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.

426 Members

21,304 Posts

0 Online

ImKramer 03/28/2013

Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C

http://www.prnewswire.com/news-releases/janssen-submits-new-drug-application-to-us-fda-for-simeprevir-tmc435-for-combination-treatment-of-adult-patients-with-genotype-1-chronic-hepatitis-c-200501671.html

ImKramer 03/28/2013

Dang ..sorry my bad. This one's with SOC. I thought it was without Interferon..I think.

dragonars 03/28/2013

brain fart

ImKramer 03/28/2013

Ah yes I knew I saw it before in Phase II no Interferon.
Trial started last Sept.
http://www.hepatitiscnewdrugresearch.com/simeprevir-tmc435-and-tmc647055.html

ImKramer 03/28/2013

Yep seems it's still saddled with PegInf ..dang

deleted_user 03/28/2013

I don't understand your "saddled" comment Kramer. It's being filed for use in an interferon-based treatment...but the actual capsules aren't combos, they're Simeprevir alone, to be taken with Interferon, etc. (that's how I read it).
This is very good news, I think. Great news. It opens up the Simeprevir-Sofosbuvir off-label possibilities that we've talked about.
And this filing has come a lot earlier than I thought...I was expecting a filing late in the year for Simeprevir.
Sofosbuvir and Simeprevir gets you close to 100% success with genotype 1...and now that's a possibility early next year, if you can find a doctor to do it and insurance to pay for it (and assuming Sofosbuvir is marketed quickly after approval).
No sure thing, but it looks like there will be an opportunity.

ImKramer 03/28/2013

Yes Slide I was saying saddled in reference to trials. Who knows what other pill combos may come along.

catmagic 03/28/2013

I take this like slide did - GREAT NEWS!

Off-label, here I come - oh, but I need my insurance to pay for it. It's possible!

deleted_user 03/28/2013

I'm glad you feel the same, Catmagic. i was hesitating to say more for fear of being tedious...but...I'll just go ahead and be tedious now.
We were talking about Simeprevir/Sofosbuvir earlier this month as a great new possibility.
The only things that weren't clear were whether Simeprevir would be filed for approval soon, whether docs/insurance companies would go for the off-label angle, and whether Gilead would be obnoxious and hold back Sofosbuvir til their combo was ready.
Now I tend to think Sofosbuvir will be released soon after approval, and now we know that Simeprevir has been filed...earlier than expected, to my mind.
The doctors might be hard to convince about this
But this still makes me very hopeful...

deleted_user 03/28/2013

Awesome post, by the way, Kramer. Sorry if I'm not totally following your disappointment about the trials...but maybe you should ask Dr. Wong if he'd consider going this off-label route. I mean, both drugs could be available at year's end now.

gkringler 03/29/2013

Saw Dr yesterday, he expects it to be approved and available within a year. He wasn't to sure about whether or not it would be with interferon. Either way it's worth a shot.

ImKramer 03/29/2013

Slide if you come across any positive data for simeprevir being used without PegInf point me there. Thanks :^)

kcaseytn 03/29/2013

Slide - if you don't mind me asking - what is your IL28B?

ImKramer 03/29/2013

Yesss..found it. I knew I had Simeprevir filed under "Good" in my brain ..lol
http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4024-croi-2013-simeprevir-sofosbuvir-demonstrates-good-early-cure-rate-with-or-without-ribavirin

deleted_user 03/29/2013

Yeah, Kramer - the Cosmo trial. You posted info on it here back on March 4, I think, under the title "Yessss Gilead," or something like that.
And Kcaseytn, I don't know my IL28B. They haven't checked that yet.
I know certain markers are more difficult...

ImKramer 03/29/2013

Thanks Slide. I write so much stuff down and knew Simeprevir was one to keep an eye on then couldn't find anything but Interferon trials yesterday ..happy once again!

Join the Conversation