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80575 tn?1207132364

I've been asked to join the Schering SCH503034 Clinical Trial....what to do?

My doctor knows that I'm a motivated patient and asked me to join the clinical trial for Schering's protease inhibitor, SCF503034.  Nationwide 300 people will be enrolled and there will be six arms of the study;

Arm 1 = PEG + RBV + SCH 503034 Placebo. @ week 13 if VL then
        switch to SCH503034 400 mg.  48 weeks.
Arm 2 = PEG + 100mg SCH503034 + Placebo RBV. 48 weeks.
Arm 3 = PEG+ 200mg SCH503034 + Placebo RBV. 48 weeks.
Arm 4 = PEG + 400mg SCH503034 + Placebo RBV.  48 weeks.
Arm 5 = PEG + 400mg SCH503034 + RBV.  24 weeks.
Arm 6 = PEG + 400mg SCH503034 + Placebo RBV.  24 weeks.

They're looking for optimum dosage and with/without RBV.

Here's my dilema.  I want to kill this virus, but, when I last went through tx (36 weeks until a viral breakthrough) I worked everyday but felt like a zombie.  I own my own business that requires lots of travel and customer meetings.  While on tx I felt like locking my office door and being left alone.  After seven months off tx I'm finally getting my business and family back together.

Last night, just thinking about being back on PEG made me edgy and kind of depressed.  If this was a 24 week stint I would do it standing on my head.  For me the sides really didn't kick in until the 4-5th month.

I'm a geno 1b with minimal scarring and inflamation (stage 1/2; grade 0).

This forum has been a God-send for me in the past.  Two questions for you guys:
1.) With the above information....would you do the trial?
2.) If I go ahead with the trial, what questions do you have for the doc and/or researchers?

Mike
44 Responses
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Avatar universal
Jim
Can you stand on your head while drinking a gallon of milk and at the same time do 3 flips and recite the latest italian study by memory.
: )
Deb in az
Helpful - 0
Avatar universal
I understand your comment to mean that someone can relpase if they drink alcohol, I hope that is not what you meant, since there is no medical data to back that up. Alcohol, excessive or otherwise, can not bring back what is not there.  If you have read studies that show the latter to be untrue, I would love to read it.
best to you

jmjm; I, for one, am not liking you feeling the need to place a disclaimer about your non medical background at every suggestion. I don't think it is fair, since no one else is doing it. As long as we(singular) make sure that the person has consulted with a physician or will in the future, and we state that is not medical advise what they are getting but our opinionsas stated in the disclaimer after their post) by writing "I believe, or I suggest, my opinion, etc", it should be enough.  You and many here are well read in the topic of hep c, and some, like you, have the ability to effect authority and knowledge very well through the written word and should not be penalized with a disclaimer about not been an MD with every post.
Yes, there are folks that are not as cyber and hep c savvy and are looking to be guided and not having to make decissions, but is not the majority and by stating that it is what we(singular) think and they need to consult with their MD, it should be enough. We once had a member that almost quit tx, due to the statements of one well versed in hep c person who wrote with authority. Some of us were concerned about a repeat. It was not personal.  We have read so many relapses even with EVR....
Cindee(if you google her name you can find her old comments) was one of them.
We talk about percentages that are closely related but they can translate into actual people that did not reach SVR for whatever reason. 93% almost as good as 89% could be 8-10 actual persons, and for them the statistical insignificance of the percentages might mean another round of meds when one round could have done it.
Everytime I read about the short courses, it is in the general context of cost effectiveness, which makes me think that they are not really thinking about the patient and their well being with their recommendations. But that is my opinion.
I once got in trouble for using the word WE so much, I was accused of MH spokeperson wanna be. So, now I place the word carefully...
Can you find a balance between the old jm and the one today?
I don't know about others, but I feel the disclaimer is not needed once you stated it was your opinion!
But, if you insist, can't you put it in Italian and German also?
and Spanish
Helpful - 0
Avatar universal
I've always taken 1 gm magnesium to stop muscle spasms.   Non-crisis dosage is 500 mg.   I tend to take higher doses of supplements than are recommended by conventional guidelines, however.   Conventional calcium-to-magnesium ratio is 2:1.   The orthomolecular m.d.'s  (docs who use vitamins like drugs)  set it at 1:1.  Magnesium at higher dosages can have a laxative effect--remember Milk of Magnesia?
Helpful - 0
Avatar universal
I don't have the AASLD web stie bookmarked on this computer, but an internet search of it should find it easily. Here the abstract numbers I have read:
67484
62580
60761
66787
60227
65594
65167
65578
72562
65969
67698
63449
66610
61151
61115 Those range from the topics you asked about, plus all VRTX and SGP abstracts, and also on Albuferon, and I think there are some current therpay studies in there also. The way they are save as pdf's I don't have the titles unless I open them up.

As far as magnesium goes, the intake is slightly different for men than women. I was on 400 mg's per day-about 300 from Natural Calm (which I actually didn't take that long due to the taste), and 100 from the vitamins. I would ask a doctor for the appropriate amount though.

I used to hate the vinegar when I had to take it as a kid, but it doesn't bother me now. You definitely taste it, but my wife dilutes it in a lot of water to lessen the taste. I was never crazy about water, so I actually like it now. You can add honey to it to change the taste. If you do buy it, make sure it is pure and organic, not the stuff from the supermarket. We get ours from www.bragg.com. Or, in their book, they also have recipes in there so you can cook with it. Balsamic and Red Wine vinegar are also very good for you. Hating vinegar might not make this easy for you to do though. They are also sold as capsules at vitamin shops, but I can't imagine that they are as beneficial to you.
Many people have muscle knots, but I really believe that with HCV they are a much bigger issue. Muscles are one of the largest organs in the body (skin is larger??) and dysfunction in a couple can easily spread on down the line. That it is why it has been documented that a trigger point in the calf could actually result in jaw pain. An odd connection, but documented in the works of Travell and Simons.
Helpful - 0
Avatar universal
tnhepguy - thanks for posting these links...they are now added to my reading list to be done before next week.

Kalio - I have not decided on the length of tx.  That will be the discussion on the 8th.  I haven't started tx so I still have time.  My doc is pushing 48wks...I told her I would research and we'll go from there.  I'm a 3a low vl at 21900 alt 89 ast 54 32yr young female stage 1 grade 1 and I've had this for about 4 1/2 years. (what a great personal ad that would make huh?!)  I'll keep you posted on how it goes with the appt next week.

Goof - well your lucky your doc doesn't do that in public...cause I was in the park walking my dog and I saw my doc hunched over licking himself...so I told him NO how rude and threw him a ball.

Deb in Az
Helpful - 0
Avatar universal
We were recently discussing the Vertex conference calls, and you responded to me:

"Also, there are other interesting abstracts on that site-like PM protein being beneficial for cirhottic patients (which I think the opposite is done), and studies on various herbal combinations that showed vl reduction and improvement in inflamation numbers, and also on Albuferon as well as many studies on current therapy. The site is pretty much a gold mine of information."

Call it brain fog, or just plain middle aged absent-mindedness, but now I can't seem to find that site again.  Thought I had bookmarked it, but no.  Could you please give me the link again?  I'm particularly interested in the info on vl reduction and improvement in inflamation numbers.  

Also, in the thread above, you discussed magnesium.  Any guidelines on how much is needed to show improvement?  I recently did a spreadsheet of all my rx, vitamins & supplements so I could track dosages of everything.  I'm only taking 30mg.  

One other thing.  I have some serious muscle knots and get massages frequently.  I hate vinegar.  How palatable is the ACV mixed with water?

Just full of questions this morning.  Thanks for your help.

DJ
Helpful - 0
Avatar universal
The timing of your visit is quite serendipitous.  A lively discussion erupted over the weekend about what, if any, value "old-timers" can offer this board.  Your comments on this thread provide the best answer: hard-earned experience.

Thank you for dropping by.  I hope the time between visits get shorter.

Susan
Helpful - 0
Avatar universal
miked,
My man is also considering a study....although I don't have the name yet, but it is one for relapsers, thanks for asking the right question to get all the answers. Good Luck!

David,
How are you doing? I am glad to see you are still lurking some. Congrats on your SVR. Thanks for the input it answered many questions I had. We miss you around here.

goofydad,
My man is 3a and txed 24/24 and relapsed..txed again 48/48 and relapsed again. Give it your best shot the first time around and you won't be kicking yourself with what if's if you aren't one of the luck ones. Good Luck!
Helpful - 0
92903 tn?1309904711
Thanks for chiming in TNhep. Your reputation precedes you. We've had some 'spirited' discussions about the Mangia study on 12 wk vs. 24 wk treatment for 2's & 3's. Without going back down that well worn road, among other things that study did show mild steatosis and normal Body Mass Index as attributes in my favor.

I'll study the links you sent and have a chat with the Docs next week. We'll see where that goes. In general, I'm not seeing my 4 week response as being a golden egg laid at my doorstep.
Helpful - 0
Avatar universal
Okay, shoot me now, but I suspect that  that anyone with fibrosis in the stage 2.75 to 4.0 range really should not consider taking shortcuts.   And believe me, tx does not get incrementally worse the longer you stay on it.  This is not to whitewash the experience, mind you, but once you pass through boot camp you can almost keep marching indefinitely.  And no, I am not and have never been a jock.  I swear on my old tattered copy of Huck Finn....
Helpful - 0
Avatar universal
Most excellent feedback above.  Quite honestly,  I believe that there should be at _least_ a year between rounds.   I, too, worry about the longterm effects of prolonged chemotherapeutic treatments.   As this area is so poorly documented (for obvious reasons) it really is a matter of following one's gut instinct:  the data just isn't there to make a purely rational choice.  Your age is, of course, a significant factor,  but as you are not racing against cirrhosis  and are not being held back by chronic viral fatigue or any other Hep-related syndromes post-tx, I would wait and not offer myself to Schering as a guinea pig.   Best of luck to you in whatever decision you make, and good to hear that your life is on the move again.
Helpful - 0
92903 tn?1309904711
...sorry. meant to title previous post
Helpful - 0
Avatar universal
Goofy said prev: "I have not seen data supporting higher SVR for 48 wks vs. 24 weeks for any 3a"
======================================

That's where I would begin the discussion with your doctor.

Also, based on everything I've read, I view your non-detectible 4-week PCR as positive predictive factor for SVR and I'll leave it at that. :)

Only other thing I might add, is that since you still have plenty of time left to make your decision, there's no reason to make a final decision now. If it were me --  and I was still uncertain --  I'd probably get a second medical opinion.

All the best.

-- Jim

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92903 tn?1309904711
You may wish to look at the gruppe with 70 pepperronis one more time :)
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Avatar universal
hey there....I'm so glad you posted all those questions.  I'm having the same discussion with my doc on the 8th.  

I'm also a 3a stage 1 grade 1 had this 4 1/2 years.  I haven't started tx but will be on the 8th/9th provided my gallbladder will behave and I can get my completed opthamology report.

The only "proof" if you call it proof is that of people I have spoken with who have relapsed from the shorter treatment.  Then the people my doc told me about who aren't relapsing after the longer tx.  (again on this I don't know the number of people and of course it is not an official study just observation on her part)  There is a member on another forum who is supposed to be sending me an article that has good information in it.  I have yet to see it though.  I will get it to you if I ever get it.

I'll keep you posted of what I find if you keep me posted.  I'm willing to do the 48 weeks iiiiif it means a better chance at clearing and staying clear.  Otherwise I'm inlcined to take my chances with 24 weeks.  

I would even wait to tx if my body wasn't so welcoming to this damn virus.

deb in az (sorry I don't have more info...but we're paddling the same boat...up stream....without....well you get the drift)
Helpful - 0
Avatar universal
Honestly, given the various studies on your genotype, I would myself lean towards the 24 week program...especially given the fact that you've responded so well at 4 weeks.  And you're right...you really don't want to pump more of this stuff into your body than you need to.

However (and this is the big however that I'm dealing with myself), I'm sure the big question you're asking yourself is, if I could tolerate going the extra time (without putting myself at additional risk) in order to make sure that darn virus is gone, wouldn't it be worth it?  And given your liver bx results, going the extra bit seems worth it.

Also, I had not heard about the alcohol history factor, and didn't quite understand if you meant you were a very social drinker in the respect that you rarely drank or if you were very social in that you did.  My brain cells seem furry today.  Sorry.  I'm surprised my socks match today.  This is the first time in two weeks that they have.  <high-fiving myself!>

Anyway, given all the factors you've laid out, if your doctor is recommending 48 weeks, I'd go for it.  If you find at 36 weeks that you don't wish to continue, you've at least given yourself an extra 12 weeks of virus-killing therapy.  

That's just my leaning.  I wouldn't fault you for going the 24 weeks.  24 weeks sounds just lovely to me right now.

Hope you're doing well on tx so far though.
Helpful - 0
92903 tn?1309904711
Jim - I'm sure I can get to the German study somehow... I'll dig it up.

------------------------------------------------------
....I can't tell you what the plunking is....

AZ - At least this finally clears up how the creek got its name. I don't mind the plunks, it's non-plunkers that stick in my craw (and elsewhere)
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Avatar universal
kalio - has your doc considered doing a biopsy now?  Or even an ultrasound.  I had the ultrasound and it showed a fatty liver.  After reading about 3as and fatty liver I decided to get a biopsy and I'm glad I did.  

Goof - if you're a nonplunker you're a non responder?  : )

deb in az

Helpful - 0
80575 tn?1207132364
Thanks guys for your input.  I'm still not certain of my decision but will go the appointment on November 9th.

to TNhepGuy....great questions to ask at the clinic.

By the way, I'm male, 47 years old and in good shape (active runner).

Mike

P.S., I've read some of the bantering comments lately....this forum means a lot to many people; let's keep up the positive support of each other.
Helpful - 0
Avatar universal
After my ultrasound, they didn't tell me about it either.  I had to argue with my pcp office to get them to fax it to me.  Then I saw the fatty liver remark and made sure I brought it to my gastro.  That was when I learned about the corelation betweem 3a and fatty liver etc etc.

Doctors are like having dogs...you have to train them every step of the way.....except dogs are much easier to train.  : )

deb in az
Helpful - 0
92903 tn?1309904711
AZ - I'm in the canoe and I get the drift, but what's all that that plunking?

Wassabi - AZ says she never let a Friday go to waste. I never understood why there's only one Friday! There's a study out there, google 'genotype 3a alcohol'. Lemme know if that doesn't work.
Helpful - 0
Avatar universal
I'd pay more attention to top line results and prior RVR studies. Traditionally, pepperoni's have been hard to count because they disappear so fast down the stomaco. Sounds like a statistical abberation to me. BTW there are no pizza makers here, just pizza eaters.

- J

Helpful - 0
92903 tn?1309904711
Sorry - No new threads. Hope no one minds me piggy-backing on here.

My first face-to-face with my Doc since starting tx 7 wks ago is coming up. I want to discuss their plan for treating 48 weeks. I'm not neccessarily advocating a different plan, I just want to have a sensible discussion.

My stats
-----------
Peg/Copeg: Standard dosage - a little extra copeg vs. weight based guidelines
Geno: 3a
Age: 46
Stage: 4-5 transitioning Ishak - entering stage 4 Metavir
Infection: 25 years
Prior Alcohol: A 'very social', social drinker
VL: 1.3M baseline/Undetectable by sensitive TMA at 25 days
ALT : Baseline:3x Normal/18 days:Normal/25 Days:Lower Normal  

My Thoughts
-----------
I have not seen data supporting higher SVR for 48 wks vs. 24 weeks for any 3a

I have read about higher relapse for 3a w/ alcohol history

I have not seen data supporting higher SVR for 3a with 4 wk response - in fact one {sensored} study suggests the opposite.

I have not seen data showing better histological response for longer treatment, except as it may correlate to higher SVR

I would not want to pump more of this junk into me than I have to

Common sense says I'm running out of runway here and I should take my best shot with 48 weeks and stop snivelling.  
-------------------------------

Anyone have anything else I should add to my discussion agenda, or commentary/addtl info on the above? Thanks!
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Avatar universal
why bother with a study.  too risky
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