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Interferon dose reduction during first 12 wks of tx and odds of SVR.
I've been searching the internet to find a study which would indicate that a dose reduction of interferon during the first 12 weeks of treatment might lessen the odds for SVR. I can't find such a study. I've Googled, Yahooed, and Asked, but the only study I've been able to find says that dose reduction of Peg during first 12 weeks doesn't significantly lower chances for SVR.
I also phoned the Pegasys hot line and asked. The nurse there said that the fact that I was undetectable at week 12 should make me feel optimistic about my chances of SVR, and that the fact that my dose was reduced shouldn't concern me. I called my own nurse at the VA hospital and asked her; she said that I was obsessing about this; I'm at week 39 and have been undetectable since being tested at week 12, that's what matters.
The only study that I've been able to find on the web says:
Reducing the dose of peginterferon alfa-2a from greater than 80% to less than 60% of the target dose within the first 20 weeks of treatment did not appear to affect either virologic response at week 20 or SVR. Reducing the dose of ribavirin from greater than 80% to less than 60% of the target dose within the first 20 weeks of therapy was associated with a significant reduction in both week 20 virologic response and SVR. In contrast, reducing the dose of either peginterferon alfa-2a or ribavirin after week 20, when patients already had undetectable serum HCV RNA, had no significant effect on SVR. These observations have important implications for the use of hematologic growth factors as adjuvant therapy...
I also phoned the Pegasys hot line and asked. The nurse there said that the fact that I was undetectable at week 12 should make me feel optimistic about my chances of SVR, and that the fact that my dose was reduced shouldn't concern me. I called my own nurse at the VA hospital and asked her; she said that I was obsessing about this; I'm at week 39 and have been undetectable since being tested at week 12, that's what matters.
The only study that I've been able to find on the web says:
Reducing the dose of peginterferon alfa-2a from greater than 80% to less than 60% of the target dose within the first 20 weeks of treatment did not appear to affect either virologic response at week 20 or SVR. Reducing the dose of ribavirin from greater than 80% to less than 60% of the target dose within the first 20 weeks of therapy was associated with a significant reduction in both week 20 virologic response and SVR. In contrast, reducing the dose of either peginterferon alfa-2a or ribavirin after week 20, when patients already had undetectable serum HCV RNA, had no significant effect on SVR. These observations have important implications for the use of hematologic growth factors as adjuvant therapy...
First I want to say thanks to all of you for your help. My husband does see a liver specialist... in fact one that we had to wait 4 months to get an appointment with because I wanted him to see this paricular one because of his great reputation. They did the 24 week test yesterday but we don't have the results back yet. At this point we are just praying that he will be UD and go for the next 24 weeks to have a SVR. The TX is taking it's toll on him but he will not give up if the Dr. says that SVR is possible. I think it was just disheartening to think that he was doing wonderful and then to be told this was not the case.
A few things may be getting lost in the translation such as a "that they hoped to see a 2 log drop by week 24".
To me that makes no sense. What I would think they would be looking for is either a two-log drop at week 4 or 12. Generally one should be non-detectible by week 24 for a good shot at SVR unless treatment is extended.
First, I'd double-check to see if they ran a week 24 test. If not, I'd ask for me, demand if necessary. Go over everything again with your doctor. If you don't get the answers you want, see another doctor. You want a hepatologist (liver specialist). They can usually be found at your larger, teaching hospitals. You may find someone who will treat your husband and give you realistic odds for SVR. Or they may tell you the same thing. It's hard to say from what you posted and also none of us here are doctors.
To me that makes no sense. What I would think they would be looking for is either a two-log drop at week 4 or 12. Generally one should be non-detectible by week 24 for a good shot at SVR unless treatment is extended.
First, I'd double-check to see if they ran a week 24 test. If not, I'd ask for me, demand if necessary. Go over everything again with your doctor. If you don't get the answers you want, see another doctor. You want a hepatologist (liver specialist). They can usually be found at your larger, teaching hospitals. You may find someone who will treat your husband and give you realistic odds for SVR. Or they may tell you the same thing. It's hard to say from what you posted and also none of us here are doctors.
AS FLguy points out, were mainly a bunch of Hep C patients here. No Docs. But stick around, you'll learn alot!
From your post, I'm assuming your husband is still on treatment? It appears he is responding well, if not ideally. To expect undetectible at 4 weeks, seems like a tall order to me. It happens in geno 1's, but it is far from the norm.
One popular treatment model says your husband should treat for a minimum of 36 weeks after reaching undetectible. So un-D at 12 weeks would mean 48 weeks total. un-D at 24 weeks would buy him 60 weeks total.
Cirrhosis can add some complications. It can make it harder to tolerate the medicine, and it can make it harder to clear the virus. I have early cirrhosis myself and there are other cirrhotics here too. Many do treat successfully and your husband seems to be headed in the right direction.
It ain't easy, but it's worth it.
From your post, I'm assuming your husband is still on treatment? It appears he is responding well, if not ideally. To expect undetectible at 4 weeks, seems like a tall order to me. It happens in geno 1's, but it is far from the norm.
One popular treatment model says your husband should treat for a minimum of 36 weeks after reaching undetectible. So un-D at 12 weeks would mean 48 weeks total. un-D at 24 weeks would buy him 60 weeks total.
Cirrhosis can add some complications. It can make it harder to tolerate the medicine, and it can make it harder to clear the virus. I have early cirrhosis myself and there are other cirrhotics here too. Many do treat successfully and your husband seems to be headed in the right direction.
It ain't easy, but it's worth it.
By the way, your hubby had a 3-log drop at 12 weeks which would indicate a viral response that should indicate continued treatment through week 48, or more. Combo treatment is not pleasant or fun, but it is the only game in town right now. His doc could be making it easier for hubby by evaluating the side effects and possibly prescribe other meds to help control some of those ill effects. Feeling tired and carppy is about normal - sorry to say, but many folks leg it out to conclusion. So you know, there are no docs here, just folks who have expereince.
The information (Geno 1) would usually call for at least 48 weeks of combo treatment, not 24. Unless the doc has some specific motive not mentioned. And, the desired 2-log drop, I believe, is an expectation at 12 weeks. Is he still taking the meds, or been off a while? Is his doc a liver specialist? If not, perhaps you should gather the reports and information you have including biopsy results, blood wrok results and pcr results and get a fresh opinion from a doc who has a bunch of case experience with hcv. Are you in the US?
I am so confused. My husband just finished week 24 for TX and we do not yet have the blood test results to see where his viral load is. It seems that what we are being told now is quite the opposite of what we were told at the start of TX. We were told that he would be tested at 4, 12, and 24 weeks and that they hoped to see a 2 log drop by week 24 and at that point they would decide whether to continue treatment or not depending on the drop. His viral load started at 2,78 million. At week 4 it was down to 12,380 and at week 12 down to 2,360. We were thrilled thinking that was great. The docs kept saying that was a good response. Now at week 24 we were told that since he was not undectable at week 4 it was unlikely he would have a SVR. If he had known that he would have stopped at week 4 and not been miserable from the treatment these last 5 months. He has lost lots of weight, feels terrible and barely makes it through the day at work.. although he is still working. What have you all been told? We don't know anyone going through this and don't have anyone to ask.
It all depends on your hubby's genotype (1a, 2b, 3a, etc). Can you post that for us?
Hey thanks, looks like there was % increase in svr for ud @ 12 weeks as opposed to > 3 log drop in that study.
I
I
You are right they do look for the two log drop more than anything as an indicator. When mine went down (3log drop) to 411 at week 12 and I was still detectible - he would NOT consider quitting and said I was doing GREAT we needed to continue. At 24 when I did test UND I saw he was right.
If I didn't listen I would have been very very upset by the 12 detectible - but it was a 3log drop and I listened to everyone in here and the doc and continued.
I do think that is the most important thing at 12 weeks - then UND by 24 otherwise he would have considered switching txs at that time for me anyway.
Good point.
If I didn't listen I would have been very very upset by the 12 detectible - but it was a 3log drop and I listened to everyone in here and the doc and continued.
I do think that is the most important thing at 12 weeks - then UND by 24 otherwise he would have considered switching txs at that time for me anyway.
Good point.
LOVE your cartoons! You have an extraordinary talent! Under the biopsy queston, Rocker posted a 2006 article about odds of SVR. I went and read it, and it is kind of long, but it will answer your questions. Here is the link:
http://www.natap.org/2006/HCV/040406_03.htm
Have a wonderful day and keep those creative juices flowing!
http://www.natap.org/2006/HCV/040406_03.htm
Have a wonderful day and keep those creative juices flowing!
I was told 2 drop log determined whether you continue with tx or not. If you get the 2 drop, you are making progress, if you dont get it, then the doc pulls you off the meds, b/c they dont expect the svr. I could have that confused though, as I dont think as clearly these days.
lilmoma
lilmoma
It's only a two-year-old study. My foggy brain made the mistake, it's not four-years-old.
Bob
Bob
A lot of emphasis placed on the ud at 12 week for obvious studied reasons. But: Is it ud at 12 weeks, or is it > 2 log drop at 12 weeks? I didn
It's a four-year-old study but it was only three-years-old when I was getting my Peg dose reductions. Here is the URL for the study:
http://scholar.google.com/scholar?hl=en&lr=&q=cache:lLLYyKAwtScJ:w3.iac.net/~mercy/e-articles/292/ShiffmanML.pdf+Studies+Pegasys+dose+during+first+12+weeks+and+SVR
http://scholar.google.com/scholar?hl=en&lr=&q=cache:lLLYyKAwtScJ:w3.iac.net/~mercy/e-articles/292/ShiffmanML.pdf+Studies+Pegasys+dose+during+first+12+weeks+and+SVR
Can't seem to find a definite answer other than an 02 study that's a bit conflicting: http://www.natap.org/2002/AASLD/day10.htm
In my case I
In my case I
Usually the doctors want a 2 log drop or better by 12 weeks. A 3 log drop is better than a 2 log drop. It sounds like you're doing well.
Bob
Bob
I think the 12 week clear will trump all else as long as you treat the 36 weeks beyond clear. My NP who went to the last liver conference in San Francisco said that the primary thing she took from the meeting (for genotype 1's) was to treat a full 36 weeks beyond clear for best chances at SVR. She made a point to tell me that at my 12 week pcr. Whatever dose reduction you had at the beginning still got you at undetectible at 12 weeks! That is a great predictor of your chances at SVR. Try not to go down the relapse road unless you have to! You'll just make yourself depressed. ;o)
I don't think you can find a better hospital in the country than Yale New Haven (I was just there visiting someone) and if the doctors are working in conjuction with them then I'd say if it's not a concern to them I wouldn't worry to much as you ARE UNDETECTIBLE so what your worry is I'm not sure.
If you DIDNT get UND yet I could see a great concern "will I get UND and SVR" but since you HAVE Und - med reduction or not....you've already GOTTEN the results you need.
Hitting that number at week 12 is the goal for you right (or at least by 24)
Sorry there are no studies but I don't really think it's that common a concern that they WOULD study it in depth or detail since it's generally trying to find what will GET people undetectible.
Try and let it go and be HAPPY that you HAVE UND - many people don't get it at week 12 and that hurts a LOT (Just ask me it took me to 24).
Best of luck. Let it go you are doing GREAT!
If you DIDNT get UND yet I could see a great concern "will I get UND and SVR" but since you HAVE Und - med reduction or not....you've already GOTTEN the results you need.
Hitting that number at week 12 is the goal for you right (or at least by 24)
Sorry there are no studies but I don't really think it's that common a concern that they WOULD study it in depth or detail since it's generally trying to find what will GET people undetectible.
Try and let it go and be HAPPY that you HAVE UND - many people don't get it at week 12 and that hurts a LOT (Just ask me it took me to 24).
Best of luck. Let it go you are doing GREAT!
Moniker says: I can tell my doctor that a guy on the internet said there were studies which showed that Peg dose reduction during the first 12 weeks of tx would lessen the chances for SVR.
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If the "guy" is me you're referring to, that's not exactly what I'm saying.
In a very general sense, compliance to meds is repeatedly cited as a positive predictor of SVR. Also, there's something called the 80/80/80 rule which says that if you take 80 per cent of your riba and 80 per cent of your peg, 80 per cent of the time, you have a greater chance of SVR. But as stated earlier by myself and Kalio, it seems you have met that criteria. Also, it appears that riba adherence is more important during the first 12 weeks that adherence to Peg -- and you had 100% adherence. Plus -- you were non-detectible at week 12.
I understand you're looking for a definitive answer to your concern -- do I extend and how long based on the missed meds -- but I really don't think such a definitive answer exists -- not here -- not anywhere on the internet. I don't think any doctor, no matter how expert, also has a definitive answer. Personally, my unprofessional opinion is that your 12 week non-detectible response trumps any negative consequences of reduced Peg.
In conclusion -- if your doctors think you don't need to extend, I'd go with their opinion. If you don't have confidence in them, I'd get a second opinion.
No harm in continuing researching if you want, but if you don't come up with something different -- at some point you should start focusing on your negative 12 week PCR and not on your missed meds.
-- Jim
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If the "guy" is me you're referring to, that's not exactly what I'm saying.
In a very general sense, compliance to meds is repeatedly cited as a positive predictor of SVR. Also, there's something called the 80/80/80 rule which says that if you take 80 per cent of your riba and 80 per cent of your peg, 80 per cent of the time, you have a greater chance of SVR. But as stated earlier by myself and Kalio, it seems you have met that criteria. Also, it appears that riba adherence is more important during the first 12 weeks that adherence to Peg -- and you had 100% adherence. Plus -- you were non-detectible at week 12.
I understand you're looking for a definitive answer to your concern -- do I extend and how long based on the missed meds -- but I really don't think such a definitive answer exists -- not here -- not anywhere on the internet. I don't think any doctor, no matter how expert, also has a definitive answer. Personally, my unprofessional opinion is that your 12 week non-detectible response trumps any negative consequences of reduced Peg.
In conclusion -- if your doctors think you don't need to extend, I'd go with their opinion. If you don't have confidence in them, I'd get a second opinion.
No harm in continuing researching if you want, but if you don't come up with something different -- at some point you should start focusing on your negative 12 week PCR and not on your missed meds.
-- Jim
nygir: My Peg dose reduction WAS during the first 12 weeks of my treatment; I'm on the full dose now, and have been on the full Peg dose since week 16(when I went on Neupogen). My Riba has been full 1200 dose from the first week of tx until now. PCRs said I was undetectable at weeks 12 and 24.
goofy: I do have a lot of confidence in my doctors at the VA Liver Clinic in West Haven, CT. These doctors also practice at Yale New Haven Hospital. They have a lot of experience with hep c because so many veterans have hepatitis c as well as other liver problems.
Jim: What is bothering me is that I can't find any studies, or any doctors who will tell me that my odds for SVR are significantly lessened because my peg dose was reduced at the start of my tx. I would like to see any studies anyone might know of which show that Peg reduction during the first 12 weeks will lessen my chances of SVR. If I could find such a study, I could make an educated choice whether to extend tx. The doctors at the VA Liver Clinic tell me that I'm doing well. It's difficult for me to think that they are wrong without some real evidence. I can tell my doctor that a guy on the internet said there were studies which showed that Peg dose reduction during the first 12 weeks of tx would lessen the chances for SVR. But the only study I've been able to find says just the opposite.
Bob
goofy: I do have a lot of confidence in my doctors at the VA Liver Clinic in West Haven, CT. These doctors also practice at Yale New Haven Hospital. They have a lot of experience with hep c because so many veterans have hepatitis c as well as other liver problems.
Jim: What is bothering me is that I can't find any studies, or any doctors who will tell me that my odds for SVR are significantly lessened because my peg dose was reduced at the start of my tx. I would like to see any studies anyone might know of which show that Peg reduction during the first 12 weeks will lessen my chances of SVR. If I could find such a study, I could make an educated choice whether to extend tx. The doctors at the VA Liver Clinic tell me that I'm doing well. It's difficult for me to think that they are wrong without some real evidence. I can tell my doctor that a guy on the internet said there were studies which showed that Peg dose reduction during the first 12 weeks of tx would lessen the chances for SVR. But the only study I've been able to find says just the opposite.
Bob
I have always heard that the first twelve weeks are the most important, and that full dose is critical during that time frame.. But at the same time, you still obtained the undetectable status.. Heck, that is a great feat in itself!! I believe the dose reduction theory is based on being able to accomplish THAT goal, undetectable!!
I know how it is to obsess.. Hmmm, every liver specialist on the East Coast was consulted about elevated liver enzymes during tx, as I just could not let it go.. It's just tx is hard, and we wanna make sure we comply and give it our best the first go round.
If I was you, I would post the question on one of the ask the Doc forums.. Try Diertich, or Cecil.. They are pretty good about giving "credtible" advice, and or opinions I would think..This is something right up their alley.
Funny how the mind works tooo, as the more people that told me I was obsessing, the more I needed a conclusive answer!!!
I know how it is to obsess.. Hmmm, every liver specialist on the East Coast was consulted about elevated liver enzymes during tx, as I just could not let it go.. It's just tx is hard, and we wanna make sure we comply and give it our best the first go round.
If I was you, I would post the question on one of the ask the Doc forums.. Try Diertich, or Cecil.. They are pretty good about giving "credtible" advice, and or opinions I would think..This is something right up their alley.
Funny how the mind works tooo, as the more people that told me I was obsessing, the more I needed a conclusive answer!!!
Can you give us the info on that study you quoted. I'd like to look at it. You have great docs--might as well trust 'em. Peace. Deb
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