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Questions About SVR Statistics With Triple Med Treatment
I have a question about the statistics for SVR among those who did triple med. treatment, especially Incivek since this is what I took.
I have read that the SVR rate for those with early viralogical response is 75-80 %. I have looked all over for the answer to my question and cannot seem to find it. .
What, exactly, is that SVR number (75-80 %) based on. Is that figure based on the number of people who started triple med treatment, including those who had to stop taking the meds due to side effects or inadequate viral response? Or is that figure based on the number of people who actually completed treatment?
It does make a difference. If 75 % of people who started triple med treatment achieved SVR, that would be a higher number than if 75 % of people who finished the full treatment achieved SVR.
I have read that the SVR rate for those with early viralogical response is 75-80 %. I have looked all over for the answer to my question and cannot seem to find it. .
What, exactly, is that SVR number (75-80 %) based on. Is that figure based on the number of people who started triple med treatment, including those who had to stop taking the meds due to side effects or inadequate viral response? Or is that figure based on the number of people who actually completed treatment?
It does make a difference. If 75 % of people who started triple med treatment achieved SVR, that would be a higher number than if 75 % of people who finished the full treatment achieved SVR.
My computer screws up too and there is no way to edit errors in spelling once posted. This bothers me as I tend to be rather detail oriented and a perfectionist to some degree (not pathological, lol, but I like my ducks in a row and I am very thorough). And this, of course, explains my questions about and my desire to understand the SVR rates.
I know I should not get overly concerned with the figures and percentages. I cannot do anything about them anyway. It is just my nature to look at the details and to try to know as much as possible.
"so would that put you closer to the 92% than the 60% :0) "
And that is what I am hoping. But, as you say, it will be what it will be. And any SVR percentage is better than no SVR (which is what my percentages would be if I did not treat).
I know I should not get overly concerned with the figures and percentages. I cannot do anything about them anyway. It is just my nature to look at the details and to try to know as much as possible.
"so would that put you closer to the 92% than the 60% :0) "
And that is what I am hoping. But, as you say, it will be what it will be. And any SVR percentage is better than no SVR (which is what my percentages would be if I did not treat).
Hey pooh...I wouldn"t get lost in all the facts and figures too much. Funny statement coming from me I know. however remeber these are all just trial statistics,,, there are lots of variables.
Plus the fact liek you mention you were <43 at week 4 well maybe you were UND at week 4 +2 days so would that put you closer to the 92% than the 60% :0)
Ppoint being just keep up the good work and it will be what it will be ..
Best
Will
Plus the fact liek you mention you were <43 at week 4 well maybe you were UND at week 4 +2 days so would that put you closer to the 92% than the 60% :0)
Ppoint being just keep up the good work and it will be what it will be ..
Best
Will
Thanks. I think I understand it now. I was just hoping I had a better chance at SVR than I do, but I still have a very good chance, I think.
Thank you very much, Will. I think it clears things up.
I was trying to determine if I had a higher chance of SVR than I do, lol. I added up all of the numbers in the table below and the total numbers indicate my chance for SVR is about 60%. That is what I was afraid of but I just wanted to make sure I was including everything in the calculations. Still, 60% is better than nil, so I will take it. Plus, I had less than 43 at 4 weeks and I was undetectable at 8 weeks (and they have no figures for those who were undetectable at 8 weeks, just for the 4 and the 12 weeks). I guess I can hope that my chances are better by being undetectable at 8 weeks, but, of course, that is based on nothing concrete and may just be wishful thinking. Anyway, as noted, 60% is better than nil, so I am in it for the long haul.
I was looking at this table:
Table 10 shows the response rates for the T12/PR and Pbo/PR48 groups.
Treatment Outcome T12/PR
Overall SVR 79% (285/363)
eRVR 58% (212/363)
SVR in eRVR subjects 92% (195/212)
No eRVR 42% (151/363) 92%
SVR in no eRVR subjects 60% (90/151)
Outcome for Subjects without SVR
On-treatment virologic failurea 7% (26/363)
Relapseb 4% (11/298)
Otherc 11% (41/363)
a On-treatment failure includes subjects who met a protocol-defined virologic stopping rule or who had detectable HCV-RNA at the time of their last dose of INCIVEK and subjects who had viral breakthrough on peginterferon alfa/ribavirin.
b Relapse rates are calculated with a denominator of subjects with undetectable HCV-RNA at the end of treatment.
c Other includes subjects with detectable HCV-RNA at the time of their last study drug but who did not have viral breakthrough, and subjects with a missing SVR assessment.
I was trying to determine if I had a higher chance of SVR than I do, lol. I added up all of the numbers in the table below and the total numbers indicate my chance for SVR is about 60%. That is what I was afraid of but I just wanted to make sure I was including everything in the calculations. Still, 60% is better than nil, so I will take it. Plus, I had less than 43 at 4 weeks and I was undetectable at 8 weeks (and they have no figures for those who were undetectable at 8 weeks, just for the 4 and the 12 weeks). I guess I can hope that my chances are better by being undetectable at 8 weeks, but, of course, that is based on nothing concrete and may just be wishful thinking. Anyway, as noted, 60% is better than nil, so I am in it for the long haul.
I was looking at this table:
Table 10 shows the response rates for the T12/PR and Pbo/PR48 groups.
Treatment Outcome T12/PR
Overall SVR 79% (285/363)
eRVR 58% (212/363)
SVR in eRVR subjects 92% (195/212)
No eRVR 42% (151/363) 92%
SVR in no eRVR subjects 60% (90/151)
Outcome for Subjects without SVR
On-treatment virologic failurea 7% (26/363)
Relapseb 4% (11/298)
Otherc 11% (41/363)
a On-treatment failure includes subjects who met a protocol-defined virologic stopping rule or who had detectable HCV-RNA at the time of their last dose of INCIVEK and subjects who had viral breakthrough on peginterferon alfa/ribavirin.
b Relapse rates are calculated with a denominator of subjects with undetectable HCV-RNA at the end of treatment.
c Other includes subjects with detectable HCV-RNA at the time of their last study drug but who did not have viral breakthrough, and subjects with a missing SVR assessment.
Also in the advance trial they only show a on-treatment virologic failure rate of 7% and a 4% relapse rate
Table 10
http://pi.vrtx.com/files/uspi_telaprevir.pdf
Table 10
http://pi.vrtx.com/files/uspi_telaprevir.pdf
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In the " Tela" Advance Trial " there was an SVR reached in a total of 285 of the 363 that were on 12 weeks INCI.(79% overall)
Of that 363 . 212 of them had an RVR and of that 212, 195 reached SVR (92%)
151 of the 363 that never reached RVR had SVR (60%)
Hope that doesn"t cloud things up further....
Will
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256328.htm