clinical trials

[his3707]

I am genotype 1a  I have gone to the Liver Institute in Dallas and I feel like that is the place for me to be.  They took several vials of blood and are going to do a fibrosure test and a hepa score test among some other tests.  I am looking into doing a clinical trial with a 3rd drug added to the standard treatment called  mk7009 by merck.  They also gave me 3 others to consider such as R05024048 by pharmaset roche (sp) and bms790052 from bristol myers squibb.   Also something called Filibuvier as  third additives to look into.  .  I dont know anything about them yet but am going to learn everything I can.  I am going to post this as a question again on the forum to see if anyone has any experience with these trials or know of anyother such as I saw in  a pod cast from the UC Davis from Dr Lorenzo Rossaro from schering, vertex and novartis.  Also was mentioned the Sanchez and Berg studies.  Any comments

[frijole]

Are you treatment naive?  I also use the Liver Institute in Dallas and was set up for an interview last December, hopefully to get into a relapser/responder trial for Telaprevir.  As it turned out they did not get the r/r tial for Telaprevir -- all they got was the naive trial. They also did not get the r/r trial for Boceprevir.  It sounded like they dropped the ball to me.  Apparently you (the clinic) have to move fast  when those trials come out to be one of the sites and if you don't you lose.  

I don't know anything about the trials you have mentioned.  Why are you referencing the Sanchez and Berg studies which impact relapsers?  Both are relative to extending to 72 weeks.
frijole

[his3707]

Yes, I am treatment naive.   I just heard about the Sanchez and Berg studies from a pod cast from University California From Dr. Lorenzo Rossaro but dont know anything about them.  Are you getting in on any of the trials I mentioned or any other studies?  I am so new at this that I really dont know what Iam talking about yet.  Just trying to search out everything

[frijole]

Since you are just starting your research, I will give you two of my favorite sites to find information.  The clinical care option site requires registration, but it is free.  The core curriculum is excellent for a initial understanding of the virus and the treatment.  They have many excellent slide presentations that can be used by medical professionals for continuing education and as a patient I get a lot of good info from them.

http://janis7hepc.com/index.htm

http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20Core%20Curriculum.aspx

I am on a waiting list at the Liver Institute for trials but I am afraid there are too many on the relapser list to ever get a call (relapser means I have failed previous treatment).  I would be pretty picky about what I accepted since my liver damage is not too bad.  have you had a biopsy yet?

frijole

[ouc]

Try to find out if your Clinic or some other place in Dallas conducts Phase III Study Treatment with a new drug Telaprevir plus Peginterferon Alfa 2a(pegasys) plus Ribavirin for Naive Subjects.
I was on that treatment recently . Dropped off after 6 weeks,and as of now (6 months later) I am undetectable . Looks like that new drug works pretty good.

[oneatenuff]

agree, agree, and agree

Hi His, if the ball is being thrown in your court by the trial doc (or his assist / trial coordinator, etc. - whoever)   I lean towards advising you to be very careful about agreeing to participate in the experimental drugs you've listed  (or the ones they've offered you)   regardless if they tell you that you'll be getting the "standard" treatment along with it.

The results of a Fibrosure probably won't be enough.  Depends on the inclusion criteria for the particular trial drug  (in other words - the "experimental drug" requires certain things be met before a subject can be considered and then included.)  

If they haven't done a biopsy yet, or if they are planning to schedule one, then one might conclude there is no rush to treat or include you in these particular trials.   I say that because it's probably going to take six months to a year to make sure you have met the inclusion criteria for a trial.   Then again, some trials in early phases might not require liver biopsy results - BUT even so, it's best for you to know (you need a biopsy.)

Trials sound wonderful (and some are.)   Others aren't. That's where "knowledge is power" will be your best friend.  

Based on what you've said about being new at this   (we were all new at one time - some found out they jumped too soon when they didn't know enough)    take six months or even possibly a year to learn  (before you make a decision)  get a liver biopsy, learn what the results mean, learn what your labs mean, study up on the newer drugs  (VX-950), ask this trial center / doc what they think about "watchful waiting" and why they think you can or can't wait, and find out what they think about VX-950.  

Good luck.  

[frijole]

Good info.  THe Liver Institute tried to get me to participate in the Omega Duros trial for r/r and I declined.  I had previously researched the Omega interferon and decided the SVR rates were not high enough.  The study involved inserting something under the skin to release the interferon at a constant rate over the course of the trial.  That may have been a good idea, but if the drug itself was not better than the alpha interferon a and b, why bother.  Sooneatstuff is right - do your homework first.
frijole

[his3707]

Does anyone know of trials for the drug Telaprevir anywhere near the Dallas/Fortworth metroplex or East Texas Just anywhere within a reasonable driving distance.   I would even pay for the drug if i could.  Ive heard more good things about this drug than any other so far.  I am still awaiting fibrosure and hepa score test results and I am getting prepared for them to want the biopsy.   I am starting to feel fatigue  and some weird feelings like pokes and twinges in my abdomen, but not sure if it is from the HCV or the new lexapro AD I am on.  I am also taking a .5 xanax at night.  Or is it just the stress of going thru  all of this. fighting off the down mood.  knowing that my son is also infected and getting ready to deal with that will take it out of you I suppose .  I just want use the best thing out there and hopefully only go thru the treatment once.  However, I do understand that I might not be able to get the best drug.  Does anyone have any idea how long it will be before the Telaprevir will be available? Or is there another one made by someone else that is pretty much the same result.     Any more opinions?  Thanks for all your input.

[oneatenuff]

Hi again, sorry your son has this virus too.  Good luck to him too.  

Lexapro can make some people feel very tired - especially in the beginning.   So can stress, hep C.... (so can getting older :)   How long have you had the virus (you know?)   You definitely want best shot when you do treat.  Is your doc offering you these trials because you voiced interest in treating now and because you want in a "trial?"   If so, that's OK.  In fact it's admirable  (that you're ready to get rid of the virus.) You shouldn't feel that it's a must to treat now, though   (you don't know where your liver stands)   and that's just something that's pretty standard (the biopsy).   You shouldn't be required to make a decision about treatment until a biopsy is done.

No one knows about the VX-950 for certain but if all goes well as some are projecting, then possibly by 2010 or 2011.  It might be available for only certain individuals or it could be available for hep C across the board and for those who can afford it.   "when"  is all a waiting game   (but if you are OK to wait based on a biopsy that doesn't indicate bad news about your liver)  then you and your doc might decide it's worth your getting in the wait game.
I've been waiting for.... 7 years.   Time flies when you're having fun?   (bad joke yea)

Here - copy this tiny url below and put it in your browser  (it's VX-950 trial info phase III).    

http://tinyurl.com/c5blgs

This is the Merck MC 7099- phase II
http://tinyurl.com/da9qjg

You probably aren't going to understand what you're looking at once you get there  (don't get bogged down with it, either).  It will give you an idea of the complexity of what's behind a trial and how confusing it can be and how long it can take  (it also lists TX trial centers.)    

Find out when they're going to do a biopsy.

[his3707]

I have no idea how long i have had the virus.  could be anywhere from 15-30+ years.  Probably more like the 30+.  Is there any way to tell how long you have had it?  I should find out in the next day or two about some more blood test.  I have been smartly advised not to jump on any band wagon until I take my time and research everything.  I am hoping I have time to wait.  I am already 50 years old otherwise in fairly good heath but dont want to wait much longer if the treatments are so hard.  I of course would like the best like everyone else.  I dont want my son to see me go thru a really hard time and have him be to scared to deal with the tx.    thanks for your reply.  I should also find out if I need a biopsy in a couple of days.   cant find any vx950 trials open.  If the mk7009 looks promising I would try that, I just dont know who in the medical field to trust.  If i waiver I might miss the boat.  The liver institute in Dallas seemed to actually care if I get well, but who knows if that is for real.  I certainly am weary.

[GreatBird]

You can't really tell from any tests how long you've had the virus. Someone with a very scarred liver has likely had hepatitis C for quite a while. You could also have a liver without much damage and had the virus for a while. Truth is, it doesn't really help to know how long you've had it.

With the new medications in trial right now (Telaprevir and boceprevir) there's a good chance that treatment lengths are getting shorter--no guarantee, but  . . . if it turns out your liver is in fairly good shape it might be worth waiting for the new drugs to be available.

I'm in a clinical trial and I think that they are a good way to treat, however . . . they are run according to certain protocols which means that the doctors have less flexibility in what they can do and how they adjust the treatment to fit the patient. Some trials allow what's called "rescue drugs" others don't and will depend on dose reductions (which can lead to viral breakthrough) in order to handle anemia, etc., which is common on treatment.

So, doing your research is a very important thing to do if you're going to participate in a clinical trial.

As to VX950 (Telaprevir), I'd be surprised if any more trials open up. It's in phase 3 right now and they are trying to get it to market in 2011. I suppose it's still possible, though.

[oneatenuff]

There's really no way to tell how long you've had it unless you knew during your acute phase (jaundiced, real sick.)  Or if you had period of IV drug use and could narrow down "probably got it then" you can guess.   For those who have symptoms, it usually start up around the 20th year (some earlier; some later)  but most begin noticing fatigue, depression, sweats, overall feeling of "not well" around the 20 year mark.

If you feel good about the The Liver Institute in Dallas, stay with them.  Get results of your lab work.    Ask doc he expects the Merck trial to start  (it may not start yet for another 6 months to a year - wouldn't be unusual for it to take that long to begin enrollment.)     Treatment is not for everyone.   Geno 1A is the toughest to treat.  Some do fine; some have a rough time.   Expect to have a rough ride if you do treat - be prepared.  Ask your doc how he'll manage any side effects and if the trials you're being offered allow helper drugs.  A phase II trial I was offered a few years ago did allow them.  

[his3707]

Thanks everyone for all your comments.  I feel like I get better answers here than with the docs.  You all give me important things to think about in my decision making.  I think the doctors just want to process you.  Even though, the Liver institute seemed more caring and interested personally in the patient.  

[terca]

I am starting in a clinical trial Jan.21 with the drug r05024048.I did do alot of research on clinical trials before I agreed to be in a trial.The care you get in a clinical trial is far better than what you would get outside of one.I do not agree with people who say if your biopsy isn`t bad then you should wait.It is a proven fact that the worse the virus gets the less chance of  a svr.If you treat when the virus isn`t strong the better your chance of getting a cure.I have had this hideous virus for over 30 years and most of that time I was trying to convince myself that all the doctors are wrong and that I didn`t really have hep c.I finally decided to stop running from it and start to fight it.I am lucky,my biopsy came back not bad.I am at stage 1.But,why would you want to wait till the biopsy comes back worse till you decide to do something.Give the clinical trial alot of thought.It`s better to fight the virus  while you are still strong and healthy.  

[Rockerforlife]

100% AGREE.Hit it hard and hit it fast.

[his3707]

I have been thinking about doing a trial but now I dont know what   I am going to send my PA at the Liver Institute and see what is up coming.  where is your trial happening?  I thought we would have enough money for me to wait unti the telaprevir and boceprevir came on the market but I think even with insurance it is going to break our bank.. How the heck is anyone going to be able to afford the treatments?  I cant believe its almost been a year since I was dx.  I will have to look back into the one you are going on.  Please let me know how you are getting along with it.  I check this forum daily I dont post much just listening and learning.  I am going to my regular doc to look at some labs I just did in between the hepatologist that I go back to in April.  

[WriteItDown]

I don't know where you're at, but if there's a trial location near you, there's a Phase III Boceprevir trial in which you are GUARANTEED to get the full course of Boceprevir. The trial is designed to test whether dose reduction or Procrit is better in treating anemia, so your Hgb has to be 15 or lower to be eligible.  If you are, it's a great deal.  Best of luck to you.

http://www.clinicaltrials.gov/ct2/show/NCT01023035?term=BOCEPREVIR&recr=Open&rank=2

[his3707]

Thank you for the info.  I sent my PA a note asking wether the Liver Institute in Dallas is getting the trial.  I couldnt tell by looking at the website unless I was looking in the wrong place.  I thought the treatment time would be less. I thought it would be 24 weeks instead of 48.  I am a geno type 1A.  I am very uneasy about doing the treatment. Quite frankly Im more afraid of the treatment than the disease right now since I dont have many symptoms.  But, I know what I have to do.  I heard in a webcast by Dr. Douglas Dietrich that treatment without interferon would probably not be any earlier than 2015 probably longer time away than that.   I think its the interferon i am most afraid of.  I just want to go in and no looking back,  Have you done the Boceprevir cocktail?  Can anyone jump in and refresh us with some experience and opinions about the new drugs.   thanks in advance  

[his3707]

My PA said I did not qualify for th Boceprevir trial because my hemogloblin was 15.8 and you have to have a level of <15.  Not sure about the context of the meaning of that.  Is my level bad?   Do they want people to start out with the level on the low side?  I looked it up and my level is in the normal range but a little on the higher side of the middle.  Im babbling but you must know what Im trying to say  Thanks

[WriteItDown]

Too bad you're not eligible for this trial, but your Hgb level is totally normal.  It's good for it to be on the high side, I think.  The only reason they are excluding people with Hgb above 15 is that the trial is supposed to be testing how to deal with anemia, so they WANT people on this trial to become anemic.  Usually about 50% of people on triple therapy with Boceprevir get anemia, but likely they want to up this number so they won't be "wasting" good trial money on non-anemic people.  It's really expensive for them to run these trials, so that's why.  But you should be happy you have a high Hgb -- it'll lower your chances of getting too anemic when you do treat.

My husband is currently participating in a clinical trial for another protease inhibitor (the same category of drugs as Telaprevir and Boceprevir), called TMC435.  We, too, wanted him to have a chance to treat for only 24 weeks, and one of the reasons we chose this trial was that 80% would get the trial drug and only treat for 24.  With Boceprevir they're still doing a 48 week treatment -- they've had somewhat better results with a longer treatment time. Telaprevir is likely going to be 24 weeks when it's approved; and with my husband's trial drug they are also shooting for a 24-week treatment.

I totally agree with you that 24 weeks is vastly preferable if you have the chance to do it that way.  Given your early stage, I personally would wait for the Telaprevir unless you find a VERY good trial. If you have decent insurance and can afford the co-pays or whatever it will end up costing you, I think waiting is a perfectly valid decision -- in fact, probably the best decision, IMHO.  You are Stage 1.  You are still pretty young, and Telaprevir is very likely to be approved in a year and a half or so.  Unless you're champing at the bit to just get it done, OR you find a really good trial, that would be my advice.

I also want to tell you that I was really scared about the drugs and their possible effects on my husband before he started this trial.  Well, he has been lucky, and, while it hasn't been a party, it also hasn't been that terrible.  He's tired and feels sick some of the time, but he is not very anemic, did not get the rash or itchies or depression or any number of other problems we worried about. So, you might very well also be lucky in that regard. Remember, the people who come to boards like this while treating are usually the ones having the most problems.  I myself post much less on my husband's behalf these days, since he really isn't having many problems.

Hope that helps somewhat!  This disease is tough and it's often hard to figure out what the best thing to do is. Good to keep asking questions and investigating your options.

[WriteItDown]

Sorry, I just re-read one of your comments where you said the Telaprevir would break the bank.  

So, revised advice: wait for a really good trial.  For me this would mean a trial involving one of the protease or polymerase inhibitors with very good preliminary data (usually available on the web) in combo with SOC, where you have a very good chance of getting the trial drug (for me that would be at least 75%, but YMMV).

Phase III trials are obviously the best, but some Phase II trials can also be good.  
Trials that allow rescue drugs are better than those that don't. You have to take a very close look at each trial and decide accordingly.  

And, if nothing comes along before the Telaprevir is approved, see how much it's going to cost and whether you can swing it.  Good luck to you!