Oh my goodness. That list and those odds are the very best possible massaging of the facts that could be done - it is a one-sided story subject to little or no cross-exaomination prepared by doctors who are richly rewarded by the pharmaceutical companies.
It contains no objective data from follow-up in say, two years or so after cessation of treatment. In fact, it may contain no objective data at all.
The FDA very recently issued rules requiring that the authors of all studies, journal articles, etc. start stating who paid them to do the research. There's a reason for those rules.
I am really sorry everyone. The BMS/PSI extension study is for GT 1a naives and GT 1a triple relapsers only as far as I know. Keep checking the clinicaltrials.gov web site for updated info. and for other similar studies using the PSI 7977. I think there is another with PSI 7977 and Tibotec 435 for all GT 1. There ought to be something for GT 2 and 3 since these are the easier to treat groups.
I finished the dosing part of the trial on Dec 18.. The ONLY side effect I had was MILD fatigue. I walked almost everyday anywhere from 2-10 miles. Mostly I pooped out earlier in the evening. For me it was no big deal at all..Almost not worth mentioning. Good luck getting in to the trial.
What else besides the PSI-7977 is given? It's not a a standalone right? Since the sx are minimal what is the combination of drugs taken? Obviously, none of interferons?
millie
It's sounding better all the time for PSI-7977! I'm going for a FibroScan around April when my hospital gets the machine and will talk to my consultant about it then. Yes, I've already been to your page and am going through the journals and posts there, which I'm finding very interesting and helpful. I also like your photo.
I just heard from someone who completed dosing on my trial maybe a week ago who thought they had no side effects during the trial but found quite a bit more energy after dosing was over. The fatique may be somewhat low level, periodic and persistent while dosing. I have been writing a lot about trials, 7977, personal reflections, interesting relevant sites etc. in my journals which you can look at by going to my page.
I've had a look through quite a few of the posts for PSI-7977 but couldn't find any experiences of side effects, so thank you for your post - heartburn is horrible, so I hope you begin to feel better soon. I'm 61, female, and must have had the virus (geno 2b) for over 30 years. I only found out a few years ago and because so far everything seems OK and has been within normal ranges etc, I decided to wait for a less vicious treatment. Fingers crossed this drug may be it. I'm in England and have either missed or can't find any trials.
Did you get your question answered about PSI 7977? Most of us have had very little in the way of side effects mostly mild fatigue and gastro complaints at the beginning. I still feel tired from time to time and heartburn but I am not inclined to think it is from the study drugs since I take other meds and have other conditions.
Thanks also to you, too, Hector for the links you sent me.
Many thanks for the link you sent me, which had similar information to the info in the post I'm looking for. I appreciate your getting back to me and thanks again.
wait till you see the victrelis pamplet. LOL
I just received my pegasys yesterday (going for first shot tonight), I was reading the the pamphlet with all the info/side effects on it...it was quite extensive and LOT of reading!
drugs.com
you can look up any of the combi therapies here.
or
http://www.drugs.com/drug-interactions/interferon-alfa-2b-ribavirin.html
Label and Approval History
Drug Name(s) PEGASYS (Brand Name Drug)
FDA Application No. (BLA) 103964
Active Ingredient(s) PEGINTERFERON ALFA-2A
Company HOFFMAN-LA ROCHE
This is the Pegasys label
the label approved on 09/29/2011 (PDF) for PEGASYS,
PEGASYS
3 (peginterferon alfa-2a)
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5204lbl.pdf
Here is the complete history of chances...
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory
Hector