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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
OK I admit it. I joined the compulsive bandwagon the last six weeks of treating. Then double checked the calendar a few times just to be sure the pills matched the date. The last one in my hand was the best.............Kim
I started counting on the last week too, and taking photos of them and in art work,
Which I did it all the way throught tx would have been a nice series
Xoxo
Ch
Which I did it all the way throught tx would have been a nice series
Xoxo
Ch
Hi Hepc
I thought I was being compulsive I've been doing the same thing lol. Counting my pills every day to make sure they end on next Tuesday 5 more of each whoopie!!!
I dont think the 4 week post would be really meaningful just us being anxious to know I think. But 4 weeks post wouldn't mean anything if undetectable and if detectable I guess I could wait for 12 weeks to hear that news.
Looks like you are done counting on the 6th tomorrow congrats! Guess you will know about the same time as I do. Come on September.
Hope you get to change your name from hepcandme to hepcfreeisme!
Lynn
I thought I was being compulsive I've been doing the same thing lol. Counting my pills every day to make sure they end on next Tuesday 5 more of each whoopie!!!
I dont think the 4 week post would be really meaningful just us being anxious to know I think. But 4 weeks post wouldn't mean anything if undetectable and if detectable I guess I could wait for 12 weeks to hear that news.
Looks like you are done counting on the 6th tomorrow congrats! Guess you will know about the same time as I do. Come on September.
Hope you get to change your name from hepcandme to hepcfreeisme!
Lynn
I'm no scientist, but I want to point out that all meds don't work on all people. Case in point, look at what has happened with antibiotics and how now, we have superbugs that don't respond to certain antibiotics. Sometimes, some of these people may have accidentally, taken their meds with some other medication that affected their absorption of the Sovaldi or the Olyssio. Or maybe they could have not been consistent on taking the meds around the same time every day? Or maybe they were drinking alcohol (secretly) during the treatment? Since we don't know the patients involved personally, it is so hard to say why? I've asked that question about why I have never cleared on all my attempts of treatment. As far as getting tested for the phenotype or the Q variant thing. My doctor when I asked him about it, said it was an expensive test and did not feel that it would change what treatment decisions him and I decided on together. I certainly don't have the money to run out and get these tests out of pocket. The current regimen that I am still waiting to get an answer on-that my doctor has prescribed will be the Sovaldi, and SOC. No Olyssio for me, so the Q variant thing is not an issue when not using the Olyssio. I am still waiting to find out if my insurance company will approve the preauthorization. Yes, for a change, I am NOT doing a trial. My husband's insurance covers these meds, IF you pass the preauth process. I should be getting an answer in the next week, I hope. I used to have 1A and 1B and somewhere along the way with one of these treatments, I lost the 1B and for the past 7 yrs, have just had 1A. I am still a low stage on my biopsy from 4 yrs ago and my doctor didn't think that I needed to get another one, because once again, I had already decided that I wanted to do the Sovaldi, so he decided it was unnecessary. Now, if I fail at this treatment, in about a year, I will need another biopsy to see where I stand. He's been staying regular with my LFT's and just did my viral load and he does all those other regular liver/kidney type of labs and ultrasounds, too. I definitely still have this, but it hasn't been progressing that fast, which is good. My viral load from 3 wks ago was 2.16 million, AST 78 and ALT 63. Liver still enlarge on ultrasound. Well, didn't mean to go on and on for a simple question, but it's easier to just put it out there in one post. Susan400
I thank all of you (especially you, Hector) for this informative thread. I reached SVR on the triple, so have not been much of an active participant as of late. However, I need to learn all of this now to advise my brother who needs to treat. These new treatments make it possible for so many more to treat and work and live at the same time.
bean
bean
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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