Continue treatment or not???

[tracyhopkins7]

HELP - this is my first time posting a question although I have been observing for some time.  I will try to be succinct as it seems as though you all are so knowledgeable!!!  I am 46, weigh 215lbs, @ 5ft 3inches fat as you can see.  I started treatment for my Hep C Genotype 1A with a plan of going 48 weeks 1200 Riba/day and Interferon 1x/wk.
Viral load started at approx. 700,000 oh by the way my cirohsis (I can never spell that) is stage 4 of 4 - that ***** right?  OK - onward...At 4 wks my viral load went down to 3,600 and I am now at week 12 and it is still detectable at 99.  I am not having horrible horrible side effects but my body is not tolerating too well the meds - my WBC is 2.2, my RBC is 3.27, hemoglobin 10.6 and hematocrit 31.4 - ok so studies say to lower riba by 200mg if my hemo goes lower than 10 and hematocrit lower than 30 - I know it is a fine line but my nurse practitioner has lowered me from 1200 to 800 and ordered me to discontinue my interferon because my WBC is so low.

She advised me that I COULD continue on w/tx if i want to and try the meds to increase WBC and HEMO (Procrit) but she said it is not a good sign that I am having to be boosted up by those meds - as I will have to continue them for the duration of tx.  So as of now I can take only 800mg riba and NO interferon for at least 2 weeks until my #'s come up.

The main question and most troublesome of all is that she told me that they now know that anyone who is NOT Virus non-detectable at 12 weeks has only a 1% chance of svr post meds which means 99% chance of virus return.  I am having a hard time finding this information online and wondered if this is something that others are experienced with?  She said she did not want to take away all hope but she is a #'s person and if it were her (which she acknowledged it is not) it would be hard to go through so many weeks of hell just to have the virus return.  She said that she has NEVER had a patient who had ANY virus detected at 12 weeks complete tx and have SVR???.

Of course my question was well will it not do any good to have the virus out of my system at ALL like even for a year?  OK so those of you who think like I do know that my real question was will it buy me another year to live if it is gone for even a while?  She said no.

So I am considering getting a 2nd opinion but before I do that I wanted to check in with the people who are living the issue like me and who are really the most in the know.  Even though I have been watching from afar your comments and conversations have boosted me far more than I could say.  Thanks for any help or info you can offer.

Tracy Hopkins

[tracyhopkins7]

OK - final verdict is in:

M  y new cbc shows:

WBC 4.7 (that neupogen is smokin' hot!) Platelets DOWN to 71; Hemo DOWN to 10.1 and Hematocrit DOWN to 30.4

So I have to take 800mg riba everyday until Procrit kicks in and I have my next labs in two weeks and FULL interferon...to be continued.
Tracy

[tracyhopkins7]

thanks for your input - did not say that i would not consider extension - would do it in a heartbeat - things are constantly changing i know - and i read the study that showed no "statistically significant" success rates in patients who went 48 or 72 - so of course that made me curious about maintenance dose as i had never heard of that.  My dr's reasoning was - that since my virus is so active going from stage 3 fibrosis to complete 4/4 in 5.5 years that ifwe could somehow keep the virus gone as long as possible (maybe until new meds come out) that just by the fact that the dsease was not active then i would have a better chance of maintining what healthy liver i have left.

I am definately on the trail of a hepatologist AS WE SPEAK.  

thoughts?  Tracy

[Trinity4]

I've heard of the maintenance dosage treatment.  It is not widely practiced and has not shown to provide marked improvement in liver histology.

Don't understand why you would consider maintenance dosage but not extension.  Tracy you a stage 4.  I'm a late stage 3 and giving it everything I have this go round.  Statistically, you chances of SVR are increased when you extend.  Given your history, like me, what other choice do we have?  I can't recall anyone on this board with the degree of liver damage you and I have and the fact they were late responders that SVR'd after 48 wks of treatment.  No one!   I don't want to do this again and I will not consider Infergen as a backup.  If I don't SVR after 72 wks I'm done.  That's it for me until the PI's come out.  
Talk with the hepatologist and see what he recommends.  I think the maintenance thing is a very questionable.  3 years is way too much exposure to interferon even a reduced dosages.  These drugs are toxic and the less exposure, the better off you are.
Good Luck
Trinity

[tracyhopkins7]

Thank you as always for your thoughtful and obviously time consuming response to my questionsl - I am not worthy! ha ha.  Tracy - curious - have you heard of people on "maintenance" doses for up to 3 years?
Tracy

[merryBe]

first of all let me say how relieved I am you were able to "reason with your DOCtor...as we had spoken privately of doing. First line of defense is always to get to the DOC not the GNP...it's faster than waiting for a liver  guy, and in this case bore some good results.

secondly I would RUN don't walk from that GNP, the fact that she wouldn't even look, when half the treaters get riba rashes, or even refer you to an ASAP immunologist or other specialist is malpractice if shingles are suspected.

third, if you have shingles you really need close monitoring. In fact the usual treatment for that is very hard on the liver so you would really want a hepatologist involved then, and it might be wisdom to consider treating the shingles, and postponing any further HCV treatment until you've won that battle. It would depend on what they put you on and how you tolerated it, but it get tricky treating an ill liver for too many conditions. This is what can drive a real shutdown and it is a concern.

Assuming you don't have shingle let's look at that study that concerns you:

>>>>>>>>
In this study, sustained virologic response (SVR)(3) with 72-week treatment was not statistically superior to the 48-week treatment in slow responders (47.9 percent (35/73) vs. 43.0 percent (37/86), respectively), the primary endpoint of the study. Relapse rates between these two arms also were not significantly different (32.7 percent (16/49) vs. 47.1 percent (32/68), respectively) and adverse events were similar among treatment groups (secondary endpoints). Early discontinuation rates were higher in the 72-week arm compared to the 48-week arm (23.3 percent (17/73) vs. 9.3 percent (8/86), respectively).

What I noticed there was that there was only a 4% drop in SVR treating out, but 2 sentence later they mention 23% dicontinuation. Question is, did they factor that discontinuation into their outcomes, because if not, then the 4% loss would be a 19% gain if it were factored in.

It gets better:
next they deal with type 2 and 3 and here they conclude with shorter treatments, (and hence no dropouts mentioned that

>>>>>>>>>>Relapse rates were lower with 24 weeks compared to 16 weeks of therapy (17.8 percent (29/163) and 16.3 percent (27/166) vs. 29.3 percent (49/167), respectively). Adverse events were similar, regardless of treatment duration or PEGINTRON dose.

ok, so here they say that there is a 12% LESS relape when treating 8 extra weeks.

see the contradiction here?  This is what makes me question their type 1a stats.
That and other studies have also confirmed that the time one treats after going UND does effect outcome. Obviously everyone can't be telling the truth. The more studies I read the more I realize how easily the numbers can be made to tell truth or lies.
It is in ShP' interest to sell more INF, so I'm not thinking they would deliberately try to stop entended treatment, quite the opposite actually, but I have seen some pretty strange mistakes in the math and dosing departments, so nothing would surprise me.

Anyway, that first set of numbers definitely don't jive at all with the second set.
And while it is true 1a is harder to treat and that could account for the disparity there it's also a good question to ask, did they figure the dropout rate into their outcomes. Without knowing the answer to that one wonders are our odds the same or less, or are they better with ex. treatment.
Might be a good idea for us to write the researchers and ask!

mb

p, glad also you got on the procrit/neupo. The only thing I read as far a long term is that it can stress out the marrow for a few...which means only take the higher dose if the lower doses aren't helping you. They started me at 40,000 procrit and went to 60,000 when that wasn't helping, but said any more would do no good and could do harm...it's important to test for available transferrin(iron) and make sure you have some for the procrit to work.
Read a few iron threads in here so you'll know what to do and not do.
and keep on trucking!

[tracyhopkins7]

Hey everyone - i tried to post this earlier and got a message that the site was being updated so - my limited typing skills will have to give it another go!!.

Wanted to give an update after seeing doc - who i liked very much (he was a gi) he spent the 1st 10 minutes completely silent reading everything in my chart which i found encouraging - did not just try to breeze through, glance and ask questions - Told him issues with np - he understood - told him upset about being so conservative about stopping treatment - at 4/4 don't have time to be conservative.

The first thing out of his mouth was "well you are not a cut an dry case - we will have to tailor our treatment plan" - my husband and i both just took a big sigh of relief and almost gave him a big kiss right then ha.  Anyway another thing he said was that even though i am not a super early responder i am definately responding and that is encouraging.  Also - when he found out that my last biopsy in 2002 was stage 3 fibrosis/borderline cirr.  He said well we know that your virus is a busy one and even if we cannot get SVR we should have a goal of und for as long as possible - even if we have to do a maintenance dose of intf/riba for even up to 3 years until something else comes along...

That was the first i had heard about a maintenance dose and I rather liked that idea if i did not have chance for a cure this time around.  With regard to restarting the meds - i had my cbc and he told me to call np tomorrow for results (i will still have to deal w/her but he will be involved too).  He said there is some debate starting about staying on rescue drugs all during tx - something about people developing blodd clot disorders...he did not really give me anything more concrete about that and said the numbers would determine his decision.

Because my body is having a hard time he wants me to stay on 800 riba and depending on white count tomorrow I can take either my full dose of interferon and if they are bad then i will take 3/4 of my dose.

In addition he have me a referral to a hepatologist - and agreed that would be a great idea.

So thank you all for arming me with info AND ammo!!!  Truthfully after he talked about tailoring my tx i knew i would really not need either of those things.  He was nice.  I am still disappointed somewhat about reduced dosages but will deal w/that with a hepa and if my numbers come up from procrit and neupa then i will definatley lobby the gi to go back up.

Thanks again to all of you - i was concerned to read the study that was just released like last month showing that there was NO STATISTICALLY significant difference between the 48 and 72 week tx patients??  It seems as though everyone is advocating long-term but the stdies are showing otherwise???  I posted  the URL a few posts back.

Thanks Tracy

[Marc1955]

Tracey:

You did have a very significant response to the medications. It's true that you didn't become undetectable by week 12, but you came quite close. Although there are no guarantees, you are on a likely path to clear the virus before week 24. Thus your chances of beating the virus are significant – not great but substantial.

The article you cite concerns 48 vs 72 week treatment regimens. I think most people on this board are advocating that you fight to maintain your treatment dosages and maintain 48 weeks of uninterrupted treatment. The question of whether you would continue past 48 weeks is a separate question, and one that only your treating physician could answer. According to the article you mentioned, there are a higher drop out rate for those treating for 72 weeks, which makes sense, since it doesn't necessarily get much easier.

[tracyhopkins7]

Thanks for your input but the specific url that antman posted discussed who could be called an evr - his contention was that i was not an early responder (the EVR was actually a 4 week number in this study)  I was telling him that i thought i was an evr based on the 100 fold decline.  did you read the url he posted?  It would be cool if you did that way i would know if i am reading correctly.

I have another question - everyone is telling me that i need to fight fight fight for longer tx but then here is this study from just a week ago???

http://www.medicalnewstoday.com/articles/148570.php

Extended Treatment Duration in Chronic Hepatitis C Genotype 1-Infected Slow Responders: Final Results of the SUCCESS Study(2)

The primary objective of the SUCCESS study was to evaluate the effect of extending treatment duration to 72 weeks with PEGINTRON and REBETOL(R) (ribavirin, USP) combination therapy in genotype 1-infected patients who have slow response to therapy, defined as having detectable virus (HCV RNA) with at least a 2 log10 reduction in viral load at treatment week 12 and undetectable virus at treatment week 24. In this large, prospective, randomized, multinational clinical trial, slow responders were randomized at treatment week 36 to receive PEGINTRON combination therapy for a total of 48 weeks (n=86) (standard approved duration) or 72 weeks (n=73). Patients with undetectable virus at week 12 (complete early virologic response), received treatment for 48 weeks (n=816), whereas patients who did not respond to treatment (less than a 2 log10 reduction in viral load at week 12) were discontinued from the study. In total, 1,419 patients were treated.

In this study, sustained virologic response (SVR)(3) with 72-week treatment was not statistically superior to the 48-week treatment in slow responders (47.9 percent (35/73) vs. 43.0 percent (37/86), respectively), the primary endpoint of the study. Relapse rates between these two arms also were not significantly different (32.7 percent (16/49) vs. 47.1 percent (32/68), respectively) and adverse events were similar among treatment groups (secondary endpoints). Early discontinuation rates were higher in the 72-week arm compared to the 48-week arm (23.3 percent (17/73) vs. 9.3 percent (8/86), respectively).

[CoWriter]

"The absence of an early virologic response [EVR] at week 12, defined as undetectable HCV RNA ( 2-log decrease in HCV RNA at week 12 who have not become HCV RNA negative by week 24."

You started with a viral load of 700,000.  A 2 log drop means you remove the last two zeros.....a decrease down to 7,000 at week 12 would be a two log drop.  And your results were 99 so you got more than a 2 log drop.  

Co  

[tracyhopkins7]

Thanks for your input - I read the info on the Url  that you posted and it said that EVR defined as undetectable or greater than 100-fold decline in HCV RNA by week 12 have a 70% chance of svr whereas those who do not have less than 3%.  With my numbers going from 700,000 down to 3,000 and then down to 99 by week 12 my reduction was a 100 fold right?

More confused  Tracy

[tracyhopkins7]

Hey everyone - I was searching for the Berg study that someone referred me to and came accross this - it is from the Hepatitis Association from April 2009 - fairly recent and I think the number that they quote is 98%.  I have included the URL and the paragraph where i got the stat from - any thoughts on this?

http://www.hepcassoc.org/news/article183.html

Stopping Treatment in Likely Nonresponders

The absence of an early virologic response [EVR] at week 12, defined as undetectable HCV RNA ( 2-log decrease in HCV RNA at week 12 who have not become HCV RNA negative by week 24. Recent studies show that this information can be used to individualize the duration of therapy.

The HCV RNA status at week 4 also provides useful prognostic information that can be used to individualize the duration of therapy in genotype 1 patients (4,5). Normalization of ALT on treatment is an indicator of a therapeutic response but lacks specificity, and, thus cannot be used in place of serum HCV RNA determinations.

[antman]

http://www.liverfoundation.org/downloads/alf_download_321.pdf

BTW- the stat for SVR at 12 weeks is <3% if not clear according to this article. you NP said 1% right? not too far off.

[antman]

you are getting good advice here. 1st thing i don't like is that you never mention the Dr.i won't go back to a Dr. that has me seeing a NP. the only time i saw mine was well into tx and i knew the routine was not changing, i was clear of the virus and because my Dr. was out of town. looking back i would have skipped that appt. but getting back to your case: i wouldn't consider dose reduction. go to a hepatologist. he should get you connected with a hemotologist(blood specialist). i don't know what your chances are at SVR,but, if you can get a Dr. to approve 72 weeks of tx. they are a lot better. BTW- i relapsed the 1st time because i still had a viral load at 12 weeks. i even knew better but the Dr. (gastro) wouldn't go for 72 weeks. the second time i went to a hepatologist. started # 2 tx  5 mos.after the 1st tx and cleared at 5 weeks. i just finished and my 7 weeks post revealed that i am still clear. good luck to you! hang tough.

[tracyhopkins7]

thanks so much for your thoughts with regard to the shingles i knew she would want me to see my gp or fam doc but because i was already IN HER OFFICE she could save me some time and money by looking oh well i am movin on up come Monday!  Have a great weekend.Tracy

[tracyhopkins7]

Yes if you read my original posts actually all my posts - she ordered me to HOLD my interferon until my white count iimproved.  I did my neupogen shot last night and call me crazy but i swear the sores in the corners of my mouth literally healed overnight! Crazy!  Tracy

[CoWriter]

I agree with Portann that your initial Riba dose may have been too low based on your weight.  Using Procrit could have allowed you to use a higher dose.   I also agree with merryBe about the insulin resistance, especially since you were having hypoglycemia which could mean that you're producing too much insulin.  

And I specially agree with Jenny Penney that you shouldn't do anything without having a doctor who can take care of any problems.  The neutrophils (which are white cells that defend you against BACTERIAL infections) may be at an acceptable level to continue treatment but you don't know if your LYMPHOCYTES are normal.  Lymphocytes are white cells that defend you against VIRAL infections.  And on one of your earlier posts you said....

"i told her I thought I might have shingles on my lower back/upper rear.  She said well I don't really see herpes so i might not know the best med and really uppity said "i mean i could look at the sore on your butt if you want me to but I dont see herpes very often"

Herpes/shingles is a VIRAL infection....so she should have been looking at your lymphocytes, not just the neutrophils.

Treatment for shingles should be started as soon as possible (preferably within the first 72 hours) or you may end up having nerve pain after the shingles are gone.  Your NP should have known that.  Her knowledge of Hep C is obviously lacking....having other active infections like herpes, CMV or Epstein Barr can lower SVR.  Hepatologists recommend that people who have herpes take an antiviral like Viraway or Acyclovir to keep the herpes suppressed during Hep C treatment.  

I can't believe she doesn't know what shingles looks like....or that she let somebody leave her office with untreated shingles knowing how painful they can be.  

I hope things go much better for you in the future.

Co

[Rockerforlife]

I still dont see why your not doing the PEG shot...did they order you not too?...from what you said they only suggested you stop

[tracyhopkins7]

Hey Trish
Thanks for checking back in with me.  I really believe that had i been able to take my shot last 5 days ago that my vl would have been 0 - we shall see.  How often did you have your blood drawn after 15 weeks?  You did not say that in your post.

The doc is a gi and that was the best i could do.  I did not know there was such a thing as a hepatologist so when i started all of this i just called a gi office.  So I will report back monday evening - if i can get him to greenlight me then i can do my shot monday and that would be a 51/2 day hold instead of 7...

Have a great weekend and thanks again.  Tracy

[Trish77]

Tracy,

Do you have your list of questions ready for the doc on Monday?  Is he a GI at least?  You called him an MD.  Your interim time while you wait to get in to a hepatologist is vitally important so I'd suggest you fight hard for full resumption of interferon AND ribavirin.  Neither of your numbers suggest a reduction at all and particularly with Stage 4/4, the line you want to get close to is pushing for treatment success as hard as possible and that means full dose for as long as possible.  If that means extra blood tests to monitor more closely then do that but reducing treatment drugs should only be done at this stage if it's clear that there is trouble.  I went through most of my treatment from 15 weeks on having weekly blood tests because my numbers were always so close to the line.

I'd rather see you do at least 1/2 or 3/4 of your interferon because it will make the ribavirin effective but I understand the hesitation.  If you're afraid she's going to pull your drugs completely, that's a tough call.  Interferon lasts 7 days in the body and that's why the shots are 7 days apart.  Right now your ribavirin is working on it's own so it's of limited effectiveness without the interferon.  Whenever you resume your interferon, your next shot should be no more than 7 days after that.  

As for your viral load being 99 at 12 weeks, think about this.  By the time you got those results, you could already have been at 0.  The same day in fact.  And that would have been a good result.  So you are really close to that and there is good reason to keep fighting.  

At some point, you might also want to start looking into going 72 weeks instead of 48.  However, get through this current challenge you've got and get your meds restored, see how your next sets of CBC's turn out, get in to your hepatologist for a 2nd opinion and hang in there.

Trish

[GSDgirl]

Glad you have a plan.  It kills me that the doc is making the big bucks but you have never seen him / her.  Good luck & you sound very determined.

Denise

[tracyhopkins7]

I am humbled by all of you - thank you so much more than a few of you need a np or md behind your name.  Here is my plan - best i could come up with:

1.  I have increased my riba up to 1000 (know i need at least 1200 but will have procrit on monday) even though she told me to go to 800
2.  Have an appt with md (who I have NEVER seen) as i said when i started this treatment i never saw a dr - only the np.
3. Taking first neupa shot tonight friday
4.  Have only skipped 1 shot of interferon (i know that is less than ideal) but with a cbc draw first thing monday am and an appt monday pm then he should get prelim cbc results by tuesday am in time for him to hopefully feel comfortable letting me take my shot on my normal day (tuesday) which will keep it at only 1 missed dose.  I know a lot of you advocated for me to do the shot anyway but besides not wanting to get in a situation where they tell me i was irresponsible for doing that against medical advice and because of that they would not refill - I had this thing in the back of my head that what if it did tank me and all i got was a big fat i told you so ha ha.  Mostly the first reason though.
5. Will have referral done to uw requested on an emergency basis (talked to guy at uw and he said he would try to rush through) so hopefully i will be delivered into the hands of a good hepatologist within 2 weeks.

You all have armed me to the teeth - i am not a shrinking violet and usually have no problem pushing my cause with dr that I am paying - i think her combative nature and defeatist tone caught me by surprise.  Because i was not armed with all the information you all have given me i was forced to comply but it will NOT happen again.

Maybe it is that woman thing of taking care of everyone else first as I have gone through similar stuff with my mom and ABSOLUTELY knew that I had to be almost more knowledgeable than the docs and was - that way i knew i could force them to give her the best care.  Why I have not become knowledgeable yet on myself is a mystery to me but in the process of being remedied.

Thanks again to you all.  Especially info on insulin resistance.  I did have a fasting sugar done a while back which was normal - i had had problems with low blood sugar mostly related to not eating very much so that would be hypoglycemic but that has been addressed with my diet.  I will look into the insulin resistance information thanks.

[Bill1954]

Without reading through the whole thread here, I think it’s important to point out that cirrhosis is reversible to a point; as long as the patient remains compensated (CTP class 1). When evidence of decompensation is present, I believe the patient will require a transplant at some point; this also marks the distinction of ESLD. This might have been noted above; I skimmed the thread, and didn’t notice it, though.

Tracy, it looks like you’re on top of things, and getting excellent advice here. Welcome to the discussion group; glad you found your way here. Take care, and good luck to you--

Bill

[merryBe]

>>>>>>>No it's just patently not true in any way shape or form.
Too bad Nurse Ratchet doesn't read studies or obviously anything new on HCV.

wow, expecting a practicing professional to keep up with current research, that really would be... "asking for the moon AND the stars"... there Betty D.!!

you are too funny!!

You ever wonder how many people have gone home to die based on the old research in the last 2 years,... since all the new contrainan study info came out....how do they sleep at night.

mb

[Trish77]

"She certainly didn't have cirrhosis and she wasn't obsese. point being that the fact her dose reduction didn't hurt her SVR really has little to do with your case. "

Before anybody gets too far off in left field thinking that I was suggesting that Tracy doesn't have to worry about a dosage reduction because I had one and SVR'd....my POINT was more to the fact that even though treatment choices have to be made, it ain't over til it's over and it can still work out.

I wasn't suggesting her case was anything at all like mine or that we're in the same boat, OTHER than having to make tough treatment choices and hoping for the best regardless and sometimes it still works out, even when you get pulled from treatment at 34 weeks.  That's it, that's all.

Simply a statement to keep the faith and don't let it get you down and hang in there.