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]

I did in fact reference my source....hvcguidelines.org.

I think a lot of confusion comes from not updating all of the material/charts etc in regards to the latest recommendations. For instance, the 'survival kit' sent with my shipment of Sovaldi/Olysio contained items that directly relate to side effects of ribivirin....the landscape of this is changing rapidly. We're on the front lines of this and unless you do your due diligence you would think you'd still have take inf/RIBA for tx.

But no worries, I'll just report back in a few weeks with my success of Sovaldi/Olysio and I'm Q80K positive. My hep doc who is on the Board and the Director of the Transplant Center that is an Institute of Excellence, my insurance, pharmacists and countless others agree with the latest recommendations of the the leading experts.

Best of luck to everyone....

[Faithdove]

There is another thing to keep in mind with treatments "the IL28B gene"

So in addition to Q80 K.....

"What is the IL28B gene?

Genes are working parts of our body inherited from our parents. They determine eye, skin, and hair color as well as blood type, height, and race. The IL28B gene is involved in the immune response to certain viruses, including hepatitis C. There are three IL28B subtypes (called genotypes): CC, CT, and TT. People with the CC genotype have a stronger immune response to HCV infection than people with the CT or TT genotypes (called non-CC genotypes). This immune response makes people who have a CC genotype more likely to clear HCV without treatment (called spontaneous viral clearance), within months of becoming infected. People who have a CC genotype are also two to three times more likely to be cured by PEG-IFN and RBV, regardless of race or HIV status."

"IL28B and new HCV drugs

Adding one of the new oral HCV drugs (called direct-acting antivirals or DAAs) to PEG-IFN and RBV or using a combination of DAAs will increase SVR rates in people with non-CC genotypes, regardless of race or ethnicity. It is still unclear whether IL28B genotype has a strong influence on cure rates from DAAs without PEG-IFN, or which DAAs are best for people with non-CC genotypes.

Regardless of your IL28B genotype, it is important to get a viral load test 4 or 12 weeks after starting HCV treatment, to see if it is working. People with an undetectable hepatitis C viral load at 4 or 12 weeks are more likely to be cured, especially if they have the IL28B CC genotype."
"How can I find out my IL28B genotype?

You can take a blood test to learn your IL28B genotype (called the IL28B genotype test). You only need to take this test once, because your IL28B genotype never changes.


IL28B genotype may determine the type—and possibly length—of your HCV treatment. It can be important information for treatment decision-making.

A person’s IL28B genotype should never be used to withhold HCV treatment, since people with non-CC genotypes can also be cured.

Soon, there will be more information about the best treatments for people with non-CC genotypes. Check with your medical providers."
http://www.treatmentactiongroup.org/hcv/factsheets/il28b

[flyinlynn]

Hi Millie

Just to throw in my 2 cents. I am a genotype 1a null responder to several treatments last on being peg intron and Ribavirin. I didn't do the incevek or telaprevir because I was diagnosed with cirrhosis before they were released.
I was dx with cirrhosis in Jan 2008 and am a child A so not very sick yet.

My Dr prescribed Olysio and Sovaldi for me I started 5 days ago. She did not even check for the Q80K as per the AASLD treatment guidelines quoted above by several people it does not matter if one is doing the off label combo. For patients like me the results have been overall 93% with Ribavirin and 100% without Ribavirin for folks with F3 and F4 fibrosis regardless of Q80K.
So IMHO Q80K doesn't come into play when taking Sovaldi Olysio together with or without interferon. That being said per the treatment guidelines "Recommended regimen for treatment-naive patients with HCV genotype 1 who are eligible to receive IFN.
Daily sofosbuvir (400 mg) and weight-based RBV (1000 mg [<75 kg] to 1200 mg [≥75 kg]) plus weekly PEG for 12 weeks is recommended for IFN-eligible persons with HCV genotype 1 infection, regardless of subtype."
So I am a little surprised they originally prescribed for you the off label combo.

I didn't read all the posts above so if this was already mentioned sorry for the repeated info but Gilead is developing their own version similar to Olysio they call ledipasvir. They submitted for FDA approval for a single dose combo pill of Solvalvi with Ledipasvir. If it is approved it would be one pill a day and hopefully cured. That maybe approved as soon as this fall.
Amazing times we live in now. Before there were no treatment options except to wait an hope now it seem our problems are which do we want to take or if we want to wait for the next thing coming. All in all I am so happy we have choices to make instead of no options at all.

Good luck on whatever you choose and hope you have an easy treatment and rapid SVR
Lynn

[JimmyMose]

From what I understand from page fresh a few minutes ago Still Last updated: March 12, 2014 links in my prior comment. The AASLD/IDSA hasn't updated their recommendations yet so maybe they will modify  sof/sim only for treatment-naive who require IMMEDIATE treatment, for GT1 in the future      

The AASLD/IDSA hepatitis C Guidance
it may be advisable to delay treatment for some patients with documented early fibrosis stage (F 0-2),
Potential advantages of waiting to begin treatment will be provided in a future update to this guidance.

Notice the difference for treatment-naive patients with HCV genotype 1 who are not eligible to receive IFN.compared to retreatment of HCV genotype 1 infection, regardless of subtype or IFN eligibility

Excerpts from GT1
Recommended regimen for treatment-naive patients with HCV genotype 1 who are not eligible to receive IFN.
Daily sofosbuvir (400 mg) plus simeprevir (150 mg), with or without weight-based RBV (1000 mg [75 kg] for 12 weeks

For patients infected with genotype 1a HCV
the finding of the Q80K polymorphism does not preclude treatment with simeprevir and sofosbuvir and testing for Q80K is not recommended
further more

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.
(my CAPS emphasis)

Recommended regimen for HCV genotype 1 PEG/RBV (without an HCV protease inhibitor) nonresponder patients:
Daily sofosbuvir (400 mg) plus simeprevir (150 mg), with or without weight-based RBV (1000 mg [75 kg]) for 12 weeks is recommended for retreatment of HCV genotype 1 infection, regardless of subtype or IFN eligibility.

Notice there is no similar mention of only in those patients who require IMMEDIATE  re-treatment but there are other specific condition warnings.

[hrsepwrguy]

"A 12-week all-oral combination of simeprevir plus sofosbuvir led to sustained virological response in 93% of genotype 1 prior null responders with mild-to-moderate liver fibrosis, working as well as a longer course of treatment or triple therapy including ribavirin, according to late-breaking findings from the COSMOS trial presented this week at the 64thAASLD Liver Meeting in Washington, DC. The study also showed that 100% of treatment-naive patients and null responders with advanced fibrosis or cirrhosis achieved early sustained response at 4 weeks post-treatment using the same dual regimen."

http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4394-aasld-2013-simeprevir-sofosbuvir-produces-high-sustained-response-rates-for-hard-to-treat-patients

[Groupergetter]

I suspect your doc is waiting for the Sovaldi/Ledipasvir or other combo.With the cost of these meds they want to give you the best shot at SVR.
Here is a link that gives results of new combo's that may be coming as well as other good information:

http://hepatitiscnewdrugresearch.com/2014-hcv-interferon-free-combinations.html