Aa
Confusion about UND
What does UND really mean?
I had a result of UND<15 at week 4, someone else a UND<10 at week 4. Is this result sensitive enough to base a decision on 24 weeks or 48 weeks? Another suggested we needed weekly or daily tests in the first four weeks to make a decision, another suggested that those results are still detectable and if present at week 12 in the same levels, needs to result in 72 weeks treatment.
Thanks for all the research responses - I am particularly interested in results for 1b on Pegaysus 2a and Ribavirin as those results differ I think to the results from all Geno 1's and Pegysus 2b
I had a result of UND<15 at week 4, someone else a UND<10 at week 4. Is this result sensitive enough to base a decision on 24 weeks or 48 weeks? Another suggested we needed weekly or daily tests in the first four weeks to make a decision, another suggested that those results are still detectable and if present at week 12 in the same levels, needs to result in 72 weeks treatment.
Thanks for all the research responses - I am particularly interested in results for 1b on Pegaysus 2a and Ribavirin as those results differ I think to the results from all Geno 1's and Pegysus 2b
Yes, <15 is UND if that is the lowest sensitivity of that particular test but is it enough for a lay person to make a decision to treat 24 instead of the 48 week SOC and chance the difference between success and failure, no. The people in the research in which the studies were compiled were monitored very closely during the course of their treatment which is not fully available to the lay person and is not the main stream of treatment given the research presented as of yet. Someday it will be, but would I be willing to take a chance even with a low viral load, without hard evidence and statistic showing there were more SVR than not, NO. Heck, I was not satisfied with the tests down to <2 and I am still not, even coming up on the one year.
You see, I was not trying to give all the research mambo jumbo and small statistics surrounding the 24 verses 48 weeks, just some common sense to someone who is, as well as my self, less knowledgeable about the research and the data with in it to put myself in a stacked deck of cards in favor of the virus and stated my opinion to that end. Nor was I challenging you or anyone else of their opinions on the subject other than the fact that almost everyone posting to this thread has completed their treatment within the SOC, for the most part, given their particular geno type, liver damage and individual viral loads which dictated the SOC for them or group.
I will ask this, are their statistics showing how many people achieved SVR in this particular 24 week group, that being, Low viral load, UND at week 4 or sooner, little or not liver damage. Can these statistics is be produced.
Not sure about the tone of the reply here, so hope no offence is taken because of the full moon.
jasper
You see, I was not trying to give all the research mambo jumbo and small statistics surrounding the 24 verses 48 weeks, just some common sense to someone who is, as well as my self, less knowledgeable about the research and the data with in it to put myself in a stacked deck of cards in favor of the virus and stated my opinion to that end. Nor was I challenging you or anyone else of their opinions on the subject other than the fact that almost everyone posting to this thread has completed their treatment within the SOC, for the most part, given their particular geno type, liver damage and individual viral loads which dictated the SOC for them or group.
I will ask this, are their statistics showing how many people achieved SVR in this particular 24 week group, that being, Low viral load, UND at week 4 or sooner, little or not liver damage. Can these statistics is be produced.
Not sure about the tone of the reply here, so hope no offence is taken because of the full moon.
jasper
"Another suggested we needed weekly or daily tests in the first four weeks to make a decision"
Blame me, I brought up the subject, a bit hypothetical mind you, certainly not something most mear mortals can accomplish though..(g)
But to the point, if it was me, and I met the reduced 24 wk from 48 wk treatment criteria, I sure would like to have the additional knowledge gained from high frequency testing in the first 4 weeks. I say this because of the addition svr predictability knowledge that would be gained when looking at biphasic viral decline
Some believe the first few days can be a very good predictor through viral kinetics.
"summary. It has recently been shown that upon initiation of interferon (IFN) treatment there is a biphasic decline in hepatitis C virus (HCV) RNA levels. In preliminary results, the rate of second phase viral decline has been shown to be an excellent predictor of treatment response. In this analysis, we determined whether the first phase viral kinetic parameters affected the rate of second phase viral decline. We also assessed whether first phase viral kinetic parameters could be used to predict treatment response within 24 h of initiating treatment. This study is a retrospective analysis of two completed studies from which detailed kinetic data were obtained in patients infected with genotype 1 HCV. In both studies, viral levels were measured frequently over the first 24 h, allowing the determination of IFNs effectiveness in blocking viral production and the viral load at the end of the first phase (v1). The second phase decline slope was calculated by log-linear regression on measurements of serum HCV RNA during days 2, 7 and 14. In study one, sustained viral response (SVR) rates were obtained, allowing the determination of the first phase's predictive power for SVR. Logistic regression and fisher exact tests were used to analyse data. In study one, no patient achieved SVR without an IFN effectiveness greater than 98% and a V1 less than 250 000 copies/mL. When V1 and IFN effectiveness werecombined to predict SVR, a negative predictive value= 100%, positive predictive value=71% and accuracy of 95% was obtained after only 24 h of IFN treatment. Both studies illustrated strong correlations for both IFN effectiveness and V1 with the rate of 2nd phase slope (P < 0.001). V1 also correlated significantly with a calculation of infected cell loss (delta), which is a major determinant of the second phase viral decline. These results suggest that early viral kinetics may predict lack of response after only 24 h of treatment initiation and indicate a strong link between the degree of viral load reduction during the first phase, and the subsequent 2nd phase decline slope. This might be explained by a viral dynamics model assuming a jump-start of the immune response when viral loads are reduced below a threshold, subsequently giving rise to a faster 2nd phase decline slope."
http://www3.interscience.wiley.com/journal/118961281/abstract?CRETRY=1&SRETRY=0
"Patients who become HCV-RNA negative after 4 weeks have the best chance of achieving an SVR. The rapidity of viral elimination may be a useful guide to tailoring the length of treatment in patients with an EVR"
http://jac.oxfordjournals.org/cgi/content/full/53/1/15
And if you want to go in deep
http://www.medigraphic.com/pdfs/hepato/ah-2002/ah022b.pdf
Blame me, I brought up the subject, a bit hypothetical mind you, certainly not something most mear mortals can accomplish though..(g)
But to the point, if it was me, and I met the reduced 24 wk from 48 wk treatment criteria, I sure would like to have the additional knowledge gained from high frequency testing in the first 4 weeks. I say this because of the addition svr predictability knowledge that would be gained when looking at biphasic viral decline
Some believe the first few days can be a very good predictor through viral kinetics.
"summary. It has recently been shown that upon initiation of interferon (IFN) treatment there is a biphasic decline in hepatitis C virus (HCV) RNA levels. In preliminary results, the rate of second phase viral decline has been shown to be an excellent predictor of treatment response. In this analysis, we determined whether the first phase viral kinetic parameters affected the rate of second phase viral decline. We also assessed whether first phase viral kinetic parameters could be used to predict treatment response within 24 h of initiating treatment. This study is a retrospective analysis of two completed studies from which detailed kinetic data were obtained in patients infected with genotype 1 HCV. In both studies, viral levels were measured frequently over the first 24 h, allowing the determination of IFNs effectiveness in blocking viral production and the viral load at the end of the first phase (v1). The second phase decline slope was calculated by log-linear regression on measurements of serum HCV RNA during days 2, 7 and 14. In study one, sustained viral response (SVR) rates were obtained, allowing the determination of the first phase's predictive power for SVR. Logistic regression and fisher exact tests were used to analyse data. In study one, no patient achieved SVR without an IFN effectiveness greater than 98% and a V1 less than 250 000 copies/mL. When V1 and IFN effectiveness werecombined to predict SVR, a negative predictive value= 100%, positive predictive value=71% and accuracy of 95% was obtained after only 24 h of IFN treatment. Both studies illustrated strong correlations for both IFN effectiveness and V1 with the rate of 2nd phase slope (P < 0.001). V1 also correlated significantly with a calculation of infected cell loss (delta), which is a major determinant of the second phase viral decline. These results suggest that early viral kinetics may predict lack of response after only 24 h of treatment initiation and indicate a strong link between the degree of viral load reduction during the first phase, and the subsequent 2nd phase decline slope. This might be explained by a viral dynamics model assuming a jump-start of the immune response when viral loads are reduced below a threshold, subsequently giving rise to a faster 2nd phase decline slope."
http://www3.interscience.wiley.com/journal/118961281/abstract?CRETRY=1&SRETRY=0
"Patients who become HCV-RNA negative after 4 weeks have the best chance of achieving an SVR. The rapidity of viral elimination may be a useful guide to tailoring the length of treatment in patients with an EVR"
http://jac.oxfordjournals.org/cgi/content/full/53/1/15
And if you want to go in deep
http://www.medigraphic.com/pdfs/hepato/ah-2002/ah022b.pdf
Getter: Back to your original question, No it is not.
--------------
Oh, almost forgot what the original question was, so I went back and read it. LOL. Respectfully, I disagree with your answer, because "<15" is UND and sensitive enough to be part of a decision whether to treat for 24 versus 48. weeks. I haven't read anywhere where "daily" or "weekly" tests are necessary -- or referenced in shorter course studies -- although some of us have had weekly tests. As to 72 weeks, that course only makes sense if you are detectible at week 12 which Jankar clearly is not.
In general, if you have a low pre-treatment viral load and are UND at week 4, there are studies that suggest that 24 weeks is a viable treatment option. Especially if you do not have significant liver damage. Jankar's original question below:
I had a result of UND<15 at week 4, someone else a UND<10 at week 4. Is this result sensitive enough to base a decision on 24 weeks or 48 weeks? Another suggested we needed weekly or daily tests in the first four weeks to make a decision, another suggested that those results are still detectable and if present at week 12 in the same levels, needs to result in 72 weeks treatment.
--------------
Oh, almost forgot what the original question was, so I went back and read it. LOL. Respectfully, I disagree with your answer, because "<15" is UND and sensitive enough to be part of a decision whether to treat for 24 versus 48. weeks. I haven't read anywhere where "daily" or "weekly" tests are necessary -- or referenced in shorter course studies -- although some of us have had weekly tests. As to 72 weeks, that course only makes sense if you are detectible at week 12 which Jankar clearly is not.
In general, if you have a low pre-treatment viral load and are UND at week 4, there are studies that suggest that 24 weeks is a viable treatment option. Especially if you do not have significant liver damage. Jankar's original question below:
I had a result of UND<15 at week 4, someone else a UND<10 at week 4. Is this result sensitive enough to base a decision on 24 weeks or 48 weeks? Another suggested we needed weekly or daily tests in the first four weeks to make a decision, another suggested that those results are still detectable and if present at week 12 in the same levels, needs to result in 72 weeks treatment.
Back to your original question, No it is not. At <15 there still may be thousands of virions floating around and many more in the tissues of the body. The best course of action is to do the SOC and that is 48 weeks. I was not in a trial and was never that lucky in Vegas to be a part of someone else opinion based on research of others and to be willing enough to take a chance in wasting my time that I have invested in treatment to cut it shorter than the prescribed time for the best chance of clearance. Everyone on this thread and most of the others here on med help did what? Went the full course of treatment and some then some. There has been a lot of good info put forth here but are you willing to be the genie pig and who will be there to hold you hand when they tell you the bad news? The www is great, but very unfeeling, so I’ll stick with my original post above.
jasper
jasper
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