark.

Susan400

[choprchk]

Hi Keith,

I'm so sorry to hear about your results on the study.  I know exactly how disappointing it can be as I have failed 3 previous attempts of tx. The last round was months of grueling hell but nothing was more painful than when I heard the dragon had returned while I was in my 83wk of tx. I know people that have cleared and I am truely thankful that they did, however, there is also this part of me that screams "WHY NOT ME!!!"  I am new to this forum and hope to be approved for the boceprevir study, p05685. Your experience has made me have a realistic level of optimism because my mind can run away with anything wheter it be positive or negative. Please don't drop out of sight, stay in touch with the forum and let us know how you're doing. Enjoy life to the fullest and take care my friend.  

choprchk

[newleaf09]

keith,
I am saddened that it did not work out.  I am also glad to find some feedback from others in the trial; I've been dying to talk to someone about it, but people don't talk in the Viral Clinic waiting room.  I've been in it for 22 weeks (the treatment naive one).  I had a very low VL and cleared after the first peg shot and have felt very, very guilty for ending up in a slot for the treatment drug when so many others needed it

I think you can tell if you are on boceprevir because of the odd taste in your mouth, especially early on,  Also there are weird gastric effects, so when your bowels move an absurd amount comes out.  It also has a severe effect on your blood, causing worse neutropenia (low bacteria-fighting neutrophills) than interferon alone.  

At 24 weeks they will measure VL and those who have not cleared with boceprevir will be dropped (why suffer more), those who got placebo will be started on boceprevir if they want, and those who cleared at 12 wks and stayed clear till 24 will be randomized again to either stopping at 28 weeks or doing a complete 48 with SOC and the boceprevir. I've memorized the protocol, I've read it so many times.

I am personally hoping hard that I end up in the 28 week arm.  The boceprevir makes treatment miserable enough that SOC looks much better to me and I'd hate to do 48 with boceprevir.  The nurse said that when we go for our 24 wk PCR, we'll only be given a week's worth of medicine, the company will take a week to re-randomize us and then we will shortly be given the quantity of meds for a short or a longer treatment.  Good luck to you all.  Keith, thanks for bringing it up and I hope you'll do well until the protease inhibitors are marketed.  Perhaps by then they will have a recommendation for a shorter treament period if you clear on the PI's. Good luck to you all.

[Kat1635]

my husband is thinking of doing the trial on the Boceprevir is there anything that he needs to watch for he has ever been treated he is genotype 1a and we are veery excited about this

[Rockerforlife]

Make sure you take the BOC on time,get extra timers,you will be taking 18 -20 pills a day at different times.

[newleaf09]

Which trial does he have an opportunity with?  Very curious to hear what opportunities are out there (as are a few others considering beginning TX).

I actually did get randomized out of the boceprevir naive trial at 28 weeks (see post above) and was darn grateful for that.  I agree with Rocker that it is very important to just keep up with the dosing, which is 4 pills every 7-9 hours (12 per day).  That is to keep the protease inhibitor at steady state in the body, so there's no chance the virus can mutate and become a less treatable form.  I was a master with setting alarms and never missed a pill throughout the 28 weeks.  There are more side effects with the boceprevir, since it destroys hemoglobin almost as badly as the ribivirin, but Schering also supplies Procrit to go with it.  They found that people who end up exhausted from low hemoglobin are less likely to stick with the trial and they don't want the ribivirin reduced (the other way to manage low hgb).  

And the boceprevir DOES work.  They are getting response rates around 80% with the naives.  Can't remember the figures for retreaters but those figures are amazingly encouraging, too.

There are probably 10 or so members of this forum from the 2008 boceprevir trials.  We would be happy to offer advice and moral support should your husband participate in an upcoming boceprevir trial.  I have to say this: the study team took very good care of us lab rats.  We were closely and carefully monitored, probably much better than we would have been in our own doctor's practice.  Good luck to you both.

[Kat1635]

we are going to Kansas City tomorrow to meet the research team at least a few of them the Dr will not be there and to get the concent forms the study is to start the second week of December I pray that he gets the med not just the fake pills also his hemo is at 16 which is good right now we have got his ALT and his AST down in the 50's both of them and they were up in the 400 and 300 range I look all the time for things to do to lower his numbers thank you for the information any thing that we can learn will be helpful as we are new at this we have known that he has the HEPC virus for a year and a half thank you again