My week 4 results

[Krusing]

I honestly didn't believe it could happen to me, BUT.......I began tx 10/05/07, my vl was 29,000,000, YES MILLION.  Week four blood tests showed vl <60~~  OMG......it's working!!  I'm believing, now that there is HOPE!  My Doc says with this kind of progress (at this moment) he thinks my chances of getting better have risen from 20 - 40% to 50 - 60%, but he thinks we need to do the full 72 weeks, as long as all my other labs stay stable.  This is, for sure, my Christmas gift to myself!

[gauf]

Wonderful news! Maybe you can talk your doc into a Heptimax test. Then you can really celebrate!

[jmjm530]

Well, first a big congratulations!

Don't know any of your stats -- genotype, age, liver condition, etc -- but going out on a limb, I'd say your chance of SVR is closer to 80 (assuming geno 1) than 50-6% and frankly have no idea where your doc came up with those pessimistic pre-treatment numbers unless perhaps you have failed treatment before or have stage 4 liver damage.

While it's true pre-tx viral load factors into the SVR equation, 29 million is not that extraordinary high, and your week 4 test trumps it anyway. For all these reasons, I would rigorously question treating 72 weeks unless (given your RVR at week 4) unless your doc provides compelling arguments to the contrary. BTW is he a liver specialist (hepatologist) or a GI? In general, hepatologists have much more experience in these things and can guide you better in important decisions such as tx lengh. Also, can I ask what test you took -- you should get your own copies of all labs -- cause I'm unfamiliar with a test that has a bottom limit of 60 IU/ml.

All the best,

-- Jim

[jmjm530]

Gauf has a good point. Your next test should be "Heptimax" or the
"HCV RNA TMA QUAL" both from Quest Diagnostic Labs. Both tests go down to 5 IU/ml.

[charm27]

That is such wonderful news! Good Luck!
Do a dance I would!



Charm27

[Krusing]

Well, first a big congratulations!

Don't know any of your stats -- genotype, age, liver condition, etc -- but going out on a limb, I'd say your chance of SVR is closer to 80 (assuming geno 1) than 50-6% and frankly have no idea where your doc came up with those pessimistic pre-treatment numbers unless perhaps you have failed treatment before or have stage 4 liver damage.

Genotype 1a, I will be 59 next week, female, my liver damage with biopsy was 3-4 with chriossis NOT being ruled out. My doc is Infectious Disease specialist, and 80% of his patients are Hep C patients.  

I do have copies of my labs, and as soon as I feel up to it, I will post them because I haven't a CLUE what anything means!

And, what is a Heptimax?

[hairtamer]

What a Blessing!  I am at the same point, I just got a phone call yesterday afternoon from my gastro office saying my 4 weeks is 0 VR!!!  If I get nothing else for Christmas, I am good!!!
In Jesus, the Reason for the Season,
Rose

[jmjm530]

Yes, you def should get copies of all your labs.

Given your stats, it makes a little more sense now. Given your age and liver damage, my doc ( a liver specialist) would probably also suggest 72 weeks, and in fact we had quite a number of discussions over that issue. I ended up getting 3 additional consults and finally decided that my RVR trumped the negative pre-tx factors and ended up doing 54 weeks. That said, your 3-4 (if it means between stage 3 and 4?) is a little higher than mine, as I figured I was around a stage 3 when I treated and age 58. So, yeah, 72 weeks is reasonable, but some liver specialists might let you off with 48 weeks. You're certainly entitled to an outside consult with a hepatologist on that matter if you want.

"Heptimax" is a very sensitive viral load test offered by Quest Diagnositic Laboratories. It goes down to 5 IU/ml , as opposed to your test which seems to only go down to 60 IU/ml. Best to go with the more sensitive tests from now on. The other test mentioned "HCV RNA QUAL TMA' is also from Quest Diagnositics.

-- Jim

[charm27]

how wonderful!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! what a xmas present!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

[hairtamer]

I got you in my prayers.  I know you are 2 weeks behind me.
God Bless,
Rose

[mikesimon]

That's a great way to start and I think you have an excellent chance of clearing this disease.
Please keep in mind that we are just patients here despite how it might appear at times. If you have confidence in your doctor let him direct your treatment. That's what he gets paid for and after all, he is a real doctor.
Good luck, Mike

[BThompson4]

Do you think doctor will stop or amend Krusing's treatment if the Heptimax pcr shows a viral load of, say, 2 iu/ml at week 6 of treatment?  What are the practical implications of getting a viral load of less than 5 iu/Ml so early in treatment?

[jmjm530]

Heptimax has a sensitivity of 5 IU/ml and I recommended it for future viral load tests so that Krusing will be assured that she's UND down to about the lowest measurable limit.

There are a number of people who carrry low-level viremia both early-on and even throughout treatment who may not be caught with a less sensitive test.

This becomes especially important at week 12, 24 and 48 -- but even at an earlier point of time -- week 6 to use your example -- it may give the clinician a greater authority of UND to make tx-related decisions such as how long to treat.

In Krusing's case, it appears he may go to 72-weeks, but if another consult was brought in the sensitivty of the tests might make a difference. It did to my consults who mentioned several times that I was UND thorughout tx with *very sensitive* tests.

I think the real question given the current testing technology is not why someone should use the most sensitive tests available, but why shouldn't someone use them? I only see an upside, no downside.

-- Jim

[jmjm530]

A fairly recent study showed that a significant portion of PCR negatives were actually TMA postive at the end of treatment. Not surprisingly, 100% of this group relapsed.

It's hard to believe that this sub-group suddenly became EOT TMA positive. More likely is that they were harboring low-level viremia all throughout treatment and it was just not picked up because of the less sensitive tests used.

Had this sub-group used more sensitive testing from the beginning, their doctors might have had time to adjust treatment to give them a better chance of SVR, or if that didnt' work, they could have cut tx short, sparing the patient tx drugs that weren't working.

[jmjm530]

From the Boston Meeting, ID #170. Again, the importance of early and *sensitive* viral load testing -- in this case weeks 4 and 12 -- to help manage therapy -- in this case to predict SVR.

"The application of the highly sensitive HCV RNA tests must be considered to be now mandatory because this new test helps to evaluate in a much more refined way treatment response as well as relapse rates and provides better clues for an individualized tailored treatment strategy."


Importance of a Minimal Residual Viremia for the Relapse Prediction in HCV Type 1 Patients Receiving Standard or Individualized Treatment Duration
T. Berg1; V. Weich1; G. Teuber2; H. Klinker3; B. Möller4; J. Rasenack5; H. Hinrichsen6; T. Gerlach7; U. Spengler8; P. Buggisch9; H. Balk10; M. Zankel10; C. Sarrazin2; S. Zeuzem2
1. Charite, Campus Virchow Klinikum, Berlin, Germany.
2. Medizinische Universitätsklinik, Frankfurt, Germany.
3. Klinikum der Universität Würzburg, Würzburg, Germany.
4. Hepatologische Schwerpunktpraxis, Berlin, Germany.
5. Medizinische Universitätsklinik, Freiburg, Germany.
6. Christian-Albrecht-Universität, Kiel, Germany.
7. Universitätsklinik, Zürich, Switzerland.
8. Medizinische Universitätsklinik, Bonn, Germany.
9. Universitätsklinik Eppendorf, Hamburg, Germany.
10. essex GmbH, München, Germany.


The exact estimation of early virologic response rates in the course of antiviral therapy is an important goal in order to improve individualized therapeutic strategies in HCV infection. The sensitive TMA test could provide better advantage to distinguish at early stages sustained from non-sustained responders. We evaluated HCV type 1 patients who took part in a prospective study asking whether the application of TMA in bDNA-negative patients may be a better indicator to predict long-term outcome of the HCV infection. Methods 433 patients were randomized to receive either 1.5ug/kg PEG-INFa-2b plus 800-1400 mg RBV for 48 weeks (n=225, group A) or an individualized tailored treatment duration (n=208, group B). In the latter group treatment duration was calculated by the time required to become for the first time HCV RNA negative as defined by bDNA assay (detection limit 615 IU/mL) multiplied by the factor 6. HCV RNA levels were quantified weekly until week 8, at week 12 and 24. For all those patients who were bDNA negative the more sensitive TMA test (detection limit 5.3 IU/mL) was also prospectively assessed. The different response groups were classified according to the HCV RNA levels at week 4 and 12 (Table). Results Table shows the relevant data and refers to the relative relapse rates in group A and B at week 4 and 12 in relation to the treatment schedule. There is clear evidence for a high relapse rate in patients with a positive TMA within the first 12 weeks of therapy being more pronounced when treatment duration shortened in the individualized treatment group. In contrast patients shown to respond as early as week 4 evidenced by a negative TMA test had relapse rates below 10% irrespectively from treatment group. Conclusion The application of the highly sensitive HCV RNA tests must be considered to be now mandatory because this new test helps to evaluate in a much more refined way treatment response as well as relapse rates and provides better clues for an individualized tailored treatment strategy. Thus our study clearly indicates that patients even with a minimal amount of HCV RNA detected at week 12 can suffer from relapse rates greater than 50%. These patients may indeed benefit when their treatment duration is adapted to their individual needs.

response groups relative relapse rate (%)

week 4
response >= log decline,
bDNA positive 36%
(all patients) 19%
(group A) 63%
(group B)
bDNA negative,
TMA positive 38%
(all patients) 22%
(group A) 49%
(group B)
bDNA negative,
TMA negative 4%
(all patients) 0%
(group A) 8%
(group B)
week 12
response >= 2log decline,
bDNA positive 77%
(all patients) 78%
(group A) 75%
(group B)
bDNA negative,
TMA positive 64%
(all patients) 56%
(group A) 69%
(group B)
bDNA negative,
TMA negative 20%
(all patients) 9%
(group A) 32%
(group B)

[nygirl7]

WOW that is just amazing what wonderful incredible glorious news!!!!!!!!!!!!!! Woo hoo to you!!!!!!!!1

I have to say, I did 72 weeks treatment myself and am ECSTATIC that I did.  I listened to the doctor, read my studies and learned what I could but in the end decided that it was the BEST way to up the odds in my favor and get rid of this disease for GOOD and it WORKED - I am 10 months SVR and grateful for every day of the 72 weeks I did.

I can't say it was easy or fun but it was WORTH IT.

I wish you ALL of the luck in the WORLD.  It sounds like you have a GREAT aggressive doctor who is really on your side.

I think that is the best news for you of all.  Congrats!

[nygirl7]

PS I agree with BThompson - the test you had was good enough - next time maybe ask for the TMA Heptimax but for this time celebrate.  When you break it down your talking about such a small number it doesn't matter - and believe me I believe being as aggressive as possible.

[jmjm530]

I'm not sure if you know what you're "agreeing" with :) I told "Krusing" to use Heptimax on the NEXT test. BThompson is questioning using a senstive test at say for example, week 6. Didn't you end up using a sensitive test before week 12 and state that it helped your medical team to determine you needed to extend?

-- Jim

[H20Lover]

What is TMA positive.....more to learn huh?  Jim, you may remember I am about to have the 4 week test.  Is this something I need to understand?  What do I ask for?

Thanks!

[jmjm530]

In general, "TMA" is a more sensitive form of testing than "PCR" although I believe LabCorp uses a PCR that's just (if not) more sensitive. In any event, you ideally want a sensitive test for your week 4 test. One readily available sensitive test (that uses both PCR and TMA technology) is "Heptimax" by Quest Diagnosics.

-- Jim

[Krusing]

It is awesome to see all these responses, all so positive and congratulatory, thanks to everyone.  I must admit, I'm understanding, the questions of test sensitivity, and did call my doc today to ask about Heptimax test next time.  He said he could arrange it, but with the results he considers to be "UND" what's the point?  I'm sure this will just be another hill in this journey.  To NYGirl, your reply stood out the most to me, my heart celebrates your victory, you sound like you have/had the same attitude that I have, if it takes 72 weeks of feeling like S*** to be healthy again, bring it on!!!