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Effect of Peginterferon Alfa-2a (Pegasys) on Liver Histology in Chronic HCV
This is very good news and adds evidence to the histolgic effects of interferon.
If anyone doesn't achieve the "12 week 2 log drop" magic number this is a good study to show to the doctors if they want you to stop treatment.
If anyone doesn't achieve the "12 week 2 log drop" magic number this is a good study to show to the doctors if they want you to stop treatment.
Dieterich works with the NIH (see above) and I think they also would have shot him down fast for making the above claim on the blood/brain barrier.
You can search Google all you like but that's not going to prove Dieterich wrong or that peginterferons do not reverse fibrosis.
You can search Google all you like but that's not going to prove Dieterich wrong or that peginterferons do not reverse fibrosis.
I believe you are engaged in sophistry of the worst kind.
I detect an anti-treatment bias in you.
You have already infected this optimistic, life-loving, HCV-fighting board with your cultural pessimism.
You almost caused BD146 to stop treatment. I find that reprehensible.
Peginterferons CLEARLY have antifibrotic properties. The evidence is in on that question -- now science needs to figure out how to expand the percentange of patients fibrosis is reversed in and someday science WILL DO THAT.
Dr. Dieterich clearly stated:
"HCV does cross the blood brain barrier, we now understand. However, so does interferon hence all those CNS side effects. When you clear the virus in the blood it is cleared everywhere and you are really rid of it everywhere in your body."
The doctor has very serious credentials -- and as I stated before: his peers would have shot him down fast for making such a false statement in public -- and you haven't provided ONE refutation of him.
I, like most of the good people here, am a fighter against this disease. Like it or not, and I don't, this is the AGE OF INTERFERON -- it is our weapon, with ribavarin, to DESTROY this disease. There are a plethora of genotype 1s here that BEAT HCV.
You go off into tangents and want to discuss what "cure" means ... cure means a SVR. Do some people who attain a SVR relapse 5-10 years down the road? Perhaps but not very many.
I have a cultural OPTIMISM that science can solve the problems of disease, given enough research and funding. You've brought a pessimism that smells of defeat to this place and I don't think it has a place here.
I don't know you and haven't researched your website, but, as Nann posted, you have an "antitreatment attitude" or bias.
Do you have HCV? If so, where are you in it? Have you treated? Are you selling something?
I detect an anti-treatment bias in you.
You have already infected this optimistic, life-loving, HCV-fighting board with your cultural pessimism.
You almost caused BD146 to stop treatment. I find that reprehensible.
Peginterferons CLEARLY have antifibrotic properties. The evidence is in on that question -- now science needs to figure out how to expand the percentange of patients fibrosis is reversed in and someday science WILL DO THAT.
Dr. Dieterich clearly stated:
"HCV does cross the blood brain barrier, we now understand. However, so does interferon hence all those CNS side effects. When you clear the virus in the blood it is cleared everywhere and you are really rid of it everywhere in your body."
The doctor has very serious credentials -- and as I stated before: his peers would have shot him down fast for making such a false statement in public -- and you haven't provided ONE refutation of him.
I, like most of the good people here, am a fighter against this disease. Like it or not, and I don't, this is the AGE OF INTERFERON -- it is our weapon, with ribavarin, to DESTROY this disease. There are a plethora of genotype 1s here that BEAT HCV.
You go off into tangents and want to discuss what "cure" means ... cure means a SVR. Do some people who attain a SVR relapse 5-10 years down the road? Perhaps but not very many.
I have a cultural OPTIMISM that science can solve the problems of disease, given enough research and funding. You've brought a pessimism that smells of defeat to this place and I don't think it has a place here.
I don't know you and haven't researched your website, but, as Nann posted, you have an "antitreatment attitude" or bias.
Do you have HCV? If so, where are you in it? Have you treated? Are you selling something?
I did some internet research to see whether this has been studies or not and what, if any information is out there.
A google search produced a number of fairly interesting site explaining the blood brain barrier. This is different than the nervous system, which is not confined to the brain.
Second, I found an article on hepnet from the consensus Management Conference written by Geoffrey Dusheiko, M.D. on the side effects of hepatitis c treatment. In it(under neuropsychiatric effects), he writes " Neuropsychiatric side effects can be the most troublesome and unpredictable, but their mechanisms are poorly understood. Interferon is not thought to readily cross the blood-brain barrier. "
The entire text can be found either at hepnet or at hcop.org under Interferon treatment. It is a public document from the NIH.
This information has been consistent at virtually every meeting and conference I have recently attended, and in a few conversations with nerologists as well. The Pegasys molecule is 40kds and the Peg Intron is slightly smaller, I believe. Both are considered too large to penetrate the blood brain barrier, but there has been a lot of discussion about how and what might need to happen on the molecular or structural level to improve the chances that it can.
Perhaps the statement "not thought to cross the blood brain barrier" in this article can be taken as a statement that is not definitive. I don't know.
Anyway, since you do have a sincere interest in this topic, if you do decide to ask Doug Dietrick his take on this, I hope this give a little bit of a basis upon which to do so.
I would be interested in his response.
A google search produced a number of fairly interesting site explaining the blood brain barrier. This is different than the nervous system, which is not confined to the brain.
Second, I found an article on hepnet from the consensus Management Conference written by Geoffrey Dusheiko, M.D. on the side effects of hepatitis c treatment. In it(under neuropsychiatric effects), he writes " Neuropsychiatric side effects can be the most troublesome and unpredictable, but their mechanisms are poorly understood. Interferon is not thought to readily cross the blood-brain barrier. "
The entire text can be found either at hepnet or at hcop.org under Interferon treatment. It is a public document from the NIH.
This information has been consistent at virtually every meeting and conference I have recently attended, and in a few conversations with nerologists as well. The Pegasys molecule is 40kds and the Peg Intron is slightly smaller, I believe. Both are considered too large to penetrate the blood brain barrier, but there has been a lot of discussion about how and what might need to happen on the molecular or structural level to improve the chances that it can.
Perhaps the statement "not thought to cross the blood brain barrier" in this article can be taken as a statement that is not definitive. I don't know.
Anyway, since you do have a sincere interest in this topic, if you do decide to ask Doug Dietrick his take on this, I hope this give a little bit of a basis upon which to do so.
I would be interested in his response.
Your great big hug has been received. Thank you! I hope you have received mine. Thank you for the human touch. God bless... Edgar
I have pulled some comments that were posted by you in this thread. I see hope hope or encouragement in any of the posts from you. Regardless of whether you HIDE behind the results of clinical studies or doctors' comments, your underlying message is quite clear. I, for one, will die from one of my other dieases. However, I would not want to read on a forum where I have been going for support, that the treatments I have been going through were all for not. I WILL NOT lay down and die when there is a chance, a glimmer of hope or a 99-1% that the treatment will work. Try pushing your "wait for something better to come along" **** over at the oral cancer forum! By the way...my brother died on August 16, 2002 of HCV related liver failure. Thank you sooo much for all of your encouragement.
"no significant reduction was observed among nonresponders"
This is not great news for those who do not respond.
Unfortunately for those who do not, the rates of histological progression is back to where it was within one to two years and can be worse in some patients.
So, for those with mild histology to begin with, who are female or who have low risk for progression, and who are genotype 1, this might be something to consider before making the decision to treat. Women of childbearing age also have issues to consider with regard to Interferon therapy.
Less than 50% of genotype 1's realize an SVR and of that some, but not all, have some histological benefit.
Those who do not respond, may have to be on interferon for a long time or intermittently for a long time, perhaps life (like insulin for diabetics) if they can tolerate the medications.
That is why, since most people do not progress or die of hepatitis C once they are diagnosed, it is really important to assess whether the risks (sides, adverse events, and possible non-responde) outweight the benefits. There has been at least one study out of the Harvard School of Public Health that concluded that the risks do outweigh the benefits for those (particulalry women) who have mild disease.
So, it isn't a matter of whether treatment is good, bad or ugly. It is a matter of optimal timing and the real likelihood that there are better options coming along for those who can wait. It might just be that those who can, should. This is one of the reasons Roche has been very careful about the 12 week PCR result. There AMY be less risk of being interferon dependent if those who probably are not going to respond discontinue if the 12 week PCR is still positive or has not revealed a 2 log drop in viral load...
The missing link is what the HALT-C is showing and that is reflected in Dr. Hoofnagel's comments at the FDA: the histological benefit runs out at 1-2 years post treatment and may begin to worsen the fibrosis. Unless those studies went out beyond 2 years, they are not going to show similar results because at the end of treatment (six months post treatment) an person with an SVR can expect to have a histological improvement, but not beyond 2 years after treatment.
So, all of the statements above are true, but it is important to know the parameters of the study in order to understand what conclusions can be drawn from the data and to know the limitations of the data.
Anyway, an SVR is a good thing, but it may or may not be a "cure." So much depends on research not yet done in neurology, nephrology, pulmonology etc etc.
I offer information that I hope will help people make a decision that is right for them. Going in knowing up front what interferon may or may not be able to provide in terms of long term benefit against the prospects of other choices. There are other choices for some patients, but no choice is completely risk free and there may come a time to reevaluate interferon thera[py or watchful waiting or any other choice that is made.
"no significant reduction was observed among nonresponders"
This is not great news for those who do not respond.
Unfortunately for those who do not, the rates of histological progression is back to where it was within one to two years and can be worse in some patients.
So, for those with mild histology to begin with, who are female or who have low risk for progression, and who are genotype 1, this might be something to consider before making the decision to treat. Women of childbearing age also have issues to consider with regard to Interferon therapy.
Less than 50% of genotype 1's realize an SVR and of that some, but not all, have some histological benefit.
Those who do not respond, may have to be on interferon for a long time or intermittently for a long time, perhaps life (like insulin for diabetics) if they can tolerate the medications.
That is why, since most people do not progress or die of hepatitis C once they are diagnosed, it is really important to assess whether the risks (sides, adverse events, and possible non-responde) outweight the benefits. There has been at least one study out of the Harvard School of Public Health that concluded that the risks do outweigh the benefits for those (particulalry women) who have mild disease.
So, it isn't a matter of whether treatment is good, bad or ugly. It is a matter of optimal timing and the real likelihood that there are better options coming along for those who can wait. It might just be that those who can, should. This is one of the reasons Roche has been very careful about the 12 week PCR result. There AMY be less risk of being interferon dependent if those who probably are not going to respond discontinue if the 12 week PCR is still positive or has not revealed a 2 log drop in viral load...
The missing link is what the HALT-C is showing and that is reflected in Dr. Hoofnagel's comments at the FDA: the histological benefit runs out at 1-2 years post treatment and may begin to worsen the fibrosis. Unless those studies went out beyond 2 years, they are not going to show similar results because at the end of treatment (six months post treatment) an person with an SVR can expect to have a histological improvement, but not beyond 2 years after treatment.
So, all of the statements above are true, but it is important to know the parameters of the study in order to understand what conclusions can be drawn from the data and to know the limitations of the data.
Anyway, an SVR is a good thing, but it may or may not be a "cure." So much depends on research not yet done in neurology, nephrology, pulmonology etc etc.
I offer information that I hope will help people make a decision that is right for them. Going in knowing up front what interferon may or may not be able to provide in terms of long term benefit against the prospects of other choices. There are other choices for some patients, but no choice is completely risk free and there may come a time to reevaluate interferon thera[py or watchful waiting or any other choice that is made.
I was on 225mg. of Effexor,4 mg. of xanax, 5mg. of Ambien. My doc cut out the Effexor, cut me back to 2mg. xanax and I still take the ambien. She and I both believe it was the high dose of Effexor.
Rev- Several months ago I was ta;lking to Mikesimon? and others and was told there are tests ongoing and they believ and are trying to prove that Pegasys/ Copegus are small enough to break blood brain barrier. That's our biggest worry, I think and pray they are right. Joni
Rev- Several months ago I was ta;lking to Mikesimon? and others and was told there are tests ongoing and they believ and are trying to prove that Pegasys/ Copegus are small enough to break blood brain barrier. That's our biggest worry, I think and pray they are right. Joni
First of all, I had nothing but studies and links, downloadable brochures,and links before 2 weeks ago when we installed new software. So, I am not sure what,exactly you were reading that you now characterize as anti-treatment at all. And, actually, what in the world is anti-treatment or pro-treatment? It just is what it is. People choose what information they want to discuss with their doctors. The best anyone here can do is open that base of information a little for purposes of a discussion.
Second, you are correct in that I do not know what the "right thing to do" is for any one individual. No one else here does, either. I cannot say, for example if a young healthy woman cares whether interferon can impact her fertility or not, but it might be important for a woman to make that choice herself based on her own values and plans for her life, rather than finding out after it is too late. I get nearly thousand emails a week from people around the world. Three thousand if you include all the spam.
If people are steered away from treatment, it might be because they are making choices for themselves based on broader information. It's all about having enough information to make choices based on your opwn values and medical situation.
Almost no one has to treat in a hurry and almost all can take the time to decide, research and plan treatment if they want treatment. Some people may not choose it, may not be medically appropriate for it or may not wish to put their lives, careers and relationships on hold. And some don't need to treat at all. I see more pressure in the other direction than anything. The treat or die message is simply a cruel hoax. We know that the majority of people with hepatitis C can live with it and will likely die of something else. THAT is a message of hope. It is especially a message of hope for those who cannot treat, cannot afford to treat, have no health insurance or are African American (for whom treatment does not work)They need hope, too. This isn't a luxury disease of the well-insured middle class.
Encouraging people to suffer needlessly is my view of cruel. Borne of good intent doesn't change the fact that no one is learning the difficulties of treatment from me. I reviewed this board before ever posting and I have offered only responses to people's queries. Discussions regarding the suffering of the treatment pre-date my arrival.
It takes someone's dignity away to make decisions about what they should be told and when. Witholding knowledge is also my version of cruel.
"Touting" the website is a time saver for me. I have complied information and letters, advice and information. Go there or not, it is your choice. It saves me time to link up rather than type out the information hundreds of times.
Second, you are correct in that I do not know what the "right thing to do" is for any one individual. No one else here does, either. I cannot say, for example if a young healthy woman cares whether interferon can impact her fertility or not, but it might be important for a woman to make that choice herself based on her own values and plans for her life, rather than finding out after it is too late. I get nearly thousand emails a week from people around the world. Three thousand if you include all the spam.
If people are steered away from treatment, it might be because they are making choices for themselves based on broader information. It's all about having enough information to make choices based on your opwn values and medical situation.
Almost no one has to treat in a hurry and almost all can take the time to decide, research and plan treatment if they want treatment. Some people may not choose it, may not be medically appropriate for it or may not wish to put their lives, careers and relationships on hold. And some don't need to treat at all. I see more pressure in the other direction than anything. The treat or die message is simply a cruel hoax. We know that the majority of people with hepatitis C can live with it and will likely die of something else. THAT is a message of hope. It is especially a message of hope for those who cannot treat, cannot afford to treat, have no health insurance or are African American (for whom treatment does not work)They need hope, too. This isn't a luxury disease of the well-insured middle class.
Encouraging people to suffer needlessly is my view of cruel. Borne of good intent doesn't change the fact that no one is learning the difficulties of treatment from me. I reviewed this board before ever posting and I have offered only responses to people's queries. Discussions regarding the suffering of the treatment pre-date my arrival.
It takes someone's dignity away to make decisions about what they should be told and when. Witholding knowledge is also my version of cruel.
"Touting" the website is a time saver for me. I have complied information and letters, advice and information. Go there or not, it is your choice. It saves me time to link up rather than type out the information hundreds of times.
I apologize, but after reading your posts for the last few days, I have felt a complete change in the feel of this Board(if that is at all possbile by reading). I have seen the hope and faith drain from normally optimistic people who are struggling to achieve a goal. People ready to stop treatment because hopelessness has been instilled? Why would you do that to people? Can't you see how things have changed? Why would you put doubts in these people's minds when it is a struggle everyday for some to continue? In my opinion, and only my opinion, a pessimistic attitude is like poison on this site. Please do not do this to them. Let them keep their faith and hope. The emotional rollercoaster that they are on, even on a "good day" where they know that they are doing the right thing, is hard enough. But to have them read some of the stuff that you post on a "bad day" is unfair and cruel.
Just my opinion.
Just my opinion.
Thanbey, "the best you can do" is give your information concisely and then leave it alone. I read your citing of studies and antitreatment attitude for a couple of years on your website. Of course you have very good points but it is all so doctrinaire. You really don't know what is the right thing to do. It comes down to a person and his/her doctor and trying to do the right thing for the quality of life and prolonging life.
It might work or it might not. I have been continuously on treatment for two years. My blood test numbers are better but I don't have the energy I had before treatment. It is a tradeoff. Side effects are not going to keep me from giving this my best shot. My feeling is that TRUST of each person's doctor is the most important thing. Also, my doctor is adamant that treatment has to be very individual. What works for one person in one situation may not work for someone else in the same situation. All he does is work with Hep C patients. The citing of references to Hep C experts is interesting to read,--if I feel like it,--but really I think having HOPE is a thousand times more important. The writers on this website are not in denial. But they want to express how they feel. As one nurse said to me--"Clear your mind, your body will follow." Simplistic, yes--but a heck of a lot more positive then the "blood brain barrier". Just what can anyone do about that, anyway?
It might work or it might not. I have been continuously on treatment for two years. My blood test numbers are better but I don't have the energy I had before treatment. It is a tradeoff. Side effects are not going to keep me from giving this my best shot. My feeling is that TRUST of each person's doctor is the most important thing. Also, my doctor is adamant that treatment has to be very individual. What works for one person in one situation may not work for someone else in the same situation. All he does is work with Hep C patients. The citing of references to Hep C experts is interesting to read,--if I feel like it,--but really I think having HOPE is a thousand times more important. The writers on this website are not in denial. But they want to express how they feel. As one nurse said to me--"Clear your mind, your body will follow." Simplistic, yes--but a heck of a lot more positive then the "blood brain barrier". Just what can anyone do about that, anyway?
A certain amount of those who respond to treatment DO have some histological benefit, but only as long as they remain on the interferon. Once interferon is discontinued, histology worsens over the next 1-2 years and even MAY increase.
So, yes, it is possible that non-responders can be maintained and receive a certain amount of histological improvement as long as they are on low dose monotherapy.
When you break it down, it looks like this:
Less than 50% of genotype 1's realize an SVR and of that some, but not all, have some histological benefit.
Those who do not respond, may have to be on interferon for a long time or intermittently for a long time, perhaps life (like insulin for diabetics) if they can tolerate the medications.
That is why, since most people do not progress or die of hepatitis C once they are diagnosed, it is really important to assess whether the risks (sides, adverse events, and possible non-responde) outweight the benefits. There has been at least one study out of the Harvard School of Public Health that concluded that the risks do outweigh the benefits for those (particulalry women) who have mild disease.
So, it isn't a matter of whether treatment is good, bad or ugly. It is a matter of optimal timing and the real likelihood that there are better options coming along for those who can wait. It might just be that those who can, should. This is one of the reasons Roche has been very careful about the 12 week PCR result. There AMY be less risk of being interferon dependent if those who probably are not going to respond discontinue if the 12 week PCR is still positive or has not revealed a 2 log drop in viral load.
I hope this helps.
thanbey
<a href="http://www.hcop.org">Hepatitis C Outreach Project</a>
So, yes, it is possible that non-responders can be maintained and receive a certain amount of histological improvement as long as they are on low dose monotherapy.
When you break it down, it looks like this:
Less than 50% of genotype 1's realize an SVR and of that some, but not all, have some histological benefit.
Those who do not respond, may have to be on interferon for a long time or intermittently for a long time, perhaps life (like insulin for diabetics) if they can tolerate the medications.
That is why, since most people do not progress or die of hepatitis C once they are diagnosed, it is really important to assess whether the risks (sides, adverse events, and possible non-responde) outweight the benefits. There has been at least one study out of the Harvard School of Public Health that concluded that the risks do outweigh the benefits for those (particulalry women) who have mild disease.
So, it isn't a matter of whether treatment is good, bad or ugly. It is a matter of optimal timing and the real likelihood that there are better options coming along for those who can wait. It might just be that those who can, should. This is one of the reasons Roche has been very careful about the 12 week PCR result. There AMY be less risk of being interferon dependent if those who probably are not going to respond discontinue if the 12 week PCR is still positive or has not revealed a 2 log drop in viral load.
I hope this helps.
thanbey
<a href="http://www.hcop.org">Hepatitis C Outreach Project</a>
I was in a study for people like you and obviously me. I started May 2002, fin'ed Oct 2002. Stupid or lucky me, I didn't realize that anyone would hesitate to tx after liver failure. And what a shame. After all, I cl'ed in only 18d's, fin 24wks-2b.
If I hadn't tx'ed, I'ld be dead.
You asked how I was. Well, I'm good b/have to watch for fluid build up. I'm looking for a good mild herbal diuritic. Also, the encephalitis-ammonia thing. Its just a balance of diet, exercise and rest. I feel much better, so good in fact, that I have to pace myself, b/c my energy is not boundless anymore.
I feel as if my liver has really improved since the hep c is gone. And I've learned not to add further insult to the liver's injuries. The longer I stay away from drugs and alcohol, the more I realize I no longer need or want them. And my liver thanks me, too. It's kinda like a pet now.
If I hadn't tx'ed, I'ld be dead.
You asked how I was. Well, I'm good b/have to watch for fluid build up. I'm looking for a good mild herbal diuritic. Also, the encephalitis-ammonia thing. Its just a balance of diet, exercise and rest. I feel much better, so good in fact, that I have to pace myself, b/c my energy is not boundless anymore.
I feel as if my liver has really improved since the hep c is gone. And I've learned not to add further insult to the liver's injuries. The longer I stay away from drugs and alcohol, the more I realize I no longer need or want them. And my liver thanks me, too. It's kinda like a pet now.
Edgar...what is your latest 12 week testing show? I know you said you didn't respond 1st round but how are you doing this time? I can only understand how you are feeling as all this reading of studies etc...can get you down big time. If you are SVR..Great...you know you did good but on the otherhand if you are a 1...and have relapse..then you are thinking..am I progressing things along on my liver? I'm like you as I get going and excited about beating this and then read more, do more reseach and then wonder if I'm doing the right thing. Its like a catch 22! My prayers are with you and I pray you don't give up at this stage of the game.
Thank you both for reaching out. I am starting to feel that ignorance is truly bliss..
I feel that at many times this forum has been very helpful, and many times it has been a depressant.
Maybe the time has come for me to put this forum down for a while.
Thank you ... Edgar
I feel that at many times this forum has been very helpful, and many times it has been a depressant.
Maybe the time has come for me to put this forum down for a while.
Thank you ... Edgar
Sometimes taking a break can help and I know at times reading different postings can make or break the day. I know at times when having a bad day...you quickly forget about it the next and things are so much brighter. Don't make any drastic decisions today but wait..and the answers will come. If you just want to talk...my email ***@****
You're saying that people who achieve a SVR only have a histological benefit if they remain on treatment? No, that simply isn't true.
I don't believe that enough studies have been done to give a final answer on peginterferons as antifibrotics. That is the reason for the HALT-C and COPILOT studies.
Sure, someone with mild damage has time to wait -- perhaps. That would depend on disease progression etc. and that's something that can't be 'predicted' in a linear matter. 'Usually' disease progression is slow but in some cases it isn't.
<a href="http://www.hepcassoc.org/news/article4.html">Antifibrotic Effect of Interferon Alfa in the Treatment of Chronic Hepatitis C:
An Unanticipated but Important End Point
</a>
I don't believe that enough studies have been done to give a final answer on peginterferons as antifibrotics. That is the reason for the HALT-C and COPILOT studies.
Sure, someone with mild damage has time to wait -- perhaps. That would depend on disease progression etc. and that's something that can't be 'predicted' in a linear matter. 'Usually' disease progression is slow but in some cases it isn't.
<a href="http://www.hepcassoc.org/news/article4.html">Antifibrotic Effect of Interferon Alfa in the Treatment of Chronic Hepatitis C:
An Unanticipated but Important End Point
</a>
I also want to say that I am not trying to get into a 'debate' with you over this stuff. It can only help if we talk about it honestly. If I am off base, simply wrong, or obviously nuts tell me. I am just a patient ... diagnosed a little more than one year ago.
Take care,
Scott
Take care,
Scott
I am sorry that that is where the data from HALTC and other studies have taken us so far. APRICOT is a study for those co-infected with HIV and this is a completely different set of circumstances that moninfected people face. I wouldn't take the conclusions for those with HIV and apply them to someone with HCV only. And we haven't even begun to get into gender specific issues, and extrahepatic HCV disease (for which there is mounting evidence, some conclusive)
This is information given by Jay Hoofnagel to the FDA during the approval hearing for Pegasys.
There is a link to the FDA transcript at the bottom of the article previously posted.
I am sorry, it is true. At least, from what is known so far.
That is what interferon and/or ribivirin maintenance therapy is all about. (see link below)
Yeah...... I know, it shocked me, too. But there it is in the hearing transcript. This is the best of the best on the part of the manufacturer in order to have their product FDA approved. Testimony given by HALTC researchers. Not statements to take lightly.
Still, for those who have enough liver damage and no contraindications for interferon therapy, the risk is still worth considering. For those who can wait, that is an option worth thinking seriously about.
Please don't shoot the messenger!
I hope this helps,
thanbey
<a href="http://www.hcop.org/hcvinfo/articles/index.cfm?articleid=62">article ribivirin mintenance therapy</a>
This is information given by Jay Hoofnagel to the FDA during the approval hearing for Pegasys.
There is a link to the FDA transcript at the bottom of the article previously posted.
I am sorry, it is true. At least, from what is known so far.
That is what interferon and/or ribivirin maintenance therapy is all about. (see link below)
Yeah...... I know, it shocked me, too. But there it is in the hearing transcript. This is the best of the best on the part of the manufacturer in order to have their product FDA approved. Testimony given by HALTC researchers. Not statements to take lightly.
Still, for those who have enough liver damage and no contraindications for interferon therapy, the risk is still worth considering. For those who can wait, that is an option worth thinking seriously about.
Please don't shoot the messenger!
I hope this helps,
thanbey
<a href="http://www.hcop.org/hcvinfo/articles/index.cfm?articleid=62">article ribivirin mintenance therapy</a>
To be clear: first I spelled ribavirin wrong, sorry.
Second, the studies shared by the above posters DO show histological response at six months post treatment. I take no issue with those results.
The missing link is what the HALT-C is showing and that is reflected in Dr. Hoofnagel's comments at the FDA: the histological benefit runs out at 1-2 years post treatment and may begin to worsen the fibrosis. Unless those studies went out beyond 2 years, they are not going to show similar results because at the end of treatment (six months post treatment) an person with an SVR can expect to have a histological improvement, but not beyond 2 years after treatment.
So, all of the statements above are true, but it is important to know the parameters of the study in order to understand what conclusions can be drawn from the data and to know the limitations of the data.
I don't see a lot talk about this. But, going to the FDA hearing transcripts, where there is no marketing or conflicts of interest to be had will give the community a glimpse in to the information that we are not getting otherwise.
I couldn't agree more that discussion are useful. It is so hard to sort through the marketing and the science and try to distinquish one from another. I am not concerned about being right, I am concerned that patients and doctors are not being fully informed so that decisions can be made on all the information available. The decisions themselves are completely between a patients and their provider.
I hope this ehlps,
thanbey
Second, the studies shared by the above posters DO show histological response at six months post treatment. I take no issue with those results.
The missing link is what the HALT-C is showing and that is reflected in Dr. Hoofnagel's comments at the FDA: the histological benefit runs out at 1-2 years post treatment and may begin to worsen the fibrosis. Unless those studies went out beyond 2 years, they are not going to show similar results because at the end of treatment (six months post treatment) an person with an SVR can expect to have a histological improvement, but not beyond 2 years after treatment.
So, all of the statements above are true, but it is important to know the parameters of the study in order to understand what conclusions can be drawn from the data and to know the limitations of the data.
I don't see a lot talk about this. But, going to the FDA hearing transcripts, where there is no marketing or conflicts of interest to be had will give the community a glimpse in to the information that we are not getting otherwise.
I couldn't agree more that discussion are useful. It is so hard to sort through the marketing and the science and try to distinquish one from another. I am not concerned about being right, I am concerned that patients and doctors are not being fully informed so that decisions can be made on all the information available. The decisions themselves are completely between a patients and their provider.
I hope this ehlps,
thanbey
Well, gee ...
You're saying that a patient's liver who is 'cured' (and let's define 'cure' to equal a sustained virologic response) becomes worse two years out? Or do you mean in non-responders? THAT I could see but in responders? I know of people that attain a SVR that go on to develop HCC ... yes, but how many? Not too many, more than likely. If the virus is not attacking the liver why would the fibrosis progress? Do we have some data showing that to be the case 2-4 years out? Dr. Hoofnagel says that this "may" happen? I am not clear on it.
You're saying that a patient's liver who is 'cured' (and let's define 'cure' to equal a sustained virologic response) becomes worse two years out? Or do you mean in non-responders? THAT I could see but in responders? I know of people that attain a SVR that go on to develop HCC ... yes, but how many? Not too many, more than likely. If the virus is not attacking the liver why would the fibrosis progress? Do we have some data showing that to be the case 2-4 years out? Dr. Hoofnagel says that this "may" happen? I am not clear on it.
You really are a Honey. You could not have picked a better name. I promise not to make any drastic decisions. Thank you again for reaching out. May Gods graces continue to be with you. Sincerely, Edgar
You said that Dr. Dieterich didn't know what he was talking about re: interferon crossing the blood/brain barrier.
Your statement:
"With all due respect to Doug Dietrick, he is not a neurologist. The researchers doing this work are: Forton in the UK, Aronow (a neurovirologist) in the USA, Firenza in Switzerland.
"Since I am not a doctor and certainly not a researcher in neurovirology, I can only tell you that Dr. Aronow has personally told me that the size of the pegylated molecule is too large to cross the blood brain barrier.
"You can ask Dr. dietrick the question, but sadnly, I cannot agree that his expertise extends into this area. It could, though. Maybe he knows something the other researchers don't know.
"thanbey"
You are saying he doesn't know what he's talking about without coming right out and saying those exact words. That suggestion is absurd.
You mean his peers wouldn't have corrected him? That would be laughable except your wrong-headed assertions could possibly steer people away from treatment.
I don't know what your agenda is but, as is often said, the truth will set us free. If you have some data contradicting Dieterich let's see it.
Take care,
Scott
Your statement:
"With all due respect to Doug Dietrick, he is not a neurologist. The researchers doing this work are: Forton in the UK, Aronow (a neurovirologist) in the USA, Firenza in Switzerland.
"Since I am not a doctor and certainly not a researcher in neurovirology, I can only tell you that Dr. Aronow has personally told me that the size of the pegylated molecule is too large to cross the blood brain barrier.
"You can ask Dr. dietrick the question, but sadnly, I cannot agree that his expertise extends into this area. It could, though. Maybe he knows something the other researchers don't know.
"thanbey"
You are saying he doesn't know what he's talking about without coming right out and saying those exact words. That suggestion is absurd.
You mean his peers wouldn't have corrected him? That would be laughable except your wrong-headed assertions could possibly steer people away from treatment.
I don't know what your agenda is but, as is often said, the truth will set us free. If you have some data contradicting Dieterich let's see it.
Take care,
Scott
With all due respect to Doug Dietrick, he is not a neurologist. The researchers doing this work are: Forton in the UK, Aronow (a neurovirologist) in the USA, Firenza in Switzerland.
Since I am not a doctor and certainly not a researcher in neurovirology, I can only tell you that Dr. Aronow has personally told me that the size of the pegylated molecule is too large to cross the blood brain barrier.
You can ask Dr. dietrick the question, but sadnly, I cannot agree that his expertise extends into this area. It could, though. Maybe he knows something the other researchers don't know.
thanbey
Since I am not a doctor and certainly not a researcher in neurovirology, I can only tell you that Dr. Aronow has personally told me that the size of the pegylated molecule is too large to cross the blood brain barrier.
You can ask Dr. dietrick the question, but sadnly, I cannot agree that his expertise extends into this area. It could, though. Maybe he knows something the other researchers don't know.
thanbey
my email is ***@****
been trying to send email unsuccessfully... Edgar
Again thank you for your research on non-responders.
been trying to send email unsuccessfully... Edgar
Again thank you for your research on non-responders.
Douglas T. Dieterich, MD, Contributing Editor
Dr. Dieterich is Vice Chair and Chief Medical Officer Department of Medicine at The Mount Sinai Medical Center. He is also an attending physician at New York University Tisch Hospital, a clinical assistant attending at Bellevue Hospital Center, and an attending physician at Beth Israel North.
A graduate of Yale University, Dr. Dieterich received his medical degree from New York University School of Medicine, and completed his internship and residency in the Department of Internal Medicine, Bellvue Hospital Center.
A fellow of the American College of Physicians and the American College of Gastroenterology, Dr. Dieterich is a member of several professional societies. He has also served on several committees of the AIDS Clinical Trials Group (ACTG) and the National Institutes of Health (NIH), including as a member of the steering committee of the Opportunistic Infections Core Committee, and a member of the Cytomegalovirus (CMV) Committee. He has also served on the NIH Study Sections for CMV and cryptosporidiosis.
Dr. Dieterich has authored numerous journal articles, abstracts, and book chapters on viral hepatitis and AIDS-associated infections of the gastrointestinal tract and liver, and their treatment. He is an internationally-recognized expert on hepatitis C infection and is involved in several research programs evaluating the management treatment of chronic hepatitis C virus (HCV) infection and co-infection with HIV/HCV.
---------------------------
Dieterich doesn't know what he is talking about? Hmmm ...
As I stated before: If you have some proof contradicting the doctor's statement re: the blood brain barrier let us see it. If not I believe the matter is settled.
Dr. Dieterich is Vice Chair and Chief Medical Officer Department of Medicine at The Mount Sinai Medical Center. He is also an attending physician at New York University Tisch Hospital, a clinical assistant attending at Bellevue Hospital Center, and an attending physician at Beth Israel North.
A graduate of Yale University, Dr. Dieterich received his medical degree from New York University School of Medicine, and completed his internship and residency in the Department of Internal Medicine, Bellvue Hospital Center.
A fellow of the American College of Physicians and the American College of Gastroenterology, Dr. Dieterich is a member of several professional societies. He has also served on several committees of the AIDS Clinical Trials Group (ACTG) and the National Institutes of Health (NIH), including as a member of the steering committee of the Opportunistic Infections Core Committee, and a member of the Cytomegalovirus (CMV) Committee. He has also served on the NIH Study Sections for CMV and cryptosporidiosis.
Dr. Dieterich has authored numerous journal articles, abstracts, and book chapters on viral hepatitis and AIDS-associated infections of the gastrointestinal tract and liver, and their treatment. He is an internationally-recognized expert on hepatitis C infection and is involved in several research programs evaluating the management treatment of chronic hepatitis C virus (HCV) infection and co-infection with HIV/HCV.
---------------------------
Dieterich doesn't know what he is talking about? Hmmm ...
As I stated before: If you have some proof contradicting the doctor's statement re: the blood brain barrier let us see it. If not I believe the matter is settled.
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