Pills, pills, pills

[Magnum]

On my next (5th) attempt in 2011, I will try Boceprevir. I also understand that it requires 12 pills per day, along with the previous 6 pills of Ribavirin and once weekly Pegasys.

I would appreciate knowing from those who have undergone this torture, relaying to me the chances of leading a normal life under this bombardment.

I say that, because I need to work, but I also need to cure. All help in knowing the expected scenario is greatly appreciated. By the way, I would like to hear from those who incrementally felt whatever side effects they felt throughout the 24 weeks or longer under this regiment... Thanks....

Magnum

[jim969]

I hope that all realize, who are hep c positive, that it may be that a change of diet, for instance a stay in someplace like the St. Helena Health Center may, (I say may) be a better route for some. It may even be less expensive than the Pegasys prescription. I've been treated in 2006, and the virus was cleared, but now and during the years perhaps starting in 2006 and continuing to the present, I've got a cognitive impairment. I'm not sure, but I think there is a strong possibility that the treatment for the hepatitis C did this to me. So, I can't go back and try and file a lawsuit against Genentech, since I signed the waiver, but I'm now without a job, since I quit in a panic. A panic or upset that wouldn't have been there before my cognitive troubles started. My doctor who treated me seems to be avoiding the idea of the possibility that the drugs he prescribed for my disease could have caused the cognitive impairment. I'm nearly sure it did and I have had a lot of experience with drugs and therapy and pretty well have experienced the mental ins and outs. I'm just saying, if you can afford it, the medications can be quite rough. It is my belief that my ears itching like crazy is because of Pegasys and also I have a lousy bunch of recurring sores that won't heal on my legs that remind me of the injection site blues, so if you've got the money. Try Dr. McDougall's St. Helena health center if you think you can hack a vegan diet for six months or maybe a bit more. It might be better than the Pegasys. It could improve your body's ability to naturally clear the disease and that's what you want, but they might not be routinely advising patients of this fact and it is a big business of course.

[IAmTheWalrus]

Yes! I am surprised you could even read my post. Also, my "1" key must be stuck :-)

I re-read it just now and ... well I guess my fingers can't keep up with my thoughts or something.  Sorry for all the typos, etc.

Brent

[Rockerforlife]

sorry bout the typing,in a hurry,im cookn my dinner

[Rockerforlife]

I never die carry my blue bombers in a cooler,i was really concerned at first,but like i said,my nurse said it was totally,ut was only one dose and it was onlt out of the fridge for 9 hours,but ya dont want to leave them out for days or weeks.

[can-do-man]

Thats odd about not needing to keep the boceprevir in a cooler, my doctor who is the lead investigator for the trial made it a point that it was not wise to leave a dose out for more then a couple hours and for sure not eight hours. I remember you saying when you was still working you carried them with you with one of those ice packs.

[willing]

Magnum : seems a good choice on the Boce  - hope all goes well with this plan - it's time!. Re the FDA, the upcoming hearing isn't focused on 'compassionate use' which I understand is a very difficult standard to meet. From their description, it sounds as if what they're looking for is a way to address two basic problems looming ahead if nothing changes over the next 3-5 years (a) no one has, and no one will, benefit from the drug combination most likely to deliver a cure (boce or tela/r7128/soc/ntz). (b) a lot of NRs will develop resistance to NS3 PIs because they can't wait and  these will be the 1st approved.

Walrus: no argument with your main point but I think you meant 100/604 is 16%. Also it's not just cirrhotics who are at increased risk:

"The average annual risk of HCC in patients with cirrhosis from HCV is 3.2% (13). The annual risk in Japan is approximately 6% to 7% (14). Among patients without cirrhosis, the annual risk increases as the stage of fibrosis increases (F0 or F1 [none or minimal portal fibrosis] = 0; F2 [periportal fibrosis] = 1.5%; F3 [bridging fibrosis] = 5.1%) (15)"
from
http://www.ncbi.nlm.nih.gov/pubmed/18628926

[annieCinMD]

That Bocep sounds like it's the bomb as far as getting folks to SVR. I'm pulling for you. You can do it!

[Rockerforlife]

i never neeed recuse drugs whule on BOC...but im not your average human

[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

[Magnum]

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

[willing]

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.

[IAmTheWalrus]

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.

[Rockerforlife]

No problems

[Gee704]

Wow, thanks for this information, Rocker!

[Rockerforlife]

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

[susan400]

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

[willing]

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).

[nygirl7]

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

[Magnum]

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

[willing]

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.

[newleaf09]

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.

[CoWriter]

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
------------

Four MI's and 3 liver cancers.  Something is wrong with this picture.

Co

[IAmTheWalrus]

Good post, Magnum. Looking at the same thing myself and wondering if I'll be able to remain employed through the whole thing.

[can-do-man]

Also as you know the Ribavirin is not to be refrigerated. BUT the boceprevir must always be.

Maybe 2 pill boxes Rocker. :)