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Lymphocytes low after RO study drug dicontinued
Has anyone that was on the recently canceled Roche RO study been denied Peg due to low lymphocytes?
On april 15 the RO drug was discontinued from the study and the doc said I need to skip the Peg untill my lymphocytes come back up to 1.5. Well it has been six weeks and I am livid that they wont let me continue even though my levals are 1.37 up from .5. I am still UND but I am worried.
On april 15 the RO drug was discontinued from the study and the doc said I need to skip the Peg untill my lymphocytes come back up to 1.5. Well it has been six weeks and I am livid that they wont let me continue even though my levals are 1.37 up from .5. I am still UND but I am worried.
Thank you to both of you for posting your experiences with dropping the Peg. I go for my blood test today and after reading how you've both fared after eliminating your Peg, I am less concerned about mine getting reduced or dropped as I was UND by 6 weeks. I'm fighting a bit of an infection right now and on antibiotics for it and hoping that goes away soon.
I'm very grateful that there are people in this trial who share what they're going through. That's been a big help. I hope you will both keep posting how you're doing with this ... I'd like to see how we all make out as we go along with the lymphocytes, the dosage reductions ... and our results as we go along and in the end.
livinminn ... hang in there. I'm glad there are experienced people in this forum who have good feedback to help you with this.
Trish
I'm very grateful that there are people in this trial who share what they're going through. That's been a big help. I hope you will both keep posting how you're doing with this ... I'd like to see how we all make out as we go along with the lymphocytes, the dosage reductions ... and our results as we go along and in the end.
livinminn ... hang in there. I'm glad there are experienced people in this forum who have good feedback to help you with this.
Trish
i am in the same study and am in the same situation as you, except that i took my last peg injection just over a month ago. i was und at 4 weeks and still und 2 weeks after stopping the peg. i've continued on the riba. i was told that i could resume the peg once my lymphocytes climb up to a level of 500 or .5? i was as low as 160 and i was at 460 after last week's test. during the study, i was dose reduced once on the peg after several weeks and later was reduced on the experimental drug by 1 pill out of the 3. i did a blood draw today so i'm confident that i will be able to resume the injections in a couple of days. my next VL test will be at week 22 which i believe is next week. this is now my most anticipated result. it's good to hear that you are at 6 wks und. if everthing goes well, i think i would've have gone 5 weeks und before resuming the peg.
fyi, i'm a male in my mid-30's and have always played a lot of sports, but i can't say i was in the best cardio shape before i started the tx. i hate jogging! the only side effect that i've noticed at times were moments of more fatigue than normal after exertion from doing something athletic. the worst was skiing for the first time this year at 11,000 ft the week after starting the tx. i had to stop every 5 turns or so to catch my breath. i'm sure that my cardio state during those times had a lot to do with it as well. my VL was at 170K before i started the tx.
fyi, i'm a male in my mid-30's and have always played a lot of sports, but i can't say i was in the best cardio shape before i started the tx. i hate jogging! the only side effect that i've noticed at times were moments of more fatigue than normal after exertion from doing something athletic. the worst was skiing for the first time this year at 11,000 ft the week after starting the tx. i had to stop every 5 turns or so to catch my breath. i'm sure that my cardio state during those times had a lot to do with it as well. my VL was at 170K before i started the tx.
Howdy. I'm just "below" you in Iowa where we've had the longest winter and the wettest spring ever. Hell of a year so far.
Dointime is right there was a 12 week arm in ......I think it was Prove 1 where people could quit after 12 weeks (based on an RVR thru week 12) . The numbers were too small to really offer solid stats but they did about 40% SVR rate If I recall. Many people dropped out due to just not knowing and being scared. I'd bet that they might have easily hit 50% SVR in a larger and better supported 12 week trial. Very Rapid responders may not take much time to totally eradicate the virus. You could be in that group.
I think a cure is coming. IF you have responded this well I think it bodes well for the potentcy of the compound. Vertex is talking about combining their protease inhibitor with a polymerase inhibitor (such as you are on) this year in Phase 3 trials, perhaps this year. They are planning on eliminating the ribaviren which I believe could help with the anemia that you are experiencing. It could be a very interesting trial. Even for people with no insurance there are often trials or assistance programs where one can get free TX drugs.
I'm hoping that you'll be alright one way or another. I'd almost imagine if you don't rebound in a week or two you might just be cured already. If you were going to rebound The odds are that it might have happened a few weeks back.
Hang in there friend.
Willy
Dointime is right there was a 12 week arm in ......I think it was Prove 1 where people could quit after 12 weeks (based on an RVR thru week 12) . The numbers were too small to really offer solid stats but they did about 40% SVR rate If I recall. Many people dropped out due to just not knowing and being scared. I'd bet that they might have easily hit 50% SVR in a larger and better supported 12 week trial. Very Rapid responders may not take much time to totally eradicate the virus. You could be in that group.
I think a cure is coming. IF you have responded this well I think it bodes well for the potentcy of the compound. Vertex is talking about combining their protease inhibitor with a polymerase inhibitor (such as you are on) this year in Phase 3 trials, perhaps this year. They are planning on eliminating the ribaviren which I believe could help with the anemia that you are experiencing. It could be a very interesting trial. Even for people with no insurance there are often trials or assistance programs where one can get free TX drugs.
I'm hoping that you'll be alright one way or another. I'd almost imagine if you don't rebound in a week or two you might just be cured already. If you were going to rebound The odds are that it might have happened a few weeks back.
Hang in there friend.
Willy
Good points Willy, thanks.
Trish,
I think I am correct in the numbers but now you got me thinking and I will have to ask the study people for my numbers again. I think I actually was down to .32 Lymphocytes at one point too. ANC was never mentioned to me.
Jim,
I was on triple drugs for 12 weeks (started Jan 25th) and am pretty sure I was not in the placebo arm. I was UND at 6 weeks I stopped the Peg and RO at 12 weeks (Apr 18th) but continued and am continuing the Riba. Still UND as of week ago Monday (June 9th). I am waiting for the next VL test. The nurse practitioner from the study was very suprised that I am still UND too. Beleive me though I am feelin very anxious and frustrated and expect it (HCV) to come back if I don't resume treatment promptly. I fear it has been too long already and have considered SOC but I am already so close to starting again. I really cant afford treatment either.
Thanks to everyone for all their input and posts, this forum is great.
Trish,
I think I am correct in the numbers but now you got me thinking and I will have to ask the study people for my numbers again. I think I actually was down to .32 Lymphocytes at one point too. ANC was never mentioned to me.
Jim,
I was on triple drugs for 12 weeks (started Jan 25th) and am pretty sure I was not in the placebo arm. I was UND at 6 weeks I stopped the Peg and RO at 12 weeks (Apr 18th) but continued and am continuing the Riba. Still UND as of week ago Monday (June 9th). I am waiting for the next VL test. The nurse practitioner from the study was very suprised that I am still UND too. Beleive me though I am feelin very anxious and frustrated and expect it (HCV) to come back if I don't resume treatment promptly. I fear it has been too long already and have considered SOC but I am already so close to starting again. I really cant afford treatment either.
Thanks to everyone for all their input and posts, this forum is great.
I'm assuming you did 12 weeks triple therapy with R1626 before stopping all drugs. Some people in the Vertex Prove trials did end up SVR after only 12 weeks tx with the right mix of drugs, so it is possible.
Fingers crossed or you,
dointime
Fingers crossed or you,
dointime
After reading half your post I was about to say that since you've been off the Peg for six weeks, then you would have to start from scratch because the virus no doubt would rebound back to beginning levels or worse. But then I read you were still UND and therefore express the same surprise as did FlGator.
While I assume you don't know what ARM you were in, would you mind sharing with us how many weeks you treated for before they pulled the plug on the Peg. Also, did you continue on with other drugs such as the experimental drug and/or riba? Also, exactly when was the test given -- in relation to stopping the Peg -- that gave you an UND result and what was its sensitivity?
If indeed, it was six weeks since you stopped taking all drugs -- and if the test was a very sensitive one, i.e. <50 IU/ml -- then there's a good chance that you are SVR. If the test wasn't very sensitive, you might want to request a sensitive test right away to confirm that possible SVR status.
-- Jim
While I assume you don't know what ARM you were in, would you mind sharing with us how many weeks you treated for before they pulled the plug on the Peg. Also, did you continue on with other drugs such as the experimental drug and/or riba? Also, exactly when was the test given -- in relation to stopping the Peg -- that gave you an UND result and what was its sensitivity?
If indeed, it was six weeks since you stopped taking all drugs -- and if the test was a very sensitive one, i.e. <50 IU/ml -- then there's a good chance that you are SVR. If the test wasn't very sensitive, you might want to request a sensitive test right away to confirm that possible SVR status.
-- Jim
Yes I am the one in the R7128 trial. I am only 1 week into it so I do not have any results yet. I feel great so far and I am confident I am going to beat this! I really think this drug has a lot of promise also. I had heard a while back that Roche was pushing R1626 over R7128 since it was their drug but there was a concern over grade 4 neutopenia with the R1626. I am hoping that is not the case with R7128 also but only time will tell.
Also It is funny that this post was here today as I was just wondering what was going on with the R1626 trial. The last I heard they were having issues with patients suffering from Neutropenia . How are you doing on the trial? Feeling OK? I hope you stay UND. and beat this! Keep us posted on everything.
As I get any results or information I will be sure to pass it along as I know people want to know how these trial drugs are progressing and doing without the spin of a pharmaceutical company. The only info I can give is so far so good.
Also It is funny that this post was here today as I was just wondering what was going on with the R1626 trial. The last I heard they were having issues with patients suffering from Neutropenia . How are you doing on the trial? Feeling OK? I hope you stay UND. and beat this! Keep us posted on everything.
As I get any results or information I will be sure to pass it along as I know people want to know how these trial drugs are progressing and doing without the spin of a pharmaceutical company. The only info I can give is so far so good.
Can't keep everyone and their trials straight...lol Now that you mention it, I think it's DragonSlayer45 in the R1726 trial? I'll have to check.
As to your question... I simply don't know how good that is. I guess...the longer the better. For me, if I put this in perspective, we want UND for six full months after stopping all drugs when done treatment to be considered cured. So...if it was me...six weeks is good, longer is better and required.
Good luck in the Vertex trial.
Trish
As to your question... I simply don't know how good that is. I guess...the longer the better. For me, if I put this in perspective, we want UND for six full months after stopping all drugs when done treatment to be considered cured. So...if it was me...six weeks is good, longer is better and required.
Good luck in the Vertex trial.
Trish
I'm in the Vertex trial, but I have been trying to follow the others (polymerase) as well. I can't seem to find enough info out there. Wondering how long it takes for the virus to rebound if it's going to...the way this post reads, it has been six weeks since last dose...and no SOC either. I am really new to this and don't know much yet...UND is always good but six weeks UND without continuing SOC...how good is that?
Gator, I'm at Week 15, was UND by 6 weeks.
Every UND is good news. We're both UND now...what matters is if we're SVR at the end so I share his concern that dosage reductions put that at some risk - risk by degrees - and I'd be concerned also that the virus might rebound. There's a reason why we keep taking the drugs to 48 weeks after and early UND even.
I do think Roche has been onto something all along with R1626 however having the drug pulled at 12 weeks instead of 24 was an unexpected bump. The trial continues as they feel the data up until then is valuable and we won't know until it's all published and out there. I never hear R1626 being talked about anymore and it's unfortunate, as it was considered very promising. So...we orphan along in the trial and hope this is still promising and wait for the data.
This big focus on the lymphocytes is frustrating as there is not enough information and I'm seeking to understand that better.
I'm very interested as you go along, Gator, on how things go with your R1726 trial.
Trish
Every UND is good news. We're both UND now...what matters is if we're SVR at the end so I share his concern that dosage reductions put that at some risk - risk by degrees - and I'd be concerned also that the virus might rebound. There's a reason why we keep taking the drugs to 48 weeks after and early UND even.
I do think Roche has been onto something all along with R1626 however having the drug pulled at 12 weeks instead of 24 was an unexpected bump. The trial continues as they feel the data up until then is valuable and we won't know until it's all published and out there. I never hear R1626 being talked about anymore and it's unfortunate, as it was considered very promising. So...we orphan along in the trial and hope this is still promising and wait for the data.
This big focus on the lymphocytes is frustrating as there is not enough information and I'm seeking to understand that better.
I'm very interested as you go along, Gator, on how things go with your R1726 trial.
Trish
Trish...what week are you in and do you know your VL?
ALL...Isn't this good news? If livin is 6 wks without meds and still UND, dispite the fact that the study was abruptly ended, dosn't it look as if Roche is on to something? Or is this livins individual response to the meds?
ALL...Isn't this good news? If livin is 6 wks without meds and still UND, dispite the fact that the study was abruptly ended, dosn't it look as if Roche is on to something? Or is this livins individual response to the meds?
Hi ... I'm in a similar situation at the moment, I'm in the R1626 trial...hoping to avoid a dosage reduction. Same question to you as Magnum though .. not clear if they've already pulled your Peg or if they are talking about doing it?
Different numbers than you .. my lymphocytes are at .3 and they want them at .5 this week or they will reduce / stop my Peg. Are you sure it's your lymphocytes and not your ANC that has to come up to 1.5? I know that's where they've always wanted to keep my ANC at or they would start talking about dosage reduction again and now it's lymphocytes that they're monitoring also.
I posted a question to Dr. Dietrich in the expert column about lymphocytes and why they pose this kind of impact. He suggests, although does not advocate, that one of my options that is entirely up to me to exercise, is to drop out of the trial and go into SOC as the requirements on a trial imposed by the FDA and by the nature of the trial itself are different than what might be on SOC.
You might want to ask your doc this question ... if you weren't on the trial would they be looking to reduce your Peg with those numbers? Then you'll know if this is because trial protocols demand a stricter set of responses to the numbers. And then decide for yourself what is most important to you.
Interesting to me to know how those numbers are faring for others in the trial since the trial drug was pulled.
Please keep posting back on how it's going. I'm particularly interested as you're in the same trial as me. And...I have the same concerns at the moment.
Good luck to you.
Trish
Different numbers than you .. my lymphocytes are at .3 and they want them at .5 this week or they will reduce / stop my Peg. Are you sure it's your lymphocytes and not your ANC that has to come up to 1.5? I know that's where they've always wanted to keep my ANC at or they would start talking about dosage reduction again and now it's lymphocytes that they're monitoring also.
I posted a question to Dr. Dietrich in the expert column about lymphocytes and why they pose this kind of impact. He suggests, although does not advocate, that one of my options that is entirely up to me to exercise, is to drop out of the trial and go into SOC as the requirements on a trial imposed by the FDA and by the nature of the trial itself are different than what might be on SOC.
You might want to ask your doc this question ... if you weren't on the trial would they be looking to reduce your Peg with those numbers? Then you'll know if this is because trial protocols demand a stricter set of responses to the numbers. And then decide for yourself what is most important to you.
Interesting to me to know how those numbers are faring for others in the trial since the trial drug was pulled.
Please keep posting back on how it's going. I'm particularly interested as you're in the same trial as me. And...I have the same concerns at the moment.
Good luck to you.
Trish
The gator makes a good point; many people will rebound quickly after stopping treatment. You have not. I surely understand your worry about stopping dosing for too long.
A few positives;
You haven't experienced any viral load rebound; surely that's good.
The neuts are rising; also good but I'm sure you wish they would hurry up and top 1.5.
The people running the trial won't risk your well being in order to deliver higher efficacy.
------- I've heard about various instances where people became seriously ill from infection due to low whites. You don't want to experience that since in addition to being dangerous it too, can be a treatment ending event.
I'm glad that your results stick and hope the road smooths out soon for you.
best,
Willy
A few positives;
You haven't experienced any viral load rebound; surely that's good.
The neuts are rising; also good but I'm sure you wish they would hurry up and top 1.5.
The people running the trial won't risk your well being in order to deliver higher efficacy.
------- I've heard about various instances where people became seriously ill from infection due to low whites. You don't want to experience that since in addition to being dangerous it too, can be a treatment ending event.
I'm glad that your results stick and hope the road smooths out soon for you.
best,
Willy
I'm sorry that I can't answer your question but I am interested in seeing that you are UND...
You obviously got the study drugs and weren't in the control group....How long were you on the drugs?
And if I am reading this right...you have been off of the meds for 6 weeks? and still UND?
How long will it take for the virus to show again if it's going to?
Best of Luck to you...
Gator
You obviously got the study drugs and weren't in the control group....How long were you on the drugs?
And if I am reading this right...you have been off of the meds for 6 weeks? and still UND?
How long will it take for the virus to show again if it's going to?
Best of Luck to you...
Gator
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