Wow...not that I'd recommend interferon/ribavirin...but definitely a stop towards IFN free treatments. Thanks for posting!

This week has been a wild one for sure!!! First Canada approves Simeprevir and they called it GALEXO...

In case you're wondering, I posted it in an earlier thread, but I don't remember if it was yesterday on the 22nd or the 21st??? Oh well, I guess I'm losing my short term memory!!! I know why!!! Duh! I have a lack of oxygen and, not enough of it is going to my brain and I'm really not kidding about that! ;>) ;>) ;>)

Now, the FDA approves Simeprevir in the USA and it's called OLYSIO... It's beginning to get confusing for me!!! what should I really call it??? GALEXOLYSIO??? Yeah! That looks about right!!! ;>)

All kidding aside, that's really great news people!!! Wow!!! They're pumping a whole lot more pressure in that pipeline, and the result is the new drugs are being starting to flow out as fast as they can name them ! ;>) Sorry about that! I couldn't help writing that. ;>)~

Now if they could just get that GS-5816 approved soon enough!!! Because that drug reads like a really good looking and sexy nude model by the way that it covers some of the known & prevalent baseline polymorphs in the NS5A gene that are associated with minor, ineffective or no antiviral response in patients for first generation NS5A inhibitors (Daclatasvir, Ledipasvir) during mono-therapy... Such as:
- L31M, Y93C, Y93H polymorphs in GT1 - GT = Geno Type
- Highly prevalent (50%) M31 polymorph in GT2
- Baseline A30K (associated with relapse in combination therapy eg. Sofosbuvir+Ledipasvir [GS-5885] & all other DAA combo's) in GT3
And previously known 1st generation NS5A inhibitor Resistance Associated Variants, or RAV's found so far from all of the genotypes...

Gs-5816 is a second generation NS5A inhibitor in development to target HCV Genotypes 1 through 6 and broad polymorphism coverage as well as covering key first generation NS5A inhibitor RAV's of other classes of Direct Acting Antivirals or DAA's...And that to me that reads like a really hot and sexy nude model of a DAA to be matched in combination with other DAA's and ultimately forming a can of whup-ass to be used on that P.O.S HCV !!!
Look it up!!! ;>) ;>) ;>)~

Respectfully,
Henry

Marron a mi!

Did anybody check out all of the drug interactions this stuff has???

It's quite a list and according to some of them this drug isn't going to be safe for me and other folks who are on some of those drugs on that list... ;>( ;>( Bummer!!! ;>(~ Oh well, there's so much coming out of the pipeline very shortly that this won't bum me out for long!!! ;>) HEY FDA!!! KEEP EM COMING!!! (;>O)~

Respectfully,
Hank

i saw this and looked. plus the same poison i took before? ill pass on this. 6 months of poison i still have side effects from almost 4yrs ago. im surprised i havent broke out in hives thinking about it. yet. 75-80% odds? the article said a lot of people got it from sex? i was with the same woman for 25yrs. she never got it. last time i read about it it said if u r with one partner they dont recommend that u have to wear a condom? http://news.yahoo.com/fda-clears-johnson-johnson-hepatitis-010651776.html

Henry just from the link provided here on Galexo, I'm assuming all the drug warnings are when it is combined with SOC. I could be wrong.
I can't seem to find any warnings on simprevir alone.

Good news in general, yes indeed.

me - no interferon - no way, never.

There are so many geno 1's - and so many of us either cannot tolerate or cannot RISK using Interferon, so I would think that the big push is coming to knock I'feron out of these regimens - however, I do realize that there are layers of bullshit to such things - as in Interferon's pharma is not going to go away without a fight. I've heard more about this little issue - as in, oh damn, I can't think of the word - some kind of "contractual" thing I'feron has until next year or something. Whatever - I don't think much about it. Damn, what is that WORD? Not "contract' .... ????? erghhhh

however, I am HOPING for off-label tx with Sofosbuvir and Simeprevir. My doc hasn't come right out and said it (yet), but I think his feeling is that I need to treat ASAP - can't be waiting for Sofos/Led or Sofos/5816, which I do agree Henry, 5816 looks REALLY awesome - used with ALL genotypes. The future is bright, once I'feron is gone - but I need to treat sooner rather than later.

Why can't the damn name just be Simeprevir anyway? Huh?

my doc already told me their was treatment without riba? this cocktail includes riba? i cant stand that shit either. kills my hemoglobin.

PATENT! That's the word I couldn't wrap my head around a while ago - yes, Interferon has some sort of patent that doesn't expire until 2014. I cannot find out much about it - except this - from some lawsuit gobbledeegook in 1996:

"As a result of the settlement, the U.S. Patent Office is expected to issue a patent to Genentech/Roche for the disputed alpha interferon claim. That patent is expected to have a term of 17 years from the date of issue."

HOW exactly this affects us/treatment options I truly don't know, except "Under terms of this arrangement,
Schering-Plough and Roche will continue to market their respective alpha interferon products." I have read that this "arrangement" is a reason why Interferon continues to be part of HCV FDA approved tx.

http://www.prnewswire.com/news-releases/schering-plough-in-agreements-resolving-alpha-interferon-patent-dispute-78056012.html

Did you see these drug interactions Kramer?

The Pharmacokinetic Interactions of the HCV Protease Inhibitor Simeprevir (TMC435) With HIV Antiretroviral Agents in Healthy Volunteers


Reported by Jules Levin
IDSA Oct 17-21 2012 San Diego

Sivi Ouwerkerk-Mahadevan, PhD,1) Vanitha Sekar, PhD,2) Alexandru Simion, MD, PhD,3 Monika Peeters, MSc,3) Maria Beumont-Mauviel, MD3 1)Janssen Research & Development, Beerse, Belgium; 2)Janssen Research & Development, Titusville, NJ, USA; 3)Janssen Infectious Diseases, Beerse, Belgium

CONCLUSIONS

Results from this PK analysis demonstrated that no dose adjustments are required when combining simeprevir with RPV, RAL or TDF Coadministration of simeprevir and EFV is not recommended due to a significant decrease in simeprevir plasma concentrations in the presence of EFV Coadministration of simeprevir and DRV/r is not recommended due to a significant increase in simeprevir exposure in the presence of DRV/r, even after dose adjustment of simeprevir from 150mg qd to 50mg qd.
Similar effects are likely to be seen with other ritonavir-boosted PIs:
All treatments were safe and well tolerated, and no SAEs were reported Once available, data from the ongoing Phase III study (NCT01479868) will further characterize the safety, tolerability, efficacy and PK profile of simeprevir in patients with chronic HCV infection who are coinfected with HIV-1

http://www.natap.org/2012/IDSA/IDSA...

http://www.fda.gov/downloads/Adviso...

This one is interesting:

http://www.hep-druginteractions.org...

"Simeprevir has a list of medications that can cause drugdrug interactions as well, those medications along with patient and prescribing information, can be found online at http://www.olysio.com/intro/.

Let this be an important reminder folks, to ensure a safe, successful treatment plan, provide a complete health history to your healthcare provider and include a list of all medications, vitamins, or herbs you are taking before and during HCV therapy. Going forward, treating with new agents, the importance of preparing for treatment can not be underestimated, communicating with your physician or treatment nurse is key to a promising outcome."

This is the most comprehensive of all the documents in this post IMHO! Here's the link:

http://onlinelibrary.wiley.com/doi/...

Check it out K!

Respectfully,
Henry "