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Treatment for Hep C will disqualify you from clinical trials for new Hep C drugs
Why get treated for Hep C using ribavirin and interferon when it will disqualify you from clinical trials for new Hep C drugs? Some trials will accept non-responders to PEGYLATED interferon but will NOT non-responders to nonpegylated interferon. Would it be advisable, if one is a non-responder to non-pegylated interferon, to undergo treatment with the pegylated variety just so one can fail that treatment and become eligible for clinical trials that require non-response to pegylated interferon? There are a few clinical trial that accept non-responders to pegylated, but here are NO clinical trilas that are open to non-responders to non-pegylated. Please note that SVR for Genotype 1 using ribavirin and peg-interferon are extremely low (less than 40%). The only effective drugs are in clinical trials, and likely will not be accessible to you for 10 years. Telaprivir is going on 10 years since it was first discovered, and it is still not available to the public.
Unless a person failed treatment many years ago with non-peg the chances are slim that a first attempt would be with anything other than peg.
I have coverage, both through one of my employers and the VA. My concern is access to effective treatment, at all, insurance coverage or not. It seems that the only way to get effective treatment is via clinical trials. Too bad one can't obtain the drugs in Mexico free from U.S. government restriction. Too bad there's not a black market.
Time marches on. We're all getting older and the damage is piling up. Life is slipping away. It takes decades for drugs to go through all the government mandated trials. There's got to be a way around the system. Maybe there are other countries where they would be more readily available. I'd pay cash money.
Here's another drug coming up, polymerase inhibitor -- http://www.clinicaltrials.gov/ct2/show/NCT01180790?term=hepatitis+c+phase+2&recr=Open&rank=38. It would be nice to be able to add this to the mix, especially for us non-responders. Unfortunately, these trials are only open to the treatment naive. Likely, it'll be at least 10 years before this ever hits the market.
Here's a whole mess of other drugs under development. I wonder how long it's going to take these to hit the market. Let's hope we all hold out for another 10 years. http://www.hivandhepatitis.com/hep_c/hepc_news_alter.html#stat
Time marches on. We're all getting older and the damage is piling up. Life is slipping away. It takes decades for drugs to go through all the government mandated trials. There's got to be a way around the system. Maybe there are other countries where they would be more readily available. I'd pay cash money.
Here's another drug coming up, polymerase inhibitor -- http://www.clinicaltrials.gov/ct2/show/NCT01180790?term=hepatitis+c+phase+2&recr=Open&rank=38. It would be nice to be able to add this to the mix, especially for us non-responders. Unfortunately, these trials are only open to the treatment naive. Likely, it'll be at least 10 years before this ever hits the market.
Here's a whole mess of other drugs under development. I wonder how long it's going to take these to hit the market. Let's hope we all hold out for another 10 years. http://www.hivandhepatitis.com/hep_c/hepc_news_alter.html#stat
"Unless a person failed treatment many years ago with non-peg the chances are slim that a first attempt would be with anything other than peg."
That's me.
That's me.
Any use of these lousey meds should be taken with the intent to be successful, not to fail. These are powerful and can have long-term after effects. I suppose that a person could go into treat with less than full inent but to me it doesn't make a lot of sense. With an experienced doc there are modifications that could be may to enhance chances of success. Or, just wait until better stuff comes along - not in a trial setting.
"At best, we're looking at perhaps 1 more year."
Then maybe it'll be better to wait it out. I've waited this long. I suppose another year is OK.
"Do you mean consensus interferon when you say non pegylated interferon?"
In many of the Telaprivir and other trials, the requirement for inclusion was failed treatment with pegylated interferon, or treatment naive. In my case, the interferon I had was not pegylated. This was back in '99-'00. I would have sought treatment again with pegylated interferon except that after further research, I found that with genotype 1 and previously failed RBV & IFN treatment, I would only stand a 10% chance of SVR.
At that point, I did some math with my viral load levels (using an exponential decay model) and determined that 20 - 22 months or so of RBV & peg IFN therapy would reduce the viral load below 1 single particle to a 50% probability. (I'm a math major.) This is provided my hematocrit would hold up.
I held up pretty well during the previous RBV & IFN treatment, working full-time in a demanding programming job. The only thing where I slowed down was that instead of taking a wilderness backpack hunting trip that year, I went on a wilderness horseback hunting trip that year. So, I figured I was strong enough to handle 22 months, especially if I took off some time from work and gradually cut back on activity. I worked as a consultant, contractor or temp doing programming.
I was starting to provide for the long period of treatment, even if I had to go to several doctors. But then, I read about protease inhibitors (VX-950) being very effective against HCV. So, I decided to forgo my plans for extended treatment, and wait a few years until it came out. Also, if the treatment failed, I did not want to create a more resistant strain of virus. Well, I've been waiting and waiting and waiting. Every year, it'll be next year.
Each year, I have to make a decision whether to get the pegylated treatment plan or wait for the protease inhibitor to come out. If I did the Ribavirin & peg interferon only, I'd arrange for up to 48 months of treatment. I want to kill the damned thing. I'm 58 now. Will I even be able to handle the 48 months? Better do it soon before I get much older.
But if it'll only be another year, maybe it's worth waiting. But it's only been another year for the last 4 years, since 2006.
Plus, there are polymerase inhibitors in development also -- http://www.outsourcing-pharma.com/Preclinical-Research/Roche-s-oral-polymerase-inhibitor-exhibits-hep-C-efficacy. Clinical trials Filibuvir -- http://www.clinicaltrials.gov/ct2/show/NCT00987337?term=polymerase+inhibitor&rank=10
In the long term there will be "quadruple therapy", with both protease and polymerase inhibitors, which promises to be very effective. The question is how long. Will we still be alive to have it? Or be too old to have it?
Then maybe it'll be better to wait it out. I've waited this long. I suppose another year is OK.
"Do you mean consensus interferon when you say non pegylated interferon?"
In many of the Telaprivir and other trials, the requirement for inclusion was failed treatment with pegylated interferon, or treatment naive. In my case, the interferon I had was not pegylated. This was back in '99-'00. I would have sought treatment again with pegylated interferon except that after further research, I found that with genotype 1 and previously failed RBV & IFN treatment, I would only stand a 10% chance of SVR.
At that point, I did some math with my viral load levels (using an exponential decay model) and determined that 20 - 22 months or so of RBV & peg IFN therapy would reduce the viral load below 1 single particle to a 50% probability. (I'm a math major.) This is provided my hematocrit would hold up.
I held up pretty well during the previous RBV & IFN treatment, working full-time in a demanding programming job. The only thing where I slowed down was that instead of taking a wilderness backpack hunting trip that year, I went on a wilderness horseback hunting trip that year. So, I figured I was strong enough to handle 22 months, especially if I took off some time from work and gradually cut back on activity. I worked as a consultant, contractor or temp doing programming.
I was starting to provide for the long period of treatment, even if I had to go to several doctors. But then, I read about protease inhibitors (VX-950) being very effective against HCV. So, I decided to forgo my plans for extended treatment, and wait a few years until it came out. Also, if the treatment failed, I did not want to create a more resistant strain of virus. Well, I've been waiting and waiting and waiting. Every year, it'll be next year.
Each year, I have to make a decision whether to get the pegylated treatment plan or wait for the protease inhibitor to come out. If I did the Ribavirin & peg interferon only, I'd arrange for up to 48 months of treatment. I want to kill the damned thing. I'm 58 now. Will I even be able to handle the 48 months? Better do it soon before I get much older.
But if it'll only be another year, maybe it's worth waiting. But it's only been another year for the last 4 years, since 2006.
Plus, there are polymerase inhibitors in development also -- http://www.outsourcing-pharma.com/Preclinical-Research/Roche-s-oral-polymerase-inhibitor-exhibits-hep-C-efficacy. Clinical trials Filibuvir -- http://www.clinicaltrials.gov/ct2/show/NCT00987337?term=polymerase+inhibitor&rank=10
In the long term there will be "quadruple therapy", with both protease and polymerase inhibitors, which promises to be very effective. The question is how long. Will we still be alive to have it? Or be too old to have it?
I would want to kill the damned thing. But I am realistic. The probability of SVR after 48 weeks RBV & peg-IFN for genotype I previous non-responders is only 10%. So likely, I would fail treatment anyway, unless I extended treatment to 96 weeks (24 months), which would be difficult to handle.
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