Relapse Rates > Merck Grazoprevir and Elbasvir

[mac790]

Hello All, I completed a 12 week clinical trial of two meds in one pill from Merck. Grazoprevir is an improved pan genotypic protease inhibitor, and Elbasvir is a NS5A inhibitor. These Merck drugs should hit the market this Summer, I would think. The director of the clinical trial wrote me, and said the relapse rate of those in the clinical trials who achieved a SVR is 1%. It is worth noting that figure may change, as these meds are still so new. I won't speculate that this relapse rate will be applicable to all the new gen HCV meds such as Harvoni and Sovaldi, etc...  They are all so similar chemically and in their method of antiviral activity, I don't think that is an unreasonable assumption. Your mileage may vary. Congrats to all who have achieved SVR and the best of luck to all those who decide tx is necessary sooner as opposed to later.       mac790

[JimmyMose]

Sorry I didn't explain more.  The trial results for shorter duration didn't have the sucess.  Once the phase 3 trials 12 week trials are complete then Merck can resubmit and it's looking real good.  I just wanted to mention not to expect FDA approval this summer.   If all is good most likely it will be near the end of thid year or early 2016 for the US.

Best wishes for achiving SVR

[Livelife777]

Good luck to you Mac.  Know you've been fighting for SVR and you've gotta hit the mark.  Let us know what's ahead.
.....Kim

[mac790]

JM,   MK-5172 is Grazoprevir, and MK-8742 is Elbasvir. These are the meds I took, combined 100 mg/50 mg in one tablet. I don't know what "expected success" means, but according to presentations @ the EASL meetings in 2014, the SVR rate for 1a GT, both tx experienced and not, cirrhotic or not, was 94%. GT 1b patients, regardless of prior tx or cirrhosis, SVR was 99%. Getting the breakthrough designation is a formality and good for advertising, but is no reflection on the drug's efficacy. As Gilead beat Merck to the punch, so to speak, there went the "breakthrough" designation. I doubt any of Gilead's meds are any better, and the Merck relapse rate of 1% is going to be pretty hard to beat. As far as unexpected side efx, it is still early in the game to be as certain.   mac790

[JimmyMose]

Unfortunately they won't hit the US market this summer.  Breakthrough status has been recinded.

http://www.forbes.com/sites/greatspeculations/2015/03/13/these-two-catalysts-can-move-mercks-stock-up/
Excerpts March 13, 2015

Merck has been looking to get a breakthrough in Hepatitis C market, but its clinical trials haven’t seen the expected success
Read more at link

The company is now focusing on clinical trials of combination of MK-5172 and MK-8742, and may file the new drug application soon. However, it has lost breakthrough therapy designation for these drugs.

[Ekkiemom]

Hi KOKO

Yep, they are getting closer to wiping this nasty virus off the face of this big blue planet!.......just as it should be right!

Hopeful for everyone
Deb

[keepingOnkeepingOn]

Wow! Here we go. Everyone who has HCV will get treated. No one needs to die from this anymore. The creator of the "Simpson's" just died from it though due to the stigma they are keeping it hush. He was from my city.

This is very good news. Thanks for posting! No one should wait to be cured and everyone needs to be tested.

[Ekkiemom]

Hi there
This term "pangenotypic" refers to all 6 genotypes.

Peace
Deb

[dragonars]

What's the geno type for these trials