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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.
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