Should I Join Study?

[3badogs]

I am trying to decide whether or not to participate in Phase 3 trial of Telaprevir/Pegasys/Copegus.  I'm in my late 50's & probably have had HCV 40+ years.  I just had liver biopsy done, but haven't rec'd results yet.  Symptoms (which have alternately been ascribed to fibromyalgia) include fatigue, chronic muscle pain, low energy levels.  

If biopsy shows liver damage occurring, I will definitely take the treatment.  However, what if it does not?  The research facility is leaning on me to join the study.  I need to make final decision by December 15. Not even sure I'll have the test results by then.

Were any of you who have taken earlier trials using Telaprevir asymptomatic at the time you started treatment?  If so, what were your reasons for participating in the study?

THANKS!

[fretboard]

Studies are a very good way to go thru tx.  Whether or not you should tx is a question that you will ultimately have to answer yourself.  Personally I am in the Boceprevir trial and I am really happy with the care I receive.  This tx can be difficult so you really need to educate yourself on the side effects that you will go thru and also the sx's that will come from the telaprevir.  I'm 55 and I've had HepC for maybe 35 or 40 yrs.  As far as your bx results go, you may not have that much liver damage, but the symptoms may lead you to want to tx, which was the case with me.  good luck with your decision

[can-do-man]

Yes studys are good, but you really need to read the fine print and understand all the risks. Will they allow rescue drugs? or do they dose reduce. They have their rules and doctors can't tx outside that. If i had little damage i would think hard before i chanced a study. From what i understand these P I'S are a one shot deal. Sometimes it might be best to wait till they come on the open market where doctors have full range.

At least from what i have heard there is no placebo in the telaprevir navie new trials, which is good....... Best to you

cando

[fretboard]

My understanding from what I've read on this forum is the Telaprevir trials do not currently offer or allow rescue drugs.  Not only that they don't tell you anything about your blood levels until you're done with 24 months.  Also, the entrance protocol is alot more stringent than the Boceprevir trials, as far as allowing someone with prescription medications.  Someone can correct me if I'm wrong.  They are both good drugs and they are both very good trials with good results.  

fret

[lapis]

I've been HCV+ for 12-14 years and I think I was having sx like you describe but didn't realize they were related to my HCV.  For me I think the sx came on so slowly that I just got used to feeling that way, and I considered myself very healthy in spite of the virus in my body.  As others have said, there are many benefits to being in a study.  I'm receiving great care, the meds, the visits, and all the labs, etc, are free.  I chose to enter the Telaprevir trial because the timing was right for me.  I'm 55, just quit my 2nd job (so now I only have one job, thank goodness, and I'm self-employed so schedule is flexible).  I have a good support system, no other major health problems, and I've read that the tx only gets harder as we get older.  I live about an hour from the major medical center where the study was being done, and like you, was basically recruited when I had a routine hepatologist visit.  Treatment is such an individual decision, and the cautions from can-do are good to consider.

Best of luck to you as you consider your options.

Lapis

[Isobella]

I am Stage 1, Grade 0 and in a Telaprevir trial for naives.  The one I am in has a placebo arm....not the one that many centers are recuiting for now.

I have been happy with the care I have received.  I am in week 19.

My decision to treat was based on several factors.  Other than fatigue, I had no symptoms.  I am young(ish) and healthy.  I wanted to fight this thing while I am strong.  Also being self employed, we self insure and the drug coverage isn't that great...so I figured a trial was a good option for me.  The timing was perfect for my life as well...this was a good time to dedicate to tx.

I did my research and went after the Vertex trial and have been very happy so far.  No rescue drugs tho.  But that has been ok for me as I am tolerating the meds well.

I will also add that I have a loved one that my center has offered the no placebo/naive
telaprevir study to.....but we are gonna wait til the drugs hit the market for that go round.  That way....full doses of meds throughout---no reductions.

Good luck to you in making your decision.  Please keep us posted.

Isobella

[copyman]

Like Isobella said the telaprevir trial they are recruiting right now has NO placebo so you will get the real drug. it really don't matter if you have to dose reduce while participating in the vertex trial because Telaprevir kills the virus within a week!  Good luck with whatever you decide

[fretboard]

I think both of the trials will dose reduce as a first line of defense when it comes to a low hemo score below 10, at least that's what I've been told in my trial.  Are either of you eligible to tx for onlly 24wks?

3badogs
You could also tx for only 24 or 28wks depending on what study you get on and whether you get and stay UND for the appropriate amount of time.  good luck

  

[Fl_Gator]

I am in a Vertex trial...same one as Isobella...different center...I have had minimal sides the worst being fatigue. I took a riba reduction around week 5 or 6 then started AD's around week 10 or so. I was taken off the meds at week 24 Thanksgiving day...I still feel like I am on them. Had a couple of good days but still feel bad. I know it will go away...I just can't sit still any longer...I wear myself out.

If I had it all to do over again the only thing I would have done different is wait for the trial that is being offered to you...the no placebo trial.

Good luck in whatever you decide...

Gator

[merryBe]

the first question is do you have insurance?

If so you have to weigh carefully benefit risk factors. Obviously you can get rescue drugs, and will be apprised on all your labs and progress and will get a FULL dose of the standard of care (SOC) drugs. You may have to treat longer with these 2 drugs (interferon/Ribavirin) but maybe not, depends on your genotype. Treatment can range from 6 to 18 months depending on your genotype and response.

If you don't have insurance the trials are very appealing. Just remember, you may be in a control group that gets lesser amounts of the trial drug, or even placbo. At least with the teleprevir trials you do get the SOC drugs as well, but you may get reduced dosing. Hence as someone said...read the fine print.
I would be very concerned if someone responded late, but had to go without rescue drugs the entire time. I mean, if your blood is being destroyed, and there is a hormone that will help you make new blood, it just seems cruel to not allow people to have it.

mb

[pilgrim1951]

You and I have similar stats.  I am in my late 50's and have probably had the virus since the early 70's.  Except for a 4 week or so period of fatigue in the late summer of '07, I wasn't aware of any symptoms.  During my annual physical in Oct of '08, my Dr. found elevated ALT/AST levels and then was diagnosed after further lab work.  I had a neighbor who was in a trial at UPenn a while back and after not being able to get an appointment with any specialist locally for at least 3 months, I had a Bx done at UPenn and was told of the upcoming trials they would be recruiting for in the near future.  My Bx revealed moderate (stage 2) fibrosis and that I was a 1a genotype.  I did a lot of nutrional changes in my diet and started taking a lot of supplemnts (including Milk Thistle) up until I started Tx last July.  I decided to go with Telaprevir as it was Phase III vs. the other Phase II and the study visit schedule was a lot less demanding with my work schedule and the commute to Philly.  I probably could have waited a couple of years to start treatment, but figure I was never going to be any younger or healthier than I was now and the hope of 24 weeks of Tx vs. 48 weeks was the final piece that decided it for me.  My doctor and study have been great all the way through and, although I have a pretty hard time with Sx's,  I am now just a month away from finding out if I will be stopping after week 24.

Best of luck with all of this and God bless you in your decision.

Pilgrim

[Fl_Gator]

merryBe you make some good points but I think that Telaprevir kills the virus so fast that dose reductions may be better than adding extra meds like procrit. I took one riba reduction when my Hgb hit a low of 10.4 and never went back to the original dose. I watched my Hgb rise to 11.6 till I ended tx at week 24...then it took an unexpected dip back to 10.2. I guess they will give me my VL info when the trial is over...I can't wait to see the results...facinating info.

I also learned some where that 2 in 3 participants doing 12 weeks of triple therapy with Telaprevir went on to SVR...I need to find that info and post it. It is possible for a GT1 to treat for 12 weeks and still achieve SVR...but the odds are better with 24 weeks.

I will grant you one other point...I didn't have bad sx...fatigue being the worst but no rash...or anything else...everyone reacts different.

I believe Mremeet also took many dose fluctuations during his telaprevir trial and went on to SVR. If I remember right he also had the rash. He is done with the trial and knows what he was given.

I am in a placebo controlled trial and still haven't been told what I was given but I was taken off the meds at 24 weeks...it's a good sign. I'll remain positive for now and believe that Telapriver is the first of many magic bullets to come...

[Isobella]

Yes, I am eligible to end tx at 24 weeks.  So, in 5 weeks I will find out.  

I don't feel I was being treated cruelly by not having access to rescue drugs.  There are specific guidelines in each trial for the use of such drugs.  One of the things they look at in these studies is limiting the amount of additional drugs in the equation.  In my trial, they do not allow your levels to get below a certain point.   They will ask you to leave the trial.  If at anytime during my trial I was at risk for being dumped because of low blood levels, I was going to continue SOC outside of the trial....rescue drugs and all.  But that is just part of the basic research that needs to be done prior to signing on the dotted line.


~~~if someone responded late, but had to go without rescue drugs the entire time. I mean, if your blood is being destroyed, and there is a hormone that will help you make new blood, it just seems cruel to not allow people to have it. ~~~~~

The above wouldn't be an option in my case.  If I was not responding appropiately to tx, I would have been dropped by the study. If a geno 1 doesnt respond by week 12 on SOC-it is a decision point even outside studies.  At this point, I would have gone to back up plan.....SOC for 72 weeks perhaps depending on my numbers.  If my blood was being "destroyed"---same concept would have applied. On to back up plan.   For me, saying cruel seems extreme.  

So, 3badogs...get as much info about your condition as possible.  Do lots of research.  There are many options for you.  Use the forum as a sounding board there is a ton of practical "been there, done that" advice here.  

I wish you the best.

Isobella

[fretboard]

Sounds like a very good trial you're in, I'm not sure I understand the no rescue drugs clause.  Does it just mean you won't get Procrit?  I've heard alot of ppl on the Telaprevir trial say they were on acid reflux drugs or AD's so obviously some drugs are allowed.  Good luck with your 24wk results, that would be great.  It looks like things are starting to really be studied with common sense, instead of across the board.  God Bless

[Fl_Gator]

yes...acid reflux drugs such as Pepcid Complete or Nexium and AD's are allowed in this trial...but no procrit...

[Isobella]

They allow many different drugs/supplements.  Just no procrit or neupogen.  They do dose reductions instead.

I discussed it with my nurse before the trial and of course as I was facing my dose reductions.....she did try to go with the "off label" excuse, but the bottom line is just introducing as few drugs as possible and determining theraputic levels of the SOC and trial drugs instead.  

The goal is to minimize exposure to the harsh drugs while maximizing our chances of SVR.  As with some others that were in the previous trials it seems there is some room to wiggle with the third drug added to SOC.

Time will tell.....that's why they are called trials.  We do remain hopeful tho!!!

Hope you are doing well, Fret =)

Iz

[3badogs]

Thank you all for your messages!  Your experiences are very helpful to me.  It's good to hear from people who have gone thru the treatments and have positive things to say.  I appreciate the cautions, also.

It's apparent there are both pros and cons to the trial... I guess I'm waiting now for biopsy results, & then will have to make up my (hopefully informed) mind.  

What are the worst side effects you have experienced, and how long did they last?  

[lapis]

Ha, ha, ha, you gotta laugh about the side effects!  Here's my first post on the forum, if you feel like doing a bit of reading lots of others chimed in.

http://www.medhelp.org/posts/show/686790?personal_page_id=321650&;post_id=post_3661800

[merryBe]

OK, fair enough, but then let me redefine cruel, cruel is when your blood tanks, and then you are given reduced dose, or taken off the trial altogether...cruel is when what could have been a better more successful tx isn't, and ends up with a number, be it 10, 20 or 30% having to driop out, and then MAYBE getting a wild strain that will be harder or impossible to treat. This has been the concern of the trials for some years, that no matter how well intentioned, certain treaters are left with highly resistant strains due to the tx protocols and group they ended up in.
If you can show me any literature where this has been proven not the case, I'd love to see it....last I read we were at 50 subtypes and counting, type 1b has 10 variants alone.
The concern is always going to be how many people can they stop early or undertreat before some incurable or highly contageous form mutates onto the scene.

In any case, trials are preferable to doing nothing.....If they are your only option, go for it.
Just know trials are not a perfect world.

[merryBe]

as an example check out the link below.

as with HIV the concerns of retroviruses are different from normal viruses in that many times a virus can mutate in 20 minutes and become adaptive to drugs or changes in our immune systems, meaning it is impotant to hit them hard and fast.

http://www.liebertonline.com/doi/abs/10.1089/107999001750277899

if I were in stage 3 or 4 of the disease, I'd try for a trial if that was my only option,
but if I were in stage 1 or 2, it would be more tempting to wait for the drug to come out...
(phase !!! is the last trial phase, then comes FDA approval process,) for if I waited I'd be sure to get the fullest most effective dose, having ergo the best chance at the cure, and also be allowed to have recue drugs if and when my blood did tank.
Early concerns with the PI classifications of new trial drugs almost exclusively revolved around it's increased risk to the blood, and it's skin reactions.
Skin reactions are not life threatening, but too low CBC counts can be. Hence rescue drugs make sense to me. That's all

[can-do-man]

From everything i've read a dose reduction is one of the last things anyone should want. I have not read where any leading hepatologist are for it. Sure there are always going to be some that SVR, just like some are forced to stop tx early and still SVR. But it seems the best chance for SVR is staying on full dose throughout tx.

As for any of these new P I's killing the virus in a week so it don't matter if one dose reduces then one would have to wonder why not just quit the P I after one is und. If its dead and gone with the P I then just finish with SOC. Just my thoughts

cando

[jmjm530]

All of the symptoms you describe may be caused by hepatitis C, or none of the symptoms you describe may be caused by hepatitis C. Or maybe it's just some of the symptoms.

No one can tell you the answer in any definite way. Nor can anyone tell you, if you do treat, whether those symptoms will become better, or whether they'll become worse. I say that because many report feeling better after treatment, but at least an equal number report feeling worse from exposure to these very strong treatment drugs.

So if you do treat, my personal suggestion is not to base your treatment decision solely on the symptoms you mention, but base it to a significant degree on how much liver damage you have. If it turns out you have a lot of liver damage, then treatment in the near future is really a must--because you want to do everything in your power to stop that liver damage, and hopefully even regress the damage. And successful treatment, has been shown to do just that.

On the other hand, if you have little or no liver damage, you reasonably have time to wait for newer drugs. To wait even beyond the current category of drugs now on trial. Newer drugs promise better results in less time and that should even get better as more time goes by.

As to the current drugs in trial, things are pretty good, but as has been stated before, trials often have some limitations. Limitations you would not have if you waited until the drugs came out of trial when you could treat it as more of an individual. Another advantage to waiting for the current trials to finish is that you will have more information as to which of the current trial drugs will give you better chance of being cured as well as more information on the toxicity profiles.

It's not an easy decision, and good minds often come to different opinions even given the same facts.

So good luck with your biopsy, and with any decisions that follow.

All the best,

Jim

[merryBe]

jim is right, all we say, take with a grain of salt..all we can do is hope to walk around the elephant and together give you an idea of what this beast might be.

can-do, it's funny because is re-researching tapering INF I came across some old studies on pulsing therapies only yesterday. They were going based of the RVR theory, that they could maybe, pulse, cut back, or up doses for breakthrough only,,and do less harm to patients and still get to SVR....funny thing is, nobodys doing it now..because A it didn't work and B no one SVR'd.  Taperin off still has vadidity I think, but tapering in with INF, or cut backs/pulsing has definitely proved deleterious.

mb