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Ambiguous reporting on newly-approved protease inhibitors?
The Business Wire/Hepatitis Central article on Incivek (Telaprevir) has some confusing statements in it. For example, what does this mean:
"After the first 12 weeks, all patients stop receiving INCIVEK and continue treatment with pegylated-interferon and ribavirin alone for an additional 12 weeks or 36 weeks of treatment."
The last time I looked, 12 plus 12 equalled 24, not 36.
How about this:
"With INCIVEK combination treatment, more than 60 percent of people treated for the first time, as well as those who relapsed after previous therapy, are expected to complete all treatment in 24 weeks -- half the time needed if they were to take pegylated-interferon and ribavirin alone."?
Sounds like advertsing hype to me. I've followed the trials, and people doing therapy for 48 weeks still do significantly better than those stopping at week 24, even with a PI added. So why run the risk of stopping after 24 weeks and relapsing? So that the drug companies can keep hyping everyone with their con/spin?
Is there anywhere a person can get real honest info on the final percentage analyses of PI therapy? Or has the truth just given up the ghost?
I checked out the writeup at hcadvocate, which usually tries to be out front, but it doesn't make any more sense than the Business Wire blurb.
The bottom line as I see it is: these drugs may not help a whole lot to cure us, but they're sure helping investors in drug companies' stock to buy that new BMW.
Mike
"After the first 12 weeks, all patients stop receiving INCIVEK and continue treatment with pegylated-interferon and ribavirin alone for an additional 12 weeks or 36 weeks of treatment."
The last time I looked, 12 plus 12 equalled 24, not 36.
How about this:
"With INCIVEK combination treatment, more than 60 percent of people treated for the first time, as well as those who relapsed after previous therapy, are expected to complete all treatment in 24 weeks -- half the time needed if they were to take pegylated-interferon and ribavirin alone."?
Sounds like advertsing hype to me. I've followed the trials, and people doing therapy for 48 weeks still do significantly better than those stopping at week 24, even with a PI added. So why run the risk of stopping after 24 weeks and relapsing? So that the drug companies can keep hyping everyone with their con/spin?
Is there anywhere a person can get real honest info on the final percentage analyses of PI therapy? Or has the truth just given up the ghost?
I checked out the writeup at hcadvocate, which usually tries to be out front, but it doesn't make any more sense than the Business Wire blurb.
The bottom line as I see it is: these drugs may not help a whole lot to cure us, but they're sure helping investors in drug companies' stock to buy that new BMW.
Mike
Muike, can we take this to email. I have no doubt that you can get the orders. I know just where to send you but I'd really rather do this in email. You can reach me at susie at hepcassoc org. Don't forget the dot.
I appreciate your concern, Susie, believe me. I've been trying to keep a stiff upper lip, but the truth is that the incompetence of the medical profession here in Argentina is really getting to me.
I've got to come back to the States in a few months to replenish my supply of alternative meds, as the last time I tried to have them shipped to me here they were sequestered by the Argentine customs and I was held up for a ransom. So, what exactly should I do, do you think, when I come back to the States?
I've just been getting in touch by email with the two labs in the U.S. that do IL28B tests, so that's probably one thing I could do there, if I can find an MD who will write me the order (I have no doctor in the U.S.).
Getting a good, sensitive PCR would be good, too. Do you think I can do that there?
Maybe I should have the three-year biopsy done there, too.
I have no insurance in the U.S. of course, so I'll have to pay through the nose for the orders and the tests. That could be a lot of money, even if I can find an MD willing to write the orders. For PCR and IL28B, I would need two blood draws and two test orders. If an MD charges me $300 for each order, that's already $1,200 just for the orders, and the tests will probably run a couple of thou more each. A biopsy will probably cost a lot more, but I have no idea how much. So I'd be looking at maybe three or four thousand in costs minimum, and maybe a lot more with the biopsy added, wouldn't you think?
If you can give me the contact details for those orgs that help people, please do so. I can maybe afford some of these tests, but getting the orders worries me. I'm gonna get soaked there.
Cheers!
Mike
I've got to come back to the States in a few months to replenish my supply of alternative meds, as the last time I tried to have them shipped to me here they were sequestered by the Argentine customs and I was held up for a ransom. So, what exactly should I do, do you think, when I come back to the States?
I've just been getting in touch by email with the two labs in the U.S. that do IL28B tests, so that's probably one thing I could do there, if I can find an MD who will write me the order (I have no doctor in the U.S.).
Getting a good, sensitive PCR would be good, too. Do you think I can do that there?
Maybe I should have the three-year biopsy done there, too.
I have no insurance in the U.S. of course, so I'll have to pay through the nose for the orders and the tests. That could be a lot of money, even if I can find an MD willing to write the orders. For PCR and IL28B, I would need two blood draws and two test orders. If an MD charges me $300 for each order, that's already $1,200 just for the orders, and the tests will probably run a couple of thou more each. A biopsy will probably cost a lot more, but I have no idea how much. So I'd be looking at maybe three or four thousand in costs minimum, and maybe a lot more with the biopsy added, wouldn't you think?
If you can give me the contact details for those orgs that help people, please do so. I can maybe afford some of these tests, but getting the orders worries me. I'm gonna get soaked there.
Cheers!
Mike
Now don't laugh please or jump all over me. I am horrified by what you wrote. I had no idea that you are in the position you just told about. So, I've been sitting here thinking about the possible options you may have. Unfortunately it doesn't sound like you have any living where you are.
Your bio (age, geno, etc.) sound like me except I have cirrhosis. Maybe I am deluded but I need to know I have tried everything to get rid of this virus. So even a lousy 30% sounds like another chance to me. You asked where can we get the truth about the stats that come out of these trials. I don't believe we can get them. There is no way to know who is compliant, who is a tt or a cc geno, or any of the other things that matter such as insulin resistance, obesity, blah blah blah.
I am wondering if it would be possible for you to get to the USA for a month. By the end of 4 weeks you would have a really good idea of knowing if you were going to respond. At that point you could arrange with your doctor in Argentina to take over the treatment. I know you can send out your blood for PCR, etc. I know that some of the HIV orgs have helped people with your scenario previously. I know that because I know some of them. I would be happy to put you in touch with a couple of these people and perhaps you could work something out. You and I are not getting any younger and personally, I am afraid to wait for even better combinations of drugs. You're never as young as you are today.
Your bio (age, geno, etc.) sound like me except I have cirrhosis. Maybe I am deluded but I need to know I have tried everything to get rid of this virus. So even a lousy 30% sounds like another chance to me. You asked where can we get the truth about the stats that come out of these trials. I don't believe we can get them. There is no way to know who is compliant, who is a tt or a cc geno, or any of the other things that matter such as insulin resistance, obesity, blah blah blah.
I am wondering if it would be possible for you to get to the USA for a month. By the end of 4 weeks you would have a really good idea of knowing if you were going to respond. At that point you could arrange with your doctor in Argentina to take over the treatment. I know you can send out your blood for PCR, etc. I know that some of the HIV orgs have helped people with your scenario previously. I know that because I know some of them. I would be happy to put you in touch with a couple of these people and perhaps you could work something out. You and I are not getting any younger and personally, I am afraid to wait for even better combinations of drugs. You're never as young as you are today.
Thanks, Jeff. Good luck to you, too. And to everyone else here. One positive about having HCV is making so many good new friends in this forum. It sort of cancels out the bad.
.
.
Uh-oh, just when I was starting to cheer up [grin].
I think I've got a fantasy where I'm going to beat the virus on my own with minimal suffering. I've always had a rich fantasy life, probably too rich. My vision is holding down the fibrosis with alternative meds until an Alinia/immunogen/vaccine cure with no side effects comes along. It's an Academy Award winner starring me. Like it?
More seriously, I don't think anyone in the forum who lives in the U.S., Canada, or Europe can get a good grasp of what my situation, and that of other hepatitics living in the Third World, really is. Sure, medicine is much more humane down here than it is up there, as I've often said. I can waltz into my hospital and chat with the MDs any time I want. I can buy a lot of meds without a scrip, or without having to renew it. There are even free public hospitals here, and a lot of the top doctors donate time at them.
But testing is a joke here. If it's by automatic machinery, maybe the results mean something. If there's human intervention, forget it. I don't know if you remember the story of my Fibroscan, where the test done at my hospital gave F3/F4 on both a first test and a repeat, but when I went to a private lab that I found by accident their Fibroscan gave me F1/F2, just like my biopsy.
And the biopsy itself was a shambles. I'm afraid to repeat it, not because it hurt or I'm scared of it, but because they did it wrong. They only got 13mm of material, when all the articles I've read say that anything under a 20mm sample size is widely unreliable. I've even printed out around ten of these articles and given them to the hepatology department of my hospital. They don't read them, naturally, but won't admit it because then they'd have to confess that they can't read English, a requisite for their training.
My VL test was an antiquated Taqman, I believe the first HCV RNA PCR commercially available, and this was two years after the Argentine National Hepatitis Congress had directed all hospitals to use the newer tests. And my hospital is on the ANHC board!
I could go on and on, like when another hospital, where I went for a second reading of the biopsy slides, broke them. Yeah, that's right, they broke my slides. Dropped them on the floor.
Starting to get the picture?
Now my hospital won't approve a second biopsy or VL if I'm not Tx-ing. They don't want to spend the extra money.
You know what it's going to be like doing Tx here? Think monitoring VL. Once a week? Once a month? Or only beforehand and at twelve weeks? With an old test that doesn't reliably show when you're undetectable.
Rescue drugs? What are those?
Is the picture getting clearer?
I went to a so-called HCV "support group" at another hospital. There were eight people there slouching in their chairs with expressionless faces plus the leader, an authoritarian psychologist who did all the talking. You had to raise your hand like in kindergarden if you wanted to speak. This leader told eveyone they had to prepare a ten minute summary of their life. When I said my life couldn't be summarized in ten minutes, he threw me out.
A friend here recently told me he chose the hospital he went to for an operation by the criterion of whether or not they used new rather than sterilized instruments. He says you can't trust them to boil them long enough. If you die of peritonitis, they hold a service for you in the hospital mortuary and everyone says "It was the will of god".
'Nuff said, or shall I go on?
So, it might be reasonable to keep all this in mind when discussing Tx success percentiles on triple Tx, leadin times, etc.
Mike
I think I've got a fantasy where I'm going to beat the virus on my own with minimal suffering. I've always had a rich fantasy life, probably too rich. My vision is holding down the fibrosis with alternative meds until an Alinia/immunogen/vaccine cure with no side effects comes along. It's an Academy Award winner starring me. Like it?
More seriously, I don't think anyone in the forum who lives in the U.S., Canada, or Europe can get a good grasp of what my situation, and that of other hepatitics living in the Third World, really is. Sure, medicine is much more humane down here than it is up there, as I've often said. I can waltz into my hospital and chat with the MDs any time I want. I can buy a lot of meds without a scrip, or without having to renew it. There are even free public hospitals here, and a lot of the top doctors donate time at them.
But testing is a joke here. If it's by automatic machinery, maybe the results mean something. If there's human intervention, forget it. I don't know if you remember the story of my Fibroscan, where the test done at my hospital gave F3/F4 on both a first test and a repeat, but when I went to a private lab that I found by accident their Fibroscan gave me F1/F2, just like my biopsy.
And the biopsy itself was a shambles. I'm afraid to repeat it, not because it hurt or I'm scared of it, but because they did it wrong. They only got 13mm of material, when all the articles I've read say that anything under a 20mm sample size is widely unreliable. I've even printed out around ten of these articles and given them to the hepatology department of my hospital. They don't read them, naturally, but won't admit it because then they'd have to confess that they can't read English, a requisite for their training.
My VL test was an antiquated Taqman, I believe the first HCV RNA PCR commercially available, and this was two years after the Argentine National Hepatitis Congress had directed all hospitals to use the newer tests. And my hospital is on the ANHC board!
I could go on and on, like when another hospital, where I went for a second reading of the biopsy slides, broke them. Yeah, that's right, they broke my slides. Dropped them on the floor.
Starting to get the picture?
Now my hospital won't approve a second biopsy or VL if I'm not Tx-ing. They don't want to spend the extra money.
You know what it's going to be like doing Tx here? Think monitoring VL. Once a week? Once a month? Or only beforehand and at twelve weeks? With an old test that doesn't reliably show when you're undetectable.
Rescue drugs? What are those?
Is the picture getting clearer?
I went to a so-called HCV "support group" at another hospital. There were eight people there slouching in their chairs with expressionless faces plus the leader, an authoritarian psychologist who did all the talking. You had to raise your hand like in kindergarden if you wanted to speak. This leader told eveyone they had to prepare a ten minute summary of their life. When I said my life couldn't be summarized in ten minutes, he threw me out.
A friend here recently told me he chose the hospital he went to for an operation by the criterion of whether or not they used new rather than sterilized instruments. He says you can't trust them to boil them long enough. If you die of peritonitis, they hold a service for you in the hospital mortuary and everyone says "It was the will of god".
'Nuff said, or shall I go on?
So, it might be reasonable to keep all this in mind when discussing Tx success percentiles on triple Tx, leadin times, etc.
Mike
Hector: Admire your positive outlook and wish you get to SVR so you won't need a liver transplant.
Mike: I was told many times by very good hepatologists that high/low viral load does not necessarily correlates with liver damage which is revealed only on biopsy. Did you have one done recently? If you feel healthy, most likely you shouldn't have major damage to your liver.
Waiting for new drugs? I hope that will come out quickly, but I remember hopes and discussions about current PIs as early as 2000 and expecting them in 3-5 years. Now it is 2011, so who knows when new drugs will be finally approved. The pharma behind current PIs probably wouldn't want new competition on the market soon...
Tx or wait is a tough decision and I wish you success and luck in whatever you decide.
Jeff
Mike: I was told many times by very good hepatologists that high/low viral load does not necessarily correlates with liver damage which is revealed only on biopsy. Did you have one done recently? If you feel healthy, most likely you shouldn't have major damage to your liver.
Waiting for new drugs? I hope that will come out quickly, but I remember hopes and discussions about current PIs as early as 2000 and expecting them in 3-5 years. Now it is 2011, so who knows when new drugs will be finally approved. The pharma behind current PIs probably wouldn't want new competition on the market soon...
Tx or wait is a tough decision and I wish you success and luck in whatever you decide.
Jeff
Thanks for the good analysis, Willy. I guess I'll have to re-think all this. Even if my chances on the triple-Tx are only around 50% (I think the high-VL + age group changes the success rate quite a bit), it might be worth a shot.
I'd like to see what my VL is now after two years on alt meds that have gotten my enzymes down to normal, but my hospital here won't do another one if I'm not Tx-ing. I was over the top on the first one (the old Taqman), so it could have been anything. Definitely high, though. My hep MD agrees that going into Tx with such a high VL isn't good.
That's another thing about Tx-ing down here: I don't know anywhere here that's got one of the new sensitive RNA tests that make "undetectable" meaningful. My hospital sure doesn't. And I remember how strong a point HR made about using these new tests for on-TX strategy.
Thanks for the bio on Andiamo. I didn't know that. It's something to think about.
Cheers!
Mike
I'd like to see what my VL is now after two years on alt meds that have gotten my enzymes down to normal, but my hospital here won't do another one if I'm not Tx-ing. I was over the top on the first one (the old Taqman), so it could have been anything. Definitely high, though. My hep MD agrees that going into Tx with such a high VL isn't good.
That's another thing about Tx-ing down here: I don't know anywhere here that's got one of the new sensitive RNA tests that make "undetectable" meaningful. My hospital sure doesn't. And I remember how strong a point HR made about using these new tests for on-TX strategy.
Thanks for the bio on Andiamo. I didn't know that. It's something to think about.
Cheers!
Mike
From a conversation I had with the renowned Hepatologist Robert Gish, who is the West Coast director of liver transplants, this disease steadily progresses. Remember that key word "progresses". This means it will not reverse with supplements or other means except treatment. You could be gambling that things will stay the same for a long time. Maybe they will.
He told me a story of one of his patients in perfect health with Hep C, and within one year was in serious trouble with his liver. Many unknown factors can attribute to this, and you really don’t know unless you have a biopsy....
If nothing else, you will buy time with treatment, even if it doesn't work. I know it's a tough decision that you must make. Whatever decision you make, I wish you the very best of luck in clearing...
Magnum
He told me a story of one of his patients in perfect health with Hep C, and within one year was in serious trouble with his liver. Many unknown factors can attribute to this, and you really don’t know unless you have a biopsy....
If nothing else, you will buy time with treatment, even if it doesn't work. I know it's a tough decision that you must make. Whatever decision you make, I wish you the very best of luck in clearing...
Magnum
Hi Mike, I would agree with others that suggest you to keep looking at the treatment, without too much emotions involved. Just go for it, and give it a try. That would be my advice.
Thank you for your comments. They were a helpful reminder for me today. Joe has been sick for a few days. He seems to have an intestinal bug...at least I hope that is all it is. We have been enjoying a long reprieve from his being sick but it doesn't take much to give me a bad memory flashback. Fear can come upon me and really mess up my thinking. Your post was just what I needed to remind me to focus on the positives and be thankful for each day.
We are all hoping that you will have an awesome story to tell about your successful transplant.
Ev
We are all hoping that you will have an awesome story to tell about your successful transplant.
Ev
I agree, great comment, Hector.
Mike, if I were you I'd try to separate out the scientific facts and your odds of success from your anger at the pharmaceutical companies. Don't make your decision based on the latter.
Mike, if I were you I'd try to separate out the scientific facts and your odds of success from your anger at the pharmaceutical companies. Don't make your decision based on the latter.
Hector....forgive me...I sent that last post before I said I wish you the very best with your challenges.. and your positive outlook is an inspiration to many of us here. :)
Will
Bravo, Hector
"God grant me the serenity to accept the things I cannot change, the courage to change the things that I can, and the wisdom to know the difference."
"God grant me the serenity to accept the things I cannot change, the courage to change the things that I can, and the wisdom to know the difference."
"Angry isn't the word for what I feel. "
Mike: This isn"t a healthy state of mind for the liver.
Hector.....well said indeed ..those of us that are still fortunate enough to have healthy livers ,regardless of the virus are extrememly lucky...especially with what seems to be in "Pharma"s pipeline. :)
Will
Mike: This isn"t a healthy state of mind for the liver.
Hector.....well said indeed ..those of us that are still fortunate enough to have healthy livers ,regardless of the virus are extrememly lucky...especially with what seems to be in "Pharma"s pipeline. :)
Will
I'd love to change the way things are set up, but we have to play the cards we are dealt. As Hector so eloquently wrote, you and I are in an almost enviable position.
We are TX naive, we have minimal or acceptable levels of fibrosis, meaning our chances when treating are better.
We have waited long enough that new forms of treatment are now approved that will shorten the treatment time and that will improve the SVR rate. It looks to me like you are awfulizing a little consider that for geno 1's the success rate of SOC is 40-50%; lets call it 45%, OK?
For a TX naive geno 1 the minimum aggregate success rate (w/ triple therapy) I think you will be looking at will be 70%. That ain't hay. Further, If you are in reasonable health, minimal damage, fit, such as I believe you are you may be in closer to the 80% group; nearly double the success rate.
Further..... if you treat with triple therapy you will have the option of a 4 week PCR. If you are clear at 4 weeks (as about 80 % are w/TVR) you will likely get a RVR. For those who RVR about 90% SVR. I see little to complain about there. If you don't RVR you can still either quit and wait for even better treatments which are also surely coming or you can just try to finish it off w/ SOC knowing that you still have improved chances over the "good old days" with only IFN and RBV. If you quit at 4 weeks it has been shown that any resistant virii seem to revert back to the wild type after about 2 years
If you recall.....Andiamo had failed TX 7 times before treating with telaprevir. He was 68 and was a stage 4 if I recall correctly. He and his doctor theorized that the only reason he was still alive was that he had kept trying to beat the virus. TX may have stalled the damage progression. If memory serves this guy who had failed so many times was clear at week 2 and maintained that status thru EOT. I think he has been SVR 3 years now.
These are some great improved treatments. They will save many of us. There are even better ones coming. You can treat or you can wait. There are never any guarantees in life but my opinion is that our lot has significantly improved. Yes, it sux that it costs so much, but there are also trials. This board is also very useful helping navigate these issues. Things could be worse.....
willy
We are TX naive, we have minimal or acceptable levels of fibrosis, meaning our chances when treating are better.
We have waited long enough that new forms of treatment are now approved that will shorten the treatment time and that will improve the SVR rate. It looks to me like you are awfulizing a little consider that for geno 1's the success rate of SOC is 40-50%; lets call it 45%, OK?
For a TX naive geno 1 the minimum aggregate success rate (w/ triple therapy) I think you will be looking at will be 70%. That ain't hay. Further, If you are in reasonable health, minimal damage, fit, such as I believe you are you may be in closer to the 80% group; nearly double the success rate.
Further..... if you treat with triple therapy you will have the option of a 4 week PCR. If you are clear at 4 weeks (as about 80 % are w/TVR) you will likely get a RVR. For those who RVR about 90% SVR. I see little to complain about there. If you don't RVR you can still either quit and wait for even better treatments which are also surely coming or you can just try to finish it off w/ SOC knowing that you still have improved chances over the "good old days" with only IFN and RBV. If you quit at 4 weeks it has been shown that any resistant virii seem to revert back to the wild type after about 2 years
If you recall.....Andiamo had failed TX 7 times before treating with telaprevir. He was 68 and was a stage 4 if I recall correctly. He and his doctor theorized that the only reason he was still alive was that he had kept trying to beat the virus. TX may have stalled the damage progression. If memory serves this guy who had failed so many times was clear at week 2 and maintained that status thru EOT. I think he has been SVR 3 years now.
These are some great improved treatments. They will save many of us. There are even better ones coming. You can treat or you can wait. There are never any guarantees in life but my opinion is that our lot has significantly improved. Yes, it sux that it costs so much, but there are also trials. This board is also very useful helping navigate these issues. Things could be worse.....
willy
Mike,
Yeah capitalism stinks. Especially when it comes to health care for profit. Everything is bought and sold. From McDonald hamburgers to life saving treatment. We've both been around long enough to know this isn't anything new I'm afraid.
Have you heard anything about debate here in the US regarding The Affordable Care Act, passed by Congress and signed into law by the President in March 2010? Some small improvements in our draconian health system, have and will be instituted because of this law, and some people are up in arms saying it the end of the world as we know it and other ridiculous nonsense. To have a system anywhere close to what you would like ain't gonna happen anything soon.
As far as the statements about the new DAAs. I don't see anything factually wrong with the article, but I wouldn't rely on "business reporters" to have any deep understanding of hepatitis C either.
"The PI/Int/Rib mix just doesn't solve the problem for people like me. "
That is fine it is your decision. No one is forcing you to do treatment. If your liver is still healthy then you don't have to treat. Hey I agree I don't want more of my hair falling out, etc. etc. the issue though is a little more serious then that if your liver progresses to ESLD. Have you seen what a patient awaiting a liver transplant looks like? Whatever HCV treatment does there is really no comparison. Do I want to turn Halloween yellow, be skin and bones but look like I'm having triplets because of fluid retention. ESLD isn't for the vain. And I am not even mentioning the suffering, pain and not knowing if you are going to live another day. No words can convey how horrible liver disease can be. At the same time I am glad that most people have no need to know about it. It is not something anybody would volunteer for.
It is nice to have the privilege of being angry I guess. I wish I had the option, but while you can blame the bad guys for all the ills in the world there is also the reality that life ain't fair. And maybe I am jealous of your ability to point the finger at others and say your the problem. But I am all out of that. Thinking about suffering and death has a way of ridding one of whatever bravado one had when live sensed endless and all was possible. Who can I blame? The virus? My immune system for not being able to clear the virus on its own? I figure it is just life and my number came up. What is fair about all the kids with cancer and others life threatening diseases that I see every time I am at the hospital?
Yeah I can't believe this is happening to me sometimes but I have to face reality and do what I gotta do everyday like it or not. My only options at this point are; giving up and plan to die (been through that evaluation and that is not an option for me) or taking each step one by one and deal with the challenges that come along. One at a time. Angry? Maybe, but it does me no good. I need to look for the positive in life. Negatively from where I'm sitting is a unproductive waste of what little energy I have. The only thing I do have control over is my attitude and behavior. I can't control what goes on inside my body. I can't control what treatments manufactured by pharma companies are available for me either. All I can do is try to live each day as best as I can and be grateful to be alive another day even it is a "bad" day it is a good day because I'm alive. I know this all sounds hokey but it is the only way myself and some of my transplant friends get through the challenges as they occur.
Meaning do whatever you want and need to do, but please don't knowingly let your liver progress to ESDL if they are treatments out there that have a chance of working.
Hey amigo, you are one of the lucky ones! You are still healthy and have enough energy to take on the villains as you see it.
Mike, listen to some Astor Piazzolla or dance the night away to tango nuevo. That is what life is about in my opinion. I just wish for myself and other who lives have been turned upside-down by illness, any illness, get a few more dances before its closing time.
Ciao
Hector
Yeah capitalism stinks. Especially when it comes to health care for profit. Everything is bought and sold. From McDonald hamburgers to life saving treatment. We've both been around long enough to know this isn't anything new I'm afraid.
Have you heard anything about debate here in the US regarding The Affordable Care Act, passed by Congress and signed into law by the President in March 2010? Some small improvements in our draconian health system, have and will be instituted because of this law, and some people are up in arms saying it the end of the world as we know it and other ridiculous nonsense. To have a system anywhere close to what you would like ain't gonna happen anything soon.
As far as the statements about the new DAAs. I don't see anything factually wrong with the article, but I wouldn't rely on "business reporters" to have any deep understanding of hepatitis C either.
"The PI/Int/Rib mix just doesn't solve the problem for people like me. "
That is fine it is your decision. No one is forcing you to do treatment. If your liver is still healthy then you don't have to treat. Hey I agree I don't want more of my hair falling out, etc. etc. the issue though is a little more serious then that if your liver progresses to ESLD. Have you seen what a patient awaiting a liver transplant looks like? Whatever HCV treatment does there is really no comparison. Do I want to turn Halloween yellow, be skin and bones but look like I'm having triplets because of fluid retention. ESLD isn't for the vain. And I am not even mentioning the suffering, pain and not knowing if you are going to live another day. No words can convey how horrible liver disease can be. At the same time I am glad that most people have no need to know about it. It is not something anybody would volunteer for.
It is nice to have the privilege of being angry I guess. I wish I had the option, but while you can blame the bad guys for all the ills in the world there is also the reality that life ain't fair. And maybe I am jealous of your ability to point the finger at others and say your the problem. But I am all out of that. Thinking about suffering and death has a way of ridding one of whatever bravado one had when live sensed endless and all was possible. Who can I blame? The virus? My immune system for not being able to clear the virus on its own? I figure it is just life and my number came up. What is fair about all the kids with cancer and others life threatening diseases that I see every time I am at the hospital?
Yeah I can't believe this is happening to me sometimes but I have to face reality and do what I gotta do everyday like it or not. My only options at this point are; giving up and plan to die (been through that evaluation and that is not an option for me) or taking each step one by one and deal with the challenges that come along. One at a time. Angry? Maybe, but it does me no good. I need to look for the positive in life. Negatively from where I'm sitting is a unproductive waste of what little energy I have. The only thing I do have control over is my attitude and behavior. I can't control what goes on inside my body. I can't control what treatments manufactured by pharma companies are available for me either. All I can do is try to live each day as best as I can and be grateful to be alive another day even it is a "bad" day it is a good day because I'm alive. I know this all sounds hokey but it is the only way myself and some of my transplant friends get through the challenges as they occur.
Meaning do whatever you want and need to do, but please don't knowingly let your liver progress to ESDL if they are treatments out there that have a chance of working.
Hey amigo, you are one of the lucky ones! You are still healthy and have enough energy to take on the villains as you see it.
Mike, listen to some Astor Piazzolla or dance the night away to tango nuevo. That is what life is about in my opinion. I just wish for myself and other who lives have been turned upside-down by illness, any illness, get a few more dances before its closing time.
Ciao
Hector
Okay, maybe I'm misreading the reports. But what I gather from all the confusing data is that my own chances (67 years old, geno 1b, high viral load) have improved, with the PI added, from around 30% to around 50%. While that's certainly a significant improvement in statistical success rate, in my case it needs to be weighed against the downside: "Thirty-nine percent of the people who received Victrelis (Boceprevir), pegylated interferon and ribavirin had dose reductions (mainly pegylated interferon/ribavirin) compared to 24% of people who received pegylated interferon and ribavirin without Victrelis." (from a report at hcvadvocate.org).
In other words, adding the PI gives me a 20% better chance of clearing the virus, but also a 15% greater chance of unacceptable side effects.
Now how the heck am I supposed to make a choice about whether to treat now or not, even with a PI added? I'm in excellent overall health. My liver functions are still good and holding steady. My hair isn't falling out, I cured my gastrointestinal trouble of three years ago. I can go tango-dancing (my only real pleasure here in this god-forsaken country), and a few women still dig me. Am I going to risk ruining my looks and health (39%!) for a 50% chance of clearing the virus? With the added, but almost never stated, huge negative of prejudicing myself for the future by creating mutated tougher virus strains if I don't clear?
You see the predicament? The PI/Int/Rib mix just doesn't solve the problem for people like me. I want to see a new therapy, like from the Alina+vaccine trials, or Globeimmune's immunogen, that gives me a good chance of eliminating the virus without ruining my health at the same time.
Am I angry? Sure I am. The funding isn't going into alternatives to int/rib, which is poison. Where do these drug companies get off making billions by charging $30k for a therapy like int/rib that wasn't even designed to fight hep C? (Int/rib came out of HIV research.) They've got the media and government bought off, don't kid yourself. I'd like to see a list of officials who retire onto the board of Merck, Schering-Plough, and Vertex.
Angry isn't the word for what I feel.
M.
In other words, adding the PI gives me a 20% better chance of clearing the virus, but also a 15% greater chance of unacceptable side effects.
Now how the heck am I supposed to make a choice about whether to treat now or not, even with a PI added? I'm in excellent overall health. My liver functions are still good and holding steady. My hair isn't falling out, I cured my gastrointestinal trouble of three years ago. I can go tango-dancing (my only real pleasure here in this god-forsaken country), and a few women still dig me. Am I going to risk ruining my looks and health (39%!) for a 50% chance of clearing the virus? With the added, but almost never stated, huge negative of prejudicing myself for the future by creating mutated tougher virus strains if I don't clear?
You see the predicament? The PI/Int/Rib mix just doesn't solve the problem for people like me. I want to see a new therapy, like from the Alina+vaccine trials, or Globeimmune's immunogen, that gives me a good chance of eliminating the virus without ruining my health at the same time.
Am I angry? Sure I am. The funding isn't going into alternatives to int/rib, which is poison. Where do these drug companies get off making billions by charging $30k for a therapy like int/rib that wasn't even designed to fight hep C? (Int/rib came out of HIV research.) They've got the media and government bought off, don't kid yourself. I'd like to see a list of officials who retire onto the board of Merck, Schering-Plough, and Vertex.
Angry isn't the word for what I feel.
M.
It says they either continue for 12 more weeks OR 36 weeks. Total treatment time is then 12+12=24, or 12+36=48.
Mike, go to the source;
http://pi.vrtx.com/files/uspi_telaprevir.pdf
Look at page 2 the answer is there and clear;
Undetectable at Weeks 4 and 12 do 12 more weeks of SOC and stop TX. (total 24 weeks)
or
Detectable (1000 IU/mL or less) at Weeks 4 and/or 12 do 36 more weeks of SOC (total TX time 48 weeks)
===============
next "gripe" about doing longer TX;
"even with a PI added. So why run the risk of stopping after 24 weeks and relapsing?
Because some of the trials showed that if you have a complete RVR (4 & 12 weeks) there was little benefit in doing an additional 24 weeks of TX. Sure 1-2% improvement but is it worth an additional 24 weeks of TX? You can decide if and when you get there. I doubt the insurance co would pay for it since it was close to statistically insignificant, whereas the cost of 24 weeks of TX will buy you several nice lunches w/ a tango lesson or 3 thrown in to boot. : )
Things may not be quite as bad as you are envisioning.....
willy
http://pi.vrtx.com/files/uspi_telaprevir.pdf
Look at page 2 the answer is there and clear;
Undetectable at Weeks 4 and 12 do 12 more weeks of SOC and stop TX. (total 24 weeks)
or
Detectable (1000 IU/mL or less) at Weeks 4 and/or 12 do 36 more weeks of SOC (total TX time 48 weeks)
===============
next "gripe" about doing longer TX;
"even with a PI added. So why run the risk of stopping after 24 weeks and relapsing?
Because some of the trials showed that if you have a complete RVR (4 & 12 weeks) there was little benefit in doing an additional 24 weeks of TX. Sure 1-2% improvement but is it worth an additional 24 weeks of TX? You can decide if and when you get there. I doubt the insurance co would pay for it since it was close to statistically insignificant, whereas the cost of 24 weeks of TX will buy you several nice lunches w/ a tango lesson or 3 thrown in to boot. : )
Things may not be quite as bad as you are envisioning.....
willy
Make that a BMW M5. Yes, there is advertising hype if you can keep in mind that Vertex is in direct competition with Merck for sales WORLDWIDE!
That is a HUGE amount of money. Let the fox out of the hen pen after he's attacked and fed, and he's not hungry for a while. Let the pharmaceutical companies make their own attack and when satisfied, change the rules, or so it seems. In most cases, people are like sheep. They need a shepherd to lead them. Those that are gullible will follow the shepherd, those that are not will ask questions...
I don't understand why doctors don't get more involved in this and toss themselves into the maelstrom of what's going on. Funny thing is that my own Gastro today said he has to do more studying on Telaprevir. So there you go, an indication that some doctors have yet to fully open their eyes regarding these new drugs. I say to assault the doctors with pertinent questions regarding the protocol of these new drugs. After all, it's possibly your life that's on the line...
Magnum
That is a HUGE amount of money. Let the fox out of the hen pen after he's attacked and fed, and he's not hungry for a while. Let the pharmaceutical companies make their own attack and when satisfied, change the rules, or so it seems. In most cases, people are like sheep. They need a shepherd to lead them. Those that are gullible will follow the shepherd, those that are not will ask questions...
I don't understand why doctors don't get more involved in this and toss themselves into the maelstrom of what's going on. Funny thing is that my own Gastro today said he has to do more studying on Telaprevir. So there you go, an indication that some doctors have yet to fully open their eyes regarding these new drugs. I say to assault the doctors with pertinent questions regarding the protocol of these new drugs. After all, it's possibly your life that's on the line...
Magnum
The way I understand it, the extra time is for those that aren't nondetectable at 4 weeks or those with other major counts against them such as cirrhosis.
I think that they are likely to help many people but null responders and those with cirrhosis may need to hold out for a double direct antiviral instead of just one.
This is the way I have understood it. Willing's posts have enlightened me a lot.
I'm glad the supplements have worked out so well for you. They sure saved the day for Joe.
Ev
I think that they are likely to help many people but null responders and those with cirrhosis may need to hold out for a double direct antiviral instead of just one.
This is the way I have understood it. Willing's posts have enlightened me a lot.
I'm glad the supplements have worked out so well for you. They sure saved the day for Joe.
Ev
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