BX Results and Clinical Trial Question/Advice

[dancegirl54]

Got biopsy results 0-1 and 0!!! I am really shocked as I have probably had this for 30 years (but only diagnosed this year)and as some of you know, I passed it on to 2 of my kids! Dr says has to have been lots of blood exchange at delivery and HIGH V/L. Going to have Fibroscan and then don't need to be seen for a year - but here is the question - especially to you jmjm - I've been invited to participate in the Vertex Vx 950 and interferon 12 week clinical trial after the first of the year.  There is strong possibility I could clear - 12 weeks - what would you do? There is a possibility that daughter could get on too. With my results I would definitely not want to treat for a year - I am sole support of family and need the income that I bring in, but I am also 50 and my gut tells me this is an opportunity even if it doesnt work? I value all of your opinions.

[GoofyDad]

go-girl: the only that will be Golden is my pee....

Vegie: Do you get the season change of colour there?

Goof: back to my spot in the corner to ponder this......

[go-girl]

I'm on synthroid as well, they gave me a cardio, there was no problem there. Yes, I realize i will be well taken care of, A gal pal from California sent me a link today on VX-950, apparently Schering is also having a study to something very similar and is in a further stage than vx unless I read it wrong and will go neck to neck with VX the vx spokesman said. I don't know how to send the link, again I can forward it to you, have it in my favorites will get the address and post it, I'm in a hurry right now. I am going to call Schering tomorrow and see about a study here for the new tx, if i find out anything will post it.
Yes all our leaves are beautiful reds, ornanges and yellows, still on the trees, you get a much colder & longer winter in the east than we do in the west, no coparison, we rarely get snow although I love the snow, don't drive in it though, were usually in California on the golf course for 5 months right about now, but thanks to this disease we rented out our house for the winter there, my nose is out of joint grrrrrr will have to put up with rain, thats what we get alot of here, same weather s Seattle.I think i will have a hissy fit just for the fun of it, and pout while I'm at it. Enjoy the white stuff, heeee heeee

[go-girl]

Well I'll tell you, I am realy having second thoughts about tx, mainly because of organ damage and heart issues etc; that people are getting even after a year of clearing. I'm 65 and feel like a million bucks except for the anxiety I'm experiencig the past few months after being diagnosed and waiting to start tx, I don't know what to do, I am stage 3, just don't know? Am going for thyroid, glucose & creatinine on Monday have to do it over again for Schering, my thyroid is slightly low and creatinine slightly high, won't be accepted till they check me out. How did you find out there is no studies in ONT? I want to see if there are any in B.C. let me know, would appreciate it. I'm glad your waiting for better things. At my age I need post tx problems like a hole in the head, or in my so called Golden Years the only that will be Golden is my pee...............

[v eggie dip]

I am so sorry you have to go through this at your age, heck at any age it is awful...I am hypothyroid (under active) and it is controlled by a med called synthroid, works well too!  I do not think that should be a problem in deciding if you can treat or not, maybe for the study it will be though...

If you are at stage 3 fibrosis, treatment is most likely necessary...At least that is what I hear all the time...I am stage 1 and have opted to wait for better meds, but if I were a 3 there would be no discusiion, I would treat now...

I recently reformatted my HD, without a back up (duh!...lol) and have not put all my bookmarks back, but if you do a search of clinical trials Hep C British Columbia it should guide you through to the site...BC is one of the best areas for medical trials I hear, so you should have success....Maybe you could do the one that uses Albumerol (I know I spelled that wrong) that one doesn't seem to have as many side effects as the riba interferon route...

If you do decide to stick with the int/riba trial remember this, being part of a study means they take extremely good care of you, you're being studied!! lol..So I am sure if you had any heart probs, or other, they would take care of it promptly...

Best of luck to you...

PS...Do you get the season change of colour there?  It is over here, and all the trees have lost their leaves, soon we will be blanketed with the white stuff! (and it's not the pleasure kind..lol)

Beth

[go-girl]

Re: VX-950 trial...I found a post on "hepatitisneighbohood.com" on the message board section, click on "open forum" Scott posted it Oct 4/05 A trial in Montreal on VX-950 doing well, or if you give me your address i will e-mail it to you if your interested. I am going to try and find out if there are other trials like it in Canada, I wouldn't mind tryig it as opposed to the Pegintron that I may be starting soon. If you should find out anything let me know, thanx

[v eggie dip]

thanks for the info, it's much appreciated..Unfortunately the Province of Quebec does not accept inter Provincial private insurance, and I am in Ontario....I was hoping to find that study in Toronto but unfortunately it is not...

Beth

Wish you well with your upcoming tx start...

[cuteus]

send me your email and I will forward it to her, I have my inbox in yahoo with a user name of cuteusbelleus. MH does not want to see us exchange emails online...

[dancegirl54]

John - It is a 12 week VX 950 with peg - after Jan 1st, I dont know start date - I was just asked while I was at Doc's office

Actually going back SOON with daughter 11/11 -she has enlarged spleen

Cuteus, You are referring to sybill right? Would love to talk to her - please send her my best

[couldn't think of a nickname]

cougar, VRTX has actually taken the opposite approach, as has Schering Plough. In their early trials they took the TOUGHEST to treat-geno 1's, and those who have failed. There is no effort to skew data.

dance, it is my understanding that the 950 trial with interferon is scheduled to be 4 weeks, and it is the monotherapy that is scheduled for early next year that is for 12 weeks. Did they recruit you for the monotherapy trial?
Also, how did you get recruited, as I am interested in participating in that trial as well?

Congrats on your biopsy score. That is amazing since you estimate you have probably had it for 30 years. If anything with this could be reassuring, it would be that at least it hasn't progressed much so far.

John

[dancegirl54]

Great response, thanks to all, it is best to get the total picture, the good thing is, I don't have to make any decisions for a while - you have all provided me with some great questions

To answer some of yours, I am a 1a and Doc is in Boston. amommy check out the archives for the I have an idea personal profiles.

And jmjm yes you will attain svr, I just know it!!!!

[jmjm530]

When u do speak to him, ask not just how many days average until clear, but what is the total length of treatment. Another good question is do they have any SVR (6 months post) data, or anything they can share. And lastly, what drugs are they using Vertex in combination with.

Yes, Vertex sounds very promising. Since I'm gonna SVR with the current poison I'll probably never have to use it but it is reassuring it's in the pike just in case.

-- Jim

[cougareyes]

I've found with most trials they try to get the most favorable candidates. Young, healthy, little or no liver damage, low vl, etc. This way they can show the most favorable results. Same with all the other studies, that's why when you start to add all the variables things get tricky.
With no liver damage I don't think I would be a guinea pig, God only knows what these new drugs will really bring. For those of us who have been or are on combo tx now, you know what I mean.  Peace

[rifleman]

I think the most imortant question is "what is your genotype?"  If you are a 2 or 3 and they are going to pay for the meds, go for it.  If a type 1 or 4, it might be better to let others be the guinea pigs.
DJL

[mistybean]

I had my first and only bio at age 38.  I may of been infected about 23 years at that time.  My bio came back 0.  Now 7 years later I am treating as I am a 2 genotype.  I myself would not do a new study?  What is your genotype?  If you are a 2..you might want to just go the oldfashion way with the current treatments and get rid of the virus.  If you are a non-2..well it is up to you?  But I am not one to rush into new studies.  Also, how old are your kids?  Are you sure you passed it on?  If they are still pretty young than you must of?  Are they adults?  My mother had 4 kids and three of us have Hep C?  We are now in our 40's ( 40, 42 and 44) and two of us are college education and the other is still using drugs.   YUK)!    However, the hard core truth is that we got this from drugs in the 70"s.  I am starting to see a trend where a young mother in the 60's and 70's got hep c from drugs and her grown children also have hep c from teen drug use.

[dancegirl54]

Thanks for your comments. I am a 1a. I definitely passed it on, the 2 that have it are teens, neither have any risk factors, never any risky behavior, daughter in college is a "church girl", the stereotypical "good girl" except with her it's real, son is special needs and very sheltered.  

[cuteus]

what great news that biopsy result! superb! great relief, I am sure.
The trial suggestion is tempting, but they are only talking about clearing the virus, not sustained viral response. You want to know if there is a chance of SVR with the 12 wks. If they can't tell you, I would not do it. Yes, they need numbers to aid their stats, but I for one wanted SVR, be free of an infectious disease, not favorable, short term numbers.

Of course we are looking to make sure that we have livers in good condition, and that is one consideration for doing or not, tx, but the fact remains, we still have hepatitis c, even with mild damage. And we will have it until we do something about it. If we can live peacefully carrying the virus, then why not do it. It it weighs heavily in our minds...
here is one article questioning the wait approach:
http://www.prnewswire.co.uk/cgi/news/release?id=143867
since hep c is known to be non linear, (people have had mild damage one biopsy and significant damage 3 yrs later), it is preferable to have another bx in three yrs, to see how stable your case has become, should you decide to wait.
The member that communicated with you, (the mom with 2 of three infected also) does not come here often, but should you need to "talk" with her at any time, I can send her a note.
Bask in the great news, but treat with proven svr meds, not those still in the testing phase.  There are no SVR results on them yet.
best to you

[johnisme]

I agree with what jim said, why rush to be the first? My reason is if the 12 weeks don't pan out then you would be considered a non-responder. Which would probaly exclude you from any further clinical trials in the future. With no damage i would let them iron out any bugs there might be. But whatever you decide i hope the best for you.....John

[friole]

This is wonderful news.  To even dream of the possibility of clearing in 12 weeks is incredible.  Even though your biopsy is excellent, you have proved to be infectious - truly an odd case, but none the less, having 2 children test positive must weigh heavy on you.  Should you and your daughter do the trial together, you couldn't ask for a better support team.  I would sure think seriously about this offer.  To clear in 12 weeks and possibly never look back?  I have done 14 weeks now, and, really, for me, it has not been bad.  But to be done - wow - what a dream.
Regards, Kathy

[v eggie dip]

I would hop on that 950 train in a NY minute (pardon the pun Debby *wink*)...But, I am sure it is not available in O'Canada...

*the dip*

[suzieq2]

You have made my day. I have been searching daily for a vx-950 trial. Can you please tell me who to contact?

[amommy]

congrats!  great news!  you are in MA right?  I'd love to talk to you some more.  I know we can't post email here but I would love to find a way to talk to you- I think I need a new doc!

[v eggie dip]

I am very interested in this trial, where is it being done?

[dancegirl54]

I will discuss further when I go for the scan. The trial is Vertex Vx 950 with peg, no riba, and the length is 12 weeks total. Doc says they are seeing clearing in 2DAYS!!!!!! He did ask if I was conservative or a risk taker, if conservative, watch and wait is the best course.

[NYgirl]

When I read this I sort of thought the same thing - why be inducted into a trial with a zero?  I know my doctor had looked at the trials as for people who do not respond basically who had significant enough damage to warrant the continuing treatment.

I am curious as to how they intend to proceed and using what combo etc.

Honestly if I was a zero - I wouldn't go through this in a million years.

Thanks for posting I am really curious about this!