Relapsed on Sovaldi - Considering Harvoni

[Lynn K]

Hi all
I am new to the forum first post so hope this is how it is done.

I have hep c GT 1a 3 time null responder first tx was interferon monotherapy then twice with interferon Ribavirin. I was diagnosed with F4 cirrhosis on biopsy in Jan 08. I take spironolactone for edema and a small amount of ascities and have varicies banded in 2012.

I treated with Sovaldi and Olysio March to June and had detectable virus 12 weeks after I stopped taking the meds so I relapsed.

I am looking at Harvoni now and have a couple of questions.

I have seen where some of the pre approval forms I have found may not allow treatment with Harvoni if you relapsed on a Sovaldi containing treatment so I am worried if my insurance will allow me to get Harvoni at all much less than for 24 weeks that I guess is the recommendation for patients with cirrhosis who were prior null responders.

Also I can't seem to find much information about efficacy of Harvoni for prior Sovaldi relapse patients which is understandable since this is all so new. But would Harvoni even work for me? I worry about running out of options and being one of he few who were not able to be cured when everyone else has and I will have nothing that will work for me.

Thanks for your thoughts
Lynn

[lporterrn]

Hi Lynn -
Welcome to the Forum. You post was perfectly fine, but your situation is such that I didn't want it to get buried in someone else's post. So, I started a new topic with a new title so anyone in your shoes will be able to find it.

Having said that, I don't have much to offer by way of answers. There just isn't data out. However , the liver meeting is in a few weeks, and maybe there will be a small study. http://www.aasld.org/livermeeting/Pages/default.aspx

As for your concerns, I think it might be too soon to worry about a denial. First see if your doc will Rx it.  If you are denied, try http://www.mysupportpath.com/ They are getting the drug out to a lot of people, even with denials.

Let us know what happens.

[Bucky]

Hello Lynn,
Well welcome, but I am sorry to hear that you relapsed. I was treated with S&O as well and am waiting until December for my week 12SVR check. If I relapse then I will be facing the questions that you are asking.
Lucinda posted a link from one insurance provider, I think it was United Health, about covering treatments and the guidelines.
The information from them did indeed say that if you had cirrhosis and used a PI (Olysio was listed) and failed treatment that 24 weeks was the length of treatment using Harvoni. The way I read it indicated that they would cover 24 weeks as well.
I would think that because you have several defining conditions indicating that your liver is pretty beat up that you would be approved. Who is you insurance provider? I have the dreaded BCBS of NC (Express Scripts) and while they approved me straight away, according to some forum members they have been a little more selective as of late.
When I finished treatment my IDS felt confident that if I relapsed that I would be approved for Harvoni. This was before it was even approved or had a name but she was well aware it was going to be approved soon. She just said that to retreat with another med would be still be cheaper than a transplant or long term care treating a failing liver.
Bucky

 


 
 

[Bucky]

Lucinda,
Could you please report the link to the insurance information.  I looked at this: http://www.aasld.org/livermeeting/Pages/default.aspx and my head exploded!
Bucky

[Lynn K]

Hi Bucky

Thanks for your reply.

I work I WA state but my employer headquarters is in IL so we have BCBS of IL and express scripts as well.

Hopefully everything will work out I am just understandably worried right now. I see my hepatologist on November 3rd. I am just trying to be proactive and get things going sooner rather than later. I need the beat this thing if I can.

[Bucky]

Hi Bucky

Thanks for your reply.

I work I WA state but my employer headquarters is in IL so we have BCBS of IL and express scripts as well.

Hopefully everything will work out I am just understandably worried right now. I see my hepatologist on November 3rd. I am just trying to be proactive and get things going sooner rather than later. I need the beat this thing if I can.

I understand completely about being proactive.  I was going to wait on Harvoni because the trial data showed a slightly higher cure rate very near 100%. The trial cure rate for S&O was around 93% so I jumped on it because my liver is banged up as well. I think that you may be the first one to post about relapsing after S&O.
I really hate it for you, but you still have hope with Harvoni.  I have a great respect for you for doing the old I & R treatments because frankly I did not have kahunas to do it.
Bucky

[Lynn K]

I am on another group also Medhelp.Sadly we have several who have relapsed on either Sovaldi Olysio or Sovaldi Ribavirin. One said he was taken off Sovaldi Ribavirin at 8 weeks because he did not achieve UND he is I believe GT 2 and he is the only one I have seen who has said they did not respond as opposed to relapse.

I just was on the phone with express scripts they are faxing the pre approval paperwork to my doctors office. My doctor messaged me earlier that she now feels after further research I should do Harvoni for 24 weeks. So we will see how it goes from here.

Good luck on your treatment I hope you achieve SVR.
Lynn

[rainbowray]

Hi Lynn,
Do you or can you get the percentage of the people that relapsed. You said several so is that more than 10%. Were more that failed on S/O or S/R.?
I'm on S/R 24 weeks, so I am very interested. I was undetected at 3-4 weeks. Gen 1B
Thanks in advance.

[Bucky]

Hello Lynn,
Here was the information I was looking for.
https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/en-US/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/Tools%20and%20Resources/Policies%20and%20Protocols/Medical%20Policies/Ox_MPUB_Future_Pharmacy/PA_Notification_Harvoni_101414.pdf
Scroll to the second page and it lists 24 weeks for patients who relapsed. I appears that United Care Health is going to cover Harvoni for 24 weeks so let's hope BCBS (SE) will do it as well.
Was it at your SVR24 week check that you found out?
Bucky

[Bucky]

Hi Lynn,
Do you or can you get the percentage of the people that relapsed. You said several so is that more than 10%. Were more that failed on S/O or S/R.?
I'm on S/R 24 weeks, so I am very interested. I was undetected at 3-4 weeks. Gen 1B
Thanks in advance.

Hi rainbowray,
 I guess we will now start seeing numbers from the medical meeting about the percentages of relapse. During clinical trials it was about 7%. Since Lynn started in March she must have been one of the very first group to start S&O treatment.
Bucky

[DesertGuy]

Yes--these are the stats I want--past few days I have found a few other forums as the one above. Interesting to look at because a lot of these people are more than 12 weeks post--that 7% , was that on S/O  or S/R ?  When I started, my Doc, who I have no respect for, played with his little round calculating wheel chart, after taking Interferon out of my treatment, gave me a 85% chance--so around April 1st I will be 12 weeks or so, so I will be watching for lots of post treatment's posts now.

[Bucky]

http://www.hepmag.com/articles/Olysio_Sovaldi_2501_25501.shtml?utm_source=mpnews&utm_medium=homepage&utm_campaign=treatment

DesertGuy, This was the information my IDS showed me back in the spring when we  started discussing S&O without ribavirin.
Bucky

[DesertGuy]

I was never shown anything!!--I blame myself for not investigating
ok-- I'm gen type 3  had a biopsy in 2006 showing cirrhosis---have known I had Hep c from 1986---could have contracted as far back as 1965 due to transfusion--never tried treatment--so anyone want to give me betting odds?

[Bucky]

Here is a link to BCBS of NC:  http://www.bcbsnc.com/assets/services/public/pdfs/formulary/harvoni_um_criteria.pdf



I wanted to add that BCBS has a disclaimer about drug use at the bottom of the page concerning the approval of Harvoni..

Bucky

[lporterrn]

Hi Everyone - Someone posted this to my blog (http://blogs.hepmag.com/lucindakporter/2014/10/harvoni_tips_for_navigating_insurance_prior_authorizations_for_hepatitis_c_treatment.html#comment-12346), and it is what I heard from someone else "in the know:"
I am a specialty pharmacist with deep experience working with providers and the insurance companies to get these drugs for my patients. Know that if you are denied by your insurance company for treatment with Sovaldi on two occasions, meaning your provider submitted the prior authorization and an appeal, but was denied on both occasions, you can apply for free Sovaldi from the Sovaldi Support Path program. Google it for info. A similar mechanism works for getting patients free Olysio from Johnson and Johnson. Know that these programs are partly income based, but if you submit a full application to each program you could bypass your insurance company entirely to get these medications supplied to you. There is currently as of this writing no way to get free Harvoni although this will probably change and Gilead will create a free Harvoni program modeled after the one for Sovaldi. Look up the programs and work with your medical provider to get the free drug if your insurance denied you. You stand a chance!

[Bucky]

I just emailed my IDS to see how many (if any) of her patients have relapsed after treatment with S&O. Her first group are now at 24 or more weeks post.
Bucky

[rainbowray]

Good Info, Lucinda

[Lynn K]

OK several questions from multiple people so here goes...

#7 rainbowray: As far as number of relapsed on med hep page a few not lots some were S/O some were S/R. But hardly a cross section of patients as many of us who have come on line to research have had hep c for a while and like myself are some of the hardest to treat. Even with that I remember the 1st person I read was treating in January 2014 was a null responder with cirrhosis and she made it to SVR. I have read that every one clears the virus on treatment although the one person on med help did not. Good luck to you I hope you make SVR the odds are in your favor.

#8 Bucky: My first test post treatment was at 12 weeks . Some people are testing at 4 weeks bet we did not. My viral load pre treatment was 2,065,760 IU/mL. At 12 weeks it was 2,422,260 IU/mL I was undetectable at 4 weeks into treatment and my liver functions went into normal range.

#14 Linda: My Support Path also shows Harvoni as well as Sovaldi so I would think they have all the same benefits for Harvoni that they have for Sovaldi

#12 DesertGuy: I looked up the Valence trial results for your genotype with cirrhosis for 24 weeks Sovaldi Ribavirin on page 27 on the prescribing information sheet https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf  it shows for treatment naive with cirrhosis 92% (12/13) and for treatment experienced with cirrhosis 60% (27/45) so it looks like you have a fighting chance there good luck I hope you make it.

Good luck everyone thanks so much for your comments I will check out your links another day.

Good luck in beating hep c

[Mike]

I discussed this topic with my GI (failing to achieve a SVR after treating with a Sovaldi-based regime). We discussed the next steps if this would happen.

Unfortuantly, there is not a next step for most, as there is no research or medical indication that a second treatment with Sovaldi would be anymore effective than the first. The other issue is that, since Sovaldi-based treatments are so new, there is no research on the impact a second round would have on the individual.

Because of this (lack of a medical treatment protocol for those who do not achieve an SVR with Sovaldi), the next step is most likely waiting for a new antiviral or a clinical trail studying the effectiveness of treating Sovaldi nonresponders/relapsers.

The good news is that new, more effective drugs will be brought to market in 2015 and beyond.

I know the wait can be tough; but it may be the only option at this time.

Best wishes, Mike

[2Blave]

Lucinda.
Thanks for all your support and input. Great info.

[Bucky]

Mike posted: "Because of this (lack of a medical treatment protocol for those who do not achieve an SVR with Sovaldi), the next step is most likely waiting for a new antiviral or a clinical trail studying the effectiveness of treating Sovaldi nonresponders/relapsers."

That information is listed on line five of BCBS treatment guidelines for Harvoni. http://www.bcbsnc.com/assets/services/public/pdfs/formulary/harvoni_um_criteria.pdf

I was so concerned about the fact that if someone had used Olysio then it was a 24 week treatment. I missed the most important fact that you pointed out.
Bucky

[2Blave]

Hi All.

Lynn, like you -I'm pretty new to site and blogging too. I am so sorry to hear you failed tx. Was wondering about the other 6-7 % who are not in the cured crowd. You're the first I've read about. Thank you for sharing your info. Just to be sure I understand, you were on S/O; cleared at 4 wks; completed tx. 12 wks after finishing tx not only did you relapse but your VL went up?
Also like you I've had concerns about insurance and pt. support if I fail or have to stop S/O tx. I am GT 1b, Stage 4 cirrosis. Was poor responder to I/R and had to stop tx before completion because VL didn't drop enough. Started S/O mid Sept. Had first VL drawn at 4 wks. Don't have results yet.
There's also some great info on this forum under Hep C Treatment, topic "Starting Harvoni" Tried to quote some of the posts but can't figure out how to do it.
At any rate, sending you best of luck.
Sending All blessings and healing thoughts.

[Bucky]

Found this http://www.gilead.com/news/press-releases/2014/4/gilead-announces-results-from-study-of-sovaldi-for-retreatment-of-chronic-hepatitis-c-in-patients-not-cured-with-prior-antiviral-therapy

Gilead states that it is beneficial for Geno 2 & 3.
Bucky

[Lynn K]

Hi all,

Mike actually at least 3 online friends of mine on MedHelp who were treated with Solvaldi at the same time as me have Harvoni in hand. They will be taking for 24 weeks.

My doctor after having discussions with different resources feels now that she will also prescribe Harvoni for 24 weeks for me as well. It is in the hands of Express Scripts at this moment.

I also found this link from United Healthcare for their Harvoni pre-approval protocol:

https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/en-US/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/Tools%20and%20Resources/Policies%20and%20Protocols/Medical%20Policies/Ox_MPUB_Future_Pharmacy/PA_Med_Nec_Harvoni_101414.pdf

One of the qualifying reasons for Harvoni for 24 weeks excerpt here from page 10:

"Patient has experienced treatment failure, defined as viral relapse/breakthrough while on therapy or non-responder to therapy, with a previous treatment regimen that included peginterferon plus ribavirin or an HCV protease inhibitor (e.g. Incivek, Olysio, Victrelis) plus peginterferon plus ribavirin or Sovaldi (sofosbuvir)"

I asked my doctor the same question when I started with Sovaldi Olysio. At that time she didn't think I would be given Harvoni if I failed. But now since I have failed and on further thought she has changed her initial opinion.

So who knows. I just know I need to be cured somehow and hopefully soon

Lynn

[Lynn K]

Hi 2Blave
 Have you looked at the Final Data from the Phase 2 COSMOS Study Simeprevir in Combination with Sofosbuvir (Sovaldi/ Olysio) Cohort 2? If not here is a link.

http://www.jnj.com/news/all/Final-Data-from-the-Phase-2-COSMOS-Study-of-Janssens-Once-Daily-Simeprevir-in-Combination-with-Sofosbuvir-Presented-at-The-International-Liver-Congress-2014-of-the-European-Association-for-the-Study-of-the-Liver-EASL

Yes the overall result was 93% SVR12 but if you drill down to patients without Q80K 88%, and METAVIR F4 (cirrhosis) it was 86% and after looking at different sites and as far as patients with cirrhosis on the cosmos trial taking Sov/Oly the re were only 14 patients so basically 12/14 made it to SVR12.

Here is some additional information about Sofosbuvir (Sovaldi) and other medicines from the University of Washington:
http://www.hepatitisc.uw.edu/page/treatment/drugs/sofosbuvir-drug

You can get payment assistance from Gilead's Support Path program you could give them a call they are very helpful and will advocate for you.

http://www.gilead.com/responsibility/us-patient-access/support%20path%20for%20sovaldi%20and%20harvoni

Also most patients have reported minimal side effects just mild headaches although Olysio has problems with sun sensitivity so you need to be careful with that. I personally can report I had no sides that I am aware of.

As far as my viral load increase I guess viral load can vary form day to day so I don't think (although I have not confirmed this idea with my doctor yet) that the change in count is what would be considered clinically significant.

Thanks for the tip on the "Starting Harvoni" thread I will have to check it out.

Good luck on treatment mat you have an easy time, complete a full weeks, and achieve SVR remember the odds are in your favor I just wasn't as fortunate as others but I hope this next treatment whatever and whenever it is will finally cure me as well.

Lynn

[Bucky]

Lynn,
Well, I am back on top of the roller coaster hill now. While I have not reached my 12 week post check up, my IDS told me when I did my work up after 12 weeks treatment that if I relapsed that "we" would do the med that was going to approved in the fall. At that time I don't think that it had a marketing name because she referred to it as Sovaldi and another inhibitor.
I saw where 24 weeks of Harvoni cost about the same as 12 weeks of S&O so it is going to be a battle especially with Express Scripts. Who was the insurance carrier for the three friends of yours that have been approved?
Bucky

[2Blave]

Hi Lynn.
Thanks for the info. I'm new to some of the lingo. Does SVR12 mean SVR after 12 weeks of treatment or still SVR 12 weeks after completing treatment?
Also, what is Q80K?
I understand the odds are in my favor and I am grateful. Was sorry to hear you were one of the unfortunate few.
Thanks also for the new sites you mentioned. Will definitely check them out. Will also check out MedHelp.
Am familiar with support path at both gilead and at jennsen. In both cases I had coupons for assistance within about 10 minutes. People at both places were professional, friendly and very willing to help. 
Thanks also to Bucky and Lucinda for their leads.
Blessings to all.

[Bucky]

2Brave,
SVR12 is twelve weeks post treatment. I see where now some consider you to be cured if UD at that time. When I started S&O in June SVR24 was considered cured. Things are changing so fast it is hard to keep up.
Bucky

[2Blave]

Bucky,
Thanks for the report posted. Just re-read it.
Got it. SVR12 means SVR 12 weeks after completion of treatment. Is this an industry standard terminology?
Also, seems all participants in this study were still using S either with Rib or S with Rib/PegI. I thought the goal was to get rid of both Rib and PegI because of their serious side effects.
Also I noticed that the GT1 group had no mention of cirrosis.

[Bucky]

Bucky,
Thanks for the report posted. Just re-read it.
Got it. SVR12 means SVR 12 weeks after completion of treatment. Is this an industry standard terminology?
Also, seems all participants in this study were still using S either with Rib or S with Rib/PegI. I thought the goal was to get rid of both Rib and PegI because of their serious side effects.
Also I noticed that the GT1 group had no mention of cirrosis.

2Brave,
You have it correct. SVR12 is 12 weeks post treatment (clinical standard) and all of us who used S&O without I&R did it off label. I think that fact is why there is a protocol problem concerning Harvoni.  I could see the insurance pushing for the results of SVR12 being cured to save the cost of more HCV tests.
Also the Q80K test was to check for resistant variant.
Bucky

[Lynn K]

About insurance one mentioned BCBC of California the other mentioned Kaiser.

One important thing to remember is even as expensive as these melds are they are less expensive to the insurance companies than a liver transplant and a lifetime of anti rejection drugs. Not to mention the costs of treating the complications of cirrhosis prior to transplant.

Q80K poly morphism is a genetic mutation that commonly found in GT1a patients. It has a substantial impact on the efficacy of simeprevir. My doctor did not test me for Q80K as the odds were still good for a cure and the result would not have changed the approach we taking at that time. Maybe could have had some explanation for my relapse. If I do have the Q80K variant, plus cirrhosis, plus 3 time null responder, and BMI 28.8. I would expect that all contributed to my relapse.

SVR means Sustained Virologic Response quoting from http://www.hepatitisc.uw.edu/pdf/evaluation-treatment/treatment-goals-predicting-response/core-concept/all

 "Durability of SVR: Long-term follow-up of patients who achieve an SVR24 has shown that 90 to 100% remain HCV RNA negative years after therapy. The largest studies have shown a minimal relapse rate, between 0 to 1%. Thus, a negative HCV RNA 24 weeks after antiviral therapy can be considered a virologic cure. The shorter duration SVR responses (SVR 12, 8, and 4) appear to have approximately the same validity as the SVR24."

I have read elsewhere that if you are able to achieve SVR12 there is a less than 1% chance you would test positive at 24 weeks post treatment.

I agree Bucky hard to keep up but at least the changes are good news!

Here is more good news from the above link:

"Impact of SVR on Survival and Natural History: In a study involving the general population, patients with advanced fibrosis who underwent antiviral therapy and achieved an SVR had reduction in overall mortality, liver-related death, liver failure, and hepatocellular carcinoma when compared with those who did not achieve an SVR. Most of this survival benefit resulted from the marked reduction in liver failure."
Lynn

[Bucky]

LynnK,
I wasn't checked for Q80K polymorphism either.
Bucky

[Mike]

That's great news! I discussed this with my GI in March. I'm glad Sovaldi relapse/nonresponders can get a second chance at treatment. This is great news.

But what's even better is that the insurers are willing to pay for a second round!!!

I'm so glad to hear this.

Best, best wishes Lynn

Mike

[Bucky]

Received this from my IDS:

Nobody has relapsed so far, but many patients still are in the waiting period.

----- Message -----
 From: xxxxxxxxxxxxxxxx
 Sent: 10/24/2014 11:22 AM EDT
 To: Marina xxxxxx, MD
Subject: Non-Urgent Medical Question

Hello Dr. xxxxxx,
I was wondering if you have had anyone relapse after treatment with Sovaldi & Olysio? One person posted on the site I visit that she had relapsed, so they have started a thread to find some information on this subject.
Thank you,
xxxxxxx


SVR24 is still the clinical standard they use at my hospital to be considered cured.
Bucky

[badbradley]

Hello all,
   Geno type 1A Q80K polymorphism resistant variant considerations are for combination regimens involving riba/interferon  - as far as I can tell.
**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
   I have read this in other places as well. Can anyone else confirm?
                                                      Thanks  -  Have a great week!!
                                                                         Bad Brad

[Lynn K]

The Q80K polymorphism primarily has an impact on the effectiveness of Olysio so patients considering the on label usage of Olysio need to be tested for Q80K.

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.

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

"**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." 

Also from Janssen (Johnson & Johnson)

http://www.jnj.com/news/all/Final-Data-from-the-Phase-2-COSMOS-Study-of-Janssens-Once-Daily-Simeprevir-in-Combination-with-Sofosbuvir-Presented-at-The-International-Liver-Congress-2014-of-the-European-Association-for-the-Study-of-the-Liver-EASL

Looking at the table for cohort @ of the Cosmos study overall Sov/Oly (Sofosbuvir/Simeprevir) SVR 12 was 93% with or without Ribavirin, but for patients without the Q80K polymorphism the results were 88% without Ribavirin and 93% Ribavirin.

However in cohort 1 results:
"Previously presented data from cohort 1 demonstrated that 93 percent and 96 percent of patients with METAVIR F0-F2 scores treated with simeprevir and sofosbuvir with or without ribavirin, respectively, for 12 weeks achieved SVR12."

and

"In genotype 1a patients with the Q80K polymorphism at baseline, 89 percent and 83 percent achieved SVR12 after 12 weeks of treatment with and without ribavirin, respectively."

So it does seem the the Q80K polymorprism does hav some inpact on treatment with Sovaldi Olysio perhaps due to Olysio not being as effective.

I hope that, as Ledipasvir is not Olysio, by treating with Harvoni I will be successful. As I have said I don't actually know my Q80K status but based on my results I am assuming it may have been a factor in my relapse.

Loking at the med help post SVR or Relapse which asked folks to post their status of treatment

http://www.medhelp.org/posts/Hepatitis-C/SVR--or-Relapse/show/2281769

Just looking for Sovaldi based treatment result reports (either with Sov/Oly, Sov/Oly/Riba, Sov/Riba, Sov/INF/Riba, Sov/Ledi) I made this anecdotal tally:

Sov/Oly = total 10 reports: 8 SVR, 1 relapse, 1 no response
Sov/Riba = total 6 reports: 4 SVR, 2 relapse
Sov/INF/Riba = total 6 reports:5 SVR, 1 Relapse
Sov/Oly/Riba = total 1 report: 1 SVR
Sov/Ledi (Harvoni) trial = total 1 report: 1 relapse

at least as best as I can count on my fingers and toes :-)

Lynn

[Lynn K]

I received this from my doctor via My Chart. I asked if I was the only failure:

"You are not the only unlucky one. I talked about your case (no names) with Gilead and they've retreated sofosbuvir failures with Harvoni and had cures. We did agree that 24 weeks is probably advisable."

Lynn

[Bucky]

Sov/Oly = total 10 reports: 8 SVR, 1 relapse, 1 no response
Sov/Riba = total 6 reports: 4 SVR, 2 relapse
Sov/INF/Riba = total 6 reports:5 SVR, 1 Relapse
Sov/Oly/Riba = total 1 report: 1 SVR
Sov/Ledi (Harvoni) trial = total 1 report: 1 relapse


Hello Lynn,
According to the above it doesn't look like we have a clear winner. What a roll of the dice!
Bucky

[Lynn K]

Well like I said this is just what others are reporting and some of the relapse patients are more ill then the ones who made SVR.

I know one was a many time null responder GT 1a who had a liver transplant and now has cirrhosis again to include major HE so he is a very ill person. He pelapsed on Sovaldi Ribavirin.

I was the 1 relapse on Sov/Oly that reported in.

Ya rolls da dice ya takes yer chances.

But at least we have chances we did not have last year. My only option for the last 7 years was to wait to decompensate and get on the transplant list.

I like my odds much better now
Lynn

[rainbowray]

Prayer could also be a great assistance to us all who are on treatment.

[Bucky]

Well like I said this is just what others are reporting and some of the relapse patients are more ill then the ones who made SVR.

I know one was a many time null responder GT 1a who had a liver transplant and now has cirrhosis again to include major HE so he is a very ill person. He pelapsed on Sovaldi Ribavirin.

I was the 1 relapse on Sov/Oly that reported in.

Ya rolls da dice ya takes yer chances.

But at least we have chances we did not have last year. My only option for the last 7 years was to wait to decompensate and get on the transplant list.

I like my odds much better now
Lynn

Lynn,
I had to rethink my reply. Although this is a small sampling with all things looking fairly equal, I must move the option with interferon to the bottom of the list as far as intolerably. It is great to have some choices. I was also wondering if everyone ate before taking Olysio?
----------------------------
• One
150 mg
capsule
taken
once
daily
with
food.
(2.1
Disclaimer: I know that these weren't listed by a clinical preference.
Bucky

[Bucky]

Prayer could also be a great assistance to us all who are on treatment.

Everyday!
Bucky

[Lynn K]

I assume they ate with the Olysio I know I ate something. I do remember wuite a few posts about what time to take the meds and what to eat and what to do if you decide to change the time from morning to later or later to earlier so I know eating with Olysio was part of their plans.

Interferon yup been there done that not fun. They won't let me take interferon now as I have cirrhosis and it could cause me to decompensate. So interferon is definately off my treatment menu.

Lynn

[Bucky]

I assume they ate with the Olysio I know I ate something. I do remember wuite a few posts about what time to take the meds and what to eat and what to do if you decide to change the time from morning to later or later to earlier so I know eating with Olysio was part of their plans.

Interferon yup been there done that not fun. They won't let me take interferon now as I have cirrhosis and it could cause me to decompensate. So interferon is definately off my treatment menu.

Lynn

I gained about 10lbs during treatment from eating so much before taking my meds. I see where Harvoni can be taken with or without food.

Bucky

[badbradley]

I gained about 10lbs during treatment from eating so much before taking my meds. I see where Harvoni can be taken with or without food.

Bucky

Its good you've taken up running then, perhaps. I always wondered what you looked like.                     Bad Brad

[Bucky]

Its good you've taken up running then, perhaps. I always wondered what you looked like.                     Bad Brad

LOL @ Badbradley!

[DesertGuy]

Lynn thanks--but please explain a little better to me please--I am confused--don't know if I am looking at a 60% chance or 93%--

[Lynn K]

Hi Desert Guy

OK what I posted before:

"I looked up the Valence trial results for your genotype with cirrhosis for 24 weeks Sovaldi Ribavirin on page 27 on the prescribing information sheet https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf 

it shows for treatment naive with cirrhosis 92% (12/13) and for treatment experienced with cirrhosis 60% (27/45) so it looks like you have a fighting chance there good luck I hope you make it."

So to clarify, for GT3, with cirrhosis, treatment naive, (that is your group as you have never treated you said) the results were 92% but there were only 13 patients in that cohort so 12 out of 13 cleared the virus.

If you are GT3 with cirrhosis and have treated unsuccessfully in the past 27 patients out of 45 patients 60% were able to beat the virus.

But statistics are statistics, which side of the stats you will fall in you'll know when you get there.

My stats were 86% but I didn't make it. Yours look like 98% but with such a small group who knows. But even if it is 60% still much better chance of a cure than anything that was previously available.

Just think positive that you will make it to the other side of being free from Hep c

Good luck
Lynn

[DesertGuy]

Thanks---best explanation so far!!!!!

[rainbowray]

Desertguy,

Because you were undetected early in treatment, your chances of cure are
more stable.  93% + is pretty darn good.
Hope your brother is doing ok.

[DesertGuy]

Thanks for asking--The trip did me good,  made me do a 180 on my attitude.
The riba rage --I could not keep under control. Tried but sure said things. I have 2 nephews that sure know their uncle better. Yep my brother is dying . he called his lung disease IPS, I think--terminal. But  being depressed I know where he is.
A wild story---middle afternoon Saturday my brother returns to where his boys and I are sitting. Looks at all of us--tells us what is on hi mind.
Makes the offer for him and I to step around the corner and , him and I shoot each other with his pistols. WOW!!!!!!!!!!!He was serious-------not going to tell where the conversation ended--but my mind sure went spinning.
After spending a sleepless night--many thoughts --many tears--and a very tense next day I'm home.
I'm a man's-man. I say things on my mind. I left my brother and his sons with this story of the day my father died and have never told.
He died of a blown aortic aneurism. He knew he was gone, but still fully aware and together. He stood up fully dressed, put his hat on, tipped it just right, and reached down and grabbed his balls, put a semi smile on his face and walked to the car.
Gone within a few hours--went out like a man!!!!!!!!!!!!

[rainbowray]

Sorry about your brother, keep an eye on your nephews cause their going to need some support.
I recently visited an old friend that was in a coma after emergency surgery. He has hepc too. They said he was going to be a vegetable, his brain was swollen, and he was in a fetal position. I prayed while on the way there, and I was with another old friend. We were like the pack rat, so we walk in, the sick friend opens his eyes in front of the family and says, what the hell are you assholes doing, what a bunch of chumps. He was thirsty, and we stayed with him for about  4 hours. I prayed with him and he was very thankful. Before we left, I noticed him moving his legs. They said he would never walk. He calls me the other day, he is home and driving to the Dr. for follow up. I tell you prayer works, in Jesus name.
The Drs. are fallible, as we know. I have been talking with this guy for the last 7 months to get treatment for the hepc, Kaiser keeps denying him, cause they think he is still a junkie, but we know its the money. But Kaiser waited till emergency was needed, and in my mind were writing him off. God has different plans, he loves the sinner.

[DesertGuy]

Amen

[elizabethfaraone]

Were you tested for the Q80K polymorphism?  Olysio is not effective in treating that genetic mutation of genotype 1a.  I am genotype 1a and I have the Q80K polymorphism.  I was undetectable four weeks after starting Harvoni.  I completed 12 weeks a week ago and remain undetectable.  I'm otherwise healthy with no fibrosis.

[Lynn K]

Hi Elizabeth

Not sure who you are commenting to about Olysio and Q80K but if it was me I have not been tested for Q80K of IL28 allele either.

I did ask my doctor about treating with Sovaldi and Olysio and should I have the Q80K test. She felt it was not needed as there is little to no effect of Q80K on Sov/Oly and that as I had no better option at that point it would not affect her treatment choice for me.

I am assuming you are asking in regards to Sov Oly tx for someone looking at the Olysio treatment yes they need to be tested for Q80K but I don't think anyone is on that tx

From my post above from Oct 26th

"The Q80K polymorphism primarily has an impact on the effectiveness of Olysio so patients considering the on label usage of Olysio need to be tested for Q80K.

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."

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

"**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."

In other words for those treating with Sovaldi Olysio there is no reason to test for Q80K

[dragonslayer]

Re the IL28B allele, CC is the favored type.. This was a big deal when treating with Interferon.   I have the very common TT result which is considered decidedly unfavorable for Interferon treatment, and, is more common, naturally.   Interestingly, everybody who failed Harvoni treatment had the NON favorable CC type.. But even more interestingly, so did 73% of the entire arm being treated... Same thing with the NS5A resistance... All who failed had that resistance, but, so did 80% of the entire treatment arm; this according to the Gilead FDA filing doc for Harvoni as can be seen here:

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205834Orig1s000MedR.pdf

[Lynn K]

But as they say it is all in the past I failed interferon, I failed interferon Ribavirin, I failed Sovaldi Olysio. Hope I hve better luck with Harvoni 24 weeks plus riba

[chino1969]

Hi Lynn.
I was on Solvadi/Olysio from April to July 2014 (12 week course of therapy).  I was SVR at 4 weeks as well as 12 weeks.  My liver chemistries were all normal. Two months later the Hep C was back.  I was denied coverage a second time because the insurance company said that I was previously treated with Solvadi and denied Harvoni.  My Dr. appealed and my case was reviewed by The Medical Review Institute of America (www.mrioa.com).  The MRIOA overturned the denial and I was approved for a full 24 week course of therapy with Harvoni.  I just completed my 2nd week.  I do have cirrhosis.  At any rate, don't take a denial as the end.  Appeal it and fight it.  Contact the MRIOA if you have to in order to find out how to get them to review your case.  In my situation, the review and overturn of denial was automatic.  Good luck. 

[Lynn K]

Hi Chino

When I first joined the forum last fall I was fighting to get Harvoni. After a lot of time on hold and some emails I was approved and started taking Harvoni on November 18th for 24 weeks. I talked to my doctor about adding Ribavirin based on my past treatment history. After getting the riba approved I started it at week four of Harvoni tx.

I will be finishing week 16 of Harvoni treatment on Monday 3/10 I have & weeks and a few days left and will be taking my last meds on May 4

Good luck on treatment