please help to decide with TX (canada)

[andy_k]

hello,
please help to decide with TX.

i'm 41 yo, gen 1, found out that have hep c last year during blood test for hep A and B.
not sure for how long i have it, feeling constantly tired for 4-5 years

virus load june 2010: 1.6*E6
alt june: 2010 - 71
alt dec:  2010 - 140
alt mar:  2011 - 129

biopcy: apr 2011, scaring 1/4, inflamation 2-3/4

the GI suggesting to start SOC as soon as possible.
he thinks it will help to prevent more liver damage and he is not sure when and how everything will work with new meds (i'm in canada).

he has some involment with clinical trails, but nothing is available at the current moment.

i'm just not sure what to do.

any advise or suggestion is welcome

thanks

[andy_k]

thanks April !

[April63]

Oh, sorry, you do have a specialist.:). Just read.
Best of luck to you, Andy.
-A.

[April63]

Hi Andy. I'm from Mississauga. My VL was very low,my damage to the liver almost nonexistent but I have decided to start treatment immediately. It wasn't hard and it wasn't easy sometimes. I was able to work full time. Had some skin complications,anemia but nothing major. I was UND at week 4 and all the way to the SVR. It was almost 2 years ago. You probably know my advise: not to wait. But that's just me. You can always try with the new meds if SOC unsuccessful. I also think that the IL28B test would be a great idea.
P.s.
I'm surprised you don't have a gastroenterologist yet. May I suggest dr.K.Menon? Wonderful doctor. Best regards-April.

[andy_k]

no problem guys :)

btw, the doc has given me approximately 50 %  :)

[Trish77]

Yep, sorry 'bout that, Andy.  Doesn't take much for a discussion to go off on a tangent around here on a particular aspect, happens all the time...LOL!  

Repeat that I wish you good luck with sorting through everything, I'm sure you'll do just fine. :)

Trish

[willbb]

all done on this  

   sorry Andy       you are in good hands with your doc it sounds like  :)

[Trish77]

Nowhere am I suggesting in any way shape or form 72 weeks of treatment and you're taking my words out of context.  The data on SVR over 48 weeks of treatment is if DET at 12 weeks and UND at 24 for 48 weeks is simply contained within this study.  THAT is completely relevant to the OP when the discussion is around SVR rates on SOC if not using a PI.

[willbb]

well thats good then    haha lets hope th OP "s doc doesn"t get into 72 weeks data with him....all done on this       as this would not be helpful to  him

[Trish77]

To be more clear...if you read the data in the link....it shows SVR rates for those doing 48 weeks of treatment if still DET at Week 12 and those SVR rates vary depending on whether the log drop was >2 logs or 4 log drop at Week 12, the SVR rate for 48 weeks of treatment IS 50%. Compare that to Week 8 results where a 2 log drop at Week 8 and DET at Week 12 is just over 47% chance of SVR all on 48 weeks of treatment.  It's very useful data for slow responders doing 48 weeks of treatment.

[Trish77]

That's right.  The study shows who would benefit...or not....from extending to 72 weeks if DET at Week 12 and if UND at 24 weeks.  It includes stats on SVR rates for those DET at 12 weeks and UND at 24 weeks - the stats I referred to and those stats are included in this study.  

Because of the PI's, yes...72 weeks is a things of the past for the most part.  My comment was really in reference to the fact that, aside from the advent of the PI's, it was thought that anybody DET at Week 12 needs to do 72 weeks and this study shows it's more granular than that.

Despite what this study's aims are, it includes important data about SVR rates based on log drops at specific intervals and you're completely ignoring that because it also happens to be discussing 72 weeks of treatment compared with 48 weeks.  That doesn't make the SVR data irrelevant.  It only makes the idea of 72 weeks of treatment of little consideration at this point due to the FDA and imminent Canadian approval of PI"s.

Frankly, it's good data.  It shows that SVR rates fluctuate for slow responders depending on log drops and do NOT have the same SVR rates for all people who are DET at Week 12 but that the SVR rate depends on what the log drops were at specific intervals leading up to that 12 weeks.  

[willbb]

that study was to determine who would benefit from extending treament to 72 weeks as a slow responder.  Talking about 72 weeks today is a thing of the past(IMHO) in light of the DAA's   and would not be even discussed with the OP with any doctor who was at all up on new protocols.

As far as your original statement that when going UND between Wk. 12 and 24  the odds of SVR were 40 _50 %  ...I have never read a study confirming that.

[Trish77]

Here is a very granular study that shows what SVR rates are for those that go UND between 12 weeks and 24 weeks and that the SVR rates differ depending on what your viral load decline is leading up to that 12 weeks.  My figures are on the most optimistic side. Yours are on the other end and even a bit optimistic.  Neither are entirely accurate on their own but rather between them represent the range of SVR rates that are entirely dependent on what rate the viral decline was at Week 4, Week 8 and Week 12, if a slow responder that is DET at Week 12 but UND at Week 24.

It also shows that 72 weeks of treatment are not indicated for ALL persons who are DET at 12 weeks across the board, that SVR rates are similar for those who are DET at 12 weeks who had a >2 log drop at Week 4 or Week 8, or a 3-4 log or >4 log drop at Week 12 - so whether one does 72 weeks of treatment is not solely indicated on whether one is DET at Week 12 but how much the viral decline was at specific markers, according to this study.

Makes a case for the validity of an 8 week PCR if still DET at week 4 and if less than a 2 log drop at Week 4 and shows the importance of frequent PCR's for the first 12 weeks.

Interested in your comments on this.

http://www.natap.org/2010/EASL/EASL_55.htm

[andy_k]

thanks a lot Trish!

[willbb]

"Success rates are 40-50% if you are not UND - undetectable until after 12 weeks."
-----------------------------------------------------------------------------------------------------------------------
I have never seen a study that showed SVR rates anywhere close to this if still DET. at WK.12....all the studys  I have read said between 25 - 30%  if UND between Wk.12 and 24.

[Trish77]

Success rates are 40-50% if you are not UND - undetectable until after 12 weeks.  Before that, your success rates are considerably higher than that if you are RVR at 4 weeks or EVR at 12 weeks - undetectable for virus at either of those points.

I understand Will's point as well - so the question then is...IF you had the IL28B test done and it shows you are TT, would it stop you from proceeding and seeing how you do at 4 weeks and at 12 weeks?  If not....then it's informational and your actual treatment results are what is important.  If the results of an IL28B test coming back as TT would make you wait on treatment for a PI, then it's a useful piece of information to have before starting treatment.

There are certainly a number of things to consider and fortunate that you know you have Hep C while you are still early stage and have time to decide.  Good luck with sorting through all this, Andy.  

Trish

[andy_k]

thanks a lot for your advises Will, i really appreciate it!

i'm just not sure what to do at the moment.

from one side i would like to get rid of it faster, but on the other side i have read a lot about all the sx and knowing the tx lenth (48 weeks) and success rates (40-50%) it is not easy to agee on it ...

anywas, now i have something to think about in a next couples of days/weeks...

thanks!

[willbb]

Hi Andy...I know it is not available in Canada ,however with a doctors prescription  and 350.00(yes a little costly) you can walk into any Lab Corp lab(closest to us is Buffalo) and have results within a week to 10 days.

Yes ..it is for info. purposes only ....my only thought was that if you are found to have the TT allele( about 20% of caucasians) then to do Soc ,according to the studies I looked at(and if I am mistaken on this I hope someone corrects me) would mean about approx.  23% chance of SVR and approx. 0% chance of RVR...so  it  could save you from possibly 12 weeks of Interferon  without the benefit of a P.I

Good tho your doc is going to evaluate anyway at week 4  and together you can make decisions from there.

Don't mean to confuse you further either...its just that with no liver damage you have the options of  kinda picking and choosing what is best for you.....but in the end taking the advice of a knowlegable doc(in HCV treatment ) is always best.

Good luck Andy...

Will

[andy_k]

Will,

i've asked him about this test as well, not available, quite costly, not really widely used, kinda experimental, mostly for information only...

he says 4 week test will show how i respond to tx anyways, why to do it if it is not used to make a decision

i will try to contact Lapcorp in US, to see if i can do it without referal...

thanks!

[andy_k]

hi Trish,

thanks a lot for the advises!

my family situation is kinda compicated at the current moment, but i'm not sure if it will be any better in the near future...

it looks like the point of the doctor is to try soc tx, monitor me closely for first 4 weeks, and after the 4 week test decide on how to proceed...it looks like he will evaluate these results and take me out of tx if it doesn't work...

he belives that additional meds adding aditional sx, as they are used on top of soc. and if i can get results without them, why don't try...

also, his concern is the price of new meds and their availability in canada (when and how it will be covered)

also, he did mention that if i try soc, and it doesn't work it can kinda give me more chance to treat again with new meds when they are available.

thanks
andy







  

[willbb]

Andy..again ...the IL28B  test would be invaluable if considering SOC.I contacted Lapcorp on  procedure for us up here if interested.

Best

Will

[Trish77]

Andy,

You're in the enviable position of being able to wait a year or so to see how things shake out with the new meds if you want to.  One of the reasons you might want to do that is so that if you start treatment without the meds and you don't get the results you want with SOC at say the 4 week mark, you can flip over to adding in one of the new meds at that point and continue treatment with the new med.  You'll know where the insurance coverage sits for these drugs, etc.

The wildcard with that is that you don't know what life is going to look like for you in a year.  Part of considering treatment is taking a look at how your life is now - work, family, relationships - and for the next 48 weeks and a bit past that, and determining if treatment fits into your life now or if it would be better to wait awhile.  Treatment is a significant commitment.

If you decided not to wait, you could see what the results are at 4 weeks and even at 12 weeks.  If RVR at 4 weeks, you have about as good a shot as if you were including a PI.  If you are UND at 12 weeks, your chances are still around 78% or so….which is somewhat less than if you were using a PI with a 4 week RVR but pretty darn close.  If you aren't clear at 12 weeks though, I would then, at that point, hold off and wait to start again with one of the PI's.

You could decide to do treatment out of Toronto Western.  I went there for my second opinion and had to have my doctor give me a referral there, which he was very willing to do.  They wouldn't take me without that.  No harm at all in calling them to ask, however I expect they will ask your doctor to refer you to their clinic.  TWH has an excellent liver clinic with a pyschiatrist who specializes in serious illnesses and Hep C on their treatment team and are well connected with clinical trials.  The docs at TWH will also have a little more leeway with getting tests done that other docs on their own might not be able to get past the government's regulations on those things.  That has been my experience.  Just the same, it's what works for you and what relationship you have with your current doc and what you're looking for.  TWH is one of the options.

The one thing you said about your current doctor's comments give me on of those little red flags.  You said he mentioned your high viral load as one of the reasons for starting treatment sooner than later.  Viral load isn't any indicator of liver damage or that your situation is better or worse.  It's simply viral load.  So not sure if I read that comment right but wanted to bring that up to you.  One of the reasons I went for the 2nd opinion to TWH was because my doctor thought my "high" viral load was a reason to get started right away and we hadn't done a biopsy.  That didn't leave me with much confidence in him treating me.  So just be sure whoever you go through treatment with….they know their stuff.  

Lots of words…I tend to do that sometimes, Andy. :)  Hope some of it is helpful and not too confusing.

Trish

[andy_k]

thanks a lot Will !
i will try to call them, will see what they say

[willbb]

Andy...maybe try calling the liver clinic yourself and see what the protocol is. I would imagine you would have to be referred there from your current family Physician or the G.I.you are seeing.

Here is the no. for T.W  416- 603-5800

[andy_k]

sorry
"not sure if i will be able to contact Toronto Western or how long can it take... ":
has to be
"not sure if i will be able to make him to contact Toronto Western or how long can it take..."
it looks like he is trying to follow the way that he used to go...

do i can contact  Toronto Western myself?