GIPA Heptimax results

[pjxak]

Hi everyone - Use for other posts if you want.

GIPA - I'm 1b and had to quit meds at 6 months because of side effects.  I had a Heptimax 2 1/2 months after stopping meds and it measured 8 IU/ml.  In a recent thread about "cure" rates, you said something about extremely low amounts (under 10) and staying at that level indefinitely.  In your experience, have you seen this happen with any of your patients?  I thought the virus replicated much faster than that.  I had a viral load of greater than 18 million the day before I started meds and was  undetectable by Heptimax (under 5 IU/ml) at 4, 12, and at the end at 24 weeks. I will test again in three months but I was wondering what your experiece was in this regard.  Thanks for your input.  pj

[GI.PA]

In my experience the lower the test goes (particularly under 50 IU/ML) the less accurate it is in determining if it is there or not.  Lab standardization simply isnt there yet on this end of the spectrum.  I would take your recent reading with a grain of salt and get retested in 3 months.  If you again show up positive, abeit low, retest again in 3 months.  I would not neccessarily retreat someone with such low levels of virus and only time would help me adequately type them as SVR or relapser.  

This technology is still so new...hard to make the call sometimes.

GI.PA

[layla]

I have seen a few times where people are doing extended tx. I have noticed that in some cases the people are doing just the peg for the extended tx and not the riba. Do you have any idea why this might be? Just wondering as I've heard it more than once. LL

[odessit]

U're welcome:)
BTW, I think the following diagram is more accurate in your case:
<IMG SRC="http://images.medscape.com/pi/editorial/cmecircle/2003/2234/fried/slide25.gif">

(Those registered at www.medscape.com should be able to see the image)

[Tri-guy]

Yup, the second chart fits my genotype.  Guess I hadn't really thought about the SVR percentages that are quoted all the time are really a mix of people who have done full treatment/reduced treatment and had to stop.  If you can maintain full treatment the percentages are definitely better.  The article is long but I think it must address at least half of the questions that regularly pop up in posts.  Again thanks for link, I really like they way it presented everything graphically.

[slarso]

When I talked to my doc re. percentages he said to watch out for statical warping. That a certain percentage of folks drop out/have to lower dose/ are not diligent/are in a bad environment, they bring the numbers down. You can see it by those slides, if you stay the course, the percentages are better! That is a great web site, the numbers made feel much beter!, no longer a carp shoot, the odds are in our favor
good luck on your test!!!!

My blood is still looking pretty good, WBC went up last week into normal, RBC is low normal, neutrophils low normal. Still about 80% of old norm run/bike. Swim is better
Steve

[Tri-guy]

Just took my 12 week shot last night and will be doing my VL test next week to see if I’ve dealt the dragon a blow and I’m undetectable.  Needless to say I’m starting to play mind games with it and I’m wondering if there are any stat’s as to what percentage of people are undetectable at their half way point in treatment (I’m on 24 weeks)?  And of the percent undetectable how many relapse after treatment?  Or how many who are detectable and continue treatment become undetectable by the end of treatment and remain SVR?  I know mid-point results don’t guarantee anything; still it’d be a nice Christmas present to have the test come back undetectable.

[odessit]

Here is your answer: http://images.medscape.com/pi/editorial/cmecircle/2003/2234/trepo/slide10.gif

More on this here: http://www.medscape.com/viewarticle/449843_8
You will have to register to access this great site:)

[Tri-guy]

Thank you odessit.  A lot of great information!

[Tri-guy]

Getting ready to watch the broadcast of this years Hawaii IM.  Should help me get pumped up for next year.  Still able to keep up the volume of my workouts up but the intensity is still sliding.  Train On!

[slarso]

just the vision of the finish line at IMW, it will keep you going

[GI.PA]

There are some patients who have failed to clear the virus with Peg/Rib combo.  They are part of the ongoing investigation into maintence therapy with low dose Peg Intron alone (go to www.haltctrial.org to see the biggest one).  The goal would not be to clear the virus but to reduce fibrosis rate and liver complications (such as failure or cancer).

Still investigational..but, in my opinion, soon to become the standard of care.

Erin

[Revenire]

Erin,

I am a 1a Stage 3 patient. I had an EVR and have remained 'clear' all the way through. I am on week 48 but pushed my nurse to go longer ... so what I am doing is 50 weeks of full dose Pegasys and 1000mg Ribavarin and then switching to half dose Pegasys -- purely for the antifibrotic effect -- for perhaps six months, if I can tolerate it (tx hasn't been easy, been hell honestly, but I've pretty much pushed on and kept working etc.) I've read that people can, potentially, go back 2 stages.

I think that if HALT-C pans out that is going to be one heck of a good thing for HCV patients. Buys time. Maybe the virus isn't so much the problems as what it does to the liver? If we had viremia but could stop the liver damage progression that would be almost as good as a SVR.

That's my layman's outlook. Is it the Pegasys talking or am I close to "where the monkey sleeps"?

Scott

[BobK]

Treatment duration of 48 weeks has been reported to improve the fibrosis score of 24% of patients and maintaining "the grade" for 68% of patients.  The results of the HALT-C and COPILOT studies will be providing more and more data on fibrosis progression in the very near future as patients complete their treatment.  The results from the gamma interferon trials should be appearing soon.  Gamma interferon is being tested for its antifibrotic properties (no viral effect) and may provide another tool for prevention of fibrosis.

In my case (n=1) treatment for 100 weeks has reversed my fibrosis from stage 3 to stage 0 as determined by biopsies pretreatment and 8 months post treatment.  I was a tough to treat case and while I didn't achieve SVR this outcome has bought me some time to consider and wait for other options to come down the road.

regards,
BobK

[rsterling]

I kind of figured that you were a doc.  I am really so new at this and that only thing that my doc has told me is that I am a geno 1, 498000 (viral load?) and I was offered treatment if I chose.  He also said that if I didn't respond at the 3 month mark that he would discontinue treatment.  After reading lots on this forum to that affect, do I have to?  What else should I know from my doc about this disease to be more informed? I read all these numbers on this forum and abbreviations and have no clue as to what they are.  Should I ask for file work from my doc?  I'm thinking at least then I would be able to go to an informed web site and know what I'm looking at.  I wasn't even told if I am 1a, 1b, etc.  Is this important.  If I should continue treatment after the 3 month mark even if I don't respond I would like to be able to discuss this informatively with my doc.  Would all the numbers really be irrelevant from the patients side if I am informed about the sides?

Thank You,  Robin

[Galen]

GI PA is a physisians assistant in a GI practice specializing in hep.  Her name is Erin and she is truly a treasure around here.

[rsterling]

Thank you GALEN, that's good enough for me.  Just waiting for the reply.

Thanks again.  Robin

[GI.PA]

Ok you are genotype 1.  The a and b dont really mean anything yet.  You have a 50% chance at the meds working (a sustained viral response = SVR defined as six months post treatment no detectable virus).  Your assumed female gender makes this even slightly better.

Your viral load is 498,000 (the units are either copies/ml or IU/mL but either way this is on the lower end of things..another score in your favor.  Lower viral loads are easier to treat than higher viral loads).

The three month respond rule is widely accepted as the standard of care (and by many insurance companies).  Unless something else in involved the first three months (such as dosage reduction), the likelyhood of responding to treatment without an early response is very low.  In fact, at that point, one must really look at the risks to treatment (side effect profile of nearly 100%) to benifit (less than 5% if no early response).  Unless the patient absolutely insists or they have a lot of fibrosis which may benifit from longer treatment (without the goal of viral response), I would hesitate to treat longer.

The one piece of information missing here is "how much damage has been done to my liver?"  Does your doctor suspect more advanced disease (some clues are on physical exam or in the blood work such as an elevated INR, low platlets, low albumin).  If these are normal and your exam is normal, cirrhosis is still possible but less likely.  How long have you had it?  People with clear exposure points 30 years ago probably have more damage than those 10 years ago.  But the ULTIMATE way of knowing how much damage there is...is liver biopsy. A small piece of liver is obtained and observed under the miroccope.  A score of inflammation and scarring is given and can give you  a more definative place on the liver disease scale.  Those who are mild on the score are given the option of treatment.  Those with worse disease are strongly encouraged to persue treatment.  I also use the biopsy to figure out how aggressive I need to keep someone on treatment.

With all this said, you need a doc/NP/PA who knows what they are doing.  Simply leaving the decision to treat up to the paitent without some idea of where the liver stands is concerning.  Either get very comfortable with this disease so you can be your own advocate or get a different doc!

GI.PA
Erin
Physician Assistant in Gastroenterology
(stomach, bowels, vomit, diarrhea and yes...the liver)

[rsterling]

Thank you for your response, it is greatly appreciated.  My doc did do a biopsy, he said the damage was minimal.  Sorry for the lack of info there.  Would that be another point in my favor? :)

Thanks so much again.  Robin

[GI.PA]

Since you are genotype 1 with only very minimal findings on biospy, your doctor was right in line with the standard of care to simply leave this up to you.  If you decide not to treat,I would want to re-biopsy in 3 years.  This should help track your progression.  If things look to be progressing, treatment can be pushed.  If there is no change in 3 years, biopsy can be re-persued every 3 years.  Each time you are re-biopsied, you and your GI should have the treatment conversation (what is out there, current data, etc).

GI.PA