2 Doctors, 2 Opinions - Your Opinions Please

[Magnum]

As most of you know, I’ve been through 4 failed treatments. Within this week I saw Dr. Robert Gish, the hepatologist, and Dr. Frank Faris, the Gastroenterologist, regarding waiting or treating.

I’ve been denied both Telepravir and Bocepravir because of failed results. Dr. Gish wants me to wait and see him in one year. Dr. Faris wants me to treat now, even if it’s the double-dosing of Pegasys with Riba.

Here’s the decision part I need your opinions on: Even if I eventually get on the VX-950 trial, I may get a placebo. However, if I don’t, the success rate for hard to clear victims such as myself is 70% or better.

The double-dosing of Pegasys with 1200mg Riba is 15-20%. That doctor would treat and if I didn’t become UND in 12 weeks, he would stop treatment.

Dr. Gish eats, sleeps and lives liver problems. The Gastro is a Jack Of All Trades, Master Of None. However, he sees an urgency now that I’m at the beginning stages of Cirrhosis.

I spoke to another member on this board who knows Dr. Gish very well and has cleared. She suggests I listen to him and wait. This is a tough decision for me at this point.

On the 16th, I will begin the banding of my Esophageal Verices. This will entail 3-6 procedures. Dr. Gish examined me and said I look well and little has changed in the past year as far as blood work and progression.

For those knowledgeable:

My MELD is 7 and has remained so for years. My ALT is 85, my AST is 74, the lowest they’ve been in years. My Bilirubin is 0.3. Glucose-Fasting is 102. Platelet Count 84. Viral Load 2,900,000. Alpha-Fetoprotein 26.0

So there it is. Your opinions are highly appreciated. Wait or treat?

Magnum

[jmjm530]

Gish is known to be very agressive therefore if he says "wait" he has weighed the risks versus rewards. I don't remember your stats, or previous tx history -- whether you were a relapser or a non-responder -- but I assume Gish has and came to the conclusion that a PI is your very best shot. If you feel you need another opinion because of your advancing Fibrosis I would not seek it from a "jack of all trades" Gastro, but from someone at Gish's level. That would require some travel as I'm thinking docs like Afdhal in Boston, Dieterich in NY, Schiff in Miami, Nelson in Chicago, and a few others.

-- JIm

[portann]

I think I'd put Dr. Faris' plan on Dr. Gish's table and have Dr. Gish dissect it.

If that's awkward, I'd get a third opinion, even if it's only by phone with another prominent hepatologist or by writing to Dr. Dieterich on the forum.

[GreatBird]

From what I've been reading here, your fasting glucose (over 100) indicates you may have insulin resistace. Have you looked at that? There's some formula of fasting glucose and insulin that will tell you. CoWriter knows it and so does Bajawoman.

[Rockerforlife]

Well...in a simple comment...i would wait for the PI drugs....odds look to low ,15-20% with the DD tx..just my opinion.

[Willy50]

Dr. Gish eats, sleeps and lives liver problems. The Gastro is a Jack Of All Trades, Master Of None. However, he sees an urgency now that I’m at the beginning stages of Cirrhosis.
========================================================

I would venture a guess that Dr. Gish is far more aware as to whether this is "urgent" or not; more so than the gastro (no offense intended to him).

I would also venture that he has a far greater grasp on the total picture than the Gastro;
  * likely more up on your current scores and their ramifications
  * on the speed which you may progress (or not) while you wait 2 years.
  * on the "toll" that treating may have on you with double dosing
  * your chances with the above (weighing in past responses to TX)
  * related factors such as your verices, already taxed liver re: double dosing

I pretty much agree with Jim down the line; IF Gish thought that double dosing was a viable option or a worth chance he would have already suggested it.

My general question to Gish would be if
  * a current biopsy/fibroscan or other means would provide use in his making his decision.  (to ensure you can wait a few years)
  * that you fear progressing or having other cirrhosis related issues that could occur before telaprevir is approved.  (ie; can you definately wait?)
  * any and all measures you must take to care for yourself and limit progression.
  * is there a possibility that even trying TX could repair and "turn back the clock" a bit and therefore actually be somewhat of an aid.... or does he see it a greater potential for being a detriment?  

I don't have an opinion of what you should do.... but I very much concur with Jim that a case like yours should only be entrusted to the best of doctors.  This is not the time to buy a Yugo.  ; )

I frankly think that the success rate will go up as you wait with triple therapy.  I think you may pick up another 5-10% chance of success in waiting for triple therapy that you might not have if you could treat today (and you may need that 10%)  They may also have the kinetics down that tell doctors that 24 weeks may be all that is needed (given a certain response) and the opposite; that given a certain response one can just quit; not do another 24 weeks.  This may not affect your chances of SVR but could affect your *QOL*.

Some of the cutting edge insulin resistance data will be better established and you may also benefit from that.  You should ask NOW about diet and IR (and any other lifestyle issues you can improve on should you decide to wait.

In a way..... this is too complicated to listen to arm chair guys like me.....and even a generalist gastro.  IF there is ever a situation where you would want a specialist this seems like one.

Good luck and thank you.  It is always interesting to hear what world class hepatologists say, think and do.

best,
Willy

[FlGuy]

Perhaps there's a third Hepatitis Doctor who can act as a tie-breaker, or give you additional knowledgeable input.

[Trinity4]

Magnum,

Four failed treatments and Gish thinks you should wait for the PI's that is what I would do.  Even double dosing the peg won't give you the odds the PI's will.  

I have consulted with Pearlman about my treatment and if I don't svr at the end of my tx he recommends a 6 month break and start on Infergen.  I respect his opinion but I will not go that route even though he is one of the best in the country.  It's just so obvious to me that if I fail on soc I need something more. You have much more time in with current soc than I will at the end of  my 72 wks but if by all indications if we don't respond favorably it's time for the big guns and I will wait for the PI's.  I have advanced liver disease and will take the risk it may advance further rather than putting myself though another round Interferon without a PI kicker.

I'm not saying you wouldn't svr with double dosing this time because we never know but the odds are against you given the extent of damage and not achieving svr previously.

I would wait for the PI's or hopefully acceptance into a trial but that's me Magnum.  You must do what you think is best for you but Gish makes perfect sense to me.

trin

[fretboard]

Since the odds are alot better for you to clear if you wait, maybe that's what you should do.  Your platlet count is low, I don't know about that, but I'm sure Gish has a plan.  I'm thinking that's why the gastro doctor wants to make a move right now.  good luck to you with your decision

[Trish77]

You don't say what Dr. Gish wants you to wait one year for ... in hopes you'll be able to get a PI?  What is his plan in one year's time?

[HectorSF]

Magnum I was reading through your profile trying to find out how you responded to treatment. Viral kinetics. Didn't see it. But did see that you were grade 3 on biopsy. Yes, fibrosis progression increases with age, but you have no signs of cirrhosis correct?

Blood indicators of cirrhosis.
* "thin" blood (An increased or prolonged prothrombin time – also called a P.T. – this test is now also defined as an "INR." The INR number increases as the liver fails.)
    * high bilirubin – greater than 2.0 mg/dL is a concern
    * low albumin – less than 3.5 mg/dL is a concern
    * low cholesterol – less than 100 mg/dL is a concern
    * low platelets – less than 100,000 is a concern (Platelets are cells involved in blood clotting.)

No portal hypertension? No enlarged spleen leading to low platelet count?

The PIs, well Telaprevir with be on the market in 2011. Two-three years from now. If you don't have cirrhosis now you surely can wait 2-3 years. I have cirrhosis and I am waiting for Telaprevir. There is no guarantee if will work. I'm seeing maybe 43% chance of UND at 12 weeks for null responders like myself. SRV rates? We'll have to see when the data comes in. With SOC I probably have less than 10% chance of SVR but my platelets run out after 12 weeks so I got no other options.

Double dosing? I'm assuming you don't become UND until after 12 weeks? From what I've seen Telaprevir is much more effective in knocking out the virus then any amount of Peg. Gish is one of the best of the best. He knows the latest data on what works and what doesn't.

You could always do the double dose for 12 weeks see how it goes. (Again I would say your past viral kinetics should indicate if this will work). Damn that has got to be brutal. But you've done 4 treatments. You know what you in for.

Whatever you decide you know we will support you and hope for success.
Hectorsf

[CockSparrow]

Your Fasting Glucose is ove 100, the chances are your are Insulin Resistant.
You should get a fasting Insulin test done to confirm this.
If you are Insulin Resistant (and you are) then the chances of DoubleDosing Pegasys working are not that good.
So I agree with Dr Gish, You should wait.
In that time you should prepare for Tx and try and undo Insullin Resistance and Oxidative stress which prevent Interferon form working.

Have you thought that that the reason a Non Responder trial is being conducted that excludes non responders can only be to fudge the stats.
They dont think its likely to work.

CS

[Magnum]

I'm a little confused about this test. It states "fasting". The order given to to to take to the lab didn't have "fasting" written on it and I didn't fast for this test. Am I correct in assuming I should have fasted for this test? Could this then be a false reading?

Thanks,

Magnum

[GreatBird]

I'm am certainly not the expert, but yes, you should have been fasting if it was a fasting test. It bears re-doing to get an accurate number.

[portann]

Dear Magnum,

I'm not an expert either but I'll bet you a dollar you should have fasted for a fasting glucose test!!

It's important to find out how long you should fast, also. I once went to the lab, having fasted for twelve hours but they wanted me to fast for fourteen. I had to return later and remember to not snack in the meantime.

Port

[orleans]

low plates indicate an enlarged spleen, a sign of liver damage--mag- tough decision but IF you do treat now I would include Alinia, why not? jerry

[CockSparrow]

You rally do need a fasting Glucose & Insulin Test.
And it would be a good idea to do a 12 hour fast first.

Think about this, show me a non responder that isnt Insulin Resistant.
CS

[jmjm530]

If you didn't fast for your glucose test then the normal range will be different and should be marked on your lab report. I agree with CS that both a fasting glucose and insulin test is a very good idea to find out if your are IR. If so, this should be discussed with Gish going forward.

But going back, I assume you have at least some fasting glucose tests prior to your four previous failed treatment? Possibly even an insulin test? If so, these values could be very important in terms of figuring out what went wrong -- because trying to get a bead on what went wrong in previous treatments is really the first step in coming up with the best strategy for the future.

-- Jim

[Magnum]

See what you make of this. I think I was supposed to fast before the Glucose test. What do you think? I did not fast and the high numbers may be because of that factor...


http://www.labtestsonline.org/understanding/analytes/glucose/test.html

Magnum

[joannatsf]

With a MELD of 7 I'd just try to enjoy life.  You've already invested years of your life in treatments that have been ineffective.  Why prolong the misery?  One shot of failed therapy was enough for me and I've concentrated on controling symptoms.

If and when I have a transplant I'll consider treatment again.  Until then I plan to enjoy my life.

[CockSparrow]

Yes Magnum having the test non fasting has corrupted the results.
This does not mean you are not Insulin Resistant.
That’s why you need to do the test again only this time fasting and with Insulin.

Here is somebodies Glucose level it was 97. Normal in other words
No matter how hard he tried he could not convince his hepatologist to run an Insulin test.
Why would he his glucose was normal.
Eventually he talked his normal Dr to run an Insulin test.
The result came back 18. This gave him a HOM-IR score of 4.48.
Damn near diabetic.
When he was on Tx he managed to only get a 0.5 log drop by week 12.

You need to find out whether you are IR or not.
And getting an Insulin test out of your Dr may not be easy, but get it anyway.

CS

[pjhep80]

if you are not late stage 3/stage 4 i would say WAIT....

i dont understand the urgency to treat or re-treat over & over with these highly toxic drugs with such terrible odds of success if you are only stage 1 or 2...

if we practice a liver friendly lifestyle MOST OF US can keep liver failure at bay for many many many years...

[mikesimon]

I would never counsel against an IR test - I think that's always a prudent course.
That being said, if you ate any significant carbohydrates with a few hours of your test then a glucose level of 103 would look very good to me. If you didn't ingest any carbs or if the test was more than 4 hours after you ate then 103 wouldn't look so good.

One thing your gastro said that just seems wrong is that if you are undetectable at week 12 then he would advise continuing treatment. I think that an undetectable reading at week 4 should be the determining factor. You've failed 4 times and though I don't know your treatment regimens I assume they were within guidelines. I don't recall if and when you became undetectable or how long you treated. But again I assume you must have had reason to re-treat. I think it is clear that you haven't responded well and if I was going to consider enduring treatment again I would want to see some very strong positive predictor and that for me would be undetectable at week 4. So, I might treat but not longer than 4 weeks if not undetectable by then.

Your bilirubin looks great to me and if it is "Total Bilirubin". If your number refers to your  "Direct" or "Conjugated Bilirubin" then I think it's OK. Different labs have different reference range but .3 is high normal on some and if the range tops out at .2 a result of .3 is still nothing alarming. I wouldn't think twice about it.

I'd ask Gish about the double treatment and ask him whether if you did treat and became undetectable by week 4 would he see a reason to continue. If he says "no" or "you'll never be undetectable at week 4" then I would take his advice and wait for the PI. He if said "yes" or "perhaps" then I might take a shot.

Mike

[Magnum]

Nasty, powerful stuff that Infergen. Nearly put me in my grave. However, I was overdosing at 24mcg daily as opposed to the typical 15mcg. For you it may be fine. Only your doctor knows for sure. I can say this, during the overdosing, it did bring my viral count from 3.2000,000 to 6200 in 12 weeks, but it was killing me at that dose. I'm electing to wait for VX-950, as Dr. Gish suggested.

Magnum

[Magnum]

I was right about the Glucose test being high and suggesting to Dr. Gish I had a problem. I was supposed to fast, but it was not written on the order. Therefore, I have to do it again with fasting. This is what happens when people don't know what they're doing when writing orders. A little less partying the night before would be a good idea for them.

Thanks to all for your input and suggestions. I'm electing to wait for VX-950 as Dr. Gish suggested. He will know at what point things get to where I will have to treat instead of waiting...

Magnum