Does anyone worry about long term side effects of drugs in trial?

[Marc1955]

So many folks on this board are involved in trials or are advised to get involved in trials. I'm curious to know whether there is any discussion or concern about unforeseen long term side effects of new and relatively untested drugs. Or do these categories of drugs simply not involved unanticipated side effects? It seems to me that the drug companies are the last people you'd want to trust on questions of safety but clearly people do not think it is important to wait until the drugs have more of a track record.

Thoughts are appreciated.

[copyman]

Hey Marc,
I know that rock can be obsessive with his many posts and he said he was going to tone it down. But I have to add that this is not "your thread". once you post in a "PUBLIC" forum it becomes Med Helps & the other members thread. Everyone is free to post as many times as they want.  I know you refer to blog etiquette but that does not apply to a medical forum like this.
I have lashed out at rock myself before and hopes he keeps his word and does tone it down some.
Happy New Year

[Rockerforlife]

Ok my man...i wont comment on your thread no more...sorry ..


HAPPY NEW YEAR

[lalapple]

i'm always worried for sx both long and short term.  as of now, i might think that maybe the long term sx are hard to determine seeing that the new drugs are relatively recent.  i was even skeptical about pegasys and riba for my tx and how it would impact my health in the future.  

[Marc1955]

Rocker – Get off my thread. You have now totally hijacked it for your own purposes. I didn't post the question to give you a chance to have fun. I posted a serious question and I was curious to get input. I think you could stand to learn a little blog etiquette.

[Rockerforlife]

Well...iam responding to SOC pretty good so far...the 6 wk PCR will the ball breaker...if you will?

[copyman]

Telaprevir is givin right from the start with the SOC drugs, no lead in. Vertex's approach is hit the virus early and eradicate it quickly.

Forgot to wish you good luck with your 6 wk pcr. I have a good feeling that you are UNDE and on your way to SVR..............

Happy New Year

[Rockerforlife]

Is this Telaprevir trial you are in,do you start the teleprevir at day one  or like us Boceprevirers and start the BOC at week 4..called a "lead in"...that was smart of you you check out your gene stats before tx...if you are clear at 3 weeks with the SOC drug only...you must be excited..KNOCK EM DEAD

[copyman]

Who really knows and of course I think about it. I'm in the 11th week of the open label (NO placebo) Telaprevir study. Like some of the others said after waiting two years I decided the risk of not treating was worse then taking the chance with a "phase 3" study drug. I have the fatigue and intense itching with a "minor" rash and hope it subsides when I stop the study drug next week.
When I first found out I had HCV I was obessed with getting as much information as I could about HCV. For 2 years I researched medical sites and visited "ALL" the forums. Also traveled hundreds of miles to consult with top hepatologist's getting fibroscan, etc.  What really convinced me to treat even though I had very little liver damage was after seeing the results of a new test called the CRS (cirrhosis risk score), It indicated that I had genes that gave me 3x's the risk  of advancing to cirrhosis. This gave me the perspective from the medical side and from real people which helped in making my decision to treat now.
After seeing that the regular combo SOC drugs (ribavirin & peg interferon) can have "long term" side effects by themselves I decided to try and get into a PI trial that would have a shorter TX duration of 24 weeks. I believe the longer you treat and expose your body to these harsh drugs the better chance of "long term" SX.
I was lucky to have been accepted into the vertex trial and feel it is all worth it. See my stats below and I think you will agree:
Age 51
GT-1a
bx, fibroscan, fibrosure = stage 1
Last VL before starting Telaprevir study, 10 million
3 weeks after starting study, UNDETECTABLE !!!
8 weeks still UNDE !!

HAPPY & HEALTHY NEW YEAR TO EVERYONE

[Rockerforlife]

Can you imagine the money they will make if the new PI drugs get approved by the FDA and the PI drugs work out the way they are doing...they wont be able to keep the stuff on the shelf...with cure rates at 82%-92% and up for naive patients...we giena pigs should also get a piece of the action

[comeagain]

I´ve been going through two soc tx first was hell all the time and the most scary thing was that my brain didn´t work as it should but afterwards it got healthier and sharper then ever, so relax its well worth it, your probably  gonna be just fine.

And rocker why do we worry now when we didn´t when we almost killed our self with the illegal stuff, the answer to that is logical you didn´t got a rash then you got a rush !!!!

Good question and since the medical care is so much about making money ( sicko M. Moore) we cant trust them its seems to be very shorttime thinking often.

[CMcH]

While these drugs are designed to help us. I believe the scorch and burn policy of destroying all things good and bad will seem very primitive to the next generation.
It's what we have now but I do worry about what an incredible imbalance  this puts are bodies through. I have never felt this bad and my brain is mush. I sure hope I am able to return to being a vital human being again. Quality of years is more important than quantity to a certain degree. I am 2/3 through 48 weeks and I do have some treaters remorse. I am grade 1/1 and would warn others to really consider what level of damage before TXing.
Doctors down play the sides during TX I can only imagine once your done with it.
Positive spin is that we are foraging a way for others.
Have a happy and healthy New Year.
Connie

[Isobella]

I do worry about the long term effects of these new drugs.  I am in week 22 of a tx naive Telaprevir trial.

I wonder if in 20 years I will have 2 billion mutant dragons eating my liver on a platter.

But-I think Epi said it very well....in those 20 years i will be 66 yrs old and could have other health issues or be dead..whether I treated or not.

Altho I specifically sought out a Vertex trial because of it's track record, my main focus on entering this trial was to make tx better for those treating in the future.  Specifically my daughter....I want a better tx for all heppers....but mostly for her sake. But that's the mom in me, lol!!!

As far as the rash goes....they do take any skin issues very seriously. And they are very strict on anyone with any history of skin rashes.  That may be why we don't hear much about it recently-they weed out those that may be prone to them...just a guess.

I also agree with Lapis that that is one of the things they are looking at in our trial with the 8 vs 12 week triple therapy.

Isobella

[Rockerforlife]

my question is...why is there no rash with the Boceprevir...but a rash with the Telaprevir?

[jacksonblue]

Happynewyear i am in telaprievir rollover prove 3 got rash week 8 only lasted 1 day last dose of trial drug was tuesday 730 am tonite i am so itchy i have coated myself 3 times in last 2 hours with calamine lotion cant stand it right now glad i have a lorazepam stashed maybe i can sleep threw it tommorrow a better day cando is correct i was told if i get rash i was to go to hospital next day they have me see dermatologist take pictuers and biopsy that it could become a medical emergency in about 9 percent i have been neg since week 2 i hope all can find some peace this year regards steve

[can-do-man]

I was told they have brought in a dermatologist to help deal with the rash in these new trials

[can-do-man]

If after all susan has been though if shes not going to worry about it then neither am i.

[zazza]

Thank you for the information. I recently read an old post about the rash which compared it to a burn, which itched like crazy and covered big parts of the body. It sounded awful. Maybe they know by now how to better handle the rash as soon as it appears?

[susan400]

I try not to worry about it as I've already been involved in two trials recently in the past 2 years!  Susan400

[Rockerforlife]

The ironic thing is...no offence to anyone...but with all the drugs some of have done in our life,that proberly almost killed us, that we should worry about taking drugs that are designed to save us...totally ironic...who says life aint strange?

[epiphiny]

I actually considered that question before I signed up for my trial and here's what I thought about it.

I looked at long term to mean 20 years because it will take at least that long to fully understand what impact these new trial drugs may have on us.  In 20 years or less (untreated) I have the potential to develop ESLD and or HCC.  I would also be 67.  I could already be dead by some other means.

Therefore, I felt that involving myself in a trial that may help thousands of other people was a worthy enough cause to take that risk, when weighed against the ESLD or HCC scenario.

Whatever we do in life involves risk and IMHO it's quality of life, rather than quantity of life that really counts.  And what we do with the life we have been given.

[Rockerforlife]

Ill take the rash over a rock hard liver

[lapis]

About the Telaprevir rash, here's what I've learned:  I read in the literature that it happens in 9% of people.  I was told by my study folks that it's most common in wks 8-12 on Telaprevir.  So one of the current studies aims to determine whether people do as well with 8 wks of Telaprevir as with 12 wks, in combo with SOC.

[lapis]

What a great question!  I thought I was pretty well-informed when I agreed to participate in a VTX trial.  I knew that I might be ill during my tx but did not really "get" that the sides could be long-lasting.  The list of potential sides for the 3 drugs was pretty daunting but I've always been a fairly healthy person and I figured it was a risk I was willing to take, to finally be rid of this disease.

After about 3 wks of tx I began reading this site a lot.  Boy, did it open my eyes!  I still don't know what the prevalence of long-lasting sides might be (sounds like no one knows that), but the folks who have them seem pretty darned miserable, and it is scary to think that it could happen to any of us.

So yes, I have a new concern, that there could be long-lasting effects from taking such a drug as Telaprevir.  Who knows what we'll learn in the future?  Meanwhile, I'm just plugging along like everyone else, going for SVR.

[Rockerforlife]

I do think tho...serioulsy...the long term effects for most people are safe ,so far anyway..IM talkn bout the SOC tx...even the PI`S have been around for quite some time ...dont they use these PI`s on AIDS patients too for a long time now?