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Roche R1626 trial update
I'm sorry, with the confusion in the forum I couldn't find the thread that got started last Thursday to add my own comments to it, so I'm just going to post them on their own.
I finally got my own update today. Indeed, the Roche R1626 trial drug is being pulled for me too. Apparently my trial centre found out last week and specific people were contacted sooner, only one from my trial centre. The rest of us weren't contacted because we're continuing with the trial drug to Week 12 and then stopping the trial drug BUT continuing the trial. Everything continues as before...the same monitoring, the trial drug is still double blinded, but instead of stopping the trial drug at Week 24, we'll be stopping at Week 12. Week 12 is this Friday for me, so I continue til this Friday and then switch over to SOC.
Much for the reasons that have already been stated. They've been finding that Lymphocytes have been dropping for enough people who are beyond the Week 12 mark, that they decided to stop it at Week 12 for everyone and sooner for those that require it. Any co-relation between dosage of trial drug and drop of Lymphocytes would be purely speculation at this point as it remains to be seen what the impact of the various combinations are...and we won't know that until the end as the trial and the double-blinding of it, continues.
So...we'll see what difference 12 weeks of R1626 makes in SVR for all of us at the end.
When we do our injection this Friday.. or when I do mine.. I guess I won't know if I'm going from 90ug (did I finally get that right, Willing? :) to 180ug or staying at 180ug. It'll be an interesting weekend, I guess.
So there we are, folks.
I finally got my own update today. Indeed, the Roche R1626 trial drug is being pulled for me too. Apparently my trial centre found out last week and specific people were contacted sooner, only one from my trial centre. The rest of us weren't contacted because we're continuing with the trial drug to Week 12 and then stopping the trial drug BUT continuing the trial. Everything continues as before...the same monitoring, the trial drug is still double blinded, but instead of stopping the trial drug at Week 24, we'll be stopping at Week 12. Week 12 is this Friday for me, so I continue til this Friday and then switch over to SOC.
Much for the reasons that have already been stated. They've been finding that Lymphocytes have been dropping for enough people who are beyond the Week 12 mark, that they decided to stop it at Week 12 for everyone and sooner for those that require it. Any co-relation between dosage of trial drug and drop of Lymphocytes would be purely speculation at this point as it remains to be seen what the impact of the various combinations are...and we won't know that until the end as the trial and the double-blinding of it, continues.
So...we'll see what difference 12 weeks of R1626 makes in SVR for all of us at the end.
When we do our injection this Friday.. or when I do mine.. I guess I won't know if I'm going from 90ug (did I finally get that right, Willing? :) to 180ug or staying at 180ug. It'll be an interesting weekend, I guess.
So there we are, folks.
Regarding the trials, well, it ain't what it used to be. Back in the 90's they weren't double-blind. You knew what you were getting. Now after I've been through 2 trials (super hi-dose interferon and inf + riba) and one SOC (peg + riba), the last one being very hard, they have these trials where they require 1) treatment naive 2) platelets at a certain level 3) double-blind. That's ridiculous to me. Of course I know from their point of view their investors want positive results. I don't know why they need double-blind so much. There have been many studies on SOC. For those that have suffered through all this and have liver disease, they should make teleprefvir available right now.
0.31 does look kinda low - hopefully they'll bounce on their own, and soon. Hang in there..
My Week 12 results from last Friday came back and my ANC is at 1.49, a .01 below where they want it. That would be okay except my Lymphocytes have gone down from 0.89 at Week 8 to .31 at Week 12. They want that up to .5 and there's the usual talk about my Peg getting reduced if that number doesn't come up fast enough. Since the trial drug stopped last Friday, that may be enough to lift it a bit .. the variable will be that I don't know if my Peg got doubled last Friday or not. It's all a numbers game and I have to go today to get my "bloods" done and hopefully they'll just keep going up. We shall see, eh?
Trish
Trish
your anc/lymphocyte drop seems consistent with what one might expect from soc alone. I had to look through my tx records recently and noticed that about 6 months from start my anc had dropped to 0.7 from 2.7 and lymphocytes to 0.8 from 1.5. Not sure the comparison sheds much light, but at least it indicates your drop is not likely to be exclusively due to the mystery pill. I didn't check the trial size numbers but I assume your current trial is much larger than the previous r1626 phaseIs - so if lymphocyte drop is a relatively infrequent sx it may not have shown up previously. And yes, either mcg or ug are abbreviations for micrograms whereas mg is milligrams.
Overall, I still think that UND is yours to keep - just keep on trucking/plodding/soldiering on...
Overall, I still think that UND is yours to keep - just keep on trucking/plodding/soldiering on...
Some forums have the ability to "merge" threads but simple continuity of starting new threads also keeps them in some sort of temporal order. You can also simply visit the JennyPenny thread and reply with a link to this thread so that people can follow them with less hassle and searching.
Vertex has serious anti viral effects but it may have an issue with potentially creating resistant virii. I think that I may have read that the Roche compound may have shown potential for having less resistance issues. If so...... slow and steady might also win the race. We have a picture of how this works that serves us.....and then new data comes up and we end up revising our understanding of "the truth". That serves us until new discoveries and new data unseat that. For now, yes, RVR is a great predictor of SVR but I would imagine that there is more than one way to skin a cat, virolgically speaking.
For what it's worth I agree with Willing that there could only be a few stragglers with issues as opposed to a trial wide issue. I'd point out that it is the design of trials to create a database in which some may be overdosing and some may be underdosing. Look at the trial that Andiamo just finished; virtually double the dose of both Telaprevir and SOC as a "12 &12". In the end the 12 and 12's had about the same SVR rate as the "24& 24". It was a tough treatment but Eric made it through with an SVR. On the other end of the spectrum there were a few arms which may have undertreated trial participants. (such as the 12 weeks and stop all triple therapy arm or the no ribaviren arm) The drug companies do the best that they can but only a trial with real people can provide them with the data that proves or disproves the suppositions.
When the dust has settled only 12 weeks may end up providing great results. Further, they may simply end up deciding that they didn't need to stop at 12 weeks. They may also create some interventions such as rescue drugs that allow a longer triple therapy treatment. Even if 12 weeks is all that they can safely do what will the effect be if it were combined with telaprevir later this year? Who knows? It could be great or a brand new "bust". Yes, I agree that things just seem to keep getting better and brighter.
Best of luck on the rest of the trial.
Willy
Vertex has serious anti viral effects but it may have an issue with potentially creating resistant virii. I think that I may have read that the Roche compound may have shown potential for having less resistance issues. If so...... slow and steady might also win the race. We have a picture of how this works that serves us.....and then new data comes up and we end up revising our understanding of "the truth". That serves us until new discoveries and new data unseat that. For now, yes, RVR is a great predictor of SVR but I would imagine that there is more than one way to skin a cat, virolgically speaking.
For what it's worth I agree with Willing that there could only be a few stragglers with issues as opposed to a trial wide issue. I'd point out that it is the design of trials to create a database in which some may be overdosing and some may be underdosing. Look at the trial that Andiamo just finished; virtually double the dose of both Telaprevir and SOC as a "12 &12". In the end the 12 and 12's had about the same SVR rate as the "24& 24". It was a tough treatment but Eric made it through with an SVR. On the other end of the spectrum there were a few arms which may have undertreated trial participants. (such as the 12 weeks and stop all triple therapy arm or the no ribaviren arm) The drug companies do the best that they can but only a trial with real people can provide them with the data that proves or disproves the suppositions.
When the dust has settled only 12 weeks may end up providing great results. Further, they may simply end up deciding that they didn't need to stop at 12 weeks. They may also create some interventions such as rescue drugs that allow a longer triple therapy treatment. Even if 12 weeks is all that they can safely do what will the effect be if it were combined with telaprevir later this year? Who knows? It could be great or a brand new "bust". Yes, I agree that things just seem to keep getting better and brighter.
Best of luck on the rest of the trial.
Willy
I didn't mean to imply that these PI treatments have only come along in the last while.. it's just that I recall people not being too sure how Telaprevir was going to turn out and alot of uncertainty even if there was excitement about it .. I know VX-950 has been around for quite some time. I just mean it seems things have been heating up in that regard with the advent of the Phase III trials, etc... and it just seems more hopeful these days.
Exciting times for treatment prospects for HCV all around, seems to me... between Alinia, statins, polymerase and protease inhibitors like Telaprevir and Boceprevir, studies showing that RVR at 4 weeks may result in shorter treatment times, etc etc.......even from the time I landed here it wasn't this exciting and I haven't been around that long, like last September.
I don't know how other people turned out... I think I know of two on the R1626 that got RVR but I know me, Emi and StainedGlass., didn't make RVR. I wish...but no. However, two of the three of us are UND by Week 12 and just waiting on Emi's results. Just the same...we're a tiny little demographic and we'll see how it all shakes out in the end.
Thanks for JennyPenny's thread... now if there was just a way to combine threads? :)
I don't know how other people turned out... I think I know of two on the R1626 that got RVR but I know me, Emi and StainedGlass., didn't make RVR. I wish...but no. However, two of the three of us are UND by Week 12 and just waiting on Emi's results. Just the same...we're a tiny little demographic and we'll see how it all shakes out in the end.
Thanks for JennyPenny's thread... now if there was just a way to combine threads? :)
By the way, the other thread on this topic started by JennyPenny is here;
http://www.medhelp.org/posts/show/519500
I heard last week that Vertex had plans this year to try telaprevir in combination with a polymerase inhibitor (such as this one) later THIS YEAR. They had planned it being a combo of telaprevir, the polymerase inhibitor, and interferon.....that's right; no ribiviren. That was mentioned in a webcast about the time that this issue was popping up. (BTW -Pharmasett/ Roche are also co-developing another polymerase inhibitor; R7128)
As willing pointed out, if 12 weeks of dosing is enough to provide RVR's and knock off the stragglers it may merely eliminate a longer and unneeded dosing time. We'll see. It could be that 12 weeks is sufficient dosing to acheive what they need. It could be that in combination with another PI, (one polymerase and protease), that the treatment time can come down while the SVR rate goes up. There are bound to be a few bumps and scares along the way. Since this trail seems to be less blinded than some other trials we may know the results sooner. We may be offered some preliminary data by the fall AASLD.
best,
Willy
http://www.medhelp.org/posts/show/519500
I heard last week that Vertex had plans this year to try telaprevir in combination with a polymerase inhibitor (such as this one) later THIS YEAR. They had planned it being a combo of telaprevir, the polymerase inhibitor, and interferon.....that's right; no ribiviren. That was mentioned in a webcast about the time that this issue was popping up. (BTW -Pharmasett/ Roche are also co-developing another polymerase inhibitor; R7128)
As willing pointed out, if 12 weeks of dosing is enough to provide RVR's and knock off the stragglers it may merely eliminate a longer and unneeded dosing time. We'll see. It could be that 12 weeks is sufficient dosing to acheive what they need. It could be that in combination with another PI, (one polymerase and protease), that the treatment time can come down while the SVR rate goes up. There are bound to be a few bumps and scares along the way. Since this trail seems to be less blinded than some other trials we may know the results sooner. We may be offered some preliminary data by the fall AASLD.
best,
Willy
And good luck with your Alinia!! That also holds some great interest and I would have went after adding Alinia to my SOC if I hadn't ended up in a trial. Was already in discussions with my son who was in San Diego to turn him into my "mule". :)
I'm hoping things go well for you, merryBe .. and for the others also trying out Alinia. It is very encouraging on the lack of side effects with that. Hoping for SVR for you.
Trish
I'm hoping things go well for you, merryBe .. and for the others also trying out Alinia. It is very encouraging on the lack of side effects with that. Hoping for SVR for you.
Trish
It's totally random what arm you get, but the dosage combinations aren't random. You get "weight based" ribavirin so that's the only dosage we always knew, we were either 1000mg or 1200mg and we knew which we had. The INF was either 90 or 180 and we didn't know and the trial drug was either 500, 1000 or 1500 twice a day and we didn't know that either.
It's not exactly underdosing or overdosing and certainly not for no good reason. They're trying to determine what works best. It's a clinical trial and that's a very good reason for using different dosage configurations. We all knew what the different arms were going into this and what the dosage was on each. The way I looked at it, I looked at the arm I wanted least and decided if I could live with that. And I could. Other people might have looked at it differently, that's just simply how I looked at it myself, along with other variables. The only thing that would have kept me out of the trial was if they played with the ribavirin. I wanted weight-based or close to it ribavirin and that would have been the area I wouldn't have compromised on. They have to find the dosage configuration with the best efficacy and I guess this is how they have to do it.
You say we get all the pain, but what motivated me to go into this trial was a shot at a drug I wouldn't have access to any other way that increased my cure rate significantly. There was data available from previous trials for me to look at. Yes, it was a risk. But also with potential for me as well. I am UND at 6 weeks. I think I got some gain. :)
Doubleblind means I know what dosage configuration I COULD be getting but not what I AM getting and the researchers don't know either. So they monitor the labs particularly closely as they go along.
It's not exactly underdosing or overdosing and certainly not for no good reason. They're trying to determine what works best. It's a clinical trial and that's a very good reason for using different dosage configurations. We all knew what the different arms were going into this and what the dosage was on each. The way I looked at it, I looked at the arm I wanted least and decided if I could live with that. And I could. Other people might have looked at it differently, that's just simply how I looked at it myself, along with other variables. The only thing that would have kept me out of the trial was if they played with the ribavirin. I wanted weight-based or close to it ribavirin and that would have been the area I wouldn't have compromised on. They have to find the dosage configuration with the best efficacy and I guess this is how they have to do it.
You say we get all the pain, but what motivated me to go into this trial was a shot at a drug I wouldn't have access to any other way that increased my cure rate significantly. There was data available from previous trials for me to look at. Yes, it was a risk. But also with potential for me as well. I am UND at 6 weeks. I think I got some gain. :)
Doubleblind means I know what dosage configuration I COULD be getting but not what I AM getting and the researchers don't know either. So they monitor the labs particularly closely as they go along.
hope it will have knocked out what SOC can't.
I'm hoping the Alinia might do that....as it has no side like the trial drugs.
I hope you end up with the 180, unless you are tiny..
I wonder if it is totally random who gets the 90 vs 180....I suppose it has to be to be truly double blind..
but I sure think that puts a lot of people in undersosing and overdosing for no good reason.
maybe you could ask if they tailored who got each arm to their weight at least.
It would be interesting to see if they might have...I'd sure like to know.
Not to, to me, seems like the biggest down side of trials...I mean..here you get all the pain, hopefully a better cure...but in the end all the suffering at what may be too low a dose to clear......that part has me bothered and concerned for all in these trials.
wish I knew more about how blind doubleblind really is...
I'm hoping the Alinia might do that....as it has no side like the trial drugs.
I hope you end up with the 180, unless you are tiny..
I wonder if it is totally random who gets the 90 vs 180....I suppose it has to be to be truly double blind..
but I sure think that puts a lot of people in undersosing and overdosing for no good reason.
maybe you could ask if they tailored who got each arm to their weight at least.
It would be interesting to see if they might have...I'd sure like to know.
Not to, to me, seems like the biggest down side of trials...I mean..here you get all the pain, hopefully a better cure...but in the end all the suffering at what may be too low a dose to clear......that part has me bothered and concerned for all in these trials.
wish I knew more about how blind doubleblind really is...
Hi Emi, in your case, this is probably a good thing to be on SOC earlier, even from an anxiety point of view. I know it has been a struggle for you to decide whether to continue with the trial drug or drop out.. at this point, your SOC drugs remain covered and you're on SOC earlier and I'm hoping hard on your Week 12 results.
Gotta admit, I was a bit nervous doing the injection last evening...wondered if things would be a bit worse. So far so good.. I would have to say I noticed some difference but nothing significant. If anything, I noticed more of a "rush" today .. then again, I was involved in some pretty exciting stuff all day and was on a "rush" anyway .. but just the same, it was also a physical thing. Doesn't matter..it's tolerable and it's done, so initial jitters over and moving forward. "Took the potion and now in forward motion" :)
Please post back your Week 12, Emi....with you all the way.
Trish
Gotta admit, I was a bit nervous doing the injection last evening...wondered if things would be a bit worse. So far so good.. I would have to say I noticed some difference but nothing significant. If anything, I noticed more of a "rush" today .. then again, I was involved in some pretty exciting stuff all day and was on a "rush" anyway .. but just the same, it was also a physical thing. Doesn't matter..it's tolerable and it's done, so initial jitters over and moving forward. "Took the potion and now in forward motion" :)
Please post back your Week 12, Emi....with you all the way.
Trish
I had my 12 Week appointment yesterday and got my Week 8 results. My ANC is 1.1 and my Lymphocytes are .89. That's gone down quite a bit from before, I checked my previous labs to compare. They'll wait to see what my Week 12 is before deciding on a dosage reduction. I will get weekly CBC's for awhile but thankfully they're letting me get them done locally and having the results faxed to them so I don't have to go to the trial centre for that, which costs me half a day of work each time. I'm not expecting a dosage reduction, we're just doing due diligence. I seem to be just skirting around all of that all the way through. I get close, we talk about it and my labs recover. And I'm tolerating well, so that helps also.
And yes, the trial continues. I was told that the feeling is that the 12 weeks of data is still valuable and so the trial continues, we're still double-blinded, it's just that we've gone on SOC at 12 weeks instead of the expected 24. Some earlier because of adverse effects but in general, that's the score. So it continues and we'll see when it's done what the SVR rates are for 12 weeks of R1626 and what picture emerges as a result.
Willing, oddly enough, my INF vials say 180 mcg. Go figure. Good thing I don't own a chainsaw? :)
Willing again.. I too find it odd that Lymphocytes didn't come out in the previous trials, however, this is Phase IIb, 7 arms.. and perhaps it's a particular dosage combination? I guess we'll see at the end. to comp
Willy ....thanks for the information you keep posting and the encouragement. It's so much appreciated. It was a bit of a blip to have them pull the trial drug, was kind of counting on keeping it til Week 24 and didn't actually consider this particular blip in all my exhaustive considerations! Expect the unexpected should be the motto with any HCV treatment and particularly a clinical trial, eh? We shall see how it all shakes out in the end. No regrets here on my part.
Trish
And yes, the trial continues. I was told that the feeling is that the 12 weeks of data is still valuable and so the trial continues, we're still double-blinded, it's just that we've gone on SOC at 12 weeks instead of the expected 24. Some earlier because of adverse effects but in general, that's the score. So it continues and we'll see when it's done what the SVR rates are for 12 weeks of R1626 and what picture emerges as a result.
Willing, oddly enough, my INF vials say 180 mcg. Go figure. Good thing I don't own a chainsaw? :)
Willing again.. I too find it odd that Lymphocytes didn't come out in the previous trials, however, this is Phase IIb, 7 arms.. and perhaps it's a particular dosage combination? I guess we'll see at the end. to comp
Willy ....thanks for the information you keep posting and the encouragement. It's so much appreciated. It was a bit of a blip to have them pull the trial drug, was kind of counting on keeping it til Week 24 and didn't actually consider this particular blip in all my exhaustive considerations! Expect the unexpected should be the motto with any HCV treatment and particularly a clinical trial, eh? We shall see how it all shakes out in the end. No regrets here on my part.
Trish
thanks for the update - I've been away and was wondering what had happened on this front. It's interesting that this side effect, lymphocyte drop, was not detected in the phase I or II studies; presumably it is relatively infrequent, unlike the neutrophil reduction which was anticipated. It would be interesting to hear how many trial participants observed a significant lymphocyte drop.
All the new PIs have very powerful anti-viral activity and R1626 also benefited from a strong resistance profile so even with cutoff at 12 weeks I have a hunch/hope that those who reached und will get to stay there.
Emilio : assuming your vl continues to drop but remains detectable at 12, it might be a good idea to start checking whether the modified trial protocol will allow extension to 72
Trish: yeah, common abbreviations are mg for milligram ug for microgram; on 90 milligrams of ifn you'd probably be playing the starring role in the 'toronto chainsaw massacre'
All the new PIs have very powerful anti-viral activity and R1626 also benefited from a strong resistance profile so even with cutoff at 12 weeks I have a hunch/hope that those who reached und will get to stay there.
Emilio : assuming your vl continues to drop but remains detectable at 12, it might be a good idea to start checking whether the modified trial protocol will allow extension to 72
Trish: yeah, common abbreviations are mg for milligram ug for microgram; on 90 milligrams of ifn you'd probably be playing the starring role in the 'toronto chainsaw massacre'
There is no update from Roche on the trial but in searching I found this link. The link also has a host of other trial info, sites the trial was offered, FAQ about trials etc. My guess is that they may have taken abrupt action on the trial but actual analysis of safety issues may not be made public anytime soon. In the absence of information, the fact that the trials are continuing should be accepted as some level of proof that things are going reasonably well. Any continued or worsened safety issues might cause a trial to end. I hope that in the absence of such an action one can conclude that things are within the range of acceptable. Good luck to all involved; we're pulling for you.
best,
Willy
http://www.roche-trials.com/patient/trials/trial110667.html
best,
Willy
http://www.roche-trials.com/patient/trials/trial110667.html
On Monday when I went to Hershey they said that Roche wasn't the ones who pulled the trial drug early. An independent company required by the FDA who does auditing for trials pulled the trial drug early.
I thought that was kind of interesting. I'm also grateful that there was someone on the outside overseeing my bloodwork expecially since I was having so much trouble.
It's been 13 days since I've been off of the trial drug and I'm finally starting to feel better.
Of course I haven't taken the full dosage of Pegasys yet, they want to work me back up to it. Right now I'm on 50 units and waiting for my blood work results to see if they'll push it to 75 units and then it's up to 100 units.
Hopefully the Nuepogen and Procrit will start working since I'm off of the trial drug.
I don't expect this will be a bed of roses for any of us....but I'm hoping it won't be the hell that I've been in over the past 3 months.
Good Luck everyone! I wish you all well!
((Hugs))
Laurie
I thought that was kind of interesting. I'm also grateful that there was someone on the outside overseeing my bloodwork expecially since I was having so much trouble.
It's been 13 days since I've been off of the trial drug and I'm finally starting to feel better.
Of course I haven't taken the full dosage of Pegasys yet, they want to work me back up to it. Right now I'm on 50 units and waiting for my blood work results to see if they'll push it to 75 units and then it's up to 100 units.
Hopefully the Nuepogen and Procrit will start working since I'm off of the trial drug.
I don't expect this will be a bed of roses for any of us....but I'm hoping it won't be the hell that I've been in over the past 3 months.
Good Luck everyone! I wish you all well!
((Hugs))
Laurie
I have been advised that I will switch this Friday as well. So the remaining 36 weeks will be SOC. For me who is struggling 100,000VL at 8 weeks it is probably a blessing as I have always had the sense that I am on 90ug PegINF. If this rings true and I am still detectable at 12 weeks, would I be considered a slow responder, considering that I was only getting half dose of PegINF?? Interesting question and I'm not sure there is a straight forward answer. Anyway I dont know that this is my dosage for sure, it will be also interesting to feel for any different effect on Friday, surely I will feel some diffference in doubling of the dose. Ah the what ifs and how comes. Hi Links I don't think we've met. Regards Emi
Hope the 12 weeks is the charm! Will you continue SOC for a total of 48 weeks?
Brent
Brent
Both of you seemed to have been blessed with an early UND so maybe the potency of the drug already benefited you all. Maybe we'll never know, however I'm sure both of you have a hunch either way. It only matters to you, as I'm only here to support and root you two on, so with that I will close and wish you zero or minimum sx's and straight to SVR for both of you, with many more to follow in your footsteps. God Bless
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