Aa
Sofobuvir or Simeprevir ??
Because I have cirrhosis and heard about all the side effects I have been reluctant to go through treatment my specialist suggesst treating me after the following drugs become FDA approved. According to my doctor there has been a very high success rate, in access of 90 percent. The following are the two drugs that may be available by then the end of the year. What does anyone know about the following drug therapies?
We expect FDA-approval of two separate regimens including the following drugs:
1. Sofosbuvir (AKA: GS-7977)
2. Simeprevir (AKA: TMC-435)
You have an excellent chance of cure since your genotype is 1b (1b is more favorable than 1a), and because your IL28B genotype is C/C.
We expect FDA-approval of two separate regimens including the following drugs:
1. Sofosbuvir (AKA: GS-7977)
2. Simeprevir (AKA: TMC-435)
You have an excellent chance of cure since your genotype is 1b (1b is more favorable than 1a), and because your IL28B genotype is C/C.
Sorry to hear about your mother's condition post-transplant. I know exactly how that feels as my husband is now cirrhotic again a year and a half post transplant. He is 68. geno1a
He just started Sovaldi + Ribavirin for 24 weeks. This is the preferred treatment for post transplant patients right now. He is on Day 10. So far so good though he is fatigued and continues to have bouts of HE. My husband's treatment is being paid for through Medicare/Medicaid.
Hope this information is helpful to you.
All the best to you and your Mom.
Nan
He just started Sovaldi + Ribavirin for 24 weeks. This is the preferred treatment for post transplant patients right now. He is on Day 10. So far so good though he is fatigued and continues to have bouts of HE. My husband's treatment is being paid for through Medicare/Medicaid.
Hope this information is helpful to you.
All the best to you and your Mom.
Nan
Just chiming in. Geno 2 Ribv/Solvaldi. 12 weeks of treatment. Almost 60 (58) years young. Cirrhosis Undetected week 2. 5-6 weeks to go. Would never consider waiting to start a newer treatment because something better may pop up around the corner. This would be like shooting myself in the foot because my arm hurts. Time is of the essence. Kim
You seem most informed on this topic. My mother is a 3 yr. liver transplant recipient- her hep c was so aggresive it has attacked new organ- docs have told her these new drugs will help her?? she is 73, currently taking spiroactone, losartan, rapumune- no interferon because can't tolerate it. We have been unable to get the insurance companies to accept payment. Is she not a candidate??
gsx, that's great news that you are UND after 4 weeks.
You really deserve it after what you have been through.
I have been reading a lot forum people on the Gilead and Abbott trials saying they have also been going UD in 3 or 4 weeks, with mild SX.
It is a pity that Sofos+GS5885 isn't expected to launch til beginning of 2015.
At least Sofosbuvir should be launched early 2014 (+Riba for GT2&3, +Riba+IFN for GT1) which could be a good compromise for many.
Also heard that early access compassionate schemes may be possible for the very ill, though not sure about this.
You really deserve it after what you have been through.
I have been reading a lot forum people on the Gilead and Abbott trials saying they have also been going UD in 3 or 4 weeks, with mild SX.
It is a pity that Sofos+GS5885 isn't expected to launch til beginning of 2015.
At least Sofosbuvir should be launched early 2014 (+Riba for GT2&3, +Riba+IFN for GT1) which could be a good compromise for many.
Also heard that early access compassionate schemes may be possible for the very ill, though not sure about this.
For what it's worth...I am cirrhotic stage 5 of 6 Ishak scale. I have failed 3 Tx attempts in 3 yrs with the last Trip Tx with victrelis. I have gone from stage 2 to stage 5 within those 3 yrs. I am a lab rat for gilead with the gs-5885/sofosbuvir (combined pill) and riba on a 12 week arm. I went UND for the first time ever at 4 weeks and have 1 week to go with no side effects. I think the outcome of the study drugs will be positive and pushed through within a 2 year period. With this being said...it will be interesting to see if I achieve SVR being cirrhotic. Some people can't wait for the drugs to be approved. I wish I would have waited 3 yrs ago for better drugs as I think the 3 attempt/failures progressed my disease. I am not a doctor and have no evidence to back this up. I may be an isolated case of rapid progression...as I haven't heard of any others who attempted/failed and progressed (disease) this fast. If already cirrhotic (which I am now)...I would probably take any treatment available to ease the damage being inflicted on the liver...but...I would try my hardest to get into one of the studies with the new drugs first. I was lucky enough to get into the Gilead study.
can-do-man
"The buzz we heard at AASLD was mainly concern that the patients being enrolled in most ongoing clinical trials are not representative of the patients that doctors see in their practices. "
All the trial programs for the HCV anti virals have enrolments that include all patient types, and have done so for several months, and before AASLD.
For instance the Gilead ION trials include around 30% fibrotics.
And Abbott, BMS etc are doing the same.
And they seem to have found that these new drugs are very effective in those with advanced liver disease, unlike the interferon based treatments, which rely more the patients own immune system to be switched on.
Which probably explains why they are so much less effective in the very sick.
"The buzz we heard at AASLD was mainly concern that the patients being enrolled in most ongoing clinical trials are not representative of the patients that doctors see in their practices. "
All the trial programs for the HCV anti virals have enrolments that include all patient types, and have done so for several months, and before AASLD.
For instance the Gilead ION trials include around 30% fibrotics.
And Abbott, BMS etc are doing the same.
And they seem to have found that these new drugs are very effective in those with advanced liver disease, unlike the interferon based treatments, which rely more the patients own immune system to be switched on.
Which probably explains why they are so much less effective in the very sick.
Pooh
"The SVR rate for cirrhotics is LOWER than for those without cirrhosis, but the SVR rate is still good (62%)."
Incorrect.
That figure of 62% is for a group of combined fibrotics and cirrhotics.
This Telaprevir study (REALIZE) gives the SVR rate for cirrhotics as 47% (naive) and 10% (prior treaters).
http://www.natap.org/2012/APASL/APASL_07.htm
WayneRoberts say he is cirrhotic.
I have heard a lot of personal experiences from various forums of people having to visit hospital for adverse events during triple tx.
To me its not inconceivable that a few cirrhotics who fail treatment may progress down the path to decompensation faster because of this treatment.
And I don't think their cases will be widely reported in the medical literature either.
"The SVR rate for cirrhotics is LOWER than for those without cirrhosis, but the SVR rate is still good (62%)."
Incorrect.
That figure of 62% is for a group of combined fibrotics and cirrhotics.
This Telaprevir study (REALIZE) gives the SVR rate for cirrhotics as 47% (naive) and 10% (prior treaters).
http://www.natap.org/2012/APASL/APASL_07.htm
WayneRoberts say he is cirrhotic.
I have heard a lot of personal experiences from various forums of people having to visit hospital for adverse events during triple tx.
To me its not inconceivable that a few cirrhotics who fail treatment may progress down the path to decompensation faster because of this treatment.
And I don't think their cases will be widely reported in the medical literature either.
Still not convinced it is a clear cut decision, with the better drugs less than a year away.
This recent paper has a table:
Table 2. Factors which affect the decision to treat now or delay therapy
Fibrosis F0–F2 = Treat now F3, F4 = Delay treatment
http://onlinelibrary.wiley.com/doi/10.1111/liv.12066/full
When doctors are presented with a very sick patient, there is a natural tendency to give them whatever drugs may cure them,
But not sure it is always based on a careful analysis of the risks and benefits.
And there is no scientific evidence comparing a random sample of treated to untreated cirrhotics and their long term health outcomes.
And when you have big pharma marketing campaigns and some doctors receiving payments (legitimate) for various services from these companies, the water becomes more muddy.
This recent paper has a table:
Table 2. Factors which affect the decision to treat now or delay therapy
Fibrosis F0–F2 = Treat now F3, F4 = Delay treatment
http://onlinelibrary.wiley.com/doi/10.1111/liv.12066/full
When doctors are presented with a very sick patient, there is a natural tendency to give them whatever drugs may cure them,
But not sure it is always based on a careful analysis of the risks and benefits.
And there is no scientific evidence comparing a random sample of treated to untreated cirrhotics and their long term health outcomes.
And when you have big pharma marketing campaigns and some doctors receiving payments (legitimate) for various services from these companies, the water becomes more muddy.
"60 isn't that old. Please.........give me a break! "
-----------------------------------
I have to agree, Mike. ^0 is not old. After all, I am 67 years old (65 when I started triple treatment with Incivek). And now I am 67 years old and SVR with a whole new Hep C free life before me (and feeling better than I have felt for 20 years).
-----------------------------------
I have to agree, Mike. ^0 is not old. After all, I am 67 years old (65 when I started triple treatment with Incivek). And now I am 67 years old and SVR with a whole new Hep C free life before me (and feeling better than I have felt for 20 years).
Besides not knowing for sure when or if these new meds will come to market as was said here they don't know yet how well they will work on us.
The buzz we heard at AASLD was mainly concern that the patients being enrolled in most ongoing clinical trials are not representative of the patients that doctors see in their practices. Companies were presenting 12-week treatment regimens with 90–100% cure rates. We are happy to see that kind of success, but most of the clinical trials exclude hard-to-treat patients. We don't see a lot of trials with interferon-free treatment regimens that include patients with cirrhosis of the liver, which is historically much harder to cure. I've seen estimates that as many as 25% of HCV patients seeking treatment are cirrhotic.
http://www.thelifesciencesreport.com/pub/na/14784
The buzz we heard at AASLD was mainly concern that the patients being enrolled in most ongoing clinical trials are not representative of the patients that doctors see in their practices. Companies were presenting 12-week treatment regimens with 90–100% cure rates. We are happy to see that kind of success, but most of the clinical trials exclude hard-to-treat patients. We don't see a lot of trials with interferon-free treatment regimens that include patients with cirrhosis of the liver, which is historically much harder to cure. I've seen estimates that as many as 25% of HCV patients seeking treatment are cirrhotic.
http://www.thelifesciencesreport.com/pub/na/14784
George, I am very sorry about your friend. It is tragic that he relapsed and it is tragic that he then committed suicide. However, that does not translate into meaning cirrhotics should wait to treat.
"I am not sure it is a clear cut decision for a 60 year old with cirrhosis to go triple tx. Maybe Wayne's specialist knows the SVR rate is low and risk of very serious adverse event is very high, for older cirrhotics."
-----------------------------------------
Every article I have read and every presentation I have seen says that cirrhotics need to treat sooner rather than later and that they should not wait for new treatments (except if they are decompensated or have some other medical condition that requires them to fore go Tx).
The SVR rate for cirrhotics is LOWER than for those without cirrhosis, but the SVR rate is still good (62%).
"Another major determinant of likelihood of SVR is the extent of liver disease. Traditionally, patients with cirrhosis responded less well to treatment with pegIFN/RBV. It appears that same effect holds true with protease inhibitor–based triple therapies. In the ADVANCE trial, 78% of patients with mild liver disease, defined as no, minimal, or portal fibrosis, achieved SVR in the 12-week telaprevir triple therapy arm (Figure 4).[5] Among patients with bridging fibrosis or cirrhosis who were treated with telaprevir triple therapy, SVR rates were lower at 62%. ..... The fact that patients with advanced liver disease respond less well to treatment in general underscores the importance of treating patients early to prevent the progression to advanced disease and to have a greater impact on long-term outcomes."
http://www.clinicaloptions.com/Hepatitis/Annual%20Updates/2012%20Annual%20Update/Modules/HCV_Management/Pages/Page%204.aspx#fa09c179-a61c-420c-9ad6-20190196b6d9
Now, a 62% SVR rate (with bridging fibrosis or cirrhosis) is lower than the 78% SVR rate that others attain, however, 62% is still good and it is certainly better than ZERO (which is the SVR rate for those who do not do TX).
As far as the risk of very serious adverse events among cirrhotics, yes it is higher than those who are not cirrhotic, but it is not "very high." (I guess that depends on one's definition of "very high.") I agree that cirrhotics do have more adverse events but if they are being managed by a competent Hepatologist most of these can be recognized and managed early and appropriately, as soon as they appear.
We have had many, many cirrhotics forum members in their 60s treat with triple med treatment. Many of them have attained SVR and are doing well.
In my opinion, in this situation (60 year old cirrhotic ... treat or not to treat) the most serious risk for cirrhotics is delayed treatment. The longer one waits the more likely it is that decompensation will occur or that some other medical disease process will make it difficult or impossible to treat.
"I am not sure it is a clear cut decision for a 60 year old with cirrhosis to go triple tx. Maybe Wayne's specialist knows the SVR rate is low and risk of very serious adverse event is very high, for older cirrhotics."
-----------------------------------------
Every article I have read and every presentation I have seen says that cirrhotics need to treat sooner rather than later and that they should not wait for new treatments (except if they are decompensated or have some other medical condition that requires them to fore go Tx).
The SVR rate for cirrhotics is LOWER than for those without cirrhosis, but the SVR rate is still good (62%).
"Another major determinant of likelihood of SVR is the extent of liver disease. Traditionally, patients with cirrhosis responded less well to treatment with pegIFN/RBV. It appears that same effect holds true with protease inhibitor–based triple therapies. In the ADVANCE trial, 78% of patients with mild liver disease, defined as no, minimal, or portal fibrosis, achieved SVR in the 12-week telaprevir triple therapy arm (Figure 4).[5] Among patients with bridging fibrosis or cirrhosis who were treated with telaprevir triple therapy, SVR rates were lower at 62%. ..... The fact that patients with advanced liver disease respond less well to treatment in general underscores the importance of treating patients early to prevent the progression to advanced disease and to have a greater impact on long-term outcomes."
http://www.clinicaloptions.com/Hepatitis/Annual%20Updates/2012%20Annual%20Update/Modules/HCV_Management/Pages/Page%204.aspx#fa09c179-a61c-420c-9ad6-20190196b6d9
Now, a 62% SVR rate (with bridging fibrosis or cirrhosis) is lower than the 78% SVR rate that others attain, however, 62% is still good and it is certainly better than ZERO (which is the SVR rate for those who do not do TX).
As far as the risk of very serious adverse events among cirrhotics, yes it is higher than those who are not cirrhotic, but it is not "very high." (I guess that depends on one's definition of "very high.") I agree that cirrhotics do have more adverse events but if they are being managed by a competent Hepatologist most of these can be recognized and managed early and appropriately, as soon as they appear.
We have had many, many cirrhotics forum members in their 60s treat with triple med treatment. Many of them have attained SVR and are doing well.
In my opinion, in this situation (60 year old cirrhotic ... treat or not to treat) the most serious risk for cirrhotics is delayed treatment. The longer one waits the more likely it is that decompensation will occur or that some other medical disease process will make it difficult or impossible to treat.
Willy I know your not cirrhotic so I understand you not being up on this, but all you have to do is some research and you will not find a good doctor suggesting us to wait....... The reason is, well just look at Hector.
I don't have statistics or studies behind this, just observation.
There are some people who......when treating and cirrhotic..... may start more towards the path of decompensation. I'm not even sure that it is fair to call it decompensation, but lets say that they are beset with more co-morbidities, post TX.
I will also float out the possibility that some people can remain seemingly static in their staging w/ cirrhosis. I don't know the answer, but their may be risk involved in treating with one form of TX that one might sidestep with a future potential approved form of TX.
I'm not dissuading or recommending, just suggesting it may be one more piece in the equation to work out w/ your doctor/team. This may be even more critical if one does not clear and yet now has new more serious medical issues.
willy
There are some people who......when treating and cirrhotic..... may start more towards the path of decompensation. I'm not even sure that it is fair to call it decompensation, but lets say that they are beset with more co-morbidities, post TX.
I will also float out the possibility that some people can remain seemingly static in their staging w/ cirrhosis. I don't know the answer, but their may be risk involved in treating with one form of TX that one might sidestep with a future potential approved form of TX.
I'm not dissuading or recommending, just suggesting it may be one more piece in the equation to work out w/ your doctor/team. This may be even more critical if one does not clear and yet now has new more serious medical issues.
willy
George there is a lot of things out there on to treat or wait, could you show me just one thats suggests somebody with cirrhosis or even close to it to wait. I just posted a new article on this and once again even the top Hep doctors that suggest to maybe wait do not if one is cirrhotic... I would be really surprised if one of these top docs thought that was a good ideal. It's all over the internet so if it's there it shouldn't be hard to find... Good luck
I am not sure it is a clear cut decision for a 60 year old with cirrhosis to go triple tx.
Maybe Wayne's specialist knows the SVR rate is low and risk of very serious adverse event is very high, for older cirrhotics.
I just heard of a forum (58 yo cirrhotic) friend who did 48 weeks of telaprevir, only to relapse at the end.
The side effects were devastating physically and mentally.
For example he dropped to 50kg in weight.
Tragically he ended up committing suicide when he got the relapse news.
Maybe Wayne's specialist knows the SVR rate is low and risk of very serious adverse event is very high, for older cirrhotics.
I just heard of a forum (58 yo cirrhotic) friend who did 48 weeks of telaprevir, only to relapse at the end.
The side effects were devastating physically and mentally.
For example he dropped to 50kg in weight.
Tragically he ended up committing suicide when he got the relapse news.
I agree with everything Hector wrote and I want to repeat this part of his post:
"Having cirrhosis you should not wait to treat. The longer you wait the harder it will be to treat and the odds of SVR will be less. If you should decompensate while waiting you will then need a liver transplant which could take years of illness to get. Also as your cirrhosis advances the higher the chances decompensation while treating.
I hope your doctor is a hepatologist although I can't imagine any hepatologist telling a cirrhotic to wait 2-3 years for treatment. .....
By choosing to wait and not treat you are playing Russian Roulette with your life. If you wait too long to treat there is no going back. .....it is not something you would ever want to have happen despite side effects and adverse events from current treatments. The suffering from living for years with decompensation and it life-threatening complications as well as being prone to liver cancer over those years and attempting to get a transplant before it is too late are no comparison to treatment side effects. "
Hopefully you can treat soon and rid yourself of this deadly virus.
"Having cirrhosis you should not wait to treat. The longer you wait the harder it will be to treat and the odds of SVR will be less. If you should decompensate while waiting you will then need a liver transplant which could take years of illness to get. Also as your cirrhosis advances the higher the chances decompensation while treating.
I hope your doctor is a hepatologist although I can't imagine any hepatologist telling a cirrhotic to wait 2-3 years for treatment. .....
By choosing to wait and not treat you are playing Russian Roulette with your life. If you wait too long to treat there is no going back. .....it is not something you would ever want to have happen despite side effects and adverse events from current treatments. The suffering from living for years with decompensation and it life-threatening complications as well as being prone to liver cancer over those years and attempting to get a transplant before it is too late are no comparison to treatment side effects. "
Hopefully you can treat soon and rid yourself of this deadly virus.
Sofosbuvir +IFN+Riba is expected to be commercially launched in less than a year,
at the start of 2014, for GT1.
This will be a large improvement over current triple TX.
As you say >90% SVR and just 12 weeks, with less SX.
So may be a good idea to wait for this.
Simeprevir is a similar story, with an FDA application submitted in a few months.
at the start of 2014, for GT1.
This will be a large improvement over current triple TX.
As you say >90% SVR and just 12 weeks, with less SX.
So may be a good idea to wait for this.
Simeprevir is a similar story, with an FDA application submitted in a few months.
Thanks! I don't think I have had the test that would indicate cc, ct, or tt. May ask my doc about it! Very helpful!
http://www.hepatitiscnewdrugresearch.com/hepatitis-c-testlikelihood-of-achieving-svr.html
If you read that article and the links within it you may get a better undertanding.
If you read that article and the links within it you may get a better undertanding.
Let me try that again, LOL. I hit the wrong button to soon,
If you go to this link and read the entire article (several pages) I think you will understand it better.
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%201.aspx
The following page is the page that talks about IL28B Genoptypes (CC, CT, TT).
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%203.aspx
I am also looking for another article which explains the CC, CT, TT genotypes in more depth. I will post it of I can find it.
If you go to this link and read the entire article (several pages) I think you will understand it better.
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%201.aspx
The following page is the page that talks about IL28B Genoptypes (CC, CT, TT).
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%203.aspx
I am also looking for another article which explains the CC, CT, TT genotypes in more depth. I will post it of I can find it.
If you go to this link and read the entire article (several pages) I think you will understand it better.
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%201.aspx
The following page is the page that talks about IL28B Gemptype, .
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%203.aspx
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%201.aspx
The following page is the page that talks about IL28B Gemptype, .
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%203.aspx
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