are you going ti in a trial?..if u are ,ur lucky... if i made it ,so can you
make sure you eat avocoda with all pills...i did for better absorbtion
Magnum, unlike the riba the boceprevir has to be taken pretty much on time, as close to 8 hours as possible. I took mine around 7am, 3pm, and around 11pm. Give or take an hour. My HGB tanked so i was on procrit most of tx, but it also tanked on just SOC. Really for me the only sx that was worse was the diarrhea....... Over all not to bad, i missed less work this time then before......... A cirrhotic SVR here
Best to you
Zach
get extra alarm clocks and a good pill box that can hold 18 pills for one days compartment
http://image.made-in-china.com/2f0j00DvAEMfJqfIbl/Twice-A-Day-Weekly-Pill-Box-HB6218-.jpg
http://www.images.asidatabuilder.com/images/prodimgs/5520000/5528177.jpg
get a big one..this is the one i used
http://www.mangarinternational.co.uk/Images/Products/max/135_max_XL%20pill%20box.jpg
Also as you know the Ribavirin is not to be refrigerated. BUT the boceprevir must always be.
Maybe 2 pill boxes Rocker. :)
Good post, Magnum. Looking at the same thing myself and wondering if I'll be able to remain employed through the whole thing.
One of the Boceprevir studies from the recent EASL in Vienna lists serious adverse events for a "long term follow-up" period of two years as follows....
"29 of 604 (5%) patients experienced serious adverse events during long-term follow-up after boceprevir exposure
All similar to those previously described with boceprevir
Most common serious adverse events
Myocardial infarction: n = 4
Malignant hepatic neoplasm: n = 3
Cholelithiasis: n = 2
Sepsis: n = 2 "
http://www.clinicaloptions.com/Hepatitis/Conference%20Coverage/Vienna%202010/Tracks/HCV/Capsules/2016.aspx
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Four MI's and 3 liver cancers. Something is wrong with this picture.
Co
Magnum-
Taking the pills on time was not a big deal once you got into the rhythm of it. They were big blue gelatin capsules and slid down as a handful. I had a pillbox for the riba and another large one for the boceprevir. I did need to set an alarm on my cell for 2 every afternoon, but just took the morning dose along with riba when I got up and the evening dose when I went to bed. Only nuisance was that I had to put the 2:00 boceprevir dose in a pillbox and carry to work refrigerator. Boceprevir has to be kept cool like the peg shots. A committed person (which you would be) would not have trouble keeping up with it all and working.
I don't know if my post-TX issues are related to boceprevir or IFN. One serious problem was related to boceprevir but could have been prevented with a more watchful medical team overseeing TX. I had a year of diarrhea from the boceprevir (continued for 5 mos. post TX), which went unmanaged and caused serious malabsorption issues leading to bone loss, which I am correcting now. Others on boceprevir were instructed to use meds to stop the diarrhea and I don't believe they had the malabsorption problem that I did. I think I was too brain-numbed to figure it out on my own. I was very responsive to IFN and the addition of the boceprevir probably made me sicker, with low neutrophils that led to infections and had to be managed and were still well below normal even 4 weeks after meds were stopped.
Even with all that I managed to work through most of TX and and kept up fairly well with a little help from my friends. I went on leave for the last month of TX and stayed out for 4 months total. In my study, 3 out of 13 had serious hemotological side effects like continuous crashing.
The guidelines for the naive study were looking for clearance after 4 weeks of boceprevir (started at week 4). They may have allowed up to 8 weeks to become UD in the retreater's study and still be considered responsive to boceprevir. Those were guidelines for shortened TX and I don't know what timeline they were seeking for a 48 week course. Anyway, I'd think you would know if boceprevir was going to work for you by the 12 week mark (4 weeks SOC lead-in plus 8 weeks boceprevir).
Cowriter, I'm not so sure the 5% long term adverse events picture is out of line from the standard SOC adverse events picture. More data will emerge over time.
Magnum - yeah, regular timing of the pills is a pain but studies have shown constant PI pressure is crucial to avoid breakthrough. BTW why did you end up settling on Boce ? I was also waiting for it, since the rash possibility pretty much rules out Tela, but was discouraged that they just announced they're not planning to file until end of the year.
Co: agree with newleaf. Not sure about MI rates, but re HCC 3/609 is less than 0.5% whereas HCC rates among advanced fibrosis/cirrhosis are measured at 3-5% per year. They don't give the staging breakdown of the 609 patients in that summary but the numbers don't seem unexpected. BTW did you notice absence of any BMI effect on SVR ? That does seem unusual, unless BMI/IR turn out to play a far less significant role in outcome when only relying on ifn for resistance mop up.
I pretty much gave up on entering a trial, since all my efforts have gone unrewarded due to the fact the even though I've been in line for the Boce trial at Cedar-Sinai hosp. In L.A. for three years, I firmly believe they are not in a hurry to enroll null responders like me.
The political ploy for them, is to enroll naive victims so that their report to the FDA will conclude a large number of responders as opposed to non-responders still hard to clear. I could be wrong, but politics play a large part in this, especially when you consider the amount of cash a pharmaceutical company will reap worldwide when a new drug is licensed.
At any rate, I will hopefully be able to wait until next year without an unexpected acceleration of my "mildly cirrhotic" condition...
Magnum
Magster if anybody can do it you can. You have persevered when mere mortal men would have long ago given up. I have absolutely no doubt that you will hold on till the day comes when you get to post "Finally I'm SVR". No doubt at all.
If we have so much faith in you then you know...it has to be true.
I might not know much about the new trial drugs but all in all - I know that.
Deb
thanks - I know you've looked at this a lot and was wondering why you settled on Boce in the end. As best I can tell the two are near equivalent, though the final Stage III test results should pin down who wins that horse race. My main reason for avoiding Tele is the rash - I had a devil of a time with rash on the last soc/tx and comments like dointime saying she'd rather be run over by a bus than face the Tele rash again strike close to home. From current reports though, Tele was expecting to file by June and Boce not til the end of the year so there could be a 6 month or so gap between the two.
And I definitely share the frustration about lack of trials for non-naive. My pet peeve is the slowness with which Roche/Pharmasset are moving forward with r7128. Still (and it seems strange to me to keep defending the drug cos) I think the FDA, not Pharma, is the one to press for increased access. The drug companies need to (a) show the drugs are safe (b) show they work (c) make money for their shareholders (hopefully in that order). Withholding drugs (once safety checks have gotten past Phase II) from those that are likely to sustain more damage by waiting is something the FDA should be concerned about (and it seems from that upcoming hearing that they're at least thinking about this).
I totally agree about the lack of trials available to non-responders!! It's even added hard to that when you are a Telaprevir failure + a null responder. I also agree that I'd rather be run over by a bus than to go through Tele rash again. I only treated in the trial for 5 wks and yet, I got the horrific rash on week 2! I definitely knew that it was the Tele because I had no Riba in the mix. Also, I've used Riba many times and I've NEVER had that happen w/Riba in Any of my many treatments. If given the opportunity, I will take a run w/the Boce. I would also consider doing a later stage trial as long as they would actually accept me and as long as they have a rollover in the mix for those patients who don't get all the drugs of the protocol. I don't want or need to get screwed again by another messed up trial. I just wish that these companies would get on with this deal... The waiting and waiting and waiting is just ridiculous at times. I even wrote a letter to the CEO of Merck-Schering-Plough telling him that I thought that if he could show that me, being a Teleprevir failure, could clear with their drug Boce, that it would be a huge help to them in marketing.., showing that I cleared with THEIR drug and not on the Tele. I doubt I'll get anywhere, but I had nothing to lose by trying, you know?
Susan 400
You dont have to carry the BOC pills around in a cooler like the PEG,even tho it says too keep in the frigde,at least this was my advice from my nurse ,she got the news from the drug company...but its wise to store them there.,i carried my 3 oclock dose around with me in my regular bag for use at work
Wow, thanks for this information, Rocker!
That is an interesting study. It was not clear to me what range of disease stage the subjects had. There resulted 3 malignant neoplasms among the 604 subjects. Once cirrhosis is established, HCC develops at an annual rate of 1% to 4% (higher estimates in the range of 5-7% have been reported from Japan). If we take a median rate of 3% then we would expect to need100 cirrhotic subjects (6% of the 604) in the test to justify 3 occurences according to normal rates. So if more than 6% of the 604 subjects in the test were already in stage 4, we could expect 3 of them to develop HCC in the first year. It wouo\ld be interesting to see how many of the 3 neoplasm subjects were SVR or whether the were relapsers.
I haven't taken the time to find data on the prevalance of MIs or the other serious events, but whatever the prevalance is, I thouk you would have to make some sort of adjustment for the overall health of this group compared to the general population. Maybe these rates of serious adverse events are not that remarkable when these things are taken into account? The statistical results do not tell us anything about the general health or risk factors that these subjects may have had for the particular events.
I'm going to sound like a broken record about this topic between now and June 30, but I doubt it's the CEO of Merck you want to write to at this point. It's the people running that FDA hearing, docket number FDA-2010-N-0107. I'm sure Merck would be happy to sell you access if they could.
I've written and spoke to FDA people regarding the "compassionate use" of the drug for early release for those in dire straits. Forget it. They told me verbatim "We have no control over the matter. The pharmaceutical companies will have to make that decision".
And so I went into a begging mode with Merck and Schering. Forget it. Their reply basically was that they do not ever want to think of the implications of immense lawsuits should the drug prove to be fatal before the clinical trials are over. And so on we go... waiting, waiting, waiting.....
Magnum
Why I settled on Boceprevir? Well, both have side effects. Tele with the rash, and Boce with the Anemia. I for one was fortunate enough never to have had the anemia problem through four treatments (although I did drop in the blood count, but not enough to warrant Procrit ). Therefore, I selected Boce.
Also, my contact at the Cedar-Sinai trials in L.A. says they have seen a better percentage results for non-responders with Boce. The percentage was not dramatic, but add everything up and you can see why I chose Boce...
Magnum
i never neeed recuse drugs whule on BOC...but im not your average human