Hepatitis C Support Group
Hepatitis C is a blood-borne viral disease which can cause liver inflammation, fibrosis, cirrhosis and liver cancer. The hepatitis C virus (HCV) is spread by blood-to-blood contact with an infected person's blood. Many people with HCV infection have no symptoms and are unaware of the need to seek treatment. Hepatitis C infects an estimated 150-200 million people worldwide.
Does "pan-genotypic" mean it will work on ALL genotypes of the disease???
Your Doctor is the one who applies for expanded access so it can be done without you moving to Houston...
There's also Compassionate Access which will do the same or better... There are plenty of links I posted that take you to both of these programs on the FDA website...
You ought to take another look @ these two programs again and then go over them including the website of the FDA with your Doctor because you may just be the perfect candidate and you don't have to MOVE!!! Go for it Marilyn!!!
Respectfully,
Henry
" Here you go Sweetie!
Now I got to warn you that there's a whole lot of reading and quite a few links but, I think you'll agree that they're all useful and helpful for you and other folks in similar predicaments to our own dilemma's.
First off. I'm not challenging you when I ask this question okay?
So, why don't you ask your Doctor about getting you on a compassionate expanded access program that some of these companies testing are now offering as the FDA approves some of these new drugs for limited treatment scenario's??? Have you read about this?
I did post in another thread earlier today or last night that I would post some info on these programs when I find it so, here's some information for you and your Doctor to go over and see if you may be eligible...
http://www.fda.gov/ForConsumers/Con...
http://www.fda.gov/ForConsumers/ByA...
http://www.fda.gov/Drugs/Developmen...
http://www.fda.gov/Drugs/Developmen...
http://www.fda.gov/ForConsumers/ByA...
A study of TMC435 in combination with GS7977 fr Genotype 1, prior null responders to SOC, treatment naive patients also for Genotype 1 only!
http://www.clinicaltrials.gov/ct2/s...
Here are the study locations:
http://www.clinicaltrials.gov/ct2/s...
Here's a very informative article on EAP's - Expanded Access Programs. Discussing their pro & cons as well as some more technical info of how they really work and even though the article is based on HIV drugs, the same rules apply for HCV studies also.
http://www.thebody.com/content/art1...
This is a link to a set of Congressional testimony for:
Availability of Investigational Drugs for Compassionate Use
http://www.fda.gov/NewsEvents/Testi...
I know, I know! It's a very long testimony but, this is how you find out the true pulse of how these programs are working and what many circles in pharma research think about these studies...
And I know that some folks in here could & would appreciate it.
So enjoy the read and I hope this post helps you out Catmagic and also to anyone else who's close to or already are at their wits end to think about what direction you all will eventually travel through in our long journey & shore up hope to become SVR for good! I'll keep posting anything new when I find it.
Respectfully,
Henry " "
Here's another link:
http://www.fda.gov/NewsEvents/Testimony/ucm115209.htm
This is one your Doctor will be interested in:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm107434.htm
And this one also:
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm163982.htm
Here are some more links:
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/ucm176098.htm
Check out these .pdf's:
http://www.fda.gov/downloads/Training/CDRHLearn/UCM180888.pdf
Bottom line is that you need to read up on this Marilyn and go over this with your Doctor.
Respectfully,
Henry
So, use only the links that are working!
Respectfully,
Henry
Henry
Marilyn, hang in there. Hugs for you today dear!.. :)
http://www.dailystrength.org/c/Hepatitis_C/forum/15692044-how-many-have-been/page-2
In this post all of the links work... Scroll down to Reply # 15 and you will find all of the links for you to read over with your Doctors Marilyn.
Respectfully,
Henry
Under the exclusions, it says "Has a history of malignancy with 5 years of the screening visit".
I went down the whole list of the studies that are recruiting, and that's the only one I saw that hopefully would apply to me. There may be more, but that's the only one I saw. And of course since I have had a cancerous tumor in my liver only 3 1/2 years ago, until I had the transplant, looks like that excludes me.
I'm going to send an email to my doctor's office reminding them that I am interested in getting into a trial, by Expanded Access or Compassionate Use, if necessary. I told him on my visit in January that I would like to get into a trial. I have an appointment with my doctor in June, so I'm not going to make a sooner appointment, because I would like to get my 3-year annual testing done and a new biopsy first. My doctor IS up on the trials.
Thank you so much for your help. Marilyn