48 vs 72 weeks of tx

[Valtod]

The research basically says (about HCV genotype 1):
1. If you're undetectable at week 12 (even better at week 4), you don't need more than 48 weeks.
2. If you're <6000 IU/mL at week 12 AND undetectable at week 24, you may need 72 weeks of tx.

http://www.hivandhepatitis.com/hep_c/news/2006/051606_b.htm

[jmjm530]

Friole said: Thanks to all on the clarification on the TMA. I was beginning to wonder if I should tell my doc tomorrow I wanted the TMA instead of the PCR, but sounds like the PCR to 2 will be good.
==============
Just to clarify -- yes, Lab Corp's quantitative PCR that goes down to 2 IU/ml should be just as good as a TMA. But keep in mind, most PCR's do not go down that low. Therefore, if you want to order a PCR instead of a TMA, make sure you tell your doctor that you want Lab Corp's PCR or you might end up getting one not very sensitive. If that gets too complicated, just order a TMA or some combo test like Quest Diatnostic's Heptimax which combines a PCR with a quantitative TMA. That's the test I used mostly. All the best luck.

[friole]

Thanks to all on the clarification on the TMA.  I was beginning to wonder if I should tell my doc tomorrow I wanted the TMA instead of the PCR, but sounds like the PCR to 2 will be good.

Willing - I was floored and excited when I read your conclusion that I had only a 15% chance of relapse at 48 weeks and going 72 weeks would only reduce that relapse rate to 12%. (I really don't want to go into overtime). However, when I read that study, I read <50 to be undetectible, since the test was only that sensitive.  WHen I study that chart, I look at myself in the OTHER column - group B - slow virologic response.  In my (maybe the glass is half empty) way of thinking Group A is clear at 12 weeks, and Group B is not.  Who knows, it could be that the 15% relapse rate of Group A were those who were not truly clear (like me).

It all goes back to what willing was saying about what is the value of the sensitive test, when all the study data go to sensitivity of 50.  Are the sensitive tests just too expensive to administer?  With SVR rates still so low, seems like we need to push for these sensitive tests to be standard.

[jmjm530]

Understood. I was referring to TMA as used and stated in the study abstract. In *general* TMA's are a lot more sensitive than PCRs and therefore the term is often used in a generic sense to mean a more sensitive test, as  the study does in its conclusion.   The sensitive Quantitative PCR Ina referred to (LabCorp) is the exception, not the rule and for whatever reason doesn't seem to be used in a lot of studies yet, at least ones I read.  

The point I was trying to get across in my previous post wasn't about TMA versus PCR as much as TMA like sensitivity, be it an actual TMA or PCR with similar limits As the study concludes, not only " superior to PCR in identifying patients with sustained HCV-RNA clearance" but IMO also useful at other points during the treatment process, especially after patient is negative using a less sensitive PCR.

One would have to read the full-text version in order to find out what sensitivities were in the study.  My guess is that Quest's quantitative Heptimax using TMA technology  (<5) or Quests qualitative HCV RNA TMA (<9) would both fit the bill OK.

-- Jim

[willing]

Bill, if you move the mouse over a link, right click and select "open in new window" you should be able to get past the MH frame

Kathy,JiM : as Ina  has pointed out, TMA is simply another amplification technique and has no intrinsic advantage over PCR or bDNA. What matters is the advertised sensitivity of the test a <2 PCR is more sensitive than a <5 TMA.

The problems in interpreting 40 at 12 shows the limited value of high sensitivity tests in guiding tx decisions. All you can do to estimate your outcome is to compare your results to the available data. Berg, figure 4, puts your relapse odds at 15% and nygirl's at 64% with 48 weeks and shows that the extra 3 months wouldn't make much difference for you (15->12) but might make a large difference for nygirl(64->40). Obviously, if you were at 49 and nygirl at 51 this quantum jump in outlook wouldn't be realistic : there are better ways of estimating SVR outcome from VL than a simple cutoff. However, because study data is not released, you're left to wonder. This is not a question of waiting for scientific advances, just giving patients/researchers access to what's already known....

BTW, many of the older studies (see RVR thread above) will confirm that UND at 12, which is what you have per the older tests, gives you great SVR odds. Berg is one of many in that regard.

[friole]

Back from my little trip --- no riba rash (whew)

Jim, you know I am cheap - abstracts are ok, but I want to read the study.  Bill, I will try to contact you tonight when I get home.

This is a real dilemma and I appreciate all the input.

Jim, I had the Labcorp PCR at 12 weeks, sensitive to 2 IU (and I tested at 40) and at 20 weeks I had the Heptimax and was clear.  I admit to still being confused on the TMA and PCR.  Doesn't the Heptimax TMA still only go to 5 IU, same as the PCR?  How can a TMA be more sensitive than a 2IU PCR?

[jmjm530]

Maybe I missed some of the earlier posts, but I think a very important element in your decision would be when you actually became non-detectible via sensitive TMA.

A study was posted here not long ago that suggested that many PCR negatives were actually TMA positives at end of treatment. 100% of this sub-set relapsed. As to your VL being dectectible at 40 IU/ml but still under the study data radar -- to me it's both good and bad news since the study data doesn't break down projections below 50 IU/ml. Then there're also factors like age, histology, etc, as discussed in the RVR thread.

I guess where I'm going with this is that in my opinion your decision is not 100% clear cut as is so often the case with this disease. I would definitely get that second opinion you've been putting off -- and get it from a hepatologist who treats large hep c populations and maybe can help make more sense out of some of the blocks you have already assembled. You've come so far, why not go the extra mile (or in this case block :))

All the best.

-- Jim

[Bill1954]

Hi Kathy,

This is frustrating; I

[Valtod]

nygirl, you were VERY low at week 12 (only 419) and the research allows for as high as 6000. So if I were you (I know how difficult it is to make this kind of decisions), I'd probably consider not 24 additional weeks but rather 4 or 6. Just to be on the save side – if there's such a thing.

I'm personally interested in this research because, while going through my old bloodwork papers from my last (unsuccessful) treatment 4 years ago, I realized I was in the same boat back then too – 2320 at week 12, undetectable at week 24. Now I'm just in my week 5, so I'll see how my body and HCV will react this time.

Good luck!

[jmjm530]

Last sentence in part should of course read:

"...being PCR negative and TMA *positive* can impact..."

[jmjm530]

I think this is the one: http://tinyurl.com/z35yb

Beyond what has already been stated, what it says to me is how important sensitive TMA testing is at any point during treatment, especially after one becomes non-detectible using less sensitive tests. In other words, being PCR negative and TMA can impact treatment decisions at any point in terms of both how long to treat, treat or stop, dosage, etc.

-- Jim

[willing]

your GI's interpretation seems  on point: your results are definitely on the sunny side of the Berg data. The only reason to push on would be wanting even better odds and that improvement isn't cheap: for most 1s the 6months from 24 to 48 only buys an extra 10% per the studies in the rvr thread above. If it's any help, remember that when you went into this your GI was probably talking about 50-60% odds and that seemed worh it at the time. Of course a lot of riba rash has passed under the bridge since then..

[52TELE]

What a perfect time of year to be in the Hill Country. The nights should be nice and cool. I live about 50 mi. south of Dallas and love the drive on 67/281 down to Kerville for the music festival every year. It should be a lot of fun. Be safe.

[friole]

This study is on my mind daily since I too was not clear at 12.  However, my vl at 12 was 40IU and this study only went to a sensitivity of 50IU so it is hard to garner a lot of sympathy from my GI - as far as he is concerned, I am in tune with the standard level of care..  Also they used 800mg riba a day and I take 1200.  Just took shot 45 a few minutes ago, and have an appointment with the GI next week.  Figure I have procrastinated too long for a consult so probably will stop at 48 (happy/sad).

Jeralice - hope you see this post--- you are the person on the forum most at the present time that make me worry if 48 is enough.  You had 45 Iu at week 12 and relapsed.  Can you tell me about your treatment? Did you have to reduce doseage?  Did you have to take Procrit or Neupogen?  Were you compliant?  I think about this alot.  

************Also wanted to tell you I am headed to the Llano river camping in a couple of hours -- your neck of the woods.  Trying out a new private campground on the Llano about 9 mi from Junction (Llanorivercamping).  Taking our 6 yo grandson.  Should be interesting, he has never been camping.  Hope that riba rash stays away*******************

[NYgirl]

Thank you, I am in this boat (was 419 at week 12 but UND at week 24) and I really really really DONT want to have to do 72 weeks but as a Geno 1A and also 1B - it seems I might have to.

I really can't think about doing another 38 weeks after tonight = getting here to week 34 has been enough already! But I would hate to see it be wasted time.

I have to make an appt. with this big New York City world renknown doctor Dr. Jacobsen and get a second opinion from him.  As one of the leading guys in the world...he will let me know honestly what is BEST.

Thanks for posting even if it's been posted before. It's so important we stay up on this sort of new information!

[Valtod]

Sorry, just noticed it was posted already here:
http://www.medhelp.org/forums/hepatitis/messages/40868.html