Aa
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
Your almost done! Hang in there! I wish you all the luck.
Sorry I dont know why that 7% doesnt achieve SVR but im sure someone on here will have an answer.
I just finished meds 2 days ago GT 1B hope i get SVR we will see..............
Sorry I dont know why that 7% doesnt achieve SVR but im sure someone on here will have an answer.
I just finished meds 2 days ago GT 1B hope i get SVR we will see..............
Lynn, correct me if I am wrong, but didn't all the 24 week S/O recipients achieve SVR? Seems as though GT1a F4 would be a candidate for 24 weeks of therapy. Maybe the absence of resistance associated variants or prior telaprevir exposure means you don't need the extra 12 weeks, but I'd check with the doc before meds run out.
Thanks for the suggestion to contact my doctor to be sure.
I guess I am doing treatment per the AASLD guidelines:
"Recommended regimen for HCV genotype 1 PEG/RBV (without an HCV protease inhibitor) nonresponder patients:
Daily sofosbuvir (400 mg) plus simeprevir (150 mg), with or without weight-based RBV (1000 mg [<75 kg] to 1200 mg [≥75 kg]) for 12 weeks is recommended for retreatment of HCV genotype 1 infection, regardless of subtype or IFN eligibility"
I was not tested for either Q80K or IL28B but have never done the triple combo with Telaprevir as I already had failed 3 times and had cirrhosis by the time it was available so odds weren't good for it to work.
Thanks again
Lynn
I guess I am doing treatment per the AASLD guidelines:
"Recommended regimen for HCV genotype 1 PEG/RBV (without an HCV protease inhibitor) nonresponder patients:
Daily sofosbuvir (400 mg) plus simeprevir (150 mg), with or without weight-based RBV (1000 mg [<75 kg] to 1200 mg [≥75 kg]) for 12 weeks is recommended for retreatment of HCV genotype 1 infection, regardless of subtype or IFN eligibility"
I was not tested for either Q80K or IL28B but have never done the triple combo with Telaprevir as I already had failed 3 times and had cirrhosis by the time it was available so odds weren't good for it to work.
Thanks again
Lynn
You are voicing what we are all wondering and fearing. Will we be in that wonderous 90+% group that reaches SVR, wondering if we could have... would have... should have... done anything differently.
Yeah exactly...
and what are those things so we can either do them or not do them
That is the question but I guess I will find out in 14 weeks
Best wishes to all
and what are those things so we can either do them or not do them
That is the question but I guess I will find out in 14 weeks
Best wishes to all
someone finally said it out loud!
or typed it
I have wondered the same thing
But I am reading a book by Bill Moyers called Healing and the Mind and it made me realize how much a positive attitude and community plays in one's health
The book doesn't discount western medicine at all but does point out the disconnect that I am certain we all have felt at times between modern medicine's ability to tackle really tough medical issues while ignoring other things that are going on with the person who is ill
Differentiates between the disease and the illness (illness is how one manifests and deals with disease)
Having a friend or family member come with you to a doctor's visit is not only good for healing but forces medical professionals to see you as a person, not just an illness
There is scientific evidence to support this notion of strong community and family bonds that promote healing. Belonging to a support group is enormously beneficial because knowledge makes us more confident and less afraid of what we don't know. Sharing symptoms, triumphs and tribulations all connect us to one another
Highly recommend the book
But back to the 7%. I keep telling myself that there is not enough data for this new regimen to accurately predict that 7% relapse number
Good luck to all. Keep sharing so we can be inspired and made stronger by your success
Just one more week for me!
or typed it
I have wondered the same thing
But I am reading a book by Bill Moyers called Healing and the Mind and it made me realize how much a positive attitude and community plays in one's health
The book doesn't discount western medicine at all but does point out the disconnect that I am certain we all have felt at times between modern medicine's ability to tackle really tough medical issues while ignoring other things that are going on with the person who is ill
Differentiates between the disease and the illness (illness is how one manifests and deals with disease)
Having a friend or family member come with you to a doctor's visit is not only good for healing but forces medical professionals to see you as a person, not just an illness
There is scientific evidence to support this notion of strong community and family bonds that promote healing. Belonging to a support group is enormously beneficial because knowledge makes us more confident and less afraid of what we don't know. Sharing symptoms, triumphs and tribulations all connect us to one another
Highly recommend the book
But back to the 7%. I keep telling myself that there is not enough data for this new regimen to accurately predict that 7% relapse number
Good luck to all. Keep sharing so we can be inspired and made stronger by your success
Just one more week for me!
That is a very good and very complex question. I will try my best make a stab at assessing what we know now about the new treatments, how things are the same and how they are different than previous interferon based treatments that many are familiar with and how this how and why people fail new Sovaldi based treatments.
First let's point out that the statement "93 or so to 100 percent make it to SVR12" is very misleading and is often believed by many that this applies to their particular case of hepatitis C regardless of other factors. Unfortunately this is not the care.
In fact the study data from COSMOS 2 cohort results for those with cirrhosis were 88%. Not much different but nowhere near 100% often claimed.
These 90% numbers get posted all the time around as fact as though they apply to everyone which simply is not the case. This is especially true when people use these figures from the original Sovaldi/sofosbuvir trials that only included treatment naive candidates assuming that these will be the SRV rate for treatment experienced patients and cirrhotics as well. Even the trial reports state this is not the case yet no one mentions it.
For example treating with SOVALDI + Peg-IFN alfa + RBV 12 weeks in the NEUTRINO study had
Overall SVR - 90% (295/327)
SVR in those having cirrhosis - 80% (43/54)
With even more host factors included we see more disparity between the toted 90+ % overall SVR rates and those with particular host factors...
Genotype 1, Metavir F3/F4 fibrosis, IL28B non-C/C, HCV RNA >800,000 IU/mL - 71% (37/52)
--------------------------------------------------------------------------------------------------------
First let's go over some of the basics we have learned from trial data in treating thousands of patients with Sovaldi based treatments.
* All people that treat with Sovaldi treatment become undetectable on treatment. (Unlike previous null responders with peg-INF/RBV treatments)
(When treating with SOV/Olysio whether or not someone is undetectable by week 4 has no correlation to who will achieve SRV.)
* There are no viral "breakthroughs" (As could happen with peg-INF/RBV treatments)
(The point being that all people will become undetectable and STAY indetectable as long as they are treating. Meaning at week 12 or 24 or 48 for that matter everyone in undetectable.)
* Therefore everyone who fails SOV/Olysio this treatment does so by relapsing after stopping treatment. (excluding those that aren't compliant with taking their meds properly)
With previous treatments the focus was on IF and WHEN someone became undetectable as they were predictors of SRV and if they had a viral breakthrough before completing treatment as well as relapse. These "null" and "partial responders" and "breakthrough" folks failed treatment. These occurrences are no longer issues with the new Sovaldi treatments. They don't happen. Therefore what is important now is what happens AFTER treatment is finished. If we are going to fail the new treatments we fail AFTER stopping treatment. Not during treatment. All people that fail do so by relapsing as other have mentioned.
Why do some people fail this (Sovaldi/Olysio) treatment or any other Sovaldi based treatment?
Well we all know treatment isn't 100% for all people. So who succeeds and who fails treatment is largely based on the "host factors" going into treatment. Meaning mainly genotype and stage of liver disease, particularly cirrhosis is a differentiating factor in success or failure. If we all were treatment naive, genotype 2 and had minimal fibrosis then almost all could be cured. Unfortunately that is not always our situation. Many of us have treated before. Some have cirrhosis or bridging fibrosis.
The good news is we are close and getting closer every day to a cure for all thankfully and I hope to live to see the day in the not to distant future. We just aren't there yet and we have to be realistic about it.
There are many factors that are known to decrease the likelihood of SVR. Most have been known for many years before our new treatments were available. Luckily with these new treatments many of these factors don't make as much difference as they used... but they still do impact many with less than ideal host factors. These factors have all been pointed out in the recent studies and the inclusions and exclusions criteria for trials are used to select certain folks for studies based upon these factors. That is why, for example, traditionally those with cirrhosis are excluded for most early trials. They are known to have poorer response to treatment. This is also why all of the early Gilead trials were for treatment naive people ONLY. They are known to be the easiest to treat. So exclude treatment experienced and cirrhotics from early trials and you see SVRs approaching 100%. That is how we first came to see these 90% SRV rates. Which is progress but not all of us are treatment naive and some of us have cirrhosis so we have to temper our expectations and look at the data that pertains to cohorts of patients that have similar attributes as ourselves if we want to really know what our chances are.
The first most obvious factor effecting SVR is genotype. If you are genotype 2 you have a much better success than someone with genotype 3, for example. Some genotype viruses are just harder to treat than others. What is new is that we now know there's quite a difference between treating genotype 2 and 3 with the same treatment. Their SVR rates are quote different then with older treatments.
Once we get beyond genotype the next biggest factor is the stage of liver disease. Particularly whether one has or doesn't have cirrhosis. The figures we see quoted doesn't include those with cirrhosis which are always lower than others. As has been know for a long time those with more advanced liver disease (F3-F4) have a harder time curing their hep C. Although the difference is much less now thankfully than when treating cirrhotics with peg-interferon based treatments.The other huge difference is that treating some cirrhotics with older treatment was risky and could cause decompensation and even liver failure at times. Sovaldi + ribavirin has proven safe in cirrhotics as well post transplantation patients. A true c change in the treatment of cirrhotics.
The true test of current treatment is SVR12, the viral load at 12 weeks after EOT. That is how SVR/success is measured in all of the new trials with these new treatments.
The good news is that there are some folks that started treating early this year and are now done with treatment. Some have posted that are still undetectable 4 weeks after EOT (end of treatment). This is a very good indication of SVR as most people relapse within the 1st month after stopping. Not all, but most. As I did in early 2013 after 48 weeks of Sovaldi and Ribavirin treatment (47 weeks + undetectable).
-----------------------------------------------------------------------------------------------
First let's point out that the statement "93 or so to 100 percent make it to SVR12" is very misleading and is often believed by many that this applies to their particular case of hepatitis C regardless of other factors. Unfortunately this is not the care.
In fact the study data from COSMOS 2 cohort results for those with cirrhosis were 88%. Not much different but nowhere near 100% often claimed.
These 90% numbers get posted all the time around as fact as though they apply to everyone which simply is not the case. This is especially true when people use these figures from the original Sovaldi/sofosbuvir trials that only included treatment naive candidates assuming that these will be the SRV rate for treatment experienced patients and cirrhotics as well. Even the trial reports state this is not the case yet no one mentions it.
For example treating with SOVALDI + Peg-IFN alfa + RBV 12 weeks in the NEUTRINO study had
Overall SVR - 90% (295/327)
SVR in those having cirrhosis - 80% (43/54)
With even more host factors included we see more disparity between the toted 90+ % overall SVR rates and those with particular host factors...
Genotype 1, Metavir F3/F4 fibrosis, IL28B non-C/C, HCV RNA >800,000 IU/mL - 71% (37/52)
--------------------------------------------------------------------------------------------------------
First let's go over some of the basics we have learned from trial data in treating thousands of patients with Sovaldi based treatments.
* All people that treat with Sovaldi treatment become undetectable on treatment. (Unlike previous null responders with peg-INF/RBV treatments)
(When treating with SOV/Olysio whether or not someone is undetectable by week 4 has no correlation to who will achieve SRV.)
* There are no viral "breakthroughs" (As could happen with peg-INF/RBV treatments)
(The point being that all people will become undetectable and STAY indetectable as long as they are treating. Meaning at week 12 or 24 or 48 for that matter everyone in undetectable.)
* Therefore everyone who fails SOV/Olysio this treatment does so by relapsing after stopping treatment. (excluding those that aren't compliant with taking their meds properly)
With previous treatments the focus was on IF and WHEN someone became undetectable as they were predictors of SRV and if they had a viral breakthrough before completing treatment as well as relapse. These "null" and "partial responders" and "breakthrough" folks failed treatment. These occurrences are no longer issues with the new Sovaldi treatments. They don't happen. Therefore what is important now is what happens AFTER treatment is finished. If we are going to fail the new treatments we fail AFTER stopping treatment. Not during treatment. All people that fail do so by relapsing as other have mentioned.
Why do some people fail this (Sovaldi/Olysio) treatment or any other Sovaldi based treatment?
Well we all know treatment isn't 100% for all people. So who succeeds and who fails treatment is largely based on the "host factors" going into treatment. Meaning mainly genotype and stage of liver disease, particularly cirrhosis is a differentiating factor in success or failure. If we all were treatment naive, genotype 2 and had minimal fibrosis then almost all could be cured. Unfortunately that is not always our situation. Many of us have treated before. Some have cirrhosis or bridging fibrosis.
The good news is we are close and getting closer every day to a cure for all thankfully and I hope to live to see the day in the not to distant future. We just aren't there yet and we have to be realistic about it.
There are many factors that are known to decrease the likelihood of SVR. Most have been known for many years before our new treatments were available. Luckily with these new treatments many of these factors don't make as much difference as they used... but they still do impact many with less than ideal host factors. These factors have all been pointed out in the recent studies and the inclusions and exclusions criteria for trials are used to select certain folks for studies based upon these factors. That is why, for example, traditionally those with cirrhosis are excluded for most early trials. They are known to have poorer response to treatment. This is also why all of the early Gilead trials were for treatment naive people ONLY. They are known to be the easiest to treat. So exclude treatment experienced and cirrhotics from early trials and you see SVRs approaching 100%. That is how we first came to see these 90% SRV rates. Which is progress but not all of us are treatment naive and some of us have cirrhosis so we have to temper our expectations and look at the data that pertains to cohorts of patients that have similar attributes as ourselves if we want to really know what our chances are.
The first most obvious factor effecting SVR is genotype. If you are genotype 2 you have a much better success than someone with genotype 3, for example. Some genotype viruses are just harder to treat than others. What is new is that we now know there's quite a difference between treating genotype 2 and 3 with the same treatment. Their SVR rates are quote different then with older treatments.
Once we get beyond genotype the next biggest factor is the stage of liver disease. Particularly whether one has or doesn't have cirrhosis. The figures we see quoted doesn't include those with cirrhosis which are always lower than others. As has been know for a long time those with more advanced liver disease (F3-F4) have a harder time curing their hep C. Although the difference is much less now thankfully than when treating cirrhotics with peg-interferon based treatments.The other huge difference is that treating some cirrhotics with older treatment was risky and could cause decompensation and even liver failure at times. Sovaldi + ribavirin has proven safe in cirrhotics as well post transplantation patients. A true c change in the treatment of cirrhotics.
The true test of current treatment is SVR12, the viral load at 12 weeks after EOT. That is how SVR/success is measured in all of the new trials with these new treatments.
The good news is that there are some folks that started treating early this year and are now done with treatment. Some have posted that are still undetectable 4 weeks after EOT (end of treatment). This is a very good indication of SVR as most people relapse within the 1st month after stopping. Not all, but most. As I did in early 2013 after 48 weeks of Sovaldi and Ribavirin treatment (47 weeks + undetectable).
-----------------------------------------------------------------------------------------------
Thanks Hector for your extremely interesting summary of factors affecting SVR with combinations of SIM-SOF. I always appreciate your contributions here, as they are medically precise, well written, and pertinent. You may recall from a previous post of mine that I am in that group that has completed SimSof+Riba. My SVR 4 was undetectable, and am waiting for early July for my 12 week SVR test.
Am I correct in reading your post that you completed 48 weeks of Sovaldi + riba and then relapsed in the first month after stopping? What a disappointment that must have been! (I can sort of empathize, since back in 2007 the latest treatment idea my doc had was to do 72 weeks of PEG+riba. After suffering through that, I relapsed after completion.)
Anyway, thanks again for you contributions.
Mark
Am I correct in reading your post that you completed 48 weeks of Sovaldi + riba and then relapsed in the first month after stopping? What a disappointment that must have been! (I can sort of empathize, since back in 2007 the latest treatment idea my doc had was to do 72 weeks of PEG+riba. After suffering through that, I relapsed after completion.)
Anyway, thanks again for you contributions.
Mark
Great summation Hector. I wish the medical jargon could be taken out of some of these published treatment results so that the information could be easier to understand. As it stands now the one pill combination of Sofusbuvir+Ledipasvir seems to be the best, but with the popularity of Sofusbuvir+Olysio the Sofusbuvir+Led information seems to have been overshadowed. I would like to get a feel for what a Genotype 1a HCV with Q80K variant present at baseline IL28B TT genotype grade 2-3's chances are with sof+Led, but it's not written clearly anywhere that I know of.
Hi Mark.
I am glad to hear you are still indetectable that is a very good sign.
As far as me relapsing after 48 weeks of Sovaldi (then called GS-7977) and Ribavirin it is a very long boring story but it wasn't a big deal as I was fighting for my life against liver cancer and was told by the time I released my liver cancer appeared terminal. So whether I dead with or without hep C really didn't matter. That was my thinking anyway...
Incredibly I finally did get a liver transplant and am at least cancer free for now. My hep C is not doing too much damage to my donor liver thankfully so I have time to wait for better treatments (obviously 12 week of Sovaldi won't do anything for me). I hope one day to be finally free of hep C but it isn't a burning issue if you know what I mean. When it comes to having advanced cancer and liver transplant hep C is only a small part of a big picture.
Take care and I am hoping for SVR for you!
Hector
I am glad to hear you are still indetectable that is a very good sign.
As far as me relapsing after 48 weeks of Sovaldi (then called GS-7977) and Ribavirin it is a very long boring story but it wasn't a big deal as I was fighting for my life against liver cancer and was told by the time I released my liver cancer appeared terminal. So whether I dead with or without hep C really didn't matter. That was my thinking anyway...
Incredibly I finally did get a liver transplant and am at least cancer free for now. My hep C is not doing too much damage to my donor liver thankfully so I have time to wait for better treatments (obviously 12 week of Sovaldi won't do anything for me). I hope one day to be finally free of hep C but it isn't a burning issue if you know what I mean. When it comes to having advanced cancer and liver transplant hep C is only a small part of a big picture.
Take care and I am hoping for SVR for you!
Hector
"the one pill combination of Sofusbuvir+Ledipasvir seems to be the best"
That pretty much sums it up. This combo is close to a cure.
The ION-2 study evaluated 440 treatment-experienced genotype 1 HCV patients who had failed past therapy with regimens containing Peg-IFN (including Peg-IFN plus a protease inhibitor). Patients received SOF/LDV with or without RBV for 12 or 24 weeks.
ION-2 study Results:
GT 1 treatment-experienced (including 20.0 percent (88/440) with cirrhosis)
SOF/LDV for 12 weeks = SVR 93.6% (102/109)
SOF/LDV+RBV for 12 weeks = SVR 96.4% (107/111)
SOF/LDV for 24 weeks = 99.1% (108/109)
SOF/LDV+RBV for 24 weeks = 99.1% (110/111)
Genotype 1a, IL28B TT as I said in my post mean less and less.
Q80K variant only matters when treating with Olysio.
"Fewer adverse events were observed in the RBV-free, fixed-dose combination arms compared to the RBV-containing arms in all ION studies. Adverse events observed in those taking the SOF/LDV tablet were generally mild and included fatigue and headache. In the RBV-containing arms of the ION studies, the most common adverse events were fatigue, headache, nausea and insomnia. Anemia, which is a common side effect associated with RBV, was reported in 0.5 percent of patients in the SOF/LDV arms versus 9.2 percent of patients in the RBV-containing arms. Less than 1 percent of patients in the studies discontinued treatment due to treatment-emergent adverse events."
This treatment is pretty much a no brainer.
Hector
That pretty much sums it up. This combo is close to a cure.
The ION-2 study evaluated 440 treatment-experienced genotype 1 HCV patients who had failed past therapy with regimens containing Peg-IFN (including Peg-IFN plus a protease inhibitor). Patients received SOF/LDV with or without RBV for 12 or 24 weeks.
ION-2 study Results:
GT 1 treatment-experienced (including 20.0 percent (88/440) with cirrhosis)
SOF/LDV for 12 weeks = SVR 93.6% (102/109)
SOF/LDV+RBV for 12 weeks = SVR 96.4% (107/111)
SOF/LDV for 24 weeks = 99.1% (108/109)
SOF/LDV+RBV for 24 weeks = 99.1% (110/111)
Genotype 1a, IL28B TT as I said in my post mean less and less.
Q80K variant only matters when treating with Olysio.
"Fewer adverse events were observed in the RBV-free, fixed-dose combination arms compared to the RBV-containing arms in all ION studies. Adverse events observed in those taking the SOF/LDV tablet were generally mild and included fatigue and headache. In the RBV-containing arms of the ION studies, the most common adverse events were fatigue, headache, nausea and insomnia. Anemia, which is a common side effect associated with RBV, was reported in 0.5 percent of patients in the SOF/LDV arms versus 9.2 percent of patients in the RBV-containing arms. Less than 1 percent of patients in the studies discontinued treatment due to treatment-emergent adverse events."
This treatment is pretty much a no brainer.
Hector
Thanks Hector! So it is a wait and see for all of us who are now post Tx. I should hear next Thursday about my 4 week EOT viral load. I am so nervous about it.—Sandi
Good luck with your 4 week viral load test Sandi!
Hoping you are still undetectable!
Be well.
Hector
Hoping you are still undetectable!
Be well.
Hector
Hi Hector
I was hoping you would see my question you always do a great job on these technical ones.
I guess one way or the other I will be a data point for Sov/Oly in GT 1a MELD 7 cirrhotic null responder crowd. Just don't know my Q80K or IL28B status but it goes without saying I am hoping I will be Hep C free 12 weeks post treatment 14 weeks from now on 9/2/14
Best to you Hector!
Lynn
I was hoping you would see my question you always do a great job on these technical ones.
I guess one way or the other I will be a data point for Sov/Oly in GT 1a MELD 7 cirrhotic null responder crowd. Just don't know my Q80K or IL28B status but it goes without saying I am hoping I will be Hep C free 12 weeks post treatment 14 weeks from now on 9/2/14
Best to you Hector!
Lynn
Great job on all the info you provided.
My husband is going on two years post transplant (June 3rd). We are just so thankful to his donor and her family - may she rest in peace. He is alive today because she signed a donor card. She saved his life. I hope everyone out there who hasn't done so will sign up as an organ donor soon.
He is now on week 16 of the Sovaldi + ribavirin treatment. I don't know if he will reach SVR as he is still on a very low dose of ribavirin (200 mg). But thank God his cirrhotic new liver is doing well and further damage has been stopped. I am anticipating that he will be taking the combo pill once approved. Though of course we are hoping he does reach SVR on this treatment, its actually so much less stressful knowing that he has that option available to him if he doesn't reach SVR. With those high cure rates, we are very hopeful that things will work out if not sooner than later.
All the best to all in their quest for a hep c free life!
Nan
My husband is going on two years post transplant (June 3rd). We are just so thankful to his donor and her family - may she rest in peace. He is alive today because she signed a donor card. She saved his life. I hope everyone out there who hasn't done so will sign up as an organ donor soon.
He is now on week 16 of the Sovaldi + ribavirin treatment. I don't know if he will reach SVR as he is still on a very low dose of ribavirin (200 mg). But thank God his cirrhotic new liver is doing well and further damage has been stopped. I am anticipating that he will be taking the combo pill once approved. Though of course we are hoping he does reach SVR on this treatment, its actually so much less stressful knowing that he has that option available to him if he doesn't reach SVR. With those high cure rates, we are very hopeful that things will work out if not sooner than later.
All the best to all in their quest for a hep c free life!
Nan
I have just completed 7 weeks out of 12 weeks with ribavirin and sovaldi and is now starting to feel more tired and losing appetite. Anyone else feels this way. Thanks.
Yes, I totally agree about the generosity of the donor community. For us that were not able to stop our liver disease before it became irreversible we know first hand that without our wonderful donors we would not be here today.
We transplant folks (all organs not just liver) live because someone else decided that they want to continue their legacy by given "the gift of life" to another person who was struggling just to survive when they the donor no longer needed it. Of course we owe our lives to all of those who helped us to make it through the transplant process (family, friends, doctors, nurses, etc.) which in my case took over 3 years. For me it is me 36 year old woman who died on November 16th last year who gave me the ability to wake up every day and open my eyes and write this post.
Why anyone would not be a donor makes no sense to me. Especially those with hepatitis C who are aware that without a healthy liver live as we knew it is over. We are all going to die one day, sorry for the spoiler, why not help others and leave something positive behind in this world?
Yes,Nan without these new treatments there wouldn't be any hope for many of us. Sovaldi saved my life even through I relapsed after 47 weeks of being undetectable and am now reinfected. My 47 weeks of being undetectable stabilized my cirrhosis so I could go through the 6 very rough liver cancer treatments (chemoembolization, injections into my tumor and radiation) I did last years which allowed me to get back within the HCC criteria for a liver transplant. Yes I can say without hesitation that without the option of a Sovaldi trial, the first trial to every treatment patients with liver cancer awaiting transplant, there is no question I would have died last year from my liver cancer. I am very very lucky for alive today and never ever forget my good fortune. Sadly many others were so lucky as I.
Tomorrow I am going to the funereal of a beautiful and gracious women who unfortunately didn't have the options myself and other have.
I can only hope that others take advantage of all of options hep C patients now because of the hard work that many people have done behind the scenes over many, many years.
Hector
We transplant folks (all organs not just liver) live because someone else decided that they want to continue their legacy by given "the gift of life" to another person who was struggling just to survive when they the donor no longer needed it. Of course we owe our lives to all of those who helped us to make it through the transplant process (family, friends, doctors, nurses, etc.) which in my case took over 3 years. For me it is me 36 year old woman who died on November 16th last year who gave me the ability to wake up every day and open my eyes and write this post.
Why anyone would not be a donor makes no sense to me. Especially those with hepatitis C who are aware that without a healthy liver live as we knew it is over. We are all going to die one day, sorry for the spoiler, why not help others and leave something positive behind in this world?
Yes,Nan without these new treatments there wouldn't be any hope for many of us. Sovaldi saved my life even through I relapsed after 47 weeks of being undetectable and am now reinfected. My 47 weeks of being undetectable stabilized my cirrhosis so I could go through the 6 very rough liver cancer treatments (chemoembolization, injections into my tumor and radiation) I did last years which allowed me to get back within the HCC criteria for a liver transplant. Yes I can say without hesitation that without the option of a Sovaldi trial, the first trial to every treatment patients with liver cancer awaiting transplant, there is no question I would have died last year from my liver cancer. I am very very lucky for alive today and never ever forget my good fortune. Sadly many others were so lucky as I.
Tomorrow I am going to the funereal of a beautiful and gracious women who unfortunately didn't have the options myself and other have.
I can only hope that others take advantage of all of options hep C patients now because of the hard work that many people have done behind the scenes over many, many years.
Hector
Please start your own thread to post the question you have. I am sure other will provide you with the information you need.
Hector
Hector
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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).
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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