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Author Topic: What exactly does it mean to be undetected?  (Read 12647 times)

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Offline atomic dog

  • Member
  • Posts: 160
What exactly does it mean to be undetected?
« on: March 11, 2015, 10:22:57 pm »
I've read on this forum that HCV/RNA can only be detected to a certain low level, but not zero. So at what level (IU/mL) are you considered to be undetected?
Infected 1969, dirty needle
Geno 1a
Stage 2 fib, some necrosis
TX naive
1/29/15 ALT61; AST43
2/16/15 Started Harvoni; VL 1.5 m;
2/19/15 ALT40; AST24
2/29/15 ALT29; AST25
3/9/15 ALT28; AST25; 
3/9/15 < 20 IU/mL (3 wks) HCV RNA remains 'detected'
3/24/15 ALT30; AST25;
3/24/15 <20 IU/mL (5 wks) HCV RNA
4/10/15 <20 IU/ml (7 weeks) HCV RNA
4/20/15 ALT36; AST27
4/20/15 UND
5/11/15 UND (EOT); ALT33; AST25
6/11/15 UND; ALT 34; AST 29
8/14/15 UND
11/15/15 SVR, 24-wk EOT

Offline DisabledHepcat

  • Member
  • Posts: 44
Re: What exactly does it mean to be undetected?
« Reply #1 on: March 12, 2015, 12:34:58 am »
Undetected is a good sign when off the meds for 12 weeks
Undetected during treatment is usual.
The IU/ML  of undetected depends on which test is done but they are all pretty much very low readings.

The major test you are concerned with is after the treatment get tested in 12 weeks.
If undetected you are considered cured but you can still get re-infected by sharing blood with another infected person. Harvoni doesn't make you immune to HCV, it murders it.

Offline Mike2

  • Member
  • Posts: 14
Re: What exactly does it mean to be undetected?
« Reply #2 on: March 12, 2015, 06:06:59 am »
Hey,
It's my understanding  Harvoni stops the ability for the virus to replicate. Even after being undetected  we will always have the antibody for Hep C. That being said if undetected after 12wks post treatment would mean that you are cured and the virus can no longer replicate itself. I'm waiting for my 31/2wk. results on Harvoni. I just found out last night my liver panel was normal first time in 40yrs!! Next week I will get my viral load. My prayers are with all of us to rid ourselves of this dilapidating disease. Good Luck.

Offline charly8

  • Member
  • Posts: 113
Re: What exactly does it mean to be undetected?
« Reply #3 on: March 12, 2015, 09:17:14 am »
Undetected means the test can not detect any virus in the sample of blood drawn.  Some tests are more sensitive then others.

Undetected does not mean that there is no virus in the sample, it could be there just in such small numbers that the test is not sensitive enough to detect them.

Undetected does not mean that there is no virus in the liver, where the virus can replicate.  The amount of virus in the liver is much larger than in the blood circulation.

From my readings, when on treatment the virus in the blood can be more easily removed, but the virus in the liver is much harder to remove because in the liver is where it can replicate and is in much larger numbers. 
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline atomic dog

  • Member
  • Posts: 160
Re: What exactly does it mean to be undetected?
« Reply #4 on: March 12, 2015, 09:59:17 am »
Appreciate the responses. I notice Charly8 that undetected in your case is <15. My understanding is that no test can detect the virus at lower levels, i.e. zero. So a sustained virology response at 12 weeks or 24 weeks, depending on the duration of the treatment (SVR or <15, for instance), indicates that the virus is gone.
Infected 1969, dirty needle
Geno 1a
Stage 2 fib, some necrosis
TX naive
1/29/15 ALT61; AST43
2/16/15 Started Harvoni; VL 1.5 m;
2/19/15 ALT40; AST24
2/29/15 ALT29; AST25
3/9/15 ALT28; AST25; 
3/9/15 < 20 IU/mL (3 wks) HCV RNA remains 'detected'
3/24/15 ALT30; AST25;
3/24/15 <20 IU/mL (5 wks) HCV RNA
4/10/15 <20 IU/ml (7 weeks) HCV RNA
4/20/15 ALT36; AST27
4/20/15 UND
5/11/15 UND (EOT); ALT33; AST25
6/11/15 UND; ALT 34; AST 29
8/14/15 UND
11/15/15 SVR, 24-wk EOT

Offline dragonslayer

  • Member
  • Posts: 873
Re: What exactly does it mean to be undetected?
« Reply #5 on: March 12, 2015, 10:04:32 am »
>> So a sustained virology response at 12 weeks or 24 weeks, depending on the duration of the treatment (SVR or <15, for instance), indicates that the virus is gone.
<<

Atomic,

Not quite... Assuming a test has an LLOQ of 15, there is a difference between 'UND' and  'Detected < 15'.  Its the former that, at 12 wks post treatment, generally equates to  SVR12.
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 charly8

  • Member
  • Posts: 113
Re: What exactly does it mean to be undetected?
« Reply #6 on: March 12, 2015, 10:18:48 am »
Appreciate the responses. I notice Charly8 that undetected in your case is <15. My understanding is that no test can detect the virus at lower levels, i.e. zero. So a sustained virology response at 12 weeks or 24 weeks, depending on the duration of the treatment (SVR or <15, for instance), indicates that the virus is gone.

SVR means the virus has not replicated back and therefore has been eradicated from the body.  Its important to note that SVR is measured at 12 weeks AFTER the end of treatment. ie 12 weeks without medication.  This gives ample time for the virus (if present) to replicate enough to be detected again by the PCR test.  The thought is that after 12 weeks if the virus is not detected than it has been removed completely from the body.
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline atomic dog

  • Member
  • Posts: 160
Re: What exactly does it mean to be undetected?
« Reply #7 on: March 12, 2015, 10:33:12 am »
Cool. Got it. BTW, what's LLOQ?
Infected 1969, dirty needle
Geno 1a
Stage 2 fib, some necrosis
TX naive
1/29/15 ALT61; AST43
2/16/15 Started Harvoni; VL 1.5 m;
2/19/15 ALT40; AST24
2/29/15 ALT29; AST25
3/9/15 ALT28; AST25; 
3/9/15 < 20 IU/mL (3 wks) HCV RNA remains 'detected'
3/24/15 ALT30; AST25;
3/24/15 <20 IU/mL (5 wks) HCV RNA
4/10/15 <20 IU/ml (7 weeks) HCV RNA
4/20/15 ALT36; AST27
4/20/15 UND
5/11/15 UND (EOT); ALT33; AST25
6/11/15 UND; ALT 34; AST 29
8/14/15 UND
11/15/15 SVR, 24-wk EOT

Offline atomic dog

  • Member
  • Posts: 160
Re: What exactly does it mean to be undetected?
« Reply #8 on: March 12, 2015, 10:35:09 am »
Charly8, If you don't mind me asking, what did your doc add RYB if you were undetected after 2 weeks?
Infected 1969, dirty needle
Geno 1a
Stage 2 fib, some necrosis
TX naive
1/29/15 ALT61; AST43
2/16/15 Started Harvoni; VL 1.5 m;
2/19/15 ALT40; AST24
2/29/15 ALT29; AST25
3/9/15 ALT28; AST25; 
3/9/15 < 20 IU/mL (3 wks) HCV RNA remains 'detected'
3/24/15 ALT30; AST25;
3/24/15 <20 IU/mL (5 wks) HCV RNA
4/10/15 <20 IU/ml (7 weeks) HCV RNA
4/20/15 ALT36; AST27
4/20/15 UND
5/11/15 UND (EOT); ALT33; AST25
6/11/15 UND; ALT 34; AST 29
8/14/15 UND
11/15/15 SVR, 24-wk EOT

Offline charly8

  • Member
  • Posts: 113
Re: What exactly does it mean to be undetected?
« Reply #9 on: March 12, 2015, 11:19:41 am »
Charly8, If you don't mind me asking, what did your doc add RYB if you were undetected after 2 weeks?

To give the best chance of SVR.  My fibrasure was showing F3 and I have been treated 2 other times.  If I was an F4 I would be going for 24 weeks.  I wanted to try to see if I could get approval for 24 weeks but my doc did not think the insurance would cover it.  So the next best thing was adding RYB.  Looking at the studies, there was not much correlation between people that went undetected at 2 weeks vs 4 weeks and their relapse rates.  Just as many people relapsed that went undetected at 2 weeks as did at 4 weeks.

 I wanted to try to extend to 24 weeks because it looks like a sure thing for SVR.  Doc said that the insurance would not cover it, so he gave me the option of adding RYB.  Harvoni has been a breeze compared to the previous treatments and 8 weeks of adding RYB is "manageable" considering I did it for 72 weeks previous.
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline Tpropane

  • Member
  • Posts: 65
  • Heal the past by living in the present.
Re: What exactly does it mean to be undetected?
« Reply #10 on: March 12, 2015, 03:21:30 pm »
The viral load can range from "not detected" to hundreds of millions. The meaning of "not detected" or "negative" differs, depending on the test used. In one lab, the detection limit for the *quantitative* HCV RNA test by *PCR* is 200 virus equivalents/ml (and with the *qualitative* test they can detect down to 10 virus equivalents/ml). The less expensive quantitative *bDNA* test has a detection limit of about 200,000 virus equivalents/ml. So it is less sensitive, but above its detection limit it is more accurate than the PCR test.
2 different tests. 1 much more sensitive than the other. That is how I knew I failed treatment on Triple therapy. I had an undetected on a quantitive test but doc ordered the qualitative test and I was still detected.
I went from less than 10 to about a million from EOT in 2011 till just before starting Harvoni.
Ask your doctor which test he/she is ordering.
Best to all!
Tpropane.
Hep C 1A / TT diagnosed 2009
Non Responder Boceprevir/riba/peg 2011
F-4 Cirrhosis
TX Harvoni 24 weeks started 1/20/15
2 week labs VL 174!
4 week labs UNDETECTED !
8 week labs UNDETECTED !

Offline dragonslayer

  • Member
  • Posts: 873
Re: What exactly does it mean to be undetected?
« Reply #11 on: March 12, 2015, 11:30:11 pm »
Cool. Got it. BTW, what's LLOQ?

LLOQ = "Lower Limit Of Quantification"
LLOD = "Lower Limit Of Detection"
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 atomic dog

  • Member
  • Posts: 160
Re: What exactly does it mean to be undetected?
« Reply #12 on: March 13, 2015, 12:21:39 am »
I've had C for almost half a century and never heard those, thx,
Infected 1969, dirty needle
Geno 1a
Stage 2 fib, some necrosis
TX naive
1/29/15 ALT61; AST43
2/16/15 Started Harvoni; VL 1.5 m;
2/19/15 ALT40; AST24
2/29/15 ALT29; AST25
3/9/15 ALT28; AST25; 
3/9/15 < 20 IU/mL (3 wks) HCV RNA remains 'detected'
3/24/15 ALT30; AST25;
3/24/15 <20 IU/mL (5 wks) HCV RNA
4/10/15 <20 IU/ml (7 weeks) HCV RNA
4/20/15 ALT36; AST27
4/20/15 UND
5/11/15 UND (EOT); ALT33; AST25
6/11/15 UND; ALT 34; AST 29
8/14/15 UND
11/15/15 SVR, 24-wk EOT

 


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