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

[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.