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1930700 tn?1327064904

Sovaldi and Olysio My Update

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
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Avatar universal
Hi Everyone, I am a relapser from the interferon/ribavirin 48 weeks treatment in 2011. Now, I'm on the Sovaldi/Olysio treatment and finishing week 7. My 4 weeks lab test still detected the virus. I was bummed as reading everyone's blog here was so encouraging when most were undetected after week 4.

Yesterday at my follow up visit, my hepatologist doctor said the virus was still detected but had gone down from a whopping 25,200,000 viral load pre treatment. Another blood test was done. I actually look forward to blood work hoping to hear better news.  He also told be about the q80k polymorphism and how that presents a resistance to the Olysio drug. We are hoping I get undetected. Will test again at end of week 12 and 3 months after that.

He told me that if I relapse, there are new medicines coming that addresses the q80k.  I, too, wonder with already having done 2 treatments, and if I need to go for treatment #3 with the high costs of treatment will Medicare and medigap will continue to help.  Any one know?  

sljl
Helpful - 0
Avatar universal
Not to cloud the decision making process, but my doc did discuss the option of re-treatment if I failed to reach SVR on Sovaldi/Olysio.  She thought new meds may be out in August.  Unfortunately treatment costs and insurance coverage are part of the equation.  My choice to treat was made easier by the stage of liver disease, and the potential of office closure, job loss, and no insurance. Because these meds are somewhat new and the cure rate high, there hasn't been much discussion of whether or when insurance would cover the cost of re-treatment?   Whatever you and your doctor decide, hope you find your cure, and path to better health.  
Helpful - 0
Avatar universal
Couldn't agree with you more....however, my docs also think I could wait for the combo as well. Ascities is stable and minimal and they are quite surprised with my labs, liver function, etc.
The bottom line for me was rolling the dice with my health not to mention with fatigue my quality of life basically *****. I could go from MELD 7 to 15 with the drop of the hat. Millie could go from F1 to F4 as well. Each persons situation needs to be an educated and well informed decision made by well informed experts along with the patient who knows their body and hopefully knows the options and consequences. This is such a fast moving and changing landscape that docs as well as patients don't have all the info. Not to mention the insurance companies trying to keep up! Not to mention the scope of trying to update ALL of the literature. Pioneers we are and on the front line until cost, availability, etc has all been sorted out.
I do think it's irresponsible to suggest that just because you have Q80K...you should wait. It's not taking all the factors of a particular persons situation into account.
But that's just MHO and we certainly all are entitled to that. :)
Helpful - 0
Avatar universal
Per hvcguidelines.org treatment naive with Sovaldi/Olysio clearly applies for you without question since you have cirrhosis and ascites. You need IMMEDIATE treatment if possible.

With milliehepc situation, also treatment naive, there is more confusion Fibrosure test stated I was F0-F1

Per hvcguidelines.org
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.
and
sob/sim w/wo rbv
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.
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1930700 tn?1327064904
Good Luck Pamelajean...I will be following your success.  

Millie
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1930700 tn?1327064904
Thank you Jimmy, Flyinlynn and Faithdove...for adding more info.  I emailed my dr. last night after getting everyone's input.  I asked him about the Janssen trial and the question that hepcat had asked me if the Solvadi had the other inhibitor..(sorry don't remember at moment).

He wrote back that it was Solvadi and Olysio!!!!! I was blown away because he had wanted me on another trial that would have required a four day stay in a hospital.  However, after the Fibrosure test he said I did not have cirrohsis so I was not a candidate...in fact the Fibrosure test stated I was F0-F1 or no Fibrosis....Then he said lets wait for the Janssen trial in May....but after I emailed him Pooh and Hepcat's comments..he said the meds were S&O....why would he put me on a trail for meds that I was already approved in the first place and later said he wanted something better because of the Q80K.  Maybe he confused my chart!

I am going to make an appointment with him and as soon as he clears this up I will post it...

Again, thank you all for your comments....and advice...much better informative than doctors can give....
Helpful - 0
Avatar universal
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....
Helpful - 0
Avatar universal
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



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683231 tn?1467323017
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
Helpful - 0
Avatar universal
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.
Helpful - 0
1747881 tn?1546175878
"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
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Avatar universal
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
Helpful - 0
1815939 tn?1377991799
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.

Helpful - 0
1930700 tn?1327064904
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. :-)

Helpful - 0
Avatar universal
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.
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Avatar universal
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
Helpful - 0
1930700 tn?1327064904
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
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Avatar universal
"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.
Helpful - 0
1815939 tn?1377991799
"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."
--------------------------------------------------

That statement is true. However, note that it says, "The efficacy of OLYSIO™ in combination with peginterferon alfa and ribavirin is greatly decreased in patients who have Genotype 1a Q80K."

It is talking about taking Olysio with Riba and Interferon, NOT about taking Olysio with Sofosbuvir.


"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."

Note, that the successful combo is an ALL ORAL combo of Sofosbuvir and Olysio.


They are two totally separate treatment regimens.
Helpful - 0
1930700 tn?1327064904
Pooh,,,I am bringing this to my doctor's attention...and ask him specifically about it...I will ask him with these findings as you stated above...why is he recommending I wait...

I appreciate your advice and will seriously address it with my dr.

Thank your for taking the time to give me the research..really appreciate it....

Millie
Helpful - 0
Avatar universal
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
Helpful - 0
1815939 tn?1377991799
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.
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1930700 tn?1327064904
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.
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Avatar universal
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."  

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