Anyone one with similar results further along in tx

[barmuckity]

I am in my third week of treatment with Incivek and I went in for my first week (actually 8days) blood work - The tech accidentally added a viral load check  along with the regular/standard blood work.
First I guess I should say that I am genotype 1a and I previously treated in 2004 temporarily cleared the virus (unmeasurable) then relapsed at the 6 month check.
My viral loads were as follows
2004 pretx 438000
2004 tx 0
2008 4,031,300
200911,495,000
2010 34,238,000  
2011 8 days into treatment 470 !!!
This number seems to be to good to be true. If  anyone has had any similar results and are futher along in tx or  maybe finished tx I would sure appreciate any insight into these results.
Thanks

[Lifenet62]

Long haul far better than no haul!!!!! Fight on slayer!!

[barmuckity]

thanks for the info - looks like I am in it for the long haul

[willbb]

but fogot to mention you have to be under a 1000 at wk 12 to continue as well.
--------------------------------
Thx. much for the follow up... :)  
Will

[hrsepwrguy]

Duration of Treatment
The recommended duration of treatment with INCIVEK is 12 weeks in combination with peginterferon alfa and ribavirin. HCV-RNA levels should be
monitored at weeks 4 and 12 to determine combination treatment duration and assess for treatment futility (Tables 1 and 2).
Table 1: Recommended Treatment Duration (See also Table 2 for Treatment Futility Rules)
Treatment-Naïve and Prior Relapse Patients
HCV-RNAa
Triple Therapy
INCIVEK,
peginterferon alfa and ribavirin
Dual Therapy
peginterferon alfa and ribavirin
Total
Treatment
Duration
Undetectable at Weeks 4 and 12 First 12 weeks Additional 12 weeks 24 weeks
Detectable (1000 IU/mL or less) at
Weeks 4 and/or 12
First 12 weeks Additional 36 weeks 48 weeks
Prior Partial and Null Responder Patients
Triple Therapy
INCIVEK,
peginterferon alfa and ribavirin
Dual Therapy
peginterferon alfa and ribavirin
Total
Treatment
Duration
All Patients First 12 weeks Additional 36 weeks 48 weeks
aIn clinical trials, HCV-RNA in plasma was measured using a COBAS® TaqMan® assay with a lower limit of quantification of 25 IU/mL and a limit of
detection of 10 IU/mL. See Laboratory Tests (5.6) for a description of HCV-RNA assay recommendations.
For the purpose of assessing response-guided therapy eligibility at weeks 4 and 12 (see Table 1), an “undetectable” HCV-RNA 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 [see
Laboratory Tests (5.6)].
Treatment-naïve patients with cirrhosis who have undetectable HCV-RNA at weeks 4 and 12 of INCIVEK combination treatment may benefit from an
additional 36 weeks of peginterferon alfa and ribavirin (48 weeks total) [see Clinical Studies (14.2)].


Will is correct(as always) but fogot to mention you have to be under a 1000 at wk 12 to continue as well.

The above is from incivek prescibing info pdf it doesn't copy and paste well but you can look at it for yourself at

http://pi.vrtx.com/files/uspi_telaprevir.pdf

[willbb]

I think you possibly still might be stating it incorrectly. :)

SVR is defined as being  virus free at the  test 6 months after treatment.
It sounds like you had virus at that test which would be considered  a relapser.

To answer your question above on how long  the protocol is this treatment.

If indeed you were are a relapser ... then with Incivek  if you are UND. at week 4 and still UND. at week12 you would do 24 weeks total(unless you are chirrotic..then 48 weeks is recommended.
If you are not UND at week 4  but <1000  and UND at week 24 then 48 weeks total is recommended.

Good luck
Will

Will

[barmuckity]

just 6 mos

[barmuckity]

I probably said it wrong -  I acheived svr at 6mos during my 2004 treatment and stayed clear until 6mos after one year of treatment  

[sandysf]

I cannot answer your question, but have a question for you.  You indicated you relapsed at 6 month check.  Did you have a VL check at 4 weeks and 3 months post tx or just at 6 months.  Just curious for my own benefit.  

[pooh55811]

I was detectable at 4 weeks but <43.

Therefore I have to do 48 weeks (because I was detectable at 4 weeks, even though I am <43).

I think there are some other parameters, too, depending on what the VL is at 8 weeks and 12 weeks and 24 weeks, but I have not gotten that far yet.

I am starting my 7th week today.

[barmuckity]

Thanks for the input- How do you know if you will have 24 or 48 weeks of treatment?
Thanks again

[lynda607]

All you reported was the RT-PCR part of the Heptimax.  Heptimax is a two part test.  First the RT-PCR is performed which will pick up HCV RNA down to 43 IU/mL.  If you only have the first part of the test done it can't detect or quantify anything below 43 IU/mL because of limitation of the assay.  With Heptimax if the RT-PCR does not pick up HCV RNA down to 43 IU/mL then TMA part of the test is performed which has an LOQ & LOD to 5 IU/mL.  Technically, there could be some low level RNA like we are seeing on the LapCorp tests where the tests reads HCV RNA below 25 IU/mL but detected.  The lowest level of detection for that test is 7.1 IU/mL but it can't quantify any RNA between 7.1 & 24 IU/mL  
  

You did not report the TMA part of your Heptimax test.  

[MsDragonSlayer]

I just called vertex, they said if I'm under <1000 I'm detectable, my doctor told me I was UND, I must be reading something wrong because I thought my blood work said I was < in the 40's, I am lost now. :( my lab work is in my journal on my site if anyone could help me find the 0 ,
thanks,
Carolync

[nygirl7]

Usually we just test at 4, 12 and 24 but I think the more testing the better.

The <2 test makes you feel pretty secure btw.  :)

[MsDragonSlayer]

I'm sorry, I meant the first 4,8,12,16, 20, 24, I am not thinking so well lately, sorry;)

[MsDragonSlayer]

Oh, that's what vertex told me the first week, that's where I got that. So the second week is lower, how does that step down?

[willbb]

Anything under 1000 is considered undetectable -UND!!
-------------------------------------------------------------------------------------------
oops    not correct.... any thing <1000 is the level that allows you to go on from week 4  on Incivec.

Undetecable  is   ..when the lab report says Undetecable ..to what ever the sensitivity of the test you have done ...usually <43 or some are as sensitive to <5 or <2
Best...
Will

[MsDragonSlayer]

Anything under 1000 is considered undetectable -UND!!
... the race is on to the finish line!

[SusieS2010]

I am not on treatment but many people who are on the triple therapy are undetected by week 4. Seems you are on your way. As a relapser you have an extremely good chance of SVR. Good luck.