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Author Topic: What is the difference between "undetectable" and "too few to count"?  (Read 8784 times)

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Offline zrjl

  • Member
  • Posts: 8
Hi, I've had my 4 week blood work done after starting Harvoni. What is the difference between "too few to count" and "Undetectable"? My MD says mine comes back as TFTC. It took me 3 weeks to get the results, and I had to have it drawn twice because the lab messed up the first blood draw. I am now at 7 weeks (Today!!).
My insurance requires the lab work to approve the final 4 weeks of treatment, and I'm just wondering what will happen.
Thanks for any help.
This is my second time treating. I did 72 weeks of riba and Interferon in 2010, which obviously, did not work :(
« Last Edit: May 11, 2016, 06:50:26 pm by zrjl »

Offline zrjl

  • Member
  • Posts: 8
 :-\  Oops, can't spell....I meant this is my second time in treatment.
Just read my actual "published" results and they only state "normal". No numbers are listed. I'm confused.

Offline dragonslayer

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  • Posts: 873
There's a ton out there about this..  Go to google and just search LLOQ.  LLOQ stands for Lower Limit Of Quantification, ie, too few to count.
Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

Offline zrjl

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  • Posts: 8
Thank you!

Offline dragonslayer

  • Member
  • Posts: 873
Yea.. it sounds like a bunch of mumbo jumbo at first...  Rna tests, ie, tests for Viral Load all have an LLOQ value..  Some of the tests have a value of 12, some have 15, some have 25, etc.. But what it means is that tests have the ability to detect the virus in such minute quantities that while they can detect them, they cant quantify them...Ergo Detected, but Too Few To Count...  And when the result reads Undetected, it doesnt mean non existant; it means the value is beneath the test's ability to detect.    That's about as good as the tests can do, but, for all intents and purposes, since HCV is a rapid replicator, ie, it has to replicate or die, a couple of these low level detecteds usually is tantamout to saying Undetected.   The most important test is that which you will have 12 wks post treatment.. If you are undetected at that marker, you are considered cured, or in viral parlance, SVR. That's as good as it gets.

Search around on the forum.. All you ever wanted to know about this is buried in threads throughout.


Best of luck!
Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

Offline zrjl

  • Member
  • Posts: 8
Thanks, again!
My insurance company will not approve the final 4 weeks of treatment unless I am undetected. I'm really hoping to complete the 12 weeks since I relapsed the first time.
I appreciate the clarification!

Offline gnatcatcher

  • Member
  • Posts: 1,372
zrjl, if your insurance company is really going to cut off your treatment even though you have gone from a high viral load to an extremely low viral load, your insurance company is %&$@! People who get to TFTC at your point in treatment frequently DO go on to UNDETECTABLE. Can you get an expedited external review so that hepatologists not beholden to the insurance company will insist that the insurance company continue your treatment? Perhaps a patient advocate can help -- our R.N.moderator Lucinda Porter recommends https://hepatitisc.pafcareline.org/
9/29/71 transfusions
HCV genotype 1a
7/09/15-9/30/15 Harvoni

Before treatment:
Viral Load 9,490,582
FibroScan 19.5 kPa [F4]
ALT 262
AST 217
ALP 183

Most recent:
VL still UNDETECTED (SVR 102)
FibroScan 7.6 kPa [F1-2]
ALT 15
AST 20
ALP 85

Offline zrjl

  • Member
  • Posts: 8
gnatcatcher - I stated that incorrectly. They will approve the final 4 weeks of treatment only if I am not undetectable. I did get my lab results which state RNA DETECTED, so I'm hopeful I will get to complete the last 4 weeks. Still waiting to hear from them :(   Hopefully soon, as I run out of meds on Tuesday! I wanted to complete the full 12 weeks even if I was undetectable since I relapsed before. Fingers crossed they approve and I get it in time.
Thanks for answering!

Offline FutureThinker

  • Member
  • Posts: 711
  • Onward and upward!
Please talk to your doctor about this possible elimination of the last 4 weeks of treatment...... this could be very detrimental for you. Most people are UD at 4 weeks,some at even 2 wks, so would that mean they would only cover 2-4 weeks????? There is no evidence in the literature at this time that would support stopping treatment at 2 or 4 weeks. Please discuss this thoroughly with your doctor.
Also, go to hcvguidelines.org for the accepted guidelines on HCV treatment.  FT
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,543
  • Get tested, get treated, get cured, fight Hep c!
Hi zrjl

I treated 3 times with interferon based treatment and was a null responder. I treated 2 years ago with 12 weeks Sovaldi Olysio but relapsed 12 weeks post (I have cirrhosis) I treated with Harvoni for 24 weeks and for 15 of those 24 with Ribavirin.

I am now cured you will be too!

Hang in there and good luck
Lynn
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline gnatcatcher

  • Member
  • Posts: 1,372
gnatcatcher - I stated that incorrectly. They will approve the final 4 weeks of treatment only if I am not undetectable. I did get my lab results which state RNA DETECTED, so I'm hopeful I will get to complete the last 4 weeks. Still waiting to hear from them :(   Hopefully soon, as I run out of meds on Tuesday! I wanted to complete the full 12 weeks even if I was undetectable since I relapsed before. Fingers crossed they approve and I get it in time.
Thanks for answering!
Oh, GOOD -- I hope they WILL approve another four weeks. My specialty pharmacy overnighted each refill, so hopefully yours will, too. Looking forward to your joining the Cured Club.
9/29/71 transfusions
HCV genotype 1a
7/09/15-9/30/15 Harvoni

Before treatment:
Viral Load 9,490,582
FibroScan 19.5 kPa [F4]
ALT 262
AST 217
ALP 183

Most recent:
VL still UNDETECTED (SVR 102)
FibroScan 7.6 kPa [F1-2]
ALT 15
AST 20
ALP 85

Offline zrjl

  • Member
  • Posts: 8
Thank you all! I'm hoping to find out tomorrow if l get to continue, but they said it may be Monday.
**fingers crossed**

Offline zrjl

  • Member
  • Posts: 8
Week 6 bloodwork - ELVIS HAS LEFT THE BUILDING!!
I'm at week 9 on Wednesday so 3 weeks left to be sure that monster is dead, dead, DEAD!!
 :D

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,543
  • Get tested, get treated, get cured, fight Hep c!
Congrats on having made not detected on treatment now after you finish treatment comes the definitive test the one 12 weeks post treatment.

Once you test as not detected 12 weeks post treatment the SVR12 test then you can say you have slayed the dragon.

If you are tested at 4 weeks post the odds of having been successfully treated are about 98.5% that you will make SVR12

But yes the odds are definitely in you favor of making it to 12 weeks post with no virus detected and cured!
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline zrjl

  • Member
  • Posts: 8
Thank you so much!
Having been undetected on the past Ribavirin/Interferon treatment and relapsing, I am holding my breath and crossing my fingers on this one!!

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,543
  • Get tested, get treated, get cured, fight Hep c!
Yeah I can so relate to that. I did not respond at all to interferon and ribavirin actually in one case my viral load actually INCREASED on treatment!

I relapsed after 12 weeks Sovaldi/Olysio that was real tough to hear as I was not detected at EOT. But I was cured by Harvoni and your odds having been a responder to interferon/ribavirin are better than mine. So ok hold your breath but remember to get a few breaths in over the next 12 weeks

Betting you got this!
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

 


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