QUANTASURE < 2 (NEGATIVE) NEED AN ADVICE

[zako7]

Hi Folks, I got the call from my Np yesterday evening informing me that my wk 38 quantasure < 2 result came back Negative from Labcorp. I thank God for that.
I have an appointment to meet with my doctor on wednesday 09/26 to discuss my treatment. I am on week 41 and will take the 42nd injection on Thursday. I am thinking base on my race and poor performance of interferon should I ask my doctor to go for more 12 weeks (adding up to 60 total) with only riba and interferon. I am treating G4 off label Vic and have to conform with Genotype 1 protocol. The advice I am seeking is this. With this quantasure negative result do I need to do another 12 more wks to improve my chances of svr or is the 48 wks enough since it is the most sensitive test?
I need your inputs so that I can have facts to present to my doctor. I can easily convince her but I want you folks with your experience to advice me which way to go. My body is very weak. I have rashes on many parts of my body but I can push to wk 60 if it will brighten my chance of svr.
Thanks for all your support.
ZAKO7

[zako7]

My doctor exactly explained it the way most you did. I want to extend but she kept telling me that extension was tried in soc. she mentioned something like '" harzt report" I didn't get the name of the report correctly. I didn't wanna seem to push her hard until i get a good evidence to support me. It looks like with the pi the maximum is 48 wk and anything more than that has not been proved to have substantial difference. I still have 6 more weeks to finish and I will continue to consult on this. If I can get a report about a higher SVR number on patients who  extended triple therapy treatment beyond 48 wks then I can present it her and make a good case for extension. I will start the search this weekend.
If anyone has something, please let me know.
Thanks for all your support.

[pooh55811]

I will try to post the links. I seem to have some problem posting the correct links, the links that get you to the presentations.

http://liverlearning.aasld.org/aasld/register/

Click on the top site.

Register (it is free)

Once registered, click on "Type of Content" located on the left side of the green bar, near the top.

This will take you to various types of presentations.

Click on the square that looks like a flat computer screen, with the colored circle in it, "80 PPT Shared"

Just keep watching presentations.

I started out watching presentations that discussed resistance issues, but then expanded to other presentations which discussed other aspects of HCV and HCV treatment.

I found these particularly interesting and informational:

Mechanisms of HCV DAA Resistance: A Primer
by Jean-Michel Pawlotsky  2012-03-16

How direct-acting antivirals (DAA) Work and Their Limitations
by Raymond Chung  2011-11-07

Will DAA Combos without IFN/ribavirin be an Option? Which Combos make Most Sense?
by Kenneth Sherman  2012-03-17

Host Genetic Factors and Response Guided Therapy for DAA
by Alex Thompson  2012-03-17

Hepatitis Debrief
by Gregory Everson  2011-11-08

The following presentation is under the "133 Video Podcasts". The one with the green circle and arrow:

Managing Null Responders
by Gary L. Davis  2012-03-17

I need to find the presentation that showed slide of the doubled SVR rates with the if the doses were increased and the Tx time was lengthened. I had a bunch of tabs open and the computer shut off for an update and I lost my tabs, LOL. I can find it again, though, because I think I have that presentation book marked.

[Idyllic]

Hey Pooh :)
Will you post the link(s) where this is mentioned?

Yeah, I am thinking the longer these PIs are out and the more they are studied along with experience clinicians gain might very well lead to tapering certain aspects of aspects of treatment duration.

[pooh55811]

Maybe I am missing something but, if extending Tx is old school and has been tossed, then why did several speakers at the March 2012 liver conference state that the way to compensate  in treating difficult to treat patients and poor responders is to raise doses or lengthen Tx or both. Those presentations repeat and repeat and repeat that length of time is critical, especially in more difficult to treat patients. There were slides that showed SVR rates doubled in poor responders when doses were increased and/or Tx time was lengthened.

Personally, I think we are going to be seeing some rethinking of the current treatment regimens, the ones most doctors are using. I think we will be seeing new treatment recommendations that are tailored to the individual patient and that take into account that we are not all alike and we are not all clones of the easiest to treat patients.

[copyman]

I agree with your doctor that extending does not increase your odds for SVR,

Extending is old school before PI's

You got it beat at this point. If I was to extend tx beyond protocol it would be to taper off the interferon over a 4 week period, 3/4 dose, 1/2 , 1/4, 1/8. This will help your immune system learn to fight on its own.

Best of luck

[Idyllic]

I was wondering what the outcome of this would be. I know there are studies that indicated there would be no added benefit for treatment naive people who are eRVR to extend treatment but that is about it.

Did your doctor happen to mention where she read this? I only ask because the longer PIs are being used the more caveats I hear that were not mentioned in the initial studies. Some are based on new data and some seem to be based on clinical experience.

Being African American and a Geno 4 to boot you truly are breaking new ground and I really hope this works out for you.

Best of luck to you and please keep us posted

[zako7]

I just finished meeting with my doctor. She said she has no problem extending my tx to another 12 weeks but recent study she quoted suggested it didn't make much difference. She suggested I concentrate and finish the 48 wks and will wait and see. She said my chance of SVR looks like 60% but I have read its between 40 to 50. She said not much is known about my genotype 4. That it may not be difficult as I thought. That African Americans here are normally genotype 1 - 3.
She told me to think about these and call her.
Zako7
So folks what do

[coraggio]

Zako, if you need procrit to stabilize the hgb it means you are absorbing the ribavirin well.  Besides, increasing the ribavirin at this stage in your treatment would not benefit you.

This is also my opinion, and I emphasize MY.  I don't think extending treatment will give you better odds of achieving SVR.  You hit the virus with everything available, and sure, as long as you're taking the interferon the virus will stay suppressed.  It's when you stop taking interferon, whether it's after 24, 48, 60 or 72 wks, that when the immune system starts gearing back down and if the virus hasn't been effectively suppressed, it's going to come back.  Years ago, they thought extending treatment to 72 wks for slow responders on SOC was the way to go but turns out it didn't have the impact on SVR rates they thought it would and that concept was tossed.

Geno 4 has shown to respond better than geno 1 so I just don't think 12 additional weeks of interferon and ribavirin is going to improve your chances of SVR.

[zako7]

Thanks to everyone who  contributed. When I went to the hospital today to collect the hard copy of my test result, I talked to the NP about extension and he said its a good idea but can only be decided by the doctor. Wednesday tomorrow I will meet the doctor to discuss this. They are treating me off label with additional cost of vic added and I just pushed them to do the quantasure test which they don't do. I have to find a way not to sound pushy.
For the HGB, any week I fail to inject procrit, it drops by .5 but if I constantly inject 20,000 every week, it stabilizes at 11. It may mean that my body is not absorbing the riba well but my doctor never call it out instead she sees it as good development. I will present to her the options of increasing dosage or tx extension and see what she says. I may have to come back here for more clarification if she offers me something different.

[pooh55811]

Whether extending Tx will be beneficial for you in your particular case, no one can say for sure.  However, the presentations by the liver experts at the liver conferences do state that the way to compensate for poorer response in more difficult to treat patients is to raise dosages and/or lengthen Tx time or both. By doing this, the SVR rates were doubled in those patients. These presentations were mostly presentations concerning Genotype 1 and Triple Med Tx. While I am not positive, it is logical that this strategy would also work for Genotype 4.

I guess, if it was me, I would extend Tx, but that is me. I am not saying you should or should not extend Tx. Just giving my opinion on what I would do given the same situation.

I surely hope you attain SVR. You certainly have put tried to do everything possible to do so.

[willbb]

At this late in the game additional ribavirin would not effective
---------------------------------------------------------

corragio is correct. This wilkl do nothing additive at this point....

Will

[coraggio]

At this late in the game additional ribavirin would not effective.  Ribavirin blood serum peaks sometime in the first 12 weeks.  If he had bumped it up in the first 12 wks then perhaps but now I see no added value, especially if he needs procrit to keep the hgb an acceptable level.

[frijole]

I am just not sure any of us can answer your questions.  I do wonder about the hemoglobin.  With only 20,000 units per week you were able to keep your HGB at 11.  With 40,000 units per week, many of us struggled to keep HGB at 9.  11 would be the optimum to me.  However, I wonder if your body needs additional ribavirin to help the interferon.  Just a thought, no science here.

[flcyclist]

Based on your comments it appears you've given serious consideration to extend the additional 12 weeks for a total of 60.  I admire your determination.  As you noted with your slow response to interferon, you didn't go und until week 12.   I agree with the comments above suggesting to extend the additional 12 weeks would be a wise option considering these factors.  If you are tolerating tx fairly well at the end of 48 weeks, I suggest to continue as long as you have no major issues.  If you have to stop, then you've done all you can.  None of us want to do this over again, and we want to give ourselves the best probability for success.  

Regarding your quick response to neupogen in raising the ANC, mine was quick also, which is normal I believe.  It's good to hear you had a quick response to procrit, which normally takes a few weeks.

Best of luck in your decision and moving forward.  

[zako7]

My hgb before start was 14 after 8 wks of tx it came down to 10.2 when I started  procrit 40,000 weekly  it went up to above 12. I reduced procrit to 20,000 ( 1 injection per wk) it stabilized at 11.
For some strange reason my body respond fast to procrit and neupogen.

[zako7]

Thanks to all of you for responding.
My pre-tx vl load 2.7 ml. Wk 4 on soc 627,000, vic added after wk 4, wk 8 1050, wk 12 und, wk 24 und, wk 29 und, wk 36 und and wk 38 negative quantasure < 2.
This my journey so far. I don't really know exactly what my odds of SVR are. I am reading studying all your inputs and so far you guys have been supportive.
Zako7

[frijole]

Remind me of your viral load tests -- pre tx, 4 week lead in and whatever you have had after the VIC was added.   And, what has your HGB been running? I am glad you are getting the QS as it is the best quantitative test we have.
Zako, I think modification -- extension or increase of Riba along with triple will be the wave of the near future as we are seeing individuals fail.  That is just my personal opinion but I do think modifications are coming.  

Can-do made some good points -- risk vs reward.  I chose to treat 56 weeks first time because I was not clear at week 12.  I was pretty much done in by then and that was without the extra sx these PI's are giving.  How bad is your rash?  Are you getting treatment?  If I were in your shoes I would probably want to extend.

bean

[FlGuy]

At what week were you first pcr-undetected?

[can-do-man]

Wow guy that is a tough one, since you had such a slow start with the lead-in the Vic has had to help, but you know because of the lead-in response, genotype, and your race your in a tough spot. Under just the old SOC rules since you was und at week 12 then 48 weeks is what is called for. BUT I can understand your thinking on wanting to extend. It gets down to the risk vs reward thing.

Would it increase your odds? Maybe, but one would think it would be very little going by the old rule of thumb... Keep in mind you have very little liver damage, there is new drugs in the pipeline, but how African-Americans will fare under them, nobody knows yet.

Would I extend? I did my first treatment, beyond the recommend 72 weeks, did it help no. But if my doctor would think in your case it might help I just might......... One has to admire how determined you are and the fight you have put up, SVR rates would be higher if everyone had your spunk. I really wish you the best, whatever you do.