Second Opinion, TX not working

[PokerRon]

Doctor ben Cecil responded to email question...
First is doctor Cecils answer, followed by my question..

my gastro doc wants me to continue for 72 weeks
he thinks im a slow responder
i will have a second opinion on tuesday at UNIV OF PENNA hospital

Your fall is too slow to get cured and going for 72 weeks will not do it for you. Week 4 was OK. You should have been below 6,390 at week 12. You need at least 90% fall every month. You lost effectiveness at week 12 and this is very clear at week 17.


You have several options left. You can change from PegIntron to Infergen 15mcg daily and continue the ribavirin. You can stop and wait for a trial with telaprevir next year. You can change to Pegasys plus ribavirin.


The problem now is that your viral level is so low that it will fall < 10 soon and you will not be able to tell if the next treatment is working great or just a little. Good luck to you.


Ben Cecil, MD


On Sep 26, 2007, at 2:58 PM, pokerron wrote:


55yrs old
gen 1 a
stage 2 grade 2 ( biopsy 2/15/2007)

being treated with
peg intron 2B, 150mcg dose once per week
1600 mg Ribivirin per day (4 tabs twice a day)

VL  8,500,000
VL   639,000  WEEK FOUR
VL    16,6000 WEEK TWELVE
VL       7,900   WEEK 17
VL        268     WEEK 24

my gastro suggest i continue tx for up to 72 weeks

do you think i should quit now or continue on
what other options do i have
is there anything you can suggest

doctor cecils response is Above

thanks
Ron

[copyman]

just wanted to wish you good luck tomorrow. please let us know what the new doc says.

[wyntre9]

NP.

Gonna try again, now

wyn

[PokerRon]

im sorry its  

dot net   NOT   dot com

im sorry to put you through all this emailing
maybe i can blame it on the riba brain fog

robbaml  at  comcast  dot net

thanks
ron

[wyntre9]

well, i tried twice

first time with an l, second time with 1.

sure it's right?

wyn

[desrt]

My point was, the world doesn't break down neatly into multiples of four. The protocols for a mythical 'average' patient will certainly use these numbers as useful guidelines, but statistically "4" only means just as many SVRs cleared at 5 as did at 3. There are way too many variables for each person (metabolism, weight, genetics, etc, etc.) and each virus (even 'same' genotypes have minor variations) to make any of this hard and fast. We're all still labratting, and until gene sequencing becomes cheap and commonplace, there's going to be an element of chance in all of this. There's not an odometer that either clicks or doesn't after the 4th, or 12th, or 24th shot.

[wyntre9]

you got mail.

wyn

[PokerRon]

hi wyn

my email address   robbaml at comcast dot com

please send me the info

thanks
ron

[wyntre9]

If you want to see the entire berg study, send me a message with your addy.

I've only got it in text format and not as a link and I can't send it as an attachment. It's too long to cut and paste the entire article.

wyntre

[jmjm530]

Tall:
BTW, did you resolve your cholesterol problem?
------------------------------
Yes, I stopped testing :) But seriously -- actually that was serious -- I'll probably be going back on a statin pretty soon. I did go on them for awhile, stopped to see if I was getting any side effects (jury still out) but probably will have to go back.

That was my feeling also on the infergen protocol, but not sure if any data for treating someone like Ron who was still detectible at week 24.

Thanks for the nice words and I'll be looking for your 'official' SVR post although I'm pretty sure you have it in the bag based on current results.

-- Jim

[Tallahassee]

Thank you, Jim, for good wishes.

I always value you advice and you always have a good point.
Ron already went through at least 24 weeks of treatment and I believe he'll have to do 36- 48 weeks of Infergen and he could be virus free next year.

If he will wait for Vertex ... he still most likely will have to do 48 weeks of SOC, plus he will subject himself to a potentially dangerous chemical -- VX ---believe me or not, but all these "skin disease manifestations" are not so innocent.  Besides, my gut feeling, that people, non-responsive to regular peg. Interferon will be prone to have a viral breakthrough on VX+SOC.  I believe that for Interferon+riba resistant people (like myself), VX (or other cocktails of potentially extremely dangerous polymerase/ protease inhibitors) + Infergen (hopefully pegalated version of Infergen) should be used.

But who know when these treatments will arrive?
Ron probably can wait up to 5 years ... until stage 3 ... and hopefully in these 5 years he will not develop diabetes, hypertension, etc.

BTW, did you resolve your cholesterol problem?
As always, thank you SO MUCH, Jim, for your great advice!! You are invaluable on this forum!!
All the best!!



The SOC (or protocol) for USA Drs (not practicing at the Universities) is to switch to Infergen if 2log viral reducion was not obsrved at 12 weeks of tx. No one specifies when UND should be observed ... but after UND, 36-48 weeks of Infergen/ interferon is recommended, IF patient can tolerate side effects and manage treatment.

[r4c7]

Hey PokerRon...

nygirl gives good advice:

"Go talk to a good heptologist - we can only speculate and we love to do our radical guessing but in the end we aren't doctors we just enjoy blabbing!"

I can attest.  I personally put three people into liver failure last week because of my own rotten advice!  :)

[nygirl7]

"Keep in mind there's nothing particularly magical about the #s 4,12, or 24. If you became UND at week 25, you  might have the same chance of SVR as a skinny person who cleared at 23 and thus was UND on their 24 week test. "

Actually I disagree completely - every study has been done based on these "magical" numbers....and it gives us the only fair "odds" that we can get.  Especially now finding out how it's not the 12 week 2 log drop that is for greatest importance it is the big 4 week UND that is the ticket!  If someone is not UND by week 24 their odds go so far drastically down that there are almost non-existent.  So...to take it out even farther than that pretty much guarantees a failure. Of course, a miracle could happen to anyone but with 50/50 odds not so great to start 99/1 doesn't sound so great.

Interferon is dangerous nasty shite - with all sort of problems that can almost parallel having the hep to start with.......autoimmune diseases and all of that -it doesn't seem worth it to me.

But remember - just because you it took 25 years to get to stage 2 does NOT mean it will take 20 years to get to stage 4.  It's not linear and there is no way to know...so perhaps having a second opinion on switching over to the infergen might be a good idea, you've put a lot of work in already...are very close to the UND so trying the more heavy duty med for another year just might do it for you.  That is what I would do anyway.  If I relapse I am going for the Infergen.

By the way I was not UND until somewhere between weeks 12 and 24. This is way back a year ago when nobody did 72 weeks.  I went and got a second opinion from Dr. Jacobson (after reading both studies) and he encouraged me to go for it.  However if I had been positive at week 24 I would not have continued. I would have stopped and I am a very skinny (well I was ha!) person.

Go talk to a good heptologist - we can only speculate and we love to do our radical guessing but in the end we aren't doctors we just enjoy blabbing!

[r4c7]

Got to agree with Dr. Cecil.  Since your only stage 2, you've got some time on the clock and better alternatives. Telepravir trial sounds like a real trump card to me.  I'm doing a high-dose Pegasys/Copegus through Roche and have had good results. Your stats and mine are quite similar: Starting weight 230 lb., 55 yo, geno 1b.

Baseline VL was 22.1million went down to 1,680 by week 4, haven't had a VL reading since but probably UND at week 8 (which is now), will know for sure at week 12 when next VL is taken.

Bottom line is there's lots of hope and better alternatives, but it might be time hit the brakes on PegIntron.  

[jmjm530]

I should also add that at the time the infergen plan was hatched, we were under the impression that I was stage 3.5, and it was made clear to me that the extended efforts were because of my advanced level of fibrosis. Ron is stage 2, and it turned out later that I probably between stage 2 and 3, not between stage 3 and 4.

-- Jim

[jmjm530]

Tall: It is current protocol to change from Peg to daily 15 mcg Infergen for approx. 1 year after UND.
---------------
My original treatment plan (first doctor) was to consider switching to Infergen if still detectible at week 12, and then treat for another year. Is this what you are referring to?


"PokerRun" on the other hand, was still detectible at week 24, and I haven't seen any protocols that suggest he should continue, be it Infergen or not.

BTW wonderful news that you're still UND 3.5 months post treatment. According to a recent study that suggests 100% correlation with SVR if you're not stage 4 -- and still a very good correlation even if you are a stage 4. So a guarded congratulations.

-- Jim

[Tallahassee]

Dr. Cecil gave you excellent, excellent recommendation.

It is current protocol to change from Peg to daily 15 mcg Infergen for approx. 1 year after UND.  For almost 10 years I was relatively flexible to change - interchange interferons, doses, lengths, and such... until in 2004-2005 Drs were given guidelines or "protocols" how to treat Hep. C patients with genotype 1.  My Dr. informed me that I should start with SOC and at 12 weeks I'll switch to daily Infergen (we new already that I'm not responsive to any other form than Infergen)... I thought it was kind of silly for me to do any SOC and I convinced my  Dr. to skip the SOC part and start with Infergen.  ... I ended up having 98+ weeks of daily Infergen with ~1400 (and more) daily Riba (with body mass 1200-110 lbs).  3.5 months post tx I was still UND ... so I keep my fingers crossed.


My personal opinion: switch to Infergen.  You are already almost UND!  You already invested a lot of time into this treatment ... don't waste it!
Note: Dr. C. gave you as the second option is to be unrolled into Vertex TRIAL!  There are can be limitation as far as treatment, diff. Hem and WBC support (such as Procrit, Neopogen). Really, nobody knows when actually new treatments will be approved, plus as a chemist, I'm not convinced that addition of protease/ polymerase inhibitors is safe than to take extra time interferon.  Unless you developed Autoimmune disease,  continue with Infergen.  Believe me, during every year of delaying you may discover new diseases related to aging and/ or outside of the live Hep. C manifestations.  I started treating at age 26 (in 1995) with regular SOC with riba (I participated for total of 66 weeks of clinical trial) and I even hardly noticed that I was treating ... I was full time working, earning phD degree --- I only knew from a study nurse that my white & red blood cells were getting low, but not low enough to remove me from study -- but I really did not feel bad at all.

I took 1.5 years off in the area of 2004 --- I though the same that I'll exercise, be healthy, may be have a baby --- and after start my treatments again.   ... well, I should say, it was more difficult to treat this time around.

I would like to add, Dr. C. is one of the most reputable Drs ... why waste and dispose his knowledge, experience, and advice???  the rest is up to you.

Good luck and all the best!!

[jmjm530]

http://www.natap.org/2006/AASLD/AASLD_34.htm

and then there's the Berg study: http://tinyurl.com/38rcwf
(couldn't find a good abstract with what you want, but you can order full copy here for $30 if no one else has it for free).
-----------
In neither case, do they hold up any hope for those detectible at week 24.

[desrt]

Keep in mind there's nothing particularly magical about the #s 4,12, or 24. If you became UND at week 25, you  might have the same chance of SVR as a skinny person who cleared at 23 and thus was UND on their 24 week test.

[jmjm530]

Definitely try and get down to your ideal weight (not just losing a few pounds) prior to treating again. This could be the most important single thing in your control for improving your chances of SVR.

As stated before, I've seen nothing to suggest you should do anything but stop treating, given you're still detectible at week 24. And given the fact that you're only stage 2, I think you will be doing yourself potentially a lot of harm. Dr. C. supposedly is very nice, kind and giving and very accessible. That doesn't mean he's right. If you have any thoughts whatsoever of continuing on, please see a liver specialist (hepatologist) who can both examine you and review your entire case.

-- Jim

[PokerRon]

STUDIES and finding....

when you guyss say that studies show that if i treat for 72weeks total
with a 268 VL ....i have only a 2% or so chance svr....
can you please post these studies online or email them to me
id like to be armed with as much hep info as possible when i see my hep doctor tommorrow

thanks
pr

[PokerRon]

my weight at the start of tx was 248lbs, my height is 5'9"
before i found out i had hepatitis in january i drank beer every weekend of my life and ate all the wrong foods.
i started tx with the high doseage 1600mg riba per day and as of right now thats what im still
taking every day..

after 7 month of tx (31weeks) my weight is 220lbs and i eat much better foods and i dont drink alcohol....

i do walk 2miles a few times a week (when side effects allow me too)
but at most i only have about five good hours a day and then im wiped out
im not sure this tiredness is due to hepattitis or the treatment of the disease..

If i do come off TX, id like to take at least a years break,
id use this time to get my body in great shape for round two
im thinking of using milk thistle, fish oil, vitamins etc
and lay off the red meat as much as possible

THANKS
RON

[nygirl7]

I have to agree - 268 is still a positive at week 24 and generally not worth treating through.  If you had a zero ok but otherwise...

I would wait a few months then start  over with the Infergen.  Harder course of treatment but supposedly very effective for geno 1 relapsers.  If you could consider yourself a relapser (even though technically you are not) and treat as if you were - you'd probably have a pretty good chance.

As it is, not even being UND at week 24 I think the odds fall of to like a 1% chance of success.

What a bummer I hate this disease so much!

By the way curious about the high concentration of riba - if you didn't clear with that much of the stuff inside you...that is a very telling comment.  Did you start on this amount or was it upped as your numbers weren't hitting?

[jmjm530]

Curious about the high riba dose. How much do you weigh and how tall?  Also, do you know what you pre-treatment hemoglobin was and what your hgb was at your week 4 draw? If you're overweight, getting down to your ideal weight would be a good idea prior to treating next time, not to mention the other health benefits.

[jmjm530]

I agree with Dr. C's statement that 72 weeks won't work.

But given you're still detectible at week 24, I see no support for the first and third of Dr. C's recommendations. The standard recommendation is to stop treatment unless you're treating for something other than SVR, for example histology, but as a stage 2, that should not be the case. Unless Dr. C. can supply you with some sort of SVR data that supports continuing beyond week 24 with those two scenarios, I would stop.

My recommendation would be to either take Dr. C's second recommendation -- Teleprevir trial -- or better still, simply wait until Teleprevir is out of trial while meantime monitoring your liver.

Since I'm not a doctor and Dr. C. probably doesn't have your complete medical records, you might want to confirm all this with an outside liver specialist (hepatologist).

All the best,

-- Jim