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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
Q80K polymorphism: QUEST-1 and QUEST-2 studies
In  the simeprevir QUEST-1 and QUEST-2 studies, researchers reported in QUEST-1 patients with HCV genotype1a had almost 20% less SVR than HCV genotype 1b. Noted, at baseline the mutation Q80K was found in approximately 1/3 of genotype 1a patients. On the contrary, in QUEST-2 this mutation was infrequent and did not impact significantly the SVR rate.

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

Before making a final decision I would ask my doctor about the results from the QUEST-2 trial which I would figure had a much larger enrollment of patients... Wishing you the Best
Helpful - 0
1815939 tn?1377991799
"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). "
----------------------------------------------------------------

If you have the Q80K polymorphism and treat with Simeprevir (Olysio), Interferon and Ribavirin, the SVR rates are considerably lower than if you did not have the Q80K polymorphism.

"Olysio (simeprevir), the first "second wave direct-acting antiviral" to treat HCV was recently FDA approved for genotype 1 in combination with peginterferon alfa and ribavirin in adults with compensated liver disease,"

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


However, if you treat with Sofosbuvir (Sovaldi) and Simeprevir (Olysio) combined, the Sofosbuvir mitigates the effect of the Q80K polymorphism and the SVR rates are high.

"**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."

Same link as above.


Ask your doctor about treating off label with Sovaldi and Olysio because the SVR rates are very high. The Sovaldi mitigates the Q80K polymorphism's effect on Olysio. Your chance of SVR (cure) with this all oral combo is excellent, even if you do have the Q80K polymorphims.


"Simeprevir and Sofosbuvir Cure Hep C Genotype 1 at High Rates"

"A 12-week regimen of Janssen’s simeprevir and Gilead Sciences’ sofosbuvir boasts high cure rates among those with genotype 1 of the virus, the most common in the United States and the most difficult to treat, aidsmap reports. .....

Each of the two drugs is weeks from a likely approval from the U.S. Food and Drug Administration. And while the FDA will not be approving simeprevir and sofosbuvir for use in combination at this time, the findings of the COSMOS study may influence clinicians’ decisions to prescribe them together off-label, in particular for patients with more urgent needs for treatment.

The trial had two groups of participants, all of whom had genotype 1 of hep C. The first included 80 people who were null-responders to previous interferon-based treatment who had absent-to-moderate fibrosis. The second group included 87 either treatment-naive or prior null-responder participants who had advanced fibrosis or compensated cirrhosis. All the participants were randomly assigned to receive either once-a-day treatment of the protease inhibitor simeprevir and the nucleotide polymerase inhibitor sofosbuvir or the same regimen plus ribavirin twice a day. The group was further randomized to receive treatment for either 12 or 24 weeks.

Among those in the first group who were treated for 12 weeks, 93 percent of the participants taking dual therapy achieved a sustained virologic response 12 weeks after completing treatment (SVR12, considered a cure), compared with 96 percent taking the triple regimen. .....

In group 2, all of the seven treatment-naive and the seven null-responder participants on the dual regimen who also had adequate follow-up reached an SVR four weeks after completing treatment (group 2 started treatment after group 1, so there is less follow-up data). Among those on the triple regimen, 100 percent of treatment-naive participants and 93 percent of the null responders achieved an SVR4."

http://www.hepmag.com/articles/sofosbuvir_simeprevir_2501_24726.shtml


"Interim results from Cohort 2 of the COSMOS study evaluating Simeprevir and Sofosbuvir in HCV patients with METAVIR scores F3-F"

In Hepatitis C patients with advanced liver fibrosis or cirrhosis (METAVIR F3 or F4) 12 weeks all oral treatment with simeprevir and sofosbuvir with or without ribavirin led to SVR4 rates of 96% and 100%, respectively.....

Stockholm, Sweden - Medivir AB (OMX: MVIR) today announced interim results from the second Cohort in the ongoing COSMOS study evaluating a once daily combination of simeprevir and sofosbuvir in hard to cure hepatitis C (HCV) patients.

SVR4 results from the 12 week arms of Cohort 2, including treatment naïve or previous null responder HCV patients all with METAVIR score F3-F4 were reported. Treatment for 12 weeks with simeprevir and sofosbuvir, with or without ribavirin, led to SVR4 rates of 96% and 100%, respectively.

Interim results from Cohort 1 of the COSMOS study, which include only prior null responder HCV patients (METAVIR F0-F2) have been reported earlier and demonstrated SVR8 rates of 96% and 93% after 12 weeks treatment simeprevir and sofosbuvir with and without ribavirin, respectively......

COSMOS is a randomized, open label, phase IIa clinical trial evaluating a once-daily combination of the HCV protease inhibitor simeprevir and the nucleotide sofosbuvir with and without ribavirin (RBV) for 12 and 24 weeks. Cohort 1 (n=80) evaluates prior null responder genotype 1 hepatitis C (HCV) patients with METAVIR scores F0-F2 and Cohort 2 (n=87) evaluates prior null responder and treatment-naïve genotype 1 hepatitis C patients with METAVIR scores F3-F4. The METAVIR score is used to quantify the degree of inflammation and fibrosis of the liver. Liver fibrosis is scored on a four-point scale. At the time of the interim analysis, SVR4 results were available for all patients (n=41) in the 12 week arms of Cohort 2. In this Cohort, 78.2% of patients had GT1a subtype with 40% of those having a Q80K baseline polymorphism, 79.3% had IL28B CT or TT genotype, 47.1% had Metavir score F4 (cirrhosis) and 54.0% were prior null responders.

In the previously reported Cohort 1, 77.5% of the patients had GT1a subtype with 50% of those having a Q80K baseline polymorphism, 93.7%, had IL28B CT or TT genotype and 58.8% had METAVIR score F2."

http://www.natap.org/2013/HCV/082913_01.htm
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Avatar universal
Olysio (Simiprevir), by Jassen, is an oral protease inhibitor and has a low to medium barrier to resistance.  Sovaldi (sofosbuvir), by Gilead, is a nucleotide analog NS5B polymerase inhibitor and has a high barrier to resistance.

It looks like your doc wants you to wait for a companion drug for Sovaldi that also has a high barrier to resistance, which is a good idea IMO.  What's producing excellent results is Sovaldi is coupled with an NS5A inhibitor, which also has a high barrier to resistance.

There are several NS5A inhibitors on the market.  As I mentioned, Ledipasvir is Gilead's NS5A inhibitor.  Bristol Myers' NS5A inhibitor is known as Daclatasvir.  (When Bristol Myers and Gilead fell out 2 years ago, people made big stink because at that time, it was the only combination of drugs (sofosbuvir & daclatasvir) with a high cure rate and a high barrier to resistance.)  In October 2013, Jassen "acquired" (purchased?) it's own NS5A inhibitor, GSK2336805, for folks with the Q80K and resistance to Olysio.  

Since NS5A inhibitors have a high barrier to resistance, Jassen has wisely acquired their own.  The "Jassen" trial they're talking about must be comprised of Sovaldi coupled with GSK2336805 (or whatever name they eventually give it) NS5A inhibitor.

Take note that ALL NS5A inhibitors (and the new oral protease inhibitors like Olysio) have to be taken with the KING of HCV drugs - Sovaldi.  If you don't have the dreaded Q80K polymorphism, you can take Sovaldi with Olysio, which a lot of folks are doing.  However, if you have Q80K, then you have to couple Sovaldi with an NS5A inhibitor.  I think all the NS5A inhibitors are comparable.

Here's a link about Jassen's acquisition of its new NS5A inhibitor.  
http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=795554

Verify that the Jassen trial you're considering will consist of Sovaldi and GSK2336805 or another NS5A inhibitor.  If so, find out how close the trial is to opening up and RUN, don't walk, to get in line.

Good luck to you,
HC

P.S. [I too had high resistant polymorphisms (to Invicek) and had to stop triple treatment after 12 weeks.  About a year after stopping, I started a Gilead trial with Sovaldi (sofosbuvir) and Ledipasvir (formerly GS-5885).  I've been cured for 10 months after taking those 2 drugs for 12 weeks.]
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Avatar universal
P.S. As far as your numbers, you should talk to your doctor about those.  I can't keep track of all those.  If your biopsy has been done and you're eligible for the trial (and it's the one you want), I say go for it.

Again, good luck!

HC
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1930700 tn?1327064904
Thank you...hepcat, wow...so happy you been cure...every minute cure is precious.  

pooh and can-do man...very thorough advice.  I am going to print it and have it when I go see my dr.  He said to come back in May...for a better trial or I guess one that he thinks its better than the combo O&S.  I am going to question him about the combo -  and the study you mention that had a better cure rate....so given that I have the dreaded Q80K...I have to wait for something that works with it...or against as it may be.

Oh, boy...so much stuff...

I thank you all..as I said I will print information/advice you sent me and study it....

You are all the best EVER...THANK YOU!
Helpful - 0
Avatar universal
Pooh said, "Ask your doctor about treating off label with Sovaldi and Olysio because the SVR rates are very high. The Sovaldi mitigates the Q80K polymorphism's effect on Olysio. Your chance of SVR (cure) with this all oral combo is excellent, even if you do have the Q80K polymorphims."

She can't take Olysio because it's resistant to Q80K polymorphisms, which she has... she needs to take Sovaldi with an NS5A inhibitor, which also has a high barrier to resistance.  Her doc advises against taking Olysio with Sovaldi (and I agree 100%), so why push for it?  She should opt for the TX that's NOT resistant, which is Sovaldi + NS5A inhibitor.

Millihepc, find out if the new trial from Jassen has Sovaldi and Jassen's NS5A inhibitor (or another NS5A inhibitor).  Don't take something to which you know you have resistance.  You'll be wasting your time and money.

Good luck,
HC

milliehepc said, "...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)"


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Avatar universal
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."
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1930700 tn?1327064904
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

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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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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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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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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
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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
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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.
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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.
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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
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
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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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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. :-)

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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.

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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
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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
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.
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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
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Getting tested for this viral infection.
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3 key steps to getting on treatment.
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4 steps to getting on therapy.
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What you need to know about Hep C drugs.
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How the drugs might affect you.
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These tips may up your chances of a cure.
Popular Resources
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
Can I get HIV from surfaces, like toilet seats?