Aa
Relapsed, from R1626, what now?
Hello, about 5 weeks ago I finished a trial with Roche's R1626, it was the Peg .75 per week Ribavarin 100mg a day plus the polymerase 1000 mg a day. I am 1A UND by week 8 and continued until I was pulled from the trial 5 weeks early because my WBC had become dangerously low and any further treatment could have caused a serious infection (lymphocytes so low it tested my CD4/CD4 and it was 173 anything under 200 is supposed to be bad. So my tx was from Feb 1st 08 until Nov 26th. In December I was UND, then Jan 3nd blood draw showed a viral load of 4M.
To get to my question, is there a another option for me? I am devastated, though I was doing so well, now I don't know. The trial medicine lowered many peoples lymphocytes which was pulled 12 weeks early and is still affecting many of us 6 months later. I would appreciate any advice information suggestions, etc. When I had my biopsy last year the lab said I was transitioning to cirrhosis so I am very afraid. Thank you Dee
To get to my question, is there a another option for me? I am devastated, though I was doing so well, now I don't know. The trial medicine lowered many peoples lymphocytes which was pulled 12 weeks early and is still affecting many of us 6 months later. I would appreciate any advice information suggestions, etc. When I had my biopsy last year the lab said I was transitioning to cirrhosis so I am very afraid. Thank you Dee
God Bless all of you, this was my first time posting, yes this is the first time I treated and I wonder if I had been able to take 100% of the Peg and not been pulled 5 weeks early if I might have SVR'd. I was UND at 8 weeks but the trial part (Polymerase inhibitor really hit my immune system hard) I started having weird symptoms about week 4 after stopping on Thanksgiving. I have been graded at 4 for cirrhosis but have been told I am in the very early stage, i.e. lab report said probable transition to cirrhosis, which confused me and the doctor so he called to double check to see if I was really a 3 but the lab said they had seen something that indicated cirrhosis. I appreciate everyone's support so much! I meet with the doctor on Wednesday to go over my options however as Trish said I may go with another doctor who is not going to have me on a trial so that they can give me some help with the sx.
Thank you again, you all have really helped me so much any advice is much appreciated. I am writing a list of questions now for the doctor and if you don't mind I will let you know what happens
Dee
Thank you again, you all have really helped me so much any advice is much appreciated. I am writing a list of questions now for the doctor and if you don't mind I will let you know what happens
Dee
Hi Dee,
I was on the same trial and was pulled as well. My nurse talked about my options, as I was told my chance of SVR was slim. I go in for a pcr on Jan 22, like Trish. If I relapse, I'm told, the drug company will cover another 48 wks of tx., after my body has a 6 month recouping period.I don't know how long I have to decide on retreatment, should I relapse. At 4 wks post I was still UND. At this point, I don't want to think that far ahead, or make any decisions. One day at a time. I'm so sorry you've relapsed, you must be devastated. Good luck to you, I hope my answer was of some help.
I was on the same trial and was pulled as well. My nurse talked about my options, as I was told my chance of SVR was slim. I go in for a pcr on Jan 22, like Trish. If I relapse, I'm told, the drug company will cover another 48 wks of tx., after my body has a 6 month recouping period.I don't know how long I have to decide on retreatment, should I relapse. At 4 wks post I was still UND. At this point, I don't want to think that far ahead, or make any decisions. One day at a time. I'm so sorry you've relapsed, you must be devastated. Good luck to you, I hope my answer was of some help.
I´m so very sorry to hear that, Im just on my way to hospital check my post 4week blood if alat has gone up they give me a pcr other vise just check me again week 12.
I have relapsed once I´m gonna tell the nurse to send the answer by letter because I dont wanna hear any bad news over the phone again, already have a trauma from first time!!
God Bless, try to just wait and heal dont make any hasty decisions I think the docs in the study has a responsibility towards you to help you with options.
ca
I have relapsed once I´m gonna tell the nurse to send the answer by letter because I dont wanna hear any bad news over the phone again, already have a trauma from first time!!
God Bless, try to just wait and heal dont make any hasty decisions I think the docs in the study has a responsibility towards you to help you with options.
ca
Hi Dee .... I'm so sorry that you've relapsed. I was in the R1626 trial too and was pulled at 34 weeks, 14 weeks early. I was still UND too 4 weeks post and will go for my 12 week post PCR on Jan. 22nd. I'm still getting my blood tests and go again for my CD4 and CBC tomorrow .. still have a low count though was taken off antibiotics finally just before Christmas. However...my immune system IS recovering and I expect that to continue and I will believe the same for you.
Alternatives.....is this the first time you've treated? The trial we were in provides us with SOC treatment for free for 48 weeks. What I don't know is if they have any conditions on it. If I relapse, I'll be looking to do treatment again at some point but more aggressively next time around as in going 72 weeks and higher doses..or wait for the boceprevir or telaprevir results to come along and see about new drugs. The difference between you and I is that I have the luxury of more time, being Stage 1. From the sounds of it, your situation is more severe than mine.
We were in a trial where our dosages were not normal treatment and we were in a Phase II trial with a drug that didn't treat our immune systems very well and some of us had dosage reductions and then pulled from treatment... situations that wouldn't have happened under regular treatment but that occurred because of the specific nature of that trial. People get pulled from treatment under SOC for adverse events...however that R1626 drug was hard on the immune system and alot of us took a hit there that we wouldn't have on SOC. That is my personal view of that.
If you have a good hepatologist that you trust, ask what your treatment options are and ask questions about the 48 weeks of SOC that Roche provides for those who don't SVR on the trial and what, if any, restrictions they put on that. I know the last thing I want if I have to retreat, is to have my options decided for me the 2nd time around and I'd rather go without the free drugs if the restrictions are too risky. Perhaps consider getting a second opinion as well about your treatment options. Perhaps even go for another liver biopsy after the trial to see if the drugs have made improvement ... it happens.
There are other trials coming along but I don't know how soon and if you'll qualify and if that will happen in a timely fashion for you. Personally ... I'd go for the aggressive SOC...perhaps others will chime in and round out the options here from other points of view.
There are others here who have treated more than once and perhaps they'll chime in also.
Best of luck, Dee ... I'll keep the hope up for you.
Trish
Alternatives.....is this the first time you've treated? The trial we were in provides us with SOC treatment for free for 48 weeks. What I don't know is if they have any conditions on it. If I relapse, I'll be looking to do treatment again at some point but more aggressively next time around as in going 72 weeks and higher doses..or wait for the boceprevir or telaprevir results to come along and see about new drugs. The difference between you and I is that I have the luxury of more time, being Stage 1. From the sounds of it, your situation is more severe than mine.
We were in a trial where our dosages were not normal treatment and we were in a Phase II trial with a drug that didn't treat our immune systems very well and some of us had dosage reductions and then pulled from treatment... situations that wouldn't have happened under regular treatment but that occurred because of the specific nature of that trial. People get pulled from treatment under SOC for adverse events...however that R1626 drug was hard on the immune system and alot of us took a hit there that we wouldn't have on SOC. That is my personal view of that.
If you have a good hepatologist that you trust, ask what your treatment options are and ask questions about the 48 weeks of SOC that Roche provides for those who don't SVR on the trial and what, if any, restrictions they put on that. I know the last thing I want if I have to retreat, is to have my options decided for me the 2nd time around and I'd rather go without the free drugs if the restrictions are too risky. Perhaps consider getting a second opinion as well about your treatment options. Perhaps even go for another liver biopsy after the trial to see if the drugs have made improvement ... it happens.
There are other trials coming along but I don't know how soon and if you'll qualify and if that will happen in a timely fashion for you. Personally ... I'd go for the aggressive SOC...perhaps others will chime in and round out the options here from other points of view.
There are others here who have treated more than once and perhaps they'll chime in also.
Best of luck, Dee ... I'll keep the hope up for you.
Trish
I believe there are at least a couple of people here who were recently on the Roche 1626 trial, although there are different arms. And two were pulled early, like you. I remember CD4 came up as a topic.
I'm sure there are other options. There are people here who have treated many times before reaching SVR. I think Andiamo treated eleven times and is now cured of the virus. Transitioning to cirrhosis sounds scary but there are many gradations within cirrhosis itself. Are you a stage 3-4?
Right now, I'd be devastated like you. You pinned your hopes on SVR. You are far, far from alone, given that 1A's have about a 50% SVR rate.
Believe me, there'll be another day to re-group and sort out your options.
Today, though, I'd just like to say how sorry I am that you relapsed and send you my reassurance that things will look brighter after you recover from the shock.
I'm sure there are other options. There are people here who have treated many times before reaching SVR. I think Andiamo treated eleven times and is now cured of the virus. Transitioning to cirrhosis sounds scary but there are many gradations within cirrhosis itself. Are you a stage 3-4?
Right now, I'd be devastated like you. You pinned your hopes on SVR. You are far, far from alone, given that 1A's have about a 50% SVR rate.
Believe me, there'll be another day to re-group and sort out your options.
Today, though, I'd just like to say how sorry I am that you relapsed and send you my reassurance that things will look brighter after you recover from the shock.
So sorry to hear of your unfortunate situation. Have you checked back with the trial center to see if they have any idea what you should do next? Does being on R1626 keep you from going on any other trial? I would think that Roche would at least be able to break you off a free set of Peg and Riba to treat again. I would write them a letter, if you can't get any assistance from the trial center. God Bless
Have an Answer?
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
