Did I have a breakthrough ? Am I finished?

[HarryNewYork]

I just got the results of my eight week blood test and my Vl went up.  I know it's not good but how bad is it?  I'm a bit freaked out.
Some background. I am 64. Last biopsy 2002. 2/2. Started triple theropy April 5th 2012 with incivek.  
Prior to treatment my Vl was 3,137,285. Genotype 1A. I have had hep c for most likely 40 years. I have never treated before. Pcr 6.50 whatever that means.
4 week test. Vl 291.  Pcr 2.46.

6 week (Vl was run by mistake) Vl 225 Pcr 2.35.

8 weeks I don't have the hard copy but nurse told me Vl went up to 552.  I was too upset to get any other numbers. She's very good so I doubt there was any error in her reading them to me.  She saw it went up.  

Am I done??

My first post but I have been checking this site daily since before I started treatment any you folks are the best. I have pick up many great tips for dealing with sx.  So many that's to you all.  

[can-do-man]

I agree with pooh that one needs to have no viral load for it to be called a breakthrough. While this is tough news one has to remember pcr testing is only recommened at weeks 4 and 12 so what happens in between alot would never know. If this would stay like it is and you would have to end treatment you would be a Partial Responder.

Partial Responder: A partial responder is someone who experiences at least a 2-log decrease in hepatitis C viral load during HCV treatment. Partial responders are more likely to respond to re-treatment than non-responders or null responders.

Hang in there, wishing you the best.

[Idyllic]

The others outline the criteria that makes you eligible to continue treatment

1) Your VL < 1000 which means you could treat until week 24. At that point you would have to stop treating if you are confirmed detectable.

2) Patients with detectable HCV RNA at either Week 4 or Week 12 will require total treatment duration of 48 weeks.


The input of someone familiar with the trials/studies for Triple Therapy would be a great help here as it would reveal the statistical likelihood you would clear the virus under these circumstances.

As others suggest I would request another test. Plus, while I am not qualified to interpret your progress, if you are doing OK with the Incivek side effects then I would also evaluate if it is worth your while to continue at least until week 12 (the end of the Incivek stage).

[ceanothus]

I can imagine how awful it must have been to hear the VL went up, but I agree with Pooh and Will that this is most likely not a deal-killer. I wish you had been given the gift of encouragement that comes with ever-declining numbers, but your numbers didn't really rise to a statistically significant degree, and there is always some chance of lab error as well. Take heart, and follow the above advice regarding blood draws and let us know how things go. You have our best hopes and wishes!

[willbb]

My typing is a tad slow at times .I see pooh has covered it....

Will

[willbb]

Hi Harry
.,
Sorry to hear you have not had a better response ,however I would doubt that this is a true breakthrough ,but just not being able to eradicate off the remaining tough virions at this juncture.

Usually a true breakthrough would result in a much higher reading of viral load.

Given the prescribing protocol is to continue as long as the viral load is < 1000 at week 4 and also at week 12 (see link below) then you are still in the game  with VL of 552IU/ML at week  8.

Your baseline viral load respresented in  "log form " was 6.5,at week 4, was 2.46 at week 6 was 2.35 and at week 8 was .2.74..
So what all that means is you really have not had any significant viral load change since week 4.

I would want a viral load done again at week 10 to see what is the trend  and then obviously at week 12 to see whether you would continue or not.

Good luck...
Will

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256328.htm

Discontinuation of Dosing

Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions. Discontinuation of therapy is recommended in all patients with (1) HCV-RNA levels of greater than or equal to 1000 IU/mL at Treatment Week 4 or 12; or (2) confirmed detectable HCV-RNA levels at Treatment Week 24 (see Table 2).

Table 2: Treatment Futility Rules: All Patients

[pooh55811]

Hello and welcome to the forum.

I am very sorry to hear this news. I know it must be very devastating and discouraging. I will try to answer your questions.


"I just got the results of my eight week blood test and my Vl went up. .....
I don't have the hard copy but nurse told me Vl went up to 552."
----------------------------------------------

While the nurse may be correct, if I were you, I would wait to see the hard copy to be sure that she did not make an error when she read it to you. Then, even if the hard copy says 552, I would ask for a redraw to be sure there was no lab error.


"4 week test. Vl 291.  Pcr 2.46.
6 week (Vl was run by mistake) Vl 225 Pcr 2.35.
8 weeks I don't have the hard copy but nurse told me Vl went up to 552."

"Did I have a breakthrough?"
_______________________________

No. You were never Undetectable so, according to terminology, you did not have a viral breakthrough.


"Am I done?"
______________________________

"For all patients treated with telaprevir, the following futility rules should be employed:"

"If HCV RNA is > 1000 IU/mL at treatment Week 4 or 12, all 3 medications should be discontinued.
If HCV RNA is detectable at Week 24, pegIFN/RBV should be discontinued. "

http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%205.aspx

So, technically, according to the Teleprevir futility rules,  you can continue on Incivek as long as you are below 1000 at weeks 4 and 12, and Undetectable at week 24.

However, I am not the expert on the forum. I believe those rules are based on blood draws at 4 weeks and 12 weeks. I am not sure how a rising VL at 8 weeks would affect those rules or if it would be advisable to continue treatment (due to possible resistance issues).  

Again, I would want a redraw to be sure that there was no lab error.

Hopefully, one of the experts will respond with more insight into your situation and whether you should continue treatment or not.

[Dee1956]

I am so very sorry for your news.  I don't really know what to say and around here that is odd for me.