Aa
Aa
A
A
A
Close
630100 tn?1222456507

Did I make a mistake siging on for Telaprevir Study?

I took my first Injection today and I feel like I may have made a big mistake.....

I know there must be people wishing to get in these studies, and I hate to seem ungrateful, but I have been 'relatively' healthy, had an almost healthy liver and I just got rushed into a Clinical trial with Peg/Interferon, Riba & Telaprevir (the triple therapy)
My concern is that this is a study with 1 out of every 3 people getting placebo and I don't know what my rush was if I end up getting on basic Peg/Interferon & Ribavin therapy.
I have avoided this therapy for a while hoping something that was less invassive would come along. So my doctors tell me there is this new wonder drug "telaprevir" and unlike the 50/50 shot I had for Genotype 1a with standard treatment, this has shown up to almost 90% success (in fact in my hospital, everyone who tried it apparently was cleared)
BUT.... Then after I signed on the dotted line, I found out that if you take into consideration that I have a 1 in 3 chance of getting Placebo, and then realize also that the nearly 90% success is for initial response, NOT SVR, which is actually 65%
So I can do the math fairly loosely and see that a 65% SVR, with the added 33.3% chance I am getting Placebo, well, that really isn't much better than the odds of standard therapy.
One of the big selling points was that it only takes 6 months rather than a year, but it turns out that even if you get the telaprevir, you still follow through with the full year of Peg/Ineterferon

My Biggest and final worry that cropped up reading these boards, is that this treatment will cause cognitive impairment.
I can honestly say that the MAIN reason I wanted to take the plunge is because I have had this virus since I was 19, and therefore have never really known an adult life without my body being under attack from a virus (my viral load was 500K) and I just want to remember what it feels like to have a clear mind and body, for at least a little while before life passes me by.

Having lasting Cognitive impairment is NOT an acceptable cost for something that I see so many people saying they are only doing because they are really sick.

Am I just having beginning jitters or is this a valid concern that maybe I didn't research before taking the plunge.
I don't want to end up in a haze of medicine and depression, unable to discern if I have legit reasons to worry, or if this is just a 'depressive' part of the treatment and I need to power through.

My first day and I'm already confused. Help!!!!

Thanks
25 Responses
Sort by: Helpful Oldest Newest
630100 tn?1222456507
Thats what I understand.

The advantage to telaprevir is that everyone (at my hospital) that has done it, cleared and was done at 6mo

But if you show no sign of response at 3mo for any arm (I think) then you stop

So odds are very good, (again, at my hospital) that you will only do 6 months

(obviously if you get some response and get placebo, you get 48+ weeks)
Helpful - 0
Avatar universal
That's interesting. So you either only do six months if you get the telaprevir and clear, which would be NICE!

If you don't clear at twelve weeks, presumably under any arm, it's full stop.

Is that correct?
Helpful - 0
630100 tn?1222456507
This may be a little late and maybe even pointless now, but to clear up what I think I mistakenly said about my trial....
1) You don't have to do the whole year if you get the telaprevir and respond (ends at 6mo)
2) If you show no response by 3 months, you stop treatment

I think thats correct looking at my little chart

Helpful - 0
412873 tn?1329174455
Awwwww-thanks badss bro!!
Helpful - 0
Avatar universal
You have been forgiven.
Helpful - 0
412873 tn?1329174455
Yeah, there is one in your study.  But not in mine-the vertex tx naive.  Sorry if I got confused which we were talking about :-)
Helpful - 0
Avatar universal
My study nurse says there is a roll over...i even have a copy of the screening papers that say so...i even get the rescue drugs for free too and a PDA to record my pill popping
Helpful - 0
Avatar universal
Hi MelonL,

The fact that you're writing so early in the morning after your first injection is a really good sign to me. I had a horrible first injection but I don't know if it was because I didn't follow the nurse's instructions about taking Tylenol. I was shivering, shaking and swearing I'd quit if I only survived. Tonight, though, week seventeen, I just returned from a two hour walk, using my walking poles to try to keep up muscle tone in my arms.  I feel almost normal, at least for now. If you'd asked me in the first few months, I would never have believed it. It seemed like one thing after another, but somehow I stayed the course. There were some dramatic moments but mostly I felt spent and crummy and isolated.

It helps to nip any emerging problem in the bud. If you have a side effect like itching in the middle of the night, try entering the word 'itching' in the search box right on the forum page, near the top, scrolling to the right, and you'll probably get hundreds of hits with different suggestions. I'd guess Gold Bond and drinking lots of water would be mentioned the most.

Sorry I have to go to sleep now. I'm thinking of you. Our very good friends just flew out of Toulouse this morning. Do you know we are as close as can be, email each other sometimes twice a day and I've never told them I have HCV or that I'm on treatment?! My hepatologist suggested I keep it under wraps and for now, that's what I'm doing.
Helpful - 0
412873 tn?1329174455
I am in the same trial you are in and our stats seem to be the same-only my vl was 1,404,000. I do shot #9 tomorrow.

Sorry to hear you are off to a rough start. I am wondering if you are drinking enough water.  That really helps with the sx.

Maybe some tylenol would help.  I use benedryl for the itching, but you have to be careful because it can dry you out even further if you are not drinking enough water and make things worse. Check with your docs tho.  Also, many here use Gold Bond lotion with good results.  

Some say that the first few weeks are hardest as your body adjusts to the meds.  Some say that it is harder from around week 7 as the drugs are then built up in your system.  It is different for different people.  

My experience so far has been positive.  I have been tolerating the drugs well ,but hit a wall of exhaustion at week 4, recovered and then again at week 7.  I am feeling pretty good right now, but the itchies are starting to get worse so I will be taking my benedryl real soon.  Once again, that works for me, but I am not having any other problems, so maybe check with the docs before trying it.  

I do wish you the best.  And hope the sides get easier on you.  Hang in there :-)

Isobella

Rocker-it is my understanding that they would not offer the rollover in this trial-but I could be wrong




Helpful - 0
630100 tn?1222456507
Sorry, but a P.S., How do you stop the ITCHING?!
Or maybe that's just me? But I a pacing around like a monkey with ticks  :p
Helpful - 0
630100 tn?1222456507
I am in France in case you didn't catch that part, and all I know from the study is that after 24 weeks, if you are a responder, you are lucky and done, if not, you have another 24 weeks to go of Interferon and Ribavarin.
So every 3rd person simply gets the standard Interferon treatment that you would have taken had they not offered this trial.
I have no knowledge, nor was I told that I could try the Telaprevir if I got the Placebo, just that I would still be getting a year of Interferon/Ribavirin treatment.

In fact, all the doctors told me in the beginning how much better it was in France and that I was at this particular hospital because it's really well known for being cutting edge, and a Biopsy was not going to be needed.
But with the Vertex study, they looked at me very seriously and said, you will have to do a biopsy to take part i the study, and there is a 1 in 3 chance you will not get treated with the medication.
Thats what I understood. I could be wrong.
But when they tell you that they had a small group prior to you finish a trial, and every single one of them cleared the virus..... It's hard to say no.

BTW, I think I would be like stage 1?  wasn't told, but they said I had "minimal damage" and a 500,000 viral load.
That's what I know & now you do too :)

I am feeling really horrid right now, and it's just my first day after my first Interferon injection, so the concept that it won't be a hassle, I think went out the window hours ago. It's not that I can't manage the discomfort and the weird feeling that my clothes are 'slicing into my skin', but it's more the fear of "How Long Can I Do This For?"

I mean, does it really get better?
Is the first Injection the worst?
I'm not trying to be a baby, but I can't imagine going for a year to a hear and a half feeling anywhere like I do right now.

Thanks again.
Helpful - 0
Avatar universal
Doesnt this new Vertex trial have a "roll over "..meaning if you do get the plecbo drugs...they will later on give you the real vetex?...im in the Boceprevir trial 3 and they do this roll over thing
Helpful - 0
80575 tn?1207132364
I was a geno 1b who started my first tx with over 3M VL and zero liver damage.  After 32 weeks I had a viral breakthrough, game over.

Next tx I entered into the Vertex Prove 3 trial, became UND between week 1-2 and recently learned that 48 weeks after stopping 24 weeks of Prove 3 tx, I am still UND.  I'm cured.

Like you I had no liver damage which I feel is an advantage to fight the virus.  Unlike you I had a much higher VL count, had a tougher genotype (1b vs. 1a) and I think I'm older; all which is to YOUR advantage.  

In Prove 3 there was no guarantee to rollover the VX950 if given the placebo.  Correct me if I'm wrong but I believe Vertex will offer you the drug if you're in the placebo group.  BTW; if you are in the placebo arm, then you're getting SOC tx anyway and you will see if you respond without VX950.

On both treatments I worked every day.  I own a business that requires significant travel, daily customer interaction and drive.  With the help of ADs started a couple of weeks before treatment. Provigil for energy and sleeping pills at night I performed pretty well.  My doc was very aggressive in treating the side effects and quick to shut off these helper drugs after tx.

I think that you're doing the right thing.  Ask your doc for ADs, Provigil, sleep help....whatever it takes to get you through the next 24 weeks.

miked
Helpful - 0
164592 tn?1222906774
I recently got the news that I am SVR after being in a Telaprevir trial.  Have you had a biopsy?  What stage is your liver?
I was only a Stage 2.  I treated once with standard treatment and was a non-resonder.  During this trial I cleared early and stayed clear.  I can honestly say that I have not only recovered from treatment, but, I feel better than I have felt in 30 years!  In my opinion, if you have any liver damage and you were planning to treat at some point, would jump at the chance to be in this trial.  I doubt there will be another treatment that is "less invasive" coming in my lifetime.
Also, don't you have to be clear at a fairly early point in the trial to continue?

Again, this is just MY opinion, but I would thank God I got into the Telaprevir trial.
On the other hand, if I had a biopsy that showed 0 liver damage...or maybe even Stage 1, that might be a different story.  I don't know.  But, I'd hate to see you squander this opportunity.
Denise
Helpful - 0
Avatar universal
Hi MelonL,

I'm glad you're here and I hope you feel a bit better, now that you've tossed around your very serious concerns and heard a variety of views.

It was chilly in the north this time last year when I was there for a month. I was in the south for most of the time and climbed to the top of Eze in my sandals, without skipping a beat. I have a photo on my bedstand of me making it to the top. Now, though, it's tough to make it up my stairs sometimes, so I hope you don't have a five storey walkup!

Must 'run' now and welcome. It's been a long day for you, so good night, your time.
Helpful - 0
630100 tn?1222456507
Thanx.... That was a succinct and helpful comment. I think it's just what I (and probably others) needed to hear :)
Helpful - 0
179856 tn?1333547362
I really don't think you'd be having any less jitters if you just did standard SOC.  It's a very scary concept injecting yourself with meds that potentially could make you quite ill....wondering how you will feel what will happen will you succeed on and on and on.

You just have to jump, get over it and then get on with treatment.  In time this will happen.  You can't guarantee what will or will not happen.  Can't guarantee if you will get 'brain fog' or not really.

You just have to take it easy and take it one day at a time.  Most of this treatment is one big giant waiting game.........we're always waiting on something - whether it be your first PCR test results or your final after treatment SVR results.....waiting and worrying is very common.

All I can tell you from my own experience and pains and fog and discomforts is that I treated for 72 weeks.  Had good days/times and bad days/times.  Rest is important. Knowing as much as you can find out about HOW To manage the side effects (proactively and after the fact) is the BEST thing you can do to help yourself.

But it works.  Almost two years later and I'm still virus free.

I wish I had done it BEFORE I was already at stage 3 liver damage and saved myself every bit of my liver I could but unfortunately I didn't know I had it.

If you can beat it NOW you will save yourself so much in the future.

And if you think about it - is there ever going to be a time you WONT be hassled by brain fog? No. After school comes work and kids and all sort of other issues. At least even IF you do have a problem with it (and don't worry it's NOT a permanent type thing in almost every case) it will be over in the future and you won't ever have to worry about it again :)

That's the good news.

Hang in there and breathe. Your feelings have been experienced by just about every person in here.

Good luck.
Helpful - 0
630100 tn?1222456507
I appreciate your comment, and you are probably right about getting it now before it causes more damage, but I do have a question about what you said.

You say (probably a little sarcastically) that you may have lost a memory or two

But honestly, do you feel that you sustained any impairment? That could mean, not as good at remembering things, or bad short term memory, or suddenly became terrible at scrabble ;-)

Point is, I am curious about this from anybody, because having my mind as sharp as can be is so important to me. I am trying to get the college education I never got and I don't see myself doing that in a 'Brain Fog'

Thanks
Helpful - 0
Avatar universal
I was in the trial for combo therapy (interferon / riba) in '96 at Mayo Clinic. It literally saved my life. It was also an awful experience. And "chemo fog" was a factor with brain functions then. May have lost a memory or two - but I have also had a great time with my son and family that looked rather bleak 12 years ago .....its only normal to be afraid of the unknown....get it done before the liver damage progresses...
Helpful - 0
232778 tn?1217447111
Even if you chose SOC you would likely have the Jitters. Try to keep your chin up, you are in for a bit of a journey, get outside and enjoy the fall air while you can.
Helpful - 0
630100 tn?1222456507
Thanks to people for responding so quickly.
No doubt I AM having jitters to a degree.
I can tell you something that may explain why I feel this 'jumped on me'
I was actually contemplating the Standard Interferon treatment, because I was working from home as a web designer and I no longer have my live in girlfriend, plus, I had the support of my family financially in case the treatment caused me not to make enough money to support myself. Also, and luckily, I happen to be in France (although I'm American) and with the Socialized medicine, the complete treatment course, including meds, etc. is all 100% free.
It seemed that if there was going to be a time to be down and out for the greater good, it would be under these circumstances. However, both my Psychiatrist and my Liver specialist agreed that I should get my body and mind 100%, as I had battled with depression recently, and I wasn't in good shape. So I set about trying to get myself in order, lost 30lbs and was planning on starting Interferon treatment in about 4 months, which is when my doctors and I projected I would have myself 'at the best point' to begin treatment.
But I was suddenly offered the telaprevir trial and told it would be the difference between 58% and 88% success and it would also be 6 months vs 1 year.
I thought I was simply lucky and shouldn't say no to something many people prayed for.
However, the Dr. just told me that far from stage 3 or 4, that I had an almost healthy liver, so rushing into this may have been something that someone who really needs this treatment NOW and honestly can't wait till there are open trials and better data on how to deal with things like adverse reactions.
Basically I know that I do have jitters and I can't say much after only 1 day on the program ( I haven't even taken the telaprevir/placebo pills yet)

So I want to thank people for responding once again, and please, if you have any objective or subjective info on cognitive impairment, especially that continues after treatment, please leave a comment.

Sincere thanks
Helpful - 0
96938 tn?1189799858
Although I have not gone back to re-read the trial protocols and arm breakdowns, I'd think that 1/3 placebo was kinda high.
Helpful - 0
Avatar universal
Vertex promises around 60% SVR in 24 weeks as compared to around 40% SVR in 48 weeks for genotype 1's. So as you can see there is a big difference here, assuming you do not get the placebo.

As to lasting cognitive impairment, yes, a number of people have posted that experience although it does seem a very small minority, but I have no doubt that it happens. During tx is another story and most have "brain fog" or similar from the drugs.

I have no idea about your history or liver status, so really can't comment on whether treatment was the right choice for you. And in fact, there is no such thing as the "right choice" because that really depends on how you as an individual processes the risks versus rewards per you own research and consultation with your doctors.

Personally, if a friend of mine had Hep C, I'd advise against treatment at this point in time unless they had signficicant liver damage -- meaning stage 3 or 4. I'd tell them to wait until the Vertex trials are over so they won't have the placebo issue to deal with plus they will have a whole lot more trial data to look at. Others here, would tell you to treat early and be happy you got into a trial with what appears to be the most promising drug being tested. Again, no right or wrong answers, it really comes down to how you feel about all this.

-- Jim
Helpful - 0
Avatar universal
It sounds like the jitters to me. Even after I started, I'd agonize about whether I'd made the right choice. In the end, it felt like all I really did was flip a coin and here I am, in treatment, having started off with only a 50% chance, the very arm that you hope you're not in. There was no urgency other than my advancing age to make the plunge and I'll never exactly know if it was the right choice.  Now that I'm in the middle of it, I have no regrets. I'm not quitting now that I've started, odds or not, and can face the future whatever the outcome (after any requisite mourning).
Helpful - 0
2
Have an Answer?

You are reading content posted in the Hepatitis C Community

Top Hepatitis Answerers
317787 tn?1473358451
DC
683231 tn?1467323017
Auburn, WA
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Answer a few simple questions about your Hep C treatment journey.

Those who qualify may receive up to $100 for their time.
Explore More In Our Hep C Learning Center
image description
Learn about this treatable virus.
image description
Getting tested for this viral infection.
image description
3 key steps to getting on treatment.
image description
4 steps to getting on therapy.
image description
What you need to know about Hep C drugs.
image description
How the drugs might affect you.
image description
These tips may up your chances of a cure.
Popular Resources
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.