So this is the trial I was on for 4 weeks with a follow up of SOC to a total of 48 weeks. It was a Phase 1B trial when I enrolled (May 2008) and I have heard other people advise folks to run not just walk away from any Phase 1 trials.
I only have good things to say about the drug and the trial I was involved in. I noticed a few 'side effects' but absolutely nothing unpleasant. I had previously treated with SOC for 24 weeks with no response so I was very aware of what were side effects from SOC and what were from the study drug.
We didn't have access to rescue drugs here in NZ and I had to take a couple of Riba reductions throughout my 48 weeks which I wasn't too happy about, however I am now SVR so I guess it worked out OK. The good thing about R7128 is that it didn't seem to hasten any anemia which has been one of the side effects with Teleprevir and Boceprevir.
You have received some excellent advice here that's for sure and indeed it is good to weigh your options. For me, I had NO options as I was considered a treatment failure and enrolling in the trial was the only hope I had in the present times to beat the virus. I made my decision within 36 hours and I absolutely do not regret my decision in any way.
I'm glad I didn't have time to think too much about, I just went for it and it worked out very well for me. As far as I know, no-one else in my study had any serious adverse effects from the study drug.
The other thing that is very positive about R7128 is that so far, in human subjects, the virus has not created a resistance to the drug! This is a major difference between the protease inhibitors and the polymerase inhibitors.
In response to notes about the renal issues detected in monkeys; I too had to sign this consent and the study doctors explained it all to me. Yes this happened in monkeys however the doses given to the monkeys are vastly different (much much higher) than what is given to the humans. I was extremely well monitored for any renal dis-function and all my creatanine levels came completely normal with every safety blood draw they did. I was tested every 3 days for the duration of the time I was on the study drug after my initial 3 days in which they tested me every hour.
I would feel very comfortable in participating in this trial again (except I don't need to!). The other great thing about doing this trial is that you will get the new 'miracle' drug 7 - 10 years earlier than anyone else. 10 years of restored health is an amazingly long time and a wonderful gift!
I hope this info helps you and if there are any questions about the trial or my experience with the drug I would be most happy to try and answer them.
All the best!
Epi :)
Thanks again for responding,
I have posted the consent of the trial on google. You can read it and let me know what you think. Here is the link.
http://docs.google.com/fileview?id=0B9IWInszSBIfZDc4MTBkYTAtM2M5NS00NGExLTg2ZmItMzhiMDBmMTVhZTgy&hl=en
Tommy
You had a good doctor, Can-do. I've read alot of trial experiences here and yours does not seem to be the norm to me. However, you point out that there are exceptions and the point is to ask the questions on where the doc stands on rescue drugs, etc before starting and know as much as you can prior to starting the trial.
Trish......... On a trial, if your red or white counts drop below the levels determined ahead of time in the trial, then there is NO choice on the part of your medical team, they will need to reduce your drugs
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Thats not always true. I just finish the boceprevir trial with schering, before i started i talked to a rep there and my hepo. My doctor had the final call. My doctor got me in the trial with lower platelets then was stated. Rescue drugs was allowed and they payed for the procrit. My HGB got as low as 8 and my platelets went down to 29. Though schering sent alot of faxes about my numbers my doctor made the calls and not once did schering make me dose reduce. One needs to talk to their doctor in any trial and find out WHO makes the final call and if hes willing to go the max with you.
TeeTom, best of luck to you on what you decide, just make sure you understand as much as you can before starting.
Cando
Roche trials seem to offer rescue drugs more readily than Schering-Plough trials. Even if a trial offers rescue drugs, you still have to get your doc to agree to give them to you.
You want rescue drugs to bring up low red counts or low white counts so that dosage reductions are not necessary. On a trial, if your red or white counts drop below the levels determined ahead of time in the trial, then there is NO choice on the part of your medical team, they will need to reduce your drugs. On trials, their cutoff point is sooner than on regular treatment as trials will take less chances with adverse effects happening and will step in to dosage reduce sooner than would happen on regular treatment. Rescue drugs help to be pro-active about that and help to avoid or mitigate that.
I would talk to your primary care physician on this trial and see what his/her attitude is about rescue drugs, find out if the trial permits it and if they're prepared to use them to avoid dosage reductions, particularly in the first 12 weeks and I'd say the first 24 weeks. All the way through is best but I'm saying particular attention to 1 through 12 weeks primarily and critically and on to 24 primarily.
Will the insurance company cover the rescue drugs? Trials will allow for rescue drugs but not all trials pay for rescue drugs - mine allowed them but didn't pay for them. So I'd ask your doc that too, who pays for the rescue drugs if the trial allows them.
If you go ahead with the trial, will they tell you your results at the test intervals? If not, you might want to get tested privately at 4 weeks and 12 weeks and I'd do 4, 8 and 12 if your insurance company will do it. If you're clear at 4 weeks, then you know your odds have just jumped up around that 75 - 80% chance of success rate.
If you're doing dismally at key points, you can drop off the trial. I don't advocate that for everybody but you're further along in your progression. I feel that people have a moral obligation to stick with a trial but docs also know that those with advanced progression of disease are going on a trial to fight for their life with greater urgency than someone like me who went on a trial at Stage 1, Grade 1.
If any of that is confusing, please just ask.
Phase III trials are better in your situation than a Phase II trial but the timing isn't always our timing, is it.
Sorry to hear you have to deal with such trouble, but sounds like you've got focus and a good clear view. Better though that you got this info sooner rather than later.
Lots of pros and cons to weigh, for sure.
When trial results are coming in at 88% undetected in 4 weeks for a geno 1s, it is certainly very encouraging. My husband is geno 1 on SOC plus Alinia, but he's doing it outside of a trial. His doc didn't think as Stage 4 with previous hcc he would be a good candidate for trial, but as a stage 3, you still have options. It took my husband 13 weeks to get to undetected, so he's doing a course of 72 weeks.
However, he's been able to somewhat call the shots (so to say) -- he doesn' t HAVE to have office visits at set intervals, and he's allowed rescue drugs (without which he probably would not have been able to continue ). He could have tried going thru the VA, but we found it more convenient and less red tape to just go thru insurance. But, even with excellent coverage, it's hundreds of dollars a month between the injections and rescue drugs.
Hope that input helps, and best wishes, whatever your decision. ~eureka