Aa
4 Week results, 5-7 detectable??
Got the call from my doctor with my 4 week results and she said it came back as 5-7 detectable. She said that the test they are using now is more sensitive than the one she was using previously so she wanted to talk to some experts to see if this is going to qualify for the rapid response, meaning I could do the 24 week treatment instead of the 48 week treatment. I am soooo confused, I'm pissed and bummed out. I really really thought I would be getting good news today. My doctor told me that this is still good news as my numbers are way under the 1000 benchmark. Has anyone had this happen to them?????
Hi bermuda..flcylist may have taken a break and doing a quick spin around the block on his tricycle so maybe this will help.
In the Incivek "Advance" trial (some stats below) those that failed to reach RVR (UND. @Wk.4) had a SVR rate of 60%.
However you will notice that those that did RVR had a success rate of 92 %..
Remeber statistics are just numbers gathered in trial to give the drug companies some parameters.
In clinical practice out here in the real world there are many contributing factors ..so possibly don't get to caught up in the stats and just try to focus on doing the best you can while treating.
Also....think about this for a second . If you were UND. one day before the 4 week test in the trial you were part of the stats that showed 92 % and if you were UND. one day after the 4 weeks you were shown as the part that was 60%.
Point being if you were clear at 4 weeks +one day you very well may be closer to the 92 % than the 60% :)
Best to you and good luck..
Will
Treatment Outcome T12/PR
N = 363
Overall SVR 79% (285/363)
eRVR 58% (212/363) SVR in eRVR subjects 92% (195/212) 93% (27/29)
No eRVR 42% (151/363)
SVR in no eRVR subjects
60% (90/151
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256328.htm
In the Incivek "Advance" trial (some stats below) those that failed to reach RVR (UND. @Wk.4) had a SVR rate of 60%.
However you will notice that those that did RVR had a success rate of 92 %..
Remeber statistics are just numbers gathered in trial to give the drug companies some parameters.
In clinical practice out here in the real world there are many contributing factors ..so possibly don't get to caught up in the stats and just try to focus on doing the best you can while treating.
Also....think about this for a second . If you were UND. one day before the 4 week test in the trial you were part of the stats that showed 92 % and if you were UND. one day after the 4 weeks you were shown as the part that was 60%.
Point being if you were clear at 4 weeks +one day you very well may be closer to the 92 % than the 60% :)
Best to you and good luck..
Will
Treatment Outcome T12/PR
N = 363
Overall SVR 79% (285/363)
eRVR 58% (212/363) SVR in eRVR subjects 92% (195/212) 93% (27/29)
No eRVR 42% (151/363)
SVR in no eRVR subjects
60% (90/151
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256328.htm
Table 10: Response Rates: Trial 108
SVR in no eRVR subjects 60% (90/151)
On-treatment virologic failure 7% (26/363)
Relapse 4% (11/298)
Other 11% (41/363)
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.
Relapse rates are calculated with a denominator of subjects with undetectable HCV-RNA (Target Not Detected) at the end of treatment.
Other includes subjects with detectable HCV-RNA at the time of their last trial drug but who did not have viral breakthrough, and subjects with a missing SVR assessment.
http://pi.vrtx.com/files/uspi_telaprevir.pdf
SVR in no eRVR subjects 60% (90/151)
On-treatment virologic failure 7% (26/363)
Relapse 4% (11/298)
Other 11% (41/363)
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.
Relapse rates are calculated with a denominator of subjects with undetectable HCV-RNA (Target Not Detected) at the end of treatment.
Other includes subjects with detectable HCV-RNA at the time of their last trial drug but who did not have viral breakthrough, and subjects with a missing SVR assessment.
http://pi.vrtx.com/files/uspi_telaprevir.pdf
As Will mentioned above, "5-7 Detectable" is an odd way for the report to read. That's why Will was requesting to get a copy of the results to post here. 5-7 is not the range. Usually the result is given as a single number if the virus was quantified.
I'd suspect that the test run was either Lapcorp's Quantasure with a lower limit of quantification of 2 iu/ml or Quest's TMA test with a limit of quantification of 5 iu/ml. These sensitive tests can both detect and quantify at very low levels.
I'd suspect that the test run was either Lapcorp's Quantasure with a lower limit of quantification of 2 iu/ml or Quest's TMA test with a limit of quantification of 5 iu/ml. These sensitive tests can both detect and quantify at very low levels.
Thanks for helping to clarify that. Are you aware of any data that predicts how people like me and Greta (detectable but not quantifiable after 4 weeks) do after 48 weeks in terms of achieving SVR?
To all
"5-7 detectable" if 5-7 is the range, dosn't "detectable" mean above 5-7?
I don't understand this, seems like less than 5-7 and they would call it undetectable.
Good day,
Griz
"5-7 detectable" if 5-7 is the range, dosn't "detectable" mean above 5-7?
I don't understand this, seems like less than 5-7 and they would call it undetectable.
Good day,
Griz
"I'm still a little unclear on what exactly that means except that I guess there's a point at which the test says that HCV is present but so low it can't be quantified."
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
That's correct. Each of the PCR's has a limit of detection (LOD) and a limit of quantification (LOQ). In sounds like in your case and Greta's, your results were below the limit that the test can quantify the virus, but above the limit at which it can detect it. It depends on the sensitivity of the test used on the values of LOD and LOQ.
Sorry to hear you have to extend tx for 48 weeks. I'm sure this news was very disappointing to hear. However, I just finished 48 weeks (SOC) and although it was a long haul, it is very doable. Hope you don't have a rough ride and tx goes well for you. Good luck.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
That's correct. Each of the PCR's has a limit of detection (LOD) and a limit of quantification (LOQ). In sounds like in your case and Greta's, your results were below the limit that the test can quantify the virus, but above the limit at which it can detect it. It depends on the sensitivity of the test used on the values of LOD and LOQ.
Sorry to hear you have to extend tx for 48 weeks. I'm sure this news was very disappointing to hear. However, I just finished 48 weeks (SOC) and although it was a long haul, it is very doable. Hope you don't have a rough ride and tx goes well for you. Good luck.
I thought I could do the ice cream with no problem.
I was wrong after 2 weeks I can't stand peanut butter or ice cream.
Just taking it one day at a time.
I was wrong after 2 weeks I can't stand peanut butter or ice cream.
Just taking it one day at a time.
Hello Greta,
I'm new to this forum and it sounds like you and I got similar week 4 results. I am just starting my 6th week on triple therapy (incivek, peg and ribavirin) and when I got the week 4 results I was told I was "detectable, but non-quantifiable." I'm still a little unclear on what exactly that means except that I guess there's a point at which the test says that HCV is present but so low it can't be quantified. Which of course sounds good. I went from baseline 700,000 to 150 at week 2 (they did a week 2 viral load test) and now at week 4 to non-quantifiable. So, like you, I was told we're doing the 48 week program. The way I've been looking at it is similar to the comments you've already received - the drugs are working, and they're going to keep working, and the point of this is to get rid of the virus and if it takes 48 weeks then that's what it takes. I would do twice that if I had to in order to get rid of this thing. I'm also fairly grossed out by the eating part but that will drop away at 12 weeks and I keep reminding myself that it's not the worst medical diet anyone had to endure.
I'm new to this forum and it sounds like you and I got similar week 4 results. I am just starting my 6th week on triple therapy (incivek, peg and ribavirin) and when I got the week 4 results I was told I was "detectable, but non-quantifiable." I'm still a little unclear on what exactly that means except that I guess there's a point at which the test says that HCV is present but so low it can't be quantified. Which of course sounds good. I went from baseline 700,000 to 150 at week 2 (they did a week 2 viral load test) and now at week 4 to non-quantifiable. So, like you, I was told we're doing the 48 week program. The way I've been looking at it is similar to the comments you've already received - the drugs are working, and they're going to keep working, and the point of this is to get rid of the virus and if it takes 48 weeks then that's what it takes. I would do twice that if I had to in order to get rid of this thing. I'm also fairly grossed out by the eating part but that will drop away at 12 weeks and I keep reminding myself that it's not the worst medical diet anyone had to endure.
Hi Greta, I am treating for 48 wks due to being detectable at wk 4, I am also late stage 3 on the batts scale, heavy bridging fibrosis, no obvious cirrhoses (borderline) It was a little tough to take at first but treating for 48 wks gives me my best shot at SVR. which is why we are doing this in the first place right. It does get a little easier after incivek, I wish you all the best moving foward. Hang in there.
I really do think once we get off Incivek it will be so much better for us! Forcefeeding more than 20 grams of fat three times daily is just sickening and I can't wait for that part to be over. Next Friday we are halfway done Incivek!!! We can do this!!! Enjoy your ice cream I'm staying up til 1 to eat stuffed shells and take my meds. (Yeah I'm totally asking for heartburn!) ...limited choices though.
Keep up the good work, lets get through these PI's and move on into SOC as UND as we can be! :)
Keep up the good work, lets get through these PI's and move on into SOC as UND as we can be! :)
Thank you for the encouraging words! I guess in my head I never even considered 48 weeks. At least the Incivek is only 12 weeks - I'm trying to force down ice cream right now :). I will try and stay focused and keep my eye on the prize!
I am probably the most uneducated when it comes to these Pcr tests...but I am curious if you had the same test I did. (In sensitivity)?? I know it doesn't matter with the PI's, but out of curiousity what was your starting VL?
I am very happy that we can see the medicine IS working for you! I know the thought of 48 weeks really can be scary, but as your nurse said they will determine that further as they dig deeper into the result. The reality of this disease is it is one tricky SOB. Just because I had UND at 4 weeks doesn't mean this couldn't come back sometime during or after treatment, and just because you had a SMALL det. amount at 4 wks doesn't mean you won't someday be svr. I think you are doing great, and will do great. I bet if you had gone one day later you would have been UND. The great thing as I said before is it appears the meds are working for you, congratulations :)
.
I am very happy that we can see the medicine IS working for you! I know the thought of 48 weeks really can be scary, but as your nurse said they will determine that further as they dig deeper into the result. The reality of this disease is it is one tricky SOB. Just because I had UND at 4 weeks doesn't mean this couldn't come back sometime during or after treatment, and just because you had a SMALL det. amount at 4 wks doesn't mean you won't someday be svr. I think you are doing great, and will do great. I bet if you had gone one day later you would have been UND. The great thing as I said before is it appears the meds are working for you, congratulations :)
.
Laboratory Tests
HCV-RNA levels should be monitored at weeks 4 and 12 and as clinically indicated. Use of a sensitive real-time RT-PCR assay for monitoring HCV-RNA levels during treatment is recommended. The assay should have a lower limit of HCV-RNA quantification equal to or less than 25 IU per mL and a limit of HCV-RNA detection of approximately 10-15 IU per mL. For the purpose of assessing response-guided therapy eligibility, an “undetectable” HCV-RNA (Target Not Detected) result is required; a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCV-RNA result (reported as "Target Not Detected" or "HCV RNA Not Detected").
http://pi.vrtx.com/files/uspi_telaprevir.pdf
HCV-RNA levels should be monitored at weeks 4 and 12 and as clinically indicated. Use of a sensitive real-time RT-PCR assay for monitoring HCV-RNA levels during treatment is recommended. The assay should have a lower limit of HCV-RNA quantification equal to or less than 25 IU per mL and a limit of HCV-RNA detection of approximately 10-15 IU per mL. For the purpose of assessing response-guided therapy eligibility, an “undetectable” HCV-RNA (Target Not Detected) result is required; a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCV-RNA result (reported as "Target Not Detected" or "HCV RNA Not Detected").
http://pi.vrtx.com/files/uspi_telaprevir.pdf
The protocol for half-time treatment is less then 7.1 IU/ml for genotype 1. Mine was less then 1.63, so I am doing half time with Boceprivir.
You are techniquely under 7.1, at 5-7, but I'm no expert, just on week 7 of treatment. Congrats on being a rapid Responder, you have a great chance at cure!
You are techniquely under 7.1, at 5-7, but I'm no expert, just on week 7 of treatment. Congrats on being a rapid Responder, you have a great chance at cure!
Hi Greta..
I am a bit confused by the interpretation of the lab report. 5 -7 DET. is not the usual reading . It would help id you had a hard copy of the report to copy here exactly what it says.
Having said that ,if you are treatment naive(never treated before) and still have some Detectable virons at Wk 4 then yes the Incivek prescribing protocol is to do 48 weeks as I have linked below.
Possibly try to get a copy of the report or at the very least if you can get a look at it and write down the exact wording it will be easier for us.
Best..
.Will
Treatment-Naïve and Prior Relapse Patients
HCV-RNA Triple Therapy
INCIVEK,
Total Treatment Duration
Undetectable at Weeks 4 and 12 Additional 12 weeks Total 24 weeks
Detectable (1000 IU/mL or less) at Weeks 4 and/or 12 First 12 weeks Additional 36 weeks 48 weeks
I am a bit confused by the interpretation of the lab report. 5 -7 DET. is not the usual reading . It would help id you had a hard copy of the report to copy here exactly what it says.
Having said that ,if you are treatment naive(never treated before) and still have some Detectable virons at Wk 4 then yes the Incivek prescribing protocol is to do 48 weeks as I have linked below.
Possibly try to get a copy of the report or at the very least if you can get a look at it and write down the exact wording it will be easier for us.
Best..
.Will
Treatment-Naïve and Prior Relapse Patients
HCV-RNA Triple Therapy
INCIVEK,
Total Treatment Duration
Undetectable at Weeks 4 and 12 Additional 12 weeks Total 24 weeks
Detectable (1000 IU/mL or less) at Weeks 4 and/or 12 First 12 weeks Additional 36 weeks 48 weeks
What medications are you treating with?
That may make a difference. Someone with greater expertise than I will be able to give you more sound information. Especially, if you're using the new medications. Don't worry too much about the 4th week tests, you still have the possibility of clearing the virus. Checking to see if you're a rapid responder is good news. You're going in the right direction.
Don't get too excited until your get some really sound info.
It's unfortunate they use tests that are not as sensitive as some and
make people crazy. Hang in there until another forum member can give you more specific info. Not eveyone clears the virus completely by week 4.
Reva
That may make a difference. Someone with greater expertise than I will be able to give you more sound information. Especially, if you're using the new medications. Don't worry too much about the 4th week tests, you still have the possibility of clearing the virus. Checking to see if you're a rapid responder is good news. You're going in the right direction.
Don't get too excited until your get some really sound info.
It's unfortunate they use tests that are not as sensitive as some and
make people crazy. Hang in there until another forum member can give you more specific info. Not eveyone clears the virus completely by week 4.
Reva
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