help-being cut off of treatment

[merryBe]

starting with a 1.4 mil VL

at 4 wks down to 300,000

at 6 wk back up to 700,000

just got the call.

thinking of continuing tx until I can get in to see Benner in Jan.
but med will run out late Dec.

suggestions for this and/or things to ask for.

please help anyone.
Mary B

[jmjm530]

MB:I'm going for the lets check my serum riba level jim suggested now...
------------------------------------------------------
I did mention testing serum riba levels in the context of perhaps something useful to know in terms of future treatments, but it was in the context of questioning whether such an approach (high dose ribavirin) was actually in your best interest -- especially now, and even with future treatments.

Certainly don't want to discourage you or anyone in pursuing whatever they think is in their bests interests, but I do think your apparent focus now on serum riba testing may be misguided -- not to mention a dilution of energies -- especially if you are using it as a way to stay on treatment against your doctor's advice. My opinion all along is that given your non-response, you should follow your doctor's advice which I believe is to stop treatment.

In terms of future treatments, while high dose ribavirin per the Lindahl studies looked very promising two years ago, I haven;'t seen any recent data released, and equally important, we now have other options in our HCV arsenal like the new PI's, a la Telaprevir. That's what I'd have my eye on today if I was either treating or re-treating. I posted more on this in this thread here:

http://www.medhelp.org/posts/show/378199

[Lady Lauri]

  I have not done ONE thing yet for Christmas, as in the shopping part! Luckily only buying for a few this year. That's great you do a childrens home! I usually do some with Salvation Army, ashamed to say haven't this year.
  Sorry to hear about the TMA test :{  I asked for one in my trial lab and get this.....they didn't know much about it or Heptimax?? ( Dr. wasn't there) I guess the blood is shipped out and they don't know what they use or do with it !! You'd think they would know!! Insisting on one tho, so she's 'looking in to it'!  Thier great there, but c'mon......get up on the facts here!

  I have a friend, 53, told 30 years ago she had Hep C, her GP never did anything! I sent her to my Dr. this year and her test came back as "yes has Hep C, but no virus in her" ......no Geno Type given either??? Is this like your sons case? Can they-is he- showing Hep C with no detectable virus?
I'll go thru your post again on 'can't find Geno'.

I also get the serum riba level test this week and another in a couple weeks, tho been reduced, type 2 and all. Least they knew what that was!!

Stay positive, hopeful.

                                                                                 LL

[merryBe]

thanks for caring you guys.

I've been bust with a gift shopping for a childrens home I do every year...

yes I got the TMA and it came back above the other test.
from 523,000 to 555,000 on the TMA

so that's not good.

but I'm still working on a TMA for son, since they think their lab is accurate, they are kinda balking at doing one on him (and he came back neg for VL.( so 2 pos, and 2 negs so far) sheesh.

I'm going for the lets check my serum riba level jim suggested now....
since my blood work is perfect, not much platelet drop...it could be I'm not absorbing well.
and so I'm working on at least a 16 week extention with upping the rRIBA dependant on the serum level there.
Mary

[Lady Lauri]

  She has been quiet??
   Glad you posted that scratchin', hadn't seen merrybe's post on the Quest Diagnosis Info....

                                                                                            LL

[scratchinghead]

Got an update on your situation? Why so quiet?

[merryBe]

would love to help you here, but this is one for HR to answer I would think.

I've got my dying mother in law here this weekend, taking up my online time, or else I'd google it for you, but try "Quest Diagnostics and gene based tx for cancer" or just leave the "tx for" out and see what you get. hmm or maybe the cancer threads in this forum would yeild folks who have looked into this more....maybe.  hope that helps.

[Lady Lauri]

Merrybe......Quest Diagnostics' gene-based testing focuses on infectious disease, oncology and heritable conditions, and helps physicians target individual treatment regimes, monitor resistance to therapies and predict predisposition to various genetic conditions. Quest Diagnostics is a leading innovator in genomics testing, through its research and development center and esoteric testing laboratory, the world-renowned Nichols Institute, as well as through alliances with leading academic and commercial technology developers.-------------

  In that paragraph.....sorry to be dingy :}........but is that about 'other' testing Quest is doing or is it related to, same as the TMA testing their working on for hep? I ask as my sister has checked in to the gene based tx for cancer, or is trying to find out more about it.

                                                                                     LL

[merryBe]

Quest Diagnostics Incorporated Quest Diagnostics Announces Availability of HEPTIMAX Ultra-Sensitive Quantitative Hepatitis C Virus Test

TETERBORO, N.J., July 23 /PRNewswire/ -- Quest Diagnostics Incorporated (NYSE: DGX - news), the nation's leading provider of gene-based medical testing, information and services, announced the availability of a new ultra-sensitive viral load test for hepatitis C virus (HCV) that is approximately 10 times more sensitive than any other commercially available test. The test detects the level of hepatitis C virus based on an innovative application of
"Transcription Mediated Amplification" (TMA)
technology to HCV testing. Quest Diagnostics developed the test and is the first laboratory in the world to offer it.

The new offering, called the HEPTIMAX(TM) viral load test, is capable of detecting minute quantities of hepatitis C virus down to as few as 5 International Units (IUs) per milliliter (ml). The ability to detect minute quantities of virus is useful to physicians in monitoring the effectiveness of various treatments for hepatitis C in patients. The HEPTIMAX(TM) viral load test not only delivers the maximum sensitivity but also offers the maximum range (5 IUs/ml to 8.3 million IUs/ml).

This proprietary test is ordered by physicians to monitor and confirm hepatitis C viral infection and to demonstrate post-treatment resolution of the infection. Because the HEPTIMAX(TM) viral load test combines the new TMA technology with traditional quantitative viral load testing using branched DNA technology, it simplifies patient management by allowing physicians to order just one test to cover the complete range of possible viral load values from 5 IUs to 8.3 million IUs per ml.

``The improved sensitivity of the HEPTIMAX(TM) viral load test is particularly relevant to physicians with the advent of new forms of hepatitis C therapeutics,'' said Jorge Leon, Ph.D., Vice President for Applied Genomics at Quest Diagnostics. ``New combination therapies utilizing sustained-action forms of interferon have shown better treatment responses in clinical trials that translate to lower levels of virus in patients.''

``Preliminary studies comparing the HEPTIMAX(TM) viral load test to other technologies and laboratories confirm it has superior sensitivity,'' said Dr. Peter Heseltine, Medical Director of Infectious Diseases for Quest Diagnostics. ``We are planning additional studies with other outside investigators to confirm and publish our findings.''

A study published in the October 2000 issue of the journal ``Hepatology'' utilizing a hepatitis C qualitative version of the TMA test, showed it to be a better predictor of end-of-treatment resolution than the other methods.

The new test was developed by Quest Diagnostics at Nichols Institute and is offered exclusively through Quest Diagnostics' national laboratory network. The highly sensitive HEPTIMAX(TM) HCV assay utilizes reagents from Bayer Diagnostics, based on proprietary TMA technology made available through Bayer's exclusive agreement with Gen-Probe, San Diego, CA.

The HEPTIMAX(TM) viral load test is the latest addition to Quest Diagnostics' comprehensive test menu for hepatitis C disease management. Quest Diagnostics provides a complete selection of tests for initial diagnosis, treatment monitoring and managing HCV infected patients. The menu also features the DupliType(TM) HCV genotype test, which helps physicians establish the appropriate duration of HCV therapy. Quest Diagnostics introduced the HCV DupliType(TM) test to provide subtyping for a broader range of hepatitis C viral isolates than was previously available using other technologies.

An estimated 4 million people are infected with hepatitis C virus in the United States, and approximately 130,000 patients currently receive treatment. Physicians monitor viral loads in infected patients to test the effectiveness of various types of combination therapies.

Quest Diagnostics' gene-based testing focuses on infectious disease, oncology and heritable conditions, and helps physicians target individual treatment regimes, monitor resistance to therapies and predict predisposition to various genetic conditions. Quest Diagnostics is a leading innovator in genomics testing, through its research and development center and esoteric testing laboratory, the world-renowned Nichols Institute, as well as through alliances with leading academic and commercial technology developers.

About Quest Diagnostics

Quest Diagnostics is the nation's leading provider of diagnostic testing, information and services with annual revenues of $3.4 billion in 2000. The company's diagnostic testing yields information that enables health care professionals and consumers to make better decisions to improve health. Quest Diagnostics offers patients and physicians the broadest access to diagnostic testing services through its national network of approximately 30 full-service laboratories, 150 rapid response laboratories and more than 1,300 patient service centers, where specimens are collected. Quest Diagnostics is the leading provider of esoteric testing, including gene-based testing, and is the leader in routine medical testing, drugs of abuse testing, and non-hospital-based anatomic pathology testing. Through partnerships with pharmaceutical, biotechnology and information technology companies, Quest Diagnostics provides support to help speed the development of health care insights and new therapeutics. Additional company information can be found on the Internet at: http://www.questdiagnostics.com

The statements in this press release which are not historical facts or information may be forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the outcome to be materially different. Certain of these risks and uncertainties are described in the Quest Diagnostics Incorporated 2000 Form 10-K and subsequent filings.

The HEPTIMAX viral load test and DupliType HCV genotype test are trademarks of Quest Diagnostics Incorporated.

SOURCE: Quest Diagnostics Incorporated

again, as I said today, the TMA can detect virus easily, genotype not so easily. that's the down side.
MAry

[merryBe]

in reading through Thomas Berg's studies into the GH/HCV connection, it also appears that INF itself helps to rejuvinate or make the pituitary start working better...again, this is thought a positive side effect. the pituitary not working means liver repair will definitely suffer as will all cell replication.

[scratchinghead]

What is TMA? Serious.

[merryBe]

it's so weird to be suggesting things like this to folk who have devoted their lives to treating patients.
Especially when you consider that the "specialist" classification should mean just that....one versed in all the lastest and willing to do it. I get the feeling not doing that test is driven by what labs they normally use and their equipment.....even though the TMA is ultimately a cheaper test. go figure.

[Lady Lauri]

  Very good words of advice, concern up there.
Just wanted to tell you very sorry to hear this, for you :{

-----------------------------------------
you....And got them to agree it should be patient driven, not jusy doc or INS.
-------------------------------------------------------
Totally agree in that, always have! And love your comment................

"no one there today had ever heard of a TMA test. no wonder they don;t like us knitting our noggins in here!!!" -----------------
So true :} Happened at my trial lab ..."D*m, she know's more than I do", LOL
Good luck ahead,
                                                                                                             LL

[merryBe]

this weeks came back 523,999 down from 700000......
still not a log drop from 1.4 but still going down again.

I think in 2 more eeks I could be at close to 2 logs.
let's hpoe so.

[merryBe]

hugs all around, definitively the patients desicion....I parked myself in the office today, until I got the lab head gal to come out an dtalk to me for 20 minutes....reinerated my hitory, and desire to fight, redid the PCR and will pay if neccessary to get to wk 24...it makes no sense to drop the ball over one bad week. And got them to agree it should be patient driven, not jusy doc or INS.
so we will see....it's into see Benner next week and Shwartz on the hill...and maybe Gish by weeks end if need be.

armed to the teeth with what YOU ALL have taught me....she courtsesy slow and lowly...

guess what, on my test PCR questions.... no one there today had ever heard of a TMA test. no wonder they don;t like us knitting our noggins in here!!!

[Mr Liver]

"even though this may seem logical, what do you say to people who didn't fit the SVR or go UND by 12 wks, yet did clear eventually, and have walked around for 2-5 years or more HCV free?"

I agree 100% in principle with what you are saying. Nine years ago when I first treated (G1) the 1st PCR done during tx wasn't administered until the end of the sixth month. This was a fairly standard practice back then and was accepted by most ins co's. I know of a couple of individuals (one personally) during this time who were not UND  (typical PCR was 650 ml detection limit) at the end of six months, yet found a way to continue (ins didn't fight it as much back then due to the lack of substantial cost effectiveness data)  and actually SVR'ed. I know positively that one remains so to this day.

I was researching one day about this same time (year 2000) and found a "new " article concerning a proposed change in the current accepted treatment algorithm based upon on a cost analysis study. I started reading, not believing the words in front of me. A group of  doctors concluded that discontinuation of therapy for geno 1's would be most economical if tested at 12 weeks using newly defined models of prediction. Well, at this time the test sensitivity was such that about 13% of those who were told to stop would have gone on to SVR had they not. Now, with test sensitivity levels currently down to 2-3 copies per ml the size of this group has shrunk exponentially, yet it is not a 100% predictive model. It was my first taste of how much the ins co's dictate our level of care.

"I've read the one week level predictives, but one day?"

All people have a >90% reduction in vl in the first few days so no predictions can currently be made based on that. This huge vl decline seen during this time is primarily the result of the direct anti-viral effect upon the virus in the sera by the IFN. I do believe though that the day is not too far off that pre-tx genetic samples will tailor the compostion of the therapy, optimizing success rates based upon geno/subtype/QS diversity along with other host factors.

There can be no argument that unless something is 100% there remains a chance. Barring the existence of serious medical complications which would contraindicate tx, I personally feel that the decision to continue should be made soley by the patient as long as there is a known chance for success that exists.. I've always felt this way, especially after reading this study nine years ago. Back then I was somewhat naive about the economics of medical care, not fully realizing how much influence the ins companies could have on the care, or lack thereof, that we recieve. Being better informed now I am definitely concerned about the use of this seemingly ever increasing sphere of influence which can result in negative impacts upon our personal healthcare.  And I think a great many people feel similar. So, although in your case I wouldn't continue tx myself, I certainly agree that a patient should have the right to make that decision for themselves. Best of luck.

regards,
Mr Liver

[Rangle]

First things first you make a good point about the GH

Is the GH treatment permanent?

I wish you the best....you know I'm new on this forum but I've been lurking for about 7months... more off than on.

Hopefully everyone gets to kick this disease....You seem prety well informed & I enjoy your posts

If we don't clear now ....we'll clear later....gl

[jmjm530]

There are a few studies that suggest SVR can be predicted very early on, with a 24 or 48 hour PCR. I have no doubt that the reason these studies haven't been expanded comes down to time and money at the expense of the patient. How many doctors and insurance companies want to run all these tests? If you want them, you have to shout for them with the recognition that study data is sparse. Part of a drug's "success" is how easy it can be put through the system. Like once a week dosing for the Peg or twice a day dosing for the pills (ribavirin). If someone came out with a hypothetical cure protcol of let's say 90% but it involved hospitalization for the first two weeks -- how easy to you think that would be to sell to the medical/insurance company establishment?

-- Jim

-- Jim

[merryBe]

I just had the GH discussion with HR two days ago, the truth is, before GH my brain fog and exaustion was total, I almost always thought my heart would not make it through the night.
Utter exaustion.

there is no research to prove GH grows virus, if there was, I would reconsider. there is one study suggesting it does not.
and umpteen studies saying it boost the immune system in hundreds of ways and causes tissue repair, which obviously my liver needs.
couple that with 20% only pituitary function before, and normal pituitary now, couple that with the pituitarty being the master gland, and if it doesn't work, nothing else will work right either.

believe me, I've asked 4 stanford docs, and HR in here, and searched pubmed etc endlessly.
there is no proof the GH is not helping more than hurting, if there was, I'd quit it in a heartbeat,
but then I'd be back to not being able to even stand up for 5 minutes in the shower. Not something to yearn to return to, if you know what I mean.

[merryBe]

I've read the one week level predictives, but one day?

even though this may seem logical, what do you say to people who didn't fit the SVR or go UND by 12 wks, yet did clear eventually, and have walked around for 2-5 years or more HCV free?

the fact that one size does not fit all should apply, only a calloused system says because we can see immediate response is predictive, no one less responsive deserves a shot (pardon the pun there).

My cousin for instance is still alert and running her business, even after 4 bouts with lymphoma.
MAybe they should have not treated because her odds were near zip....but nobody told her or her doc to give up. Nobody denied her INF and whatever else was appropriate,

which is why she is still here.
I will read the viral kinetics, but not quite ready to impale myself on a satistical spear.
I understand your point though, thank you.

[Mr Liver]

I'm sorry to hear about your response to treatment. It's tough to quit once a physical and emotional investment has been made.

If I was to counsel a family member in the same spot I would suggest that they take advantage of all that has been learned about early viral kinetics and discontinue. In my personal estimation I see no sense in possibly compounding an already difficult situation by continuing to expose yourself to IFN/Riba in light of the probablilities for success.  It is my belief that a person should not use these drugs unless it is convincingly shown to be both necessary and appropriate. I'm not sure of your medical necessity for tx-- so my comments are really limited to the appropriateness of treating in a situation such as yours.

Again, I'm sorry for your results. Should you decide to continue though, I'll be pulling for you.

regards,
Mr Liver

http://www.natap.org/2001/aasld2/day28.htm

[Rangle]

I 'm not a doctor either,... no one addressed the fact that your taking growth hormone,My son was on it for 3 yrs,.. Everything in his body grew bones organs feet... It's in my view that it would be capable of growing a virus also?

What to do? I wouldn't be taking growth hormone & trying to treat this,.....better to have a clean system then treat,... Obviously It' too late for that for you....I agree with Jim,..Your doctors don't sound too swift....you need to start responding or change something especially if after week 12 no response...I'm in week 3 myself & have other complications,ie Ulcers diabetes....my counts were better the first blood test after 2weeks ALT & AST,.... PCR is pending My hemo is dropping though to 12....jmo  Hope that helpsgl

[merryBe]

many more thanks, and yes to stetosis, bridging fibrosis..so not much wait around time here.

We call a call back saying sure I can have a new PCR for me, and go 12 weeks but NO to doubling up doses even IF I PAY for the extra meds to try it!!!!!!

They said they never see results that way so are reticent to load people on what never seems to work.

Got them to at least agree to fax my file up to the Hill...Jonathan Shwartz, but he's a protege of Benner's (according to Benner's clinic) though so not sure how much good it will do. He is the transplant king up there, so that's good.

Apparently Goofy dad, performance of the modified plan is not in their vocabulary here, so I'll have to see if someone else will try.

What I was told today is "we didn't say anything at 1 month, because we like people to have hope...
but we do like to see more than a one log drop."

"so your doing fine"  is all I heard!!!!
so basically, let me retranslate......"you just lost me a month when you could have been more agressive without even asking me would I pay for the extra meds if insurance refused or did not...
which, considering I told Benner UP FRONT I would pay for what INS did not...makes utterly no sense to me now.
Maybe this seems right to them, but it feels like a gut punch to me!!!

[jmjm530]

I agree :) But not to split virons, somewhat unknown territory when going to the "performance of the modified plan" therefore lots of other variables already discussed might be taken into consideration. BTW last statement btw does not contradict anything you've said, just my own add-on. But this is an interesting area, and surprised so little data/discussion within the medical community on this?

-- Jim

[GoofyDad]

I'm not taking a position on what she should do - my only point is that studies showing importance of EVR are not relevant to significantly modified treatment plans. In these cases one needs to look at performance of the modified plan - not history of the aborted plan - when projecting likelyhood of SVR.