emo Do not worry Detected or Undetected if below LLoQ

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6 years 7 months ago #7354

I could not believe that there are persons who have been detected at end of treatment and then achieved SVR 24. According to Gilead, for Harvoni, UND is NOT the measure of SVR. They are using a LLOQ of 25 and are defining SVR as a quant rna number of less than 25, not UND. At the time of trials with Harvoni the LLOQ have been 25 IU/ml, now they have updated to 25 and 15. This is from their prescribing document describing how SVR was defined in the trials:

"All three Phase 3 trials evaluated efficacy of HARVONI (one fixed-dose tablet of 90 mg of ledipasvir and 400 mg of sofosbuvir administered once daily) with or without ribavirin. Treatment duration was fixed in each trial. Serum HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System. The assay had a lower limit of quantification (LLOQ) of 25 IU/mL. Sustained virologic response (SVR) was the primary endpoint and was defined as HCV RNA less than LLOQ at 12 weeks after the cessation of treatment. Relapse was a secondary endpoint, which was defined as HCV RNA greater than or equal to LLOQ with 2 consecutive values or last available post-treatment measurement during the posttreatment period after achieving HCV RNA less than LLOQ at end of treatment."

The data of one person:
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
48 wk post tx: UNDETECTED SVR48


Male, Fibro F1. Geno 1b. ALT 67 before treatment Viral load 5 million. My huge viral load replicates in my nervous system as I suffer anxiety.
Started Twinvir 12/12/15.
Two weeks
ALT 17 at 2 weeks
Viral Load UND at 2 weeks
ALT 13.5 at 7 weeks EOT
ALT 10.5 at 15 weeks EOT
ALT 13 at 27 weeks EOT, VL UND, Cured
Last Edit: 6 years 7 months ago by Enkel.
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6 years 6 months ago #8757

I am confused...I was just grazing the internet, despite knowing that can be a risk, and MedicineNet.com stated that 'achieving an SVR is NOT a CURE" !!!!!!! Pardon? ...please can I have medical feedback. I thought an SVR meant cured. I am so confused, how can achieving an SVR not equate to a cure? Is this a lexical semantic or what....comments please :)


Gen 1a
Peg/inf/riba 2012(!) stop @ Wk 43 potassium low +issues (rlps week 4 post tx, VL120,000) scnds eg. adenomas.
pre sof/led VL 240,000 Fibsc F0
Day 25 <30
Day 32 UND
Week 10 UND
EOT UND ALT11AST17GGT19
SVR4 UND ALT10 AST16 GGT13
SVR8 UND ALT <9 AST16 GGT15
SVR12 UND ALT14 AST19 GGT12 Bili 5
EOT +18 ALT13 AST20 GGT9 Bili 5
EOT +21 ALT11AST15
Cured SVR12
Dysplasia Adenomas RemvdAug '16
SVR24 UND ALT11AST16
ColonoscopyClear Nov17
LumpectomyClear ‘18
LithotripsyCytoscopyBiopsy 4/18
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6 years 6 months ago #8759

SVR maybe not but SVR12 is a cure 99% SVR24 is almost 99.9


Male, Fibro F1. Geno 1b. ALT 67 before treatment Viral load 5 million. My huge viral load replicates in my nervous system as I suffer anxiety.
Started Twinvir 12/12/15.
Two weeks
ALT 17 at 2 weeks
Viral Load UND at 2 weeks
ALT 13.5 at 7 weeks EOT
ALT 10.5 at 15 weeks EOT
ALT 13 at 27 weeks EOT, VL UND, Cured
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6 years 6 months ago #8772

Yep, as you say......and Enkel also in a different way, it is semantics. They can't give a 100% guarantee that you have got rid of the virus 24 weeks post treatment (or even 240 or 2400 weeks) so they are not prepared to call it "cured" but rather a "sustained" response. To you and me it is cured!!! :)

But wait.....the same website you quote also has a definition of "cure" that would seem to include what we experience during SVR.

"Cure: 1. To heal, to make well, to restore to good health. 2. A time without recurrence of a disease so that the risk of recurrence is small."

www.medicinenet.com/script/main/art.asp?articlekey=31243

Methinks they are having a dollar each way. :evil:

It comes down to what Abraham Lincoln said about not trusting what you read on the Internet. :whistle:


G3a since '78 - Dx '12 - F4 (2xHCC)
24wk Tx - PEG/Riba/Dac 2013 relapsed
24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 - 22/06/17 UND
SRV12 - 27/07/17 UND
SVR24 - 26/10/17 UND
:cheer: :cheer: :cheer:
Last Edit: 6 years 6 months ago by Gaj.
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6 years 6 months ago #8961

At SVR4 there is a 96% chance you never have detectable virus again
At SVR12 it is 99%
At SVR24 it is 99.9%

So if the HCV is not back within 6 months of EOT you have a 1000:1 chance of never seeing it again, and going on to die of ripe old age.

Personally I'd call that cured.


YMMV

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