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683231 tn?1467323017

Why do some fail Sovaldi Olysio?

I am curious if anyone knows why some of the patients taking Sovaldi Olysio failed to acheive SVR?

The Cosmos trial numbers look great 93 or so to 100 percent make it to SVR12 but what about the 7 percent who relapsed?

Just nervous I guess. I have 12 days to go on the 12 week treatment. I'm 3 time null responder GT 1a with cirrhosis and hella hoping it works this time.

Best wishes to all my fellow heppers and their supporters,
Lynn
Best Answer
446474 tn?1446347682
((Sorry everyone for the long winded post but for those interested here is the 2nd part.))

For Sovaldi/Olyio COSMOS trial cohort 1
(Treatment naive and null responders with F0-F2 liver disease)  

Factors Predictive of Response to Simeprevir Plus Sofosbuvir:
After excluding patients with nonvirologic failure, subgroup analysis identified factors associated with lower SVR12 rates

* Genotype 1a HCV with Q80K variant present at baseline
* IL28B TT genotype

All 3 patients who relapsed after end of treatment had genotype 1a HCV with Q80K variant at baseline and IL28B TT genotype

Viral kinetics profiles in these patients fell within ranges observed for patients who attained SVR12" (Meaning the RVR makes no different in outcome). Or as the study report states it "After excluding patients with nonvirologic failure, subgroup analysis found no relationship between RVR and SVR12"

(Since F3 or F4 candidates were excluded from the trial we have no data on the difference between SRV rates and cirrhosis vs non-cirrhosis as we do in some of the Solvaldi phase 3 trials).
---------------------------------------------------------------------------------------
COSMOS Cohort 2: 12-24 Weeks of Simeprevir + Sofosbuvir:
Treatment-naive patients and previous null responders with genotype 1 HCV infection and METAVIR F3-F4 fibrosis

The trial only contained 87 patients and so data is limited. Further phase 3 studies will be done to learn more about this treatment is those with advanced liver disease.

In this study no common factors could be found among those who relapsed.

" * Analysis of 3 patients who relapsed after end of treatment (EOT) identified no common factors predictive of relapse
* All patients completed study therapy and had undetectable HCV RNA at EOT period
* Viral kinetics revealed HCV RNA for relapsers decreased to within or below ranges observed for patients who attained SVR12"

Remember we have made tremendous progress in the last few years and treatments have never been more effective and safe. Because of these new breakthroughs in treatment many will be saved from having to advance to cirrhosis and suffer with liver failure or liver cancer and need to have liver transplants to continue living. A great deal has already been accomplished. Unfortunately we aren't at the point were everyone of us can be cure just yet. Hopefully soon very soon. While it is appropriate to be excited about the new options we all have now... Believing that we all have a 90% chance of cure no matter what our genotype or history of liver disease could be very disappointing for the minority that will fail. I believe we all should be hopeful and positive but realistic about our real chances of SRV. Maybe sharing the real SRV data would be more helpful than saying because you are undetectable at week 4 or end of treatment you will be cured for sure because that is just no true no matter how much we would like it to be.

Newer and better treatments will be coming soon so for most people there is always a fall back plan. A chance to retreat with better treatments. For those with advanced cirrhosis and liver cancer there is hope also. We still have liver transplantation which has never had such good outcomes and with the new hep C treatments even us, the hearest of the hard to treat have more hope than ever for curing our hep C post transplant. We won't have only a 30% of cure our hep C post transplant as others did only a few years ago. Yes, we have an excellent chance of being the first group of hep C transplant patients to live as long as others transplanted for other liver diseases for the very first time. Truly a brighter future lies ahead for all of us no matter what out particular medical situation is.

Lynn, I hope this at least stimulated thought about where we have been, where we are now and where we are headed with treatment. And particularly pointing out some of the challenges for us folks who are the more difficult to treat. We have come a very long way already but we just aren't where we want and need to be. Not just yet. Luckily the near future holds great promise for all of us. We just have to hang tough, do what we need to do while accepting where we are today, and knowing and believing  that tomorrow while be a better day for all of us.

Hector  




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317787 tn?1473358451
I would like to say once again how sorry I am for your loss.  From what I remember your Mom just died this past year so it has not been very long.
I would be very sad if I were you.  
Take Care
Dee
Helpful - 0
683231 tn?1467323017
Her medical problems and from what  understand having once had cancer there are long term effects from fighting such a terrible illness and the effects of the meds as well after cancer and chemo one is seldom the same.

I also have lost both my parents a year apart and basically as a result of smoking they passed away in 1985 and 1986 they were both 72 years old.

It does take time to heal from the loss of your parents but as they say time heals all if you will allow it.

I hope you can allow time to do its work and allow your self to heal I cannot imagine how difficult is is to have such an aching wound in your heart for so long.

Peace to you
Helpful - 0
Avatar universal
"and my mother's other problems", what problems do you speak of?  
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Avatar universal
Prior to Solvadi & Olysio, other than hepatitis C, she didn't have any medical issues.  Yes she was a cancer survivor from years earlier that was completely in remission.  Her Waldenstrom was presented two days before her death, as a result of the medicine we believe. She was completely healthy before she took Solvadi & Olysio.

Your post asked about failure, my mother's death was certainly a failure.

I'm glad it was a godsend for people, they are truly lucky, my mother was not one of them.

and I will never find peace, but I will tell her story until the day I die.
Helpful - 0
683231 tn?1467323017
Sorry about your loss of your I believe you have previously posted she had other underlying medical conditions didn't she have Waldstrom Cancer?

Perhaps her other medical conditions like being a survivor of lymphoma and her advanced age may have caused an increased sensitivity to Sovaldi that most do not experience

I know you are still struggling with your loss and sadly your mothers other problems were not found in time

Many have cured of hepatitis c who had no hope for a cure for decades. So for those patients Sovaldi was a god send I am sorry it did not work out that way for your mother.

I hope you can find peace
Lynn
Helpful - 0
Avatar universal
not sure, but it killed my mother... I'd say it sure failed there.
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Avatar universal
I am UND at 12-week EOT with cirrhosis. My transplant team does not consider it a cure until 24-week EOT lab when you have cirrhosis, but they say most relapse soon after EOT. I have until 5/1/15 to know for sure. I failed 3 treatments also, including Incivek which showed UND until 2 weeks after treatment and it turned positive immediately. Null-responder on the others.
Helpful - 0
683231 tn?1467323017
Hi

I was found to have relapsed at my 12 week post treatment test in September.

I am currently treating with Harvoni for 24 weeks plus added ribivirin part way into treatment.

My case is more difficult than many. I failed treatment 3 times as a null responder to interferon based treatment. I was diagnosed with cirrhosis in Jan 2008. So all that makes me more difficult to cure which is why I asked the initial guestion last year about failure because I was worried about my odds based on my treatment history.

Many are curing with Sovaldi and Olysio but kinda surprised they are not treating with the newest med Harvoni. But the odds either way are in your favor.

Good luck
Lynn
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Avatar universal
Excellent! Perfect post. Worth rereading.
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Avatar universal
Hi, my name is Sherry. I started the S/O treatment today. I was curious if you have been cleared of the virus. I found out that I have this in June. Many test, biopsies and tears I have finally began treatment. I lost my mom in 2008 from Hep c complications so I am really hoping for success. I hope all is well with you and you are living a happy life.
Helpful - 0
Avatar universal
Hector,
Fyi I am 3 years post transplant  Sept 2011 genotype 1b hep c for 40 years. Liver cancer ablation Dec 2009  F2. treatment naive. Started Solvaldi/Olysio 1 Feb EOT 28/Apr SVR20 and counting. Received transplant and tx in SF.
Helpful - 0
10560775 tn?1411052744
As one of the failure of Sovaldi, I am 5 weeks out of a 28 week treatment.  Disappointment is the hardest right now.  But my liver enzymes are still low, and my Dr said new treatments are on the way so to stay hopeful.  I worked throughout the entire 28 weeks to keep my insurance to pay for the treatment and the hardest was the nausea at work and sleeping 14 hours a day just to get to work.  I have been looking for the "what next" drug but have found very little info on it.  If anyone has any information please let me know.  My liver is in stage 4.
Helpful - 0
Avatar universal
Hi Hector,
Just finished reading your May post saying you had liver cancer and a liver transplant...and relapsed HepC treatment. I have gone the same route and just learned that after 5 weeks since 12 weeks - EOT with Sovaldi and Olysio, my liver enzymes are going back up. ALT is 280, AST is 208 and A: is 134. You wrote that you weren't very worried about further HepC liver damage to the new liver...while waiting for new meds options. Can you say anything more about that. Not sure if I should try another 12 weeks (if that is even an options), wait for additional treatment options or??? Thanks for your posts.
Mike
Helpful - 0
683231 tn?1467323017
Hi Tommy

The treatment I was on was only Sovaldi and Olysio. No interferon and no Ribavirin. Looks like success has been in trials about a low of 88% and as high as 100%.

Hopefully to be approved by the FDA this fall is a single pill combo of Sovaldi/ Ledipasvir.

I was diagnosed in 1989 with GT 1a and was a 3 time null responder. Since I have cirrhosis I have a need to bu cured as soon as possible so that was why I treated as soon a I could. Hopefully I will be SVR in Sept

Good luck
Lynn
Helpful - 0
Avatar universal
I'll wait until they can achieve 100% before I take any treatments. I was diagnosed in 2003 and have been successful in reversing all of my liver damage at home. My viral load is very high but my liver is completely normal according to my liver doctor. Hopefully science will achieve 100% cure rate for genotype 1-a. I wish you all the best. My problem is I'm very susceptible to rage when taking medications. So the interferon treatments are out of the question for me. In order for me to try this new treatment I would have to make arrangements to live alone until I completed any treatments. This would be very costly for me so I need to be very sure. When they have a treatment that cures everyone, then I'll make arrangements.  
Helpful - 0
683231 tn?1467323017
Nothing as fancy as a champagne glass but I gave the last dose a kiss for luck then they were on their way into the battle. And so now the 12 week for hopefully SVR begins for several here good luck to the waiting ones
Helpful - 0
7469840 tn?1409845836
Hi Hector, I don't know if you saw my posts in other areas, but I was UND at 4 weeks EOT. Blood levels are all back within normal range, though my ALT was 10 (low), but my AST was 19. My doctor said the week 4 test was a good indicator of SVR, but I will be relieved after my 24 week EOT test.
Helpful - 0
Avatar universal
Waiting for you now.....I do think your 4 days are up!   Enjoy that final pill cause I think it will be your last..       Kim
Helpful - 0
Avatar universal
I will toast to you (minus champagne) many awesome virus free years ahead. You made it and are now in our new group "The Waiting Warriors" and soon to be SVR we did it group. Welcome and cheers..        ..Kim
Helpful - 0
Avatar universal
Congratulations!!!  Wishing you an SVR and good health.

Those still in treatment and us waiting, an old WWII phrase comes to mind:  'Praise God and pass the ammunition', in this case our precious Meds.
Helpful - 0
Avatar universal
Thats great news. Huge milestone. I mean, each of us has a check list whenever we are faced with things we need to get through. As patients, as people living our daily lives as best we can...I guess we have alot of checklists...but this line item in the HCV checklist is one we all go through at least once after many steps have already been checked to get to this step (if we choose to treat)...Cheers/Congratulations!



.
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683231 tn?1467323017
Wow what a great idea! A toast to a long and healthy life!

I am sure I won't be quite that creative but here's to you me and all dragon warriors out there may we win this fight.

Like the singer says "you're gonna hear me roar!"

Lynn
Helpful - 0
6708370 tn?1471490210
I'm done!!

I put my last Sovaldi pill in an elegant martini glass and made a toast - Buh Bye Hep C! Hello SVR! (fingers crossed) Took photos and sent to my friends who have been cheering me on with the message - I think I'll take the last pill of this $ 84,000 treatment. Thanks Kaiser!

A little strange to not have that ritual of taking those pills at the same time every day but I'm getting used to it

I convinced my doc to order a viral load test at 4 weeks too. He agreed that if it made me more comfortable to not have to wait an entire 3 more months, I could have the labs done post 4, 12 and 24 weeks. Everyone in the department seemed super confident of my success so that was encouraging

Looking forward to some renewed energy and I am so grateful that the stars aligned so that I was able to participate in this new regimen

Couldn't have done it without the support and knowledge that I received from this group

Thanks

Helpful - 0
Avatar universal
4 day dance, or is it 3 now!!
Xoxo CH
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