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FDA considers

FDA considers expanded use of HCV drugs

http://www.medpagetoday.com/InfectiousDisease/Hepatitis/19858
25 Responses
Avatar universal
Thanks for finding this link.  I have been anxiously wating to read the results of the hearing.  I'm Hopeful, but  worry that the time short.
897070 tn?1320656229
Thanks for the post mate, we live in hope
Avatar universal
"pegylated interferon alfa-2a and ribavirin (Rebetol) -- is highly toxic with a response rate of about 50%, clinical data show. That number is much lower in real-world cases, according to a number of physicians who testified during the public hearing."

I have always contended that response rates are lower despite the many posts we see stating a 50% chance or greater of SVR with the current SOC.  It's not a matter of presenting just positives as in seeing the glass half full instead of half empty; it's a matter of solid facts.  The response rate with SOC is less than 50% under the best of circumstances and those numbers go down with age, how long you've had the virus, degree of liver damage, existing medical problems and so on.  

We need these protease inhibitors NOW.  Who wants to have to treat with SOC multiple times to no avail.  At least with the PI's we stand a greater chance of attaining an SVR.  Yes, there will still be failures and those who fail will develop resistances to the drug but at least the success numbers will increase dramatically.

The number of HCV infections increase everyday.  Roughly 400 million with HCV and
32 million with HIV worldwide yet we can't get the drugs we need now?  If it's because we can live with HCV for years before it takes its toll that's about to come to an end.
The baby boomers make up the largest percentage of those infected with HCV (at least in this country) and maybe our train has moved very slowly down the track for years and years but soon that HCV train will be at the end of the track for many of us and once it pulls into the station we all know what happens next.

Trin
148588 tn?1465782409
The question I have is:
How does FDA approved 'compassionate use' differ from single patient 'compassionate use'?
As you can see from Magnum's efforts to get 'single patient' last year

http://www.medhelp.org/posts/Hepatitis-C/Compassionate-Use-for-VX-950-more-complicated/show/797902

the stumbling block was not the FDA, but rather the fact that Vertex was not allowed to charge for meds used under this exemption. Thus for every 'c u', they lost a paying customer. Hence, tons of red tape and no actual exemptions ever granted.
Would FDA approved 'c u' allow them to charge and, if so, how would they set price? Would there be grants or other funding involved?
It sounds as if, by the time all these hoops are jumped through, the drug will be approved anyway.
Avatar universal
the FDA is still reeling from the thalidomide debacle in the 50's.  But the science should be better now, do not always understand why it still takes so long - except that companies often fudge their numbers on side effects, etc.
148588 tn?1465782409
Everyone FDA, doctors, and drug companies are going to be cautious after what happened with the protease inhibitor BILN 2061. My understanding is, that it showed even fewer overt side effects than tele' and was already into phase III human testing when it was suddenly yanked and all trials stopped due to cardio toxicity that showed up in primate testing. If the pharmas are allowed to charge for meds that haven't been fully tested, it opens up a boatload of liability issues. If they give them away on a large scale, they lose the incentive ($) for expending the millions it cost to develop them in the first place. It's a fine line.
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