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80575 tn?1207135964

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
Avatar universal
yes that is a tough call but as mentioned you have minimal damage. if i had a personal inclination it would be to hold off but i'd need more info to base a decision on. as mentioned age ect. would play into this decision. i've also read information that led me to believe the rate of damage may not be consistent. i'm just starting to poke around to be better informed but some of the newer drugs in trial sound promising. i "think" VX-950 is targeted for 08-09 and valopicitabine from Idenix looks to be doing well.

good luck with your decision

couldn't, it sounds like you've done a fair amount of reasearch.
Avatar universal
Some questions and/or considerations to ask yourself and/or your caregivers might be:

- if I'm waiting for something "easier" and "more tolerable" to come along, is there truly such a drug out there being developed? Or is it more likely that any drug being developed will be part of a regime that will include interferon and/or riba (as most of the researches agree will be the case). And that the newer drug itself will have it's own set of sx's (e.g. - the whole class of protease inhibitors are anything but 'benign', as is evidenced by the some of the sx's that HIV patients experience). And what are the guarntees that this new drug (be it "tolerable" or not) will make it all the way through the arduous phases of trials and FDA approval process? And just how many years from today will that be?

- if it's therefore most likely that you will have to take some combination of these drugs that will include interferon and/or riba, when will you physically, mentally, financially, work-relatedly (<--- new word, perhaps?) best be able to tolerate the new tx - today, next year, 5 years from now? Will any of those factors (physical, mental, financial, work) change over any period of time in your future to make tx'ing more acceptable? In other words, is it possible that postponing tx in the hope of something "more tolerable" to arrive really is akin to leaving you sitting at the train station awaiting on a train that is never makes it to your particular stop? And the whole while nothing in your personal circumstance has changed to make the day of tx'ing any 'easier' - except more time has now passed?

- if your current lower level of histological damage increases your odds of tx success, how much are you willing to gamble that any increase in liver damage over time will then contribute to a possible correlating decrease in SVR chances?

- and in any discussion of postponement there is also the question of what waiting does in terms of the many non-hepatic sx's that can (and do) manifest themselves?



As far as questions about this particualr trial, the first one that I notice in regards to what you have posted is: if you end up in "Arm 1" (PEG + RBV + SCH 503034 Placebo. @ week 13 if VL then switch to SCH503034 400 mg. 48 weeks) and do show detectible at week #13, are they switching you to mono SCH503034 400 mg. 48 weeks, or will you be continuing in combination with the interferon and riba for the 48?

(it should be fairly obvious if you end up in any of the arms with the riba involved, with the resulting dramtic decreases in hemoglobin and hematocrit).


Some other questions to ask are:

- will they rx you Procrit and Neupogen during the course of tx? And at what blood levels will they intervene?

- what criteria will they use to end your tx early? (ie - what 'targets' and 'milestones' will you need to 'hit' along the way to continue forward)?

- how often will you have 'regular' bloodwork done?

- how frequently will PCR's be done?

- will you be allowed to see your ongoing lab results?

- who will be overseeing your tx?

- how will your primary doc and gastro/hepatoloist (and their offices) be involved?

- how much of your tx and testing can be handled by your local doc and lab to minimize overall time and travel?

- who do you contact if you have any kind of problem, need or concern?

- is payment for the meds (including Procrit, Neupogen, sleep aids, anti-depressents, etc.) fully covered?

- where (if at all) will you be needing any type of your own medical insurance coverage in all of this? (good to pose this to your insurer ahead of time, too).

- who will be supplying the meds? your hosptial's pharmacy? an outside pharmacy? will your pharmacy be needed? (good to let your pharmacy know ahead of time whatever meds they may need to have in stock for you).

- will you be reimbursed for any expenses (travel, etc)?



As far as if with the information you have supplied above, would I do the trail? Given that you are motivated to reach SVR status, have already experienced what the major tx sx's are and how they affect you physically, mentally and otherwise - I would take this opportunity to tx by planning as best as is possible for the inevitable times when you will suffer in your physical, family and work life. The extreme points will be just that - extreme. But in all probability the majority of the tx time will be mostly similar to what you have already experienced prior. And you can use that as a template in planning and coordinating this upcoming trial. Obviously you can always opt out at any point along the way on your own terms, so I would plan that possibility into the mix as well. An absolute 'bail-out' point, as it were.

But I would ask myself what tx opprotunties are avialable to me now given that I am a breaktrhough patient, and how long might it be before something truly viable will realistcally come down the pike for me?



May God's blessings and mercy be upon you.


TnHepGuy
Avatar universal
I would not make a decission based on liver damage alone, to me if a person wants to rid their life of hcv they should do so regardless of liver damage. What I find a negative is the fact that your virus bounced back after 9 months, you might have a new quasispecies that might not respond to current meds and dosages as well. You need customize tx, and a trial will not do that. If your goal is to be hcv free, a trial can not be the way. They put too many restrictions in their protocols. You and your virus need individual attention.  You are no longer tx naive and if you relapse again or don't respond, you will be classified a two time non responder, that could exclude you from other trials that might offer a better chance at SVR.
best to you in your decission.
Avatar universal
We missed YOU!
HOw is HCV FREE life?
Is your hip pain history?
Avatar universal
That's a tough one. It looks like you have minimal damage, and might be able to afford to wait (I am not qualified to make that judgement of course). Since peg and riba affected you so badly before, 13-24 weeks sounds rough. VX-950 is a month or 2 away from phase 2 in the states, and that will be without riba, but with peg, and for only 4 weeks. That might be more tolerable for you. The problem is, if you wait for that, do you lose out on getting into a SGP trial?
I have a problem with Schering. That problem is that they have said absolutely nothing about their drug. Nothing on sides, nothing on efficacy. The only data I know about comes from the AASLD abstract which is in the public domain, which they won't comment on. They got a 2.07 log drop at their best dose group in 2 weeks. Obviously much better than current treatment, but not as effective (from what I can see) compared to 950, which is why their trials are scheduled to be longer.
Conversely, VRTX has been very forthcoming with all 950 data, including sides, cardiac tox. studies, etc.
It is my opinion that SGP is making a big mistake here. Some will say big pharma doesn't like to telegraph what they have. Everyone knows about it anyway. They are letting a small biotech dominate them in the news area. And, if this were HIV, I believe there would be an outcry for more info on that drug, but it doesn't seem to be seen in the same light.

Good luck with your decision. Whatever you decide, I am sure it will be the right one, even if it doesn't seem so at the time.
107513 tn?1232290064
Though decision, and TOTALLY a personal choice on your part. Personally if I was in your shoes, I would opt to wait, seeing scarring and fibrosis are minimal..
Good luck man with whatever you do.
Avatar universal
Mike,,,I agree with Snook on this one,,,,Hard decision for us to say,,,What is your age and VL?
Avatar universal
With the above information I personally would not do the trial.
Given your minimal liver damage, you  still have time to wait and hopefully within a few years these trials will provide more definitive data. Also keep in mind that some of the arms are probably going to do a lot better than others, and you may not know which arm you will be enrolled in. Your doctor should have complete information on this in written form. All the best with your decision.

-- Jim
43671 tn?1205934471

TnHepGuy covered most any input I could give you, and I agree with his Input.
Remember to take each day at a time. If you were to do the trial and things got real bad during TX, you may be able to have a Peg dose adjustment. On another note, did you use any med's for depression during you last TX ? You might want to think about that if you decide to join the clinical trial.




                 God Bless

                     TonyZ

PS. <font size="2" color="#6600CC">"TnHepGuy" it is indeed good to hear from you again..</font>
92903 tn?1309908311
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!
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.
92903 tn?1309908311
...sorry. meant to title previous post
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

92903 tn?1309908311
You may wish to look at the gruppe with 70 pepperronis one more time :)
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)
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.
92903 tn?1309908311
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)
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

80575 tn?1207135964
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.
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
92903 tn?1309908311
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.
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

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....
Avatar universal
why bother with a study.  too risky
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