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.
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.
Have an Answer?
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
