Sovaldi and Olysio My Update

[milliehepc]

I was approved for both S&O...however my test came back that I was resistant to Olysio becaue the Q80K was detected.  The Q8OK polymorphism has been found to have a significant impact on SVR in patients with HCV genotype 1A (me).  I don't know why they didn't mention Solvaldi...but will ask on a follow-up with Dr.  He said, since I was resistant (80% chance) I should wait for a better treatment or trial and mentioned one that will come out in May - called Jenssen.  (better over 90% cure..rate)

He did a Fibrosure which the good new was that I was not a candidate for some other trial called Abbvie.....(sorry don't have exact names.  He said, you don't have the C word which I took as good news.  My 2011 biopsy said was 2/3...

Now:  The Fibrosure Score. 0.16 Fibrosis Stage F0 - No Fibrosis, Necroinflammat Activity Grade: A-2 moderate activity..something called Apolipoprotein - A-1 at 211 which is High... (don't know what that means).  

I am treatment naive...(been waiting for the orals)...so was excited that finally I got the orals and APPROVED by insurance only to find I am resistant to at least Olysio. :-(

Anyone familiar Jassen trial?  Do my numbers above still look good?

As always, thanks for your continuous help...
Millie

[pooh55811]

Well, you are not correct. I suggest you do a bit more research and reading.

As for me, I have spent enough time on this topic. The data is on the internet in several places. All one has to do it read it.

[milliehepc]

PS...last note....I just email my doctor and specifically asked him>
Will the Jassen trial you're considering consist of Sovaldi and GSK2336805 or another NS5A inhibitor??

I looked up the links you all sent...and notice the Jassen trial has Olysio...I reminded him I was resistant to Olysio...even though...I understand I am also going to question him regarding Pooh's research...

I asked for an appointment before May..

Anyway, now he is going to think I am super brilliant. :-)

[hepcat1954]

Yep Milliehepc, your doc's opinion (and yours) are the only ones that count.

See what he thinks and talk it over with him.  Good luck with your decision.

[hepcat1954]

The first article Pooh listed

http://hepatitiscnewdrugresearch.com/olysiotrade-simeprevir-fda-approved.html

"In the QUEST-1 and QUEST-2 studies, among genotype 1a treatment-naïve patients receiving OLYSIOTM who had the Q80K polymorphism (a naturally occurring variation in the HCV NS3/4A protease enzyme), 58 percent achieved SVR12 versus 84 percent of patients without the Q80K polymorphism."  

and

"**A study of an all-oral combination of simeprevir with Gilead's sofosbuvir has shown that the regimen mitigates the effect Q80K has on simeprevir, Gaston Picchio, hepatitis disease area leader at J&J's Janssen unit, said during the meeting."

So this Picchio person mentions a "study" (which one?? when was it?? where's the data??) at a meeting (what meeting??) and using a "combination of simeprevir with Gilead's sofosbuvir has shown that the regimen mitigates the effect Q80K has on simeprevir."

So the regimen takes the 58% SVR rate up to what?  65%?? higher?? lower??  This is murky data at best.  

The 2nd link by Pooh, http://www.hepmag.com/articles/sofosbuvir_simeprevir_2501_24726.shtml

This article doesn't even mention resistance or Q80K.  Everyone knows that Olysio and Sovaldi are effective without the presence of the Q80K polymorphism as this article states, but Milliehepc has Q80K.  That changes things.

Pamelajean doesn't list her sources so I can't check that data.

IMO, taking Olysio when you've got Q80K, even with Sofosbuvir is not a good idea.  I have seen no data that convinces me otherwise.

OK I guess that's it for me...
HC

[milliehepc]

That was funny....the conversation....I will have two flies...hepcat and Pooh...but either way...I hope to make the right decision.....its all so overwhelming.  

I take everything everyone writes here very seriously....and I will address both opposing if we want to call it opposing views with the Dr.  and ask.  Doc...what is the plan for me..and when...

Good luck to all...and my most sincere gratitude....
Milie

[JimmyMose]

"Thus Q80K testing can be considered but is not strongly recommended."
There was another line under the above

This regimen should be considered only in those patients who require immediate treatment, because it is anticipated that safer and more effective IFN-free regimens will be available by 2015.

http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection-patients-starting-treatment
Last updated: March 12, 2014

milliehepc  Best wishes for getting the best treatment in the not too distant future.  My guess is your doctor is providing the best advice at this time.