Simeprevir Will Most Likely be Approved by the FDA
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Simeprevir Shines in Hep C Trial
by David Wild
Orlando, Fla.—Of patients who relapsed following treatment with peginterferon (PEG-IFN)-based therapy for chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, 80% experienced rapid and sustained virologic response with triple therapy including PEG-IFN-2a, ribavirin (RBV) and simeprevir, an experimental oral, once-daily HCV NS3/4A protease inhibitor (PI). Results from the Phase III PROMISE study were presented at the 2013 Digestive Disease Week meeting (abstract 869b).
The findings led Gregory Gores, MD, executive dean for research at Mayo Clinic, Rochester, Minn., to speculate that simeprevir will soon be added to the clinician’s HCV treatment toolbox.
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16 Comments
After dealing with first non-A/non-B, then HCV for 30 years AND 4 (four!) failed attempts @ SVR, I sincerely HOPE this latest-and-greatest “therapy” works for not only me, but the multitudes of my fellow “hard-to-treats.” Incivek DAMN-near killed my bald butt; however, the 6 months of “perceived” SVR were the happiest I’d had in the last 3 decades. But, oh BOY, what an absolute heartbreak occurred when I got “the call.” BTW: It’s been 2 years since Tx & I STILL have 10-15 bouts of the “Icicle Death Sweats” A DAY!! Good Luck & god (or whom or what ever or not) speed…
Hi SmoothHead, So “Icicle Death Sweats” a day! Well put, but those people really make me miserable. I feel absolutely awful about what you have gone through. Personally I attempted therapy once, in 2006. It was so awful, and after 48 hard weeks, one week after it was over, the virus was back. I always tried to talk myself into, believing that maybe it bought me some extra time, but after losing my sanity, and two years of memory, my wife (because I wasn’t any fun anymore), and too many other unpleasant symptoms to go into, I decided never would I put Interferon or ribavirin into my body again. I am so tired of outrageous fatigue, where I just plain don’t care about anything more than laying down. I just want to lay down for 23 hours out of the day. The only thing that helps a little is that I take medication for adult A.D.D. This was something that I had to talk my doctor into writing up for me. Some days I do get a bit of relief,, but would still just as soon be sleeping. Waiting for Obama care to kick in, and will probably begin early Social Security, because making ends meet has been absolutely hard too! I just want to start one more time at treatment without the evil drugs. I’ve personally been waiting for almost ten years, although at the time of my “therapy”, It would still be about 3 more years to wait for that New “therapy”. 9 years later, and I’m still waiting.
Sorry to hear that your hard fought battle ended that way, quick question when you say 6 months of SVR was that during treatment or did you finish tx and 6 months post tx you relapsed Daniel
Thanks, Daniel; the latter or a ‘blend’ of both. VL bottomed-out during tx, 6 months post-tx later – BAM! The worse part of this tx was the relasping. At least with the other (fully completed) three I didn’t “re-catch” it. Rd 3 had its brutality, as well. Alternating, blood-letting with transfusions. “It couldn’t get any worse” isn’t (& hasn’t been) in my usage for a LONG time! “A day above ground beats Tupelo” has… Hope this helps. Take care & if I can be of further assistance, just let me know.
Is this a medication I can take if I have choosen NOT to take the conventional meds so far? Does it workon it’s own or do I need to take the other treatment as well? what if any are the side effects please?
Wait for Gilead’s new treatment with NO interferon or ribavirin. 90 percent srv and almost NO side effects!!!!
…need to know more,Karen, re/Gilead’s new treatment.
For those of us who have failed (or later,the HCV rebounded), hope is possibly on the horizon(?)____
Vicki
Yes, there is the hope we have been waiting for.
Gilead’s in phase 3, maybe next year?
I agree! skip in sun city, ca
that is what my hepatologist said here at a top liver transplant program…..I can’t tolerate ribavirin well cause I have low platelets already, as do many liver patients, cause the platelets are absorbed into the spleen…please God, reveal the best treatment for those of us who have carried this disease for way too long…hey, it’s almost 2014 scientists at CDC and NIH……
With ANY of the new meds that come out, unless symptomatic, it might pay to check the drugs efficacy at LEAST 6 months after it’s FDA approved/released. THAT is where the “rubber meets the road.” Just an opinion. I’m neither a doctor, nor do I play one on TV!!
Can we combine this with Gilead double?
I think you are right, I started Incivek within 3 months of release. I should have waited
many say sofosbuvir from Gilead Science and daclatasvir from Bristol Meyers works. 90% success rate with very little side affects. for some reason Gilead Science pulled the plug to go it on there own. insane!
I’m GT 1a. I guess all treatments being developed for my GT is going to include interferon. Does anyone know of a trial for GT 1a, compensated cirrhosis naïve treatment that does not have interferon?
what is the name of the other drug that starts with an A?