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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
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
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
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
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
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
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.
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
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.
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
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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