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

[Pamelajean1]

More experts that support pooh's research. Note the last sentence...

HCVguidelines.org.....updated 2/13/2014

"The American Association for the Study of Liver Diseases (AASLD), the Infectious Diseases Society of America (IDSA), and the International Antiviral Society-USA (IAS-USA) this week announced the first new hepatitis C treatment guidelines that include next-generation direct-acting antiviral agents recently approved by the FDA. The guidance is available on a new website, HCVguidelines.org, that will enable frequent updates to reflect emerging data.

"It is important to keep in mind that FDA only will approve drugs that have gone through rigorous testing," said IAS-USA panel co-chair Michael Saag from the University of Alabama at Birmingham. "We cannot run a Phase 3 trial on every possible [drug] combination or every possible patient population. The website allows experts in the field to look at the emerging data and craft what we feel the evidence supports, [which] may fall short of what is specifically in an FDA-approved package insert."

"For genotype 1 patients who cannot take interferon, the panel recommends sofosbuvir plus the HCV protease inhibitor simeprevir (Olysio), with or without ribavirin, again for 12 weeks. This off-label regimen has not been through full Phase 3 testing, but performed very well in the Phase 2 COSMOS trial.
An alternative for this group is sofosbuvir plus ribavirin for 24 weeks, though the panel noted that it is not as effective as sofosbuvir plus simeprevir, especially for patients with liver cirrhosis."

"For patients infected with genotype 1a HCV, baseline resistance testing for the Q80K polymorphism may be considered. However, in contrast to using simeprevir to treat a genotype 1a HCV patient with PEG/RBV when the mutation markedly alters the probability of an SVR, the finding of the Q80K polymorphism does not preclude treatment with simeprevir and sofosbuvir, because the SVR rate was high in patients with genotype 1a/Q80K infection (SVR12 rate for cohort 1 was 86% [24 of 28 patients]; SVR4 rate for cohort 2 was 90% [10 of 11 patients]). To date, virologic failure has not been observed in patients in either cohort infected with HCV genotype 1b and with HCV genotype 1a in the absence of the Q80K polymorphism. Thus Q80K testing can be considered but is not strongly recommended."

[milliehepc]

Yes...my test's comments indicated: Q80K.  The Q80K polymorphism has been found to have a significant impact on Sustained virologic response in patients with HCV genotype 1a treat with simeprevir...(Olysio...

I like to wait just a bit to see if I have an opportunity for something that has a 90 and above cure rate as opposed to the 80% (though some may consider better than nothing).  But, at a price of $2,000 a day...(I will have to pay some out of pocket...but very lucky to have insurance)...I like to wait just a couple of months..to see what my dr. advices since he did say to wait until May.

Pooh...I can always decide or insist to take S&O....I can ask my dr. again...I will bring these findings to him...I am sure he knows them being the director of heptalogy at NYU Medical Center in NY...

Pamelajean...thanks for the additional information...

I am conflicted given the information from all...but no worries...May is around the corner and hopefully my dr. has the alternative plan..we want 100% cure...lol

[hepcat1954]

I checked the clinical trial website and this is the only Janssen trial with GSK23336805 and it does NOT contain Sovaldi but it DOES contain Interferon.  

http://www.clinicaltrials.gov/ct2/show/NCT01724086?term=GSK2336805&recr=Open&type=Intr&rank=1

Here's a list of all Janssen trials listed on the government site.  

http://www.clinicaltrials.gov/ct2/results?term=janssen+hcv&recr=Open

Janssen might have something in the works that's not listed.  If you can take any combination of drugs you want, then I'd wait for the first NS5A inhibitor to get approved, i.e., Daclatasvir, Ledipasvir or GSK23336805 and take it with Sovaldi, off label.  You will have a 95% chance of SVR even with the Q80K.

As far as using Olysio when you are known to have Q80K polymorphism, this statement is straight from the olysio.com site...

"The efficacy of OLYSIO™ in combination with peginterferon alfa and ribavirin is greatly decreased in patients who have Genotype 1a Q80K. Please talk to your doctor about testing for Genotype 1a Q80K and using a different therapy when Genotype 1a Q80K is present."

http://www.olysio.com/chronic-hepatitis-c-treatment

That statement is listed under all Olysio's charts.  I'd rather take a drug that is highly effective rather than one that has been proven to be "greatly decreased" in efficacy "when Genotype 1a Q80K is present."  

[milliehepc]

hepcat..what you recommended is what my dr. said was coming out in May...at least that is what I understood.  That I will take Solvadi with something else...something that I will not show to have a resistant for...as you said...I will run...to sign up...they said they already put me on the "list".  

I will update everyone when I have more information.

[pooh55811]

All of the data I posted, which is from studies on Sofosbuvir and Simeprevir combined,  state that people with the Q80K polymorphism have excellent SVR rates when they treat with a Sofosbuvir and Simeprevir regimen. The study results are quite clear. Even if one has the Q80K polymorphism, the effect of the polymorphism is mitigated if one also takes Sofosbuvir as part of the regimen.

"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."

http://hepatitiscnewdrugresearch.com/olysiosimeprevir-resistant-variant-q80k.html


There are many articles and links that will confirm these study results.

[hepcat1954]

LOL, Milliehepc, I'd like to be a fly on the wall for that conversation:

Big NY hep doc: I'd recommend not taking Olysio with Sovaldi because you've tested positive for the polymorphism Q80K.

Milliehepc: Here's my research that says I should take it anyway.  I'm inclined to insist.  Please write me a prescription for them.

Big NY hep doc: I advise against it.

Milliehepc: Thanks for the advice but please give it to me anyway...

Let me know how that conversation goes.  Could you try asking your doc about coupling Sovaldi with an NS5A inhibitor, either off label or by getting into a trial?  He might think that's a good idea.  Or you could try to find out what his plan is for you.  I'm sure he has one in mind.

I've iterated the Sovaldi + NS5A inhibitor solution many times on this post... Hopefully it will get heard.

Anyway, regardless, good luck...
HC