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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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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
Helpful - 0
Avatar universal
Excellent! Perfect post. Worth rereading.
Helpful - 0
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.
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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.
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