Schering Plough trial, SCH 503034

[Ironduke]

I am currently enrolled in the Schering trial for their Protease Inhibitor SCH 503034 and wanted to find out if there are others Medhelp readers who are in this trial and to ask how you are doing.  

This is a Phase ll trial for Genotype 1, treatment naive patients.  There are 5 arms to the study:
1.  SOC for 48 weeks.  If virus still detectable at week 24, patient has the option to continue with SOC plus SCH 503034 for up to another 54 weeks depending on .
2.  SOC for 28 weeks plus 800 mg SCH 503034 3x/day for 28 weeks.
3.  SOC for 28 weeks plus 800 mg SCH 503034 3x/day for 24 weeks after 4 weeks of SOC
4.  SOC for 48 weeks plus 800 mg SCH 503034 3x/day for 48 weeks
5.  SOC for 48 weeks plus 800 mg SCH 503034 3x/day for 44 weeks added after 4 weeks of SOC.

I was assigned to arm 4 and am currently at week 25.  I got into the study at the last minute, so presumably everyone in the study are at least 25 weeks into it.  I believe there are a total of 400 patients enrolled.  I have had a PCR every 2 weeks up to 12, then at 16, 20 and 24.  I have been UND since the first PCR at week 2.  Sides have been typical with SOC including anemia, nausea, fatigue and mild rash.  My HGB dropped to 9.1, was put on Procrit and have been doing better the last 12 weeks or so.  

Are there any others out there who are in this study who would like to tell us how you are doing?  My result so far is very encouraging, it would helpful to know if others are having the same positive result.  

Thanks and best wishes to all Heppers out there.

Ironduke

[Diamando6]

Anyway Ironduke, that is great, keep on going, I am sure, you will achieve SVR, even after therapy. Good luck!

[Diamando6]

This is good. I dont know why we dont have so much trials over here where I live. Too bad. So much more people would have been cured. I suppose, we are at the edge of Euope, that is why!

[jerryk1000]

My side effects were general flu-like symptoms, and after 60 days my hgb dropped <10.0 g/dL. Anemia stayed mildly throughout the course and I remained on 1000 mg Rebetol. It has been over two years and I am still undetected. I wish you the best in your long journey. jerr

[CoWriter]

Can you tell us what side effects continued?  Did the anemia go away?

Co

[CoWriter]

"Yes they did lower my Riba to 600mg.  With the anemia back under control, the dosage has been upped to 800.  I hope this will not lessen my chances for SVR. "
---------

Are they keeping you on 800mg for the rest of the treatment?

Co  

[jerryk1000]

I was also in the clinical trial of SCH 503034. Six months in tx my hemoglobin dropped to 9.7 and the principal investigator treated the anemia with procrit and lessened my rebavirin dose from 1200 to 1000 mg. I was told the side effects would go away within 6 months after stopping the drug therapy. My side effects continued to worsen. I would like to know if any one else continues to suffer side effects of the study drugs. I will browse this blog each day to hear from anyone suffering side effects of the study drug research sponsored by Schering Plough. If so, did the prinicpal investigator deny follow up care of the side effects?

[dointime]

ah'm readin it, ah'm readin it!  But not ready for another round until they get a pill that works 100% with no sides.:))
dointime.

[Ironduke]

2 more weeks to go, man it must feel good to know you are almost done.  23 more for me, feels like an eternity.  Like you say, I take it a day at a time.  I really needed the rescue drug, I was down for the count for the first 8-10 weeks.  I missed a lot of work.  I'm now able to work full time again, hoping it stays as is for the remainder.

Please let us know how your post treatment tests go.  I'll be rooting for you!

Ironduke

[JOHNWS]

Yes. You are right on the rash. I believe based on my experience and asking nurses questions the rash is more or a Vertex thing whereas the Schering drug seems to add more potential for anemia. Half way through the protocol they added a statement that we had to sign saying that this combination does appear to cause slightly more anemia than SOC. My hemo has hovered around the mid 9's most of treatment, no rescue drugs, you just have to take it one day at a time. My thought is 28 weeks is plenty of time to get SCR. Undetectable the whole way with no breakthrough should put me in the 90% odds of SCR.

[mremeet]

So you're also in the sch503034 trial?? If so thanks for weighing in. And although we certainly cannot ascertain the likelihood sch503034 induces rash (or not) based on only two anecdotal reports so far, that really would be a big step forward if this drug has a much lower incidence of rash than telaprevir, whilst also preserving the full antiviral punch of a PI. The thing is, is that even those who didn't get an outright rash from telaprevir more often than not do describe an underlying irritation from it. Sounds like you guys say it's a very non-eventful experience, which is promising. You reading this dointime? ;-)

And yes Schering definitely seems to be very low key about this drug. They're a much bigger company so I suppose they don't have to generate all the hype that Vertex does. Vertex has an awful lot riding on Teleprevir, whereas Schering could easily survive SCH503034 failing. Plus by not hyping it up and keeping a lid on it, it helps keep the competition in the dark - possibly enhancing the amount of time they'll have to profit from an exclusive HCV treatment market share. Either way time will tell, I'm just glad it seems to be coming along nicely and will hopefully soon be yet another straight and sharp arrow in our anti-HCV quiver.

[JOHNWS]

I am treatment arm 2 28 weeks of triple thearpy. I am in week 26. Everything has gone great. I also have been undetectable since the first blood draw week 2. Starting viral load 6 million. No rash. The only side effects have been the anemia. I believe this drug is better than Vertex based on the rash issues alone. Schering just does not share information as much as Vertex does.

[susan400]

I'd like to see, a couple of years from now, if anybody that had the rash in Prove 3 and had to be taken off of it for non-response, or whatever-if they try this Schering drug-if they don't get a rash??   I'd be really interested in trying it if it doesn't give the rash and you get to have the rescue drugs to boot!  Hopefully, with time, they'll offer this drug to non-responders in a later trial and by that point-we should know from people like you who are testing it out-if it's a good possibility for others.  At this point, I'm just in waiting mode.  I know I will treat again someday.  I'm still pre-cirrhosis and would like to keep from progressing if I can.   Susan

[mremeet]

SOC = Standard of Care, which basically means the standard FDA approved treatment for HCV (which is peg IFN + riba right now)

[Marl37]

Can someone remind me what SOC means - curse this memory loss.

[glucklich]

What a fantastic opportunity for you and all of us. I hpe we hear more as you progress. Good clearing!

[Ironduke]

Yes they did lower my Riba to 600mg.  With the anemia back under control, the dosage has been upped to 800.  I hope this will not lessen my chances for SVR.  

Previous trials of this drug showed minimal side effects, the most prevelant being headaches and metallic taste.  I have not suffered from headaches.  There was an Interesting comment from another reader in a recent thread on rescue drugs in clinical trials:

"I'm in the Scherring-Plough trial.  They weren't going to allow rescue drugs but so many people headed toward anemia that they changed the protocol and they sprung for Procrit."

In my case procrit has been prescribed but the cost is not covered by S-P.  

So I am wondering now if the drug does contribute to problems with anemia.  I just assumed my anemia was from the riba.

Thanks for your kind words of support.  This forum has been a really great resource for information and support.  Here's to everyone achieving SVR!  

Ironduke

[mremeet]

Good stuff, finally a little bit of light is shed on this mysterious drug. Looks like it offers similar performance as Telaprevir, which was expected I guess. Interesting to hear you only have a minor SOC rash, I wonder if SCH503034 will have a significantly lower incidence of rash when compared to VX? I guess time will tell, but for you it ain't nuthin but a thang...count your lucky stars! It's also very cool that they're letting you take Procrit while you're still on the research drug. I wonder if they've found that this drug contributes to anemia too. Have they provided you with any side effect information yet? Our VX trial consent form disclosed all of the known side effects, so it would be interesting to hear about SCH503034 in that regard as well. Also nice to see they had the wisdom to not have any riba-free groups either.

Anyway, congrats on lucking out and ending up in the best group of the trial...or at least the safest in terms of ensuring an SVR. Sure sounds you have your SVR locked down at this point, good luck during the rest of the ride!

[r4c7]

Very promising results...wow!  I'm curious about the anemia. When you went on Procrit, did they lower your ribavirin?