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complete 12 weeks of PI

Hi it's Diane04. I finished 12 weeks of roche PI. Und between 4-6 weeks and RVR. I have not had much SX except fatigue. what I wanted to know it now that i am on SOC will I be a little better off than with the TRIO? From what i can tell i am on arm d which is 12 weeks trio and 36 SOC. I am considering stopping all the drugs at 24 weeks. I don't feel it is necessary as arm A is identical to D with the exception of time 24/48. I know I got study drug based on what the nurse told me. I  was given the trio and 1 day later they tested VL and again  a week later and every 2 weeks since. Today is 12 week UND. Has anyone heard any information about the R7128 as the paperwork says they will report on effectiveness after 8 and 12 weeks are complete. Also whats the odds of relapse is I quit at 24 weeks. Roscoe seems to think it will be fine. Oh yea he's starting in a different study soon, we will keep you posted. thanks Diane04 and Roscoe (at odds)
17 Responses
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577132 tn?1314266526
Well my trial was sponsored by Roche and Pharmasset so I can't speak for the Schering study.  The only information I got was that I had gotten the actual study drug rather than placebo, as evidenced by my excellent results.  I found that unless you really ask for results do they give them to you and I also found, after I studied the presentation on my study, that what they are looking for is not what we think it is.  It all depends on the reason for the trial.  Mine was to study safety and pharmacokinetics of the drug in a human subject.  It was interesting to see what information was presented at the conference.

You could find out if your data has already been presented by going to the website of the sponsoring company and see what they are/have posted at prior or upcoming conferences.  I only found my info by that method, it wasn't proffered to me.

It was pretty cool to see the presented study and it felt really good to know that I had contributed to the fight against HCV, not just for me but for others!
Helpful - 0
717272 tn?1277590780
I think the question is whether Diane cleared in 4-6 weeks from Day 1 or 4-6 weeks from the day they started the PI.  Some of the investigating drug companies do a lead-in with SOC for the first 4 weeks before starting the PI.  The other question is what are the investigators looking for to declare an early response and place the patients in a response guided category.  

I was in the boceprevir trial but randomized out early.  I can well imagine that Great Bird felt a great deal better after dropping the boceprevir and returning to just the peg/riba standard of care.  In the informed consent paperwork it tells the potential side effects of the 3 drugs.  Safetywise, it said that IFN lowers neutrophils and platelets, ribivirin lowers hemoglobin and the boceprevir lowers both neutrophils AND hemoglobin.  Getting off the boceprevir should make hemoglobin go up and make you feel a lot better.  Diane, look at the side effects in your informed consent and that should give you a good indication of what should improve after the PI is dropped from the dosing.

Epi, in the unblinding, will we learn only which arm we were in or will there be more information?   I participated in the Schering side study that took DNA samples to see if  the patient's genetics affected their cure.  I'd like to think that my little tablespoon of blood taken in November contributed to the genetics information released in August about genetic response to interferon.
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577132 tn?1314266526
Btw, I was also on a R7128 (phase 1b) and my results were already presented at the 2008 San Fransisco AADLS Conference while I was still on the SOC.  We are just numbers, ratios, percentages, and statistics and we will will never actually know our specific results unless you request copies of everything once the trial in unblinded.

Epi
Helpful - 0
577132 tn?1314266526
I would also encourage you to go the full 48, hit it hard and hopefully only the once.  

I'm waiting for my 24 week post tx result and I can tell you that I am so glad that I fought to stay on for 48 weeks despite having an RVR at 4 weeks as I KNOW I did everything I could to beat the beast.  48 weeks certainly wasn't easy and I also had the major fatigue that you speak of, however I believe it was worth going through if the outcome is that I reach SVR.

If you really think this is about you first (which I don't disagree with) then I would say fight on, my friend.

As for the obligation to the trial, as far as I understand it, your obligation ended when they stopped giving you the study drug as they were testing the efficacy and pharmacokinetics of the new drug, not the already established and approved drugs.  They give you the SOC drugs as a 'thank you' for testing out their unknown drug.

Ultimately they only care about whether the new drug worked, which in your case it did, by allowing you to achieve UND between 4 & 6 weeks (which is not RVR as Marcia pointed out) so you are already a successful statistic.  Unless your trial specifically states they are studying the long term results of people who achieve RVR or EVR via the new drug and then go on to achieve SVR with SOC then you are free of your commitments to the trial.

Therefore, it's your choice to continue on with SOC or not. But it would seem a great waste for yourself if you were to pull out early.  No-one else is going to give you this chance again, or all those free, extremely expensive drugs...

Short term or long term thinking is at question here, and as others have pointed you have not fulfilled all the requirements that would suggest a 24 week treatment would be a good choice for you.
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338734 tn?1377160168
Don't take the chance on relapse. Finish the trial and the HCV. It may be not only the right thing to do, but the smart thing as well.
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179856 tn?1333547362
Please someone correct me, if I am wrong on this.

No Marcia you are correct as far as I read it myself.

Roscoe - just about everyone in here has experienced the lethargy and fatigue in the same manner....it totally ***** but if you want to make sure you do get SVR you gotta do what you gotta do. Lots of  folks have suffered through and made it out the other side, it's a fair tradeoff in the end.

Helpful - 0
971268 tn?1253200799
Thanks, that's interesting.  My husband has no bad taste going on (that seems to be just with Boceprevir, as far as I've read), but I'll be curious to see if he experiences any changes in week 13.  We have no way of knowing what arm he's on, of course, so it's all going to be a guessing game.  

Glad you are feeling better now on SOC!
Helpful - 0
476246 tn?1418870914
verify....

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476246 tn?1418870914
I just reread your original post and wanted to veryfy if you were RVR or not, as you stated that you went UND between week 4 and 6.  That would actually be EVR, as RVR is UND by week 4.

In the case that you were not RVR, but were EVR, I would in no way consider stopping at 24 weeks... you would jeopardize the outcome of your tx, even though you were on triple therapy.

Please someone correct me, if I am wrong on this.
Helpful - 0
9648 tn?1290091207
I am still on the Boceprevir trial til mid November.  I have to say that my tx journey has been pretty individual, so I don't know if you can gauge anything according to my experience, but here goes.

I was really lucky that my husband took care of EVERYTHING while I was on triple therapy because I could do almost nothing. All I had to do was be compliant on my meds and keep up with the finances (which I made a mess of, oh well).

I knew within two days that I'd been randomized off the PI at week 28. The biggest change was that I no longer had the awful taste from the Boceprevir and the dinosaur burps from hell. Within the next couple of weeks I noticed myself perking up. It's like I had been behind some layer of gauze or part of me had been sleeping. I was sharper. My brain was working better. And (here's one I haven't heard from anyone else) my creativity was back. That's huge for me.

Other improvements after losing the PI: my digestion was much better, my energy was much better, my anemia was better (still borderline but no longer taking Procrit--which I did not react well to).  My focus came back, but not all the way. Still, I could even knit and start to think through problems. I could make decisions.

I was feeling so much better so quickly that I stopped being bummed I wasn't randomized off the trial at week 28.
Helpful - 0
412873 tn?1329174455
Agreeing with GreatBird....you may be surprised how much better (relatively speaking) you feel being on SOC as opposed to triple therapy. Take it a day at a time.

Agreeing with Marcia, too.  You only want to do this once. Hang in as long as you can.

What was your VL when you started? That, as well as when you cleared will play a part in your success rate, I think

I was in a trial also.  And while we all recognize the importance of our commitments ...I'm agreeing with you on this point....our health is the most important thing in the long run. I completed my full 48 weeks, but had a back-up plan in place outside of the trial in case things headed south on me.  

I wish you luck.

Take Care,

Isobella

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971268 tn?1253200799
Hi GreatBird -- you were on the Boceprevir trial, right?  May I ask you what symptoms you had that got better or went away after you reverted from triple therapy to SOC?

My husband has just finished his 8th week of a trial in which he has an 80% chance of being on triple therapy.  Half of the people on triple therapy will end the trial drug at 12 weeks, so we're wondering if there might be any changes coming up then.

Diane, I'm curious what makes you think you're on the 48 week arm? I don't have any advice for you, but I totally understand your wanting to do a shorter tx.  That was a major part of the reason my husband decided on this trial -- the 80% who get the trial drug will get to stop at 24.... unless, I guess, the higher-ups deem it necessary to go on.  Good luck to you whatever you do.
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9648 tn?1290091207
I've been on a trial and found it MUCH easier once I got re-randomized into taking just the SOC with a placebo at week 28.

One thing I've discovered is that it's hard to project how things will be down the road. Any guesses I had at week 20 about how I'd be feeling at week 40 were very wrong. I felt MUCH better at week 40. Of course, that's just me, but my point is take it a week at a time. If and when it gets to the point that you can't take it any more then you deal with that.

Since you are in a study, no one's going to know what your odds of relapsing are. The study is what establishes those odds.

Good luck and hang in there.
Helpful - 0
476246 tn?1418870914
I don't know if this is of any help to you.

I was in bed all the way through treatment. Sometimes I couldn't even turn in my bed. I would stare at the ceiling for hours. I had to sit on the floor in the shower, as I often couldn't stand up or would collapse. etc, etc.... I can count how many times I actually went out of my home. Couldn't even wash the dishes.

The thing which helped me through was my attitude. I wanted to get rid of the virus and I didn't want to have to do it again. So I was prepared and willing to suffer through this, no matter how hard it would become. My hgb was always hovering just above procrit time and my blood pressure was very low. I was supposed to treat 24 weeks, but ended up doing 32, as I didn't clear by 4 weeks. I actually fought for an extension, even though I was debilitated. It was better to suffer at the time, than having to treat again and the next time double time.

Why give up now and risk having to do it all over again? I'm just trying to cheer you on and help give you some strength to continue.



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Avatar universal
I just wanted to say that I understand my obligation to the study as far as completing tx. However, my first obligation is to myself. I find it disturbing that some folks here are just all about that. I have experienced little sx except fatigue and it is awful. I didn't want to go there in case someone else is basing starting  tx on these posts. My fatigue is almost dabilitating at times, I hold myself up at the counter to load the dishwasher, i cant hardly breathe at times or make it up 5 steps. Sorry to say I don't know how much longer I want to go through this. Doc says I am right at the level of anemia however sees no need to treat. I just know that before I started meds I was not sick and felt great like a 25 year old now I feel 50.  All i wanted to know since I cant see blood work is how long should I take the meds to have a better chance of svr in the event I do quit. Roscoe is really trying to help but he is biased to what I want and I am not sure hes looking at the big picture. thanks anyway,  Diane04
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179856 tn?1333547362
Well I do agree with HCA in that the only reason that you should drop out of the arm of a trial would be because you absolutely had to.  The drug company spent a lot of money on the meds that you took with the understanding that in return you will repay them with your data.

If you relapse after taking a PI there is no other shot out there right now for you.  Once you've taken one I don't believe you will be allowed into another trial.  So if you do relapse you are really going to be up the creek.  If for some reason they are indeed not as effective after you have taken them before.......what will your course of action be?

Best to finish - be of value to the company that spent so much  money on the meds for you and be cured.  Otherwise it's all a waste.
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Avatar universal
HCA
Legally you can quit when you want.
There is a moral imperative insofar as you have accepted a course of expensive drugs in exchange for helping the drug company company and in turn other Hep C sufferers compare the comparitive efficiency of different treatment protocols.
If everyone quit when they felt like it the trials would collapse.
The only bona fide reason for quitting is because of clinical issues.
I am in a similar position doing 48 weeks of a telaprevir trial-currently on week 37.
I had mentioned that I felt I had done enough but the trial controller was not happy.
I am going to try to get to the finish line for this reason and also to maximise my chances.
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