pegasys extension question

[wheatgrass]

I'm 49 and have type 1 hep c. My only known risk factor is that my mother (a nurse during the 1950's and 60's) had hep c, so it's possible I've had this a very long time. I found out I had it 6 years ago. Liver biopsy showed stage 2 inflammation and stage 1 fibrosis.

I'm in week 14 of treatment with Pegasys (180) and Ribavirin (1200). My baseline was ALT 50% above the high end of normal, and viral load 6.7 million.

At the week 4 test, my ALT had dropped into the top end of the normal range, where it's stayed. I just got my 12 week results (first viral load test since the baseline), and they were better than I was hoping, given my age and somewhat high viral load. The 12 week viral load came in at 760.

I have read that it may improve SVR chances if I have 36 weeks of treatment after going undetectable, which I haven't reached yet (but almost). My next viral load test isn't scheduled until week 24.

I don't have good insurance. The deductible is high enough that doctor visits and lab tests are all paid out of my pocket. Insurance pays 50% of the prescription (but probably nothing beyond 48 weeks). I'm thinking of having the viral load test every 4 weeks, and if I go undetectable, go 36 weeks of treatment from that point.

Does this make sense to others here? Any ideas or suggestions?

As an aside, I read many post here before starting treatment, and it really helped a lot in preparing myself, and becoming more knowledgable. Thanks to all who have poste

[layla]

I think you are right and I would do the same. My doc actually had one woman do 3 years but finally got SVR. At the time he told me she was SVR over 1 year. Hang in there. I know it must be so hard for you to do this so long. My 18 months were very hard but I would have went on if I had to also. I take your on full doing or more. I really admire you and wish the very best for you. Please keep me posted. I'll be watching for your lost. LL

[twotells]

I'm so happy to hear that you had a good response and have no cryo level.  Your extension sounds reasonable.  I'll keep an ear out for your next test result.  I wish you the best,  Dave

[BostonGirl]

Hi Layla;
        My nurse called yesterday and gave me the good news. I am not undetectable, but getting closer all the time > 1600 at 16 weeks. I guess starting out with 55,967,000 is why it's taking longer.  

They told me that I would clear the Hep C first, then the cryo levels would go down. It's the opposite> cryo levels are undetectable, but I still have a very low viral load. Weird huh? I guess these so called experts don't know everything. LOL!

My nurse told me that my doctor said ( if I choose ) I could go 36 weeks at the point that I get to zero. But I am thinking that I will go for 72 weeks. I only want to do this once.

(((((((( Sue )))))))))

[layla]

Let us know how your 16 weeks lab results turn out. I really wish you the best. I know that wait really stinks! LL

[scruffy]

Yeah, it's amazing that I remembered to take the meds cause I have a very spotty memory. But I bought this great little pillbox on e-bay. It's gold with green and a double headed eagle design(old I think). I carried my riba in it. I developed a routine-take morning riba at 9:00 and put the other dose in the pillbox-then if they were still in the pillbox later then nine that night I knew I was late but took them then. Shots I simply remembered to do cause it was the Friday night thrill.I had a numbered chart to not repeat shot sites.A little drawing of torso with numbers on thighs and stomach.smile Now off tx -The herbs,vitamins and such I had to go go to a larger and not as cool pillbox and I sometimes forget to take them. oh well. frank

[BostonGirl]

Hello Wheatgrass;
                 I am sort of in the same boat as you. I began at 55,967,000 viral load. Geno 1A and stage 0/1 ( but was diagnosed with cryoglobulemia ) it's my primary reason for treating.

Anyway at week 2-3 the viral load dropped all the way down to 303,000 which is outstanding, considering where I began. My 12 week PCR is still showing a viral load of 18,000. My cryo levels are at zero, so this tx is working.

We are doing PCR's every 4 weeks, so we will know when I do clear. I am currently waiting for results of my 16 week PCR and praying it will be zero.

Going into this I knew I would probably do extended tx because of the high load & cryo. We are now looking at a minimum of 18 months. It's Ok though, at this point I really only want to do this tx once and if it means extra shots, so be it.

Since you did not clear at 12 weeks ( but are darn close ) you are still considered a slow responder, like me. Extended tx will raise your success rate quite a bit. If you stop tx at 48 weeks, you have a higher relapse rate. Like I said, you only want to do this once.

If your insurance will not pay for additional tx past the 48 weeks, you can contact the Pegasus Commitment to care program. They give free drugs to those who qualify. I am not sure of the guildlines, but it's worth a try to ask and hopefully you will be able to extend your tx.

Good luck on your tx journey & God Bless, Sue

[cuteus]

yes, lol, still hacking away. Latin curse or blessing as it fits.
The 200th is in! still counting...

you only missed 1/2 riba dose?
I honestly can't remember how many times I forgot my riba, it was scary that early fog.  I guess the extension counteracted it somehow.
I always wonder if I would have SVR with 48 wks after reading those that did with suboptimal dosing!  I just did not want to chance it. Look at Honey, only 52 wks did it for her, and tnguy at 48, and some others, then you get bobL with 72 and relapsing.  We have to go by studies stats and a lot of GUT feeling with this virus. I just can't see stopping if  you are a slow responder just because liver damage is mild, seems like a waste of effort of the first 48...but if the meds are doing more damage than good at that point, is a different story.

When do you sleep? getting your 8 hrs? don't cheat your brain of rest, ok?

HOney, Amerabrit: you guys out there?

[scruffy]

Just want to add to this subject on the adherence to therapy-During my 48 week peg-intron/1200mg riba ride I missed only one half riba dose one time. Still though <600iu/ml at twelve weeks but detectable-relapsed anyway. I'm thinking that adherence certainly matters but that treatment length is more critical to SVR.Of course, missing a shot or two would'nt help any.just my opinion based on my riba ride. frank

[scruffy]

Hee-Hee-cute fish.(it's back to the old hepatic grind)be of good cheer and good health. frank

[cuteus]

I would not call it getting offended, just a little irked, you should have seen me on Riba! or maybe not. I am sorry the tx is getting to you, I hope the sides pass quickly for you.

wheat; Layla summarized well, if you(hypothetical you) are going for it, do it all the way, be it 48 if RVR or 72 if slow responder, see it through the end.  Doing this twice or longer because we did not give it our best shot, really sucks.
be well

[layla]

I know what you mean about being contagious. I personally would treat for that issue alone. Of coarse it was not the only factor for me, another was the fact that progression is faster after the age of 50. I had no liver damage despite the fact I had this disease for about 28 years. I did start having symptoms even with no damage about 7 years ago and the joint pain was getting pretty bad. I also had a friend who has/had HCV with no liver damage. He was 45 when tested then 2 years later his next biopsy showed stage 2. He had to do extended tx with neupogen but fortunately he is SVR now. It is truly different for each person but I understand what your saying. I think if your going to do it go for it all the way. Beleive me you do not want to do this twice even if it means 72 weeks of tx. I am 1 year post tx next week and it already seems like time is flying once again. LL

[wheatgrass]

I'm not offended by your post. I understand what you're saying, and you are right, I did consider long and hard. I had the biopsy about 5 years ago. At that time my AST was still normal and ALT only a bit above normal. Viral load was between 1 & 2 million. I chose watchful waiting, and since my liver was in pretty good shape, opted to not do another unpleasant biopsy.

About two years ago my AST went above normal for the first time ever (and stayed there), and my ALT and viral load started rising at an increasing rate with each test. In addition, I have a 7 year old daughter that despite what I know about transmission I am so afraid of giving this to her that I am not as close to as I would be if I didn't have this. Even though I know the odds are miniscule, I always come back to "How did I get it from my Mom? At birth? While she was dressing a scratched knee? Something else? Did she cut her finger making salad and I bit my cheek?". Who knows?

I'll never know, but I think I might have got it during the third grade when I had something they finally diagnosed as Mononucleosis (symptoms like hepatitis). I spent a week in the hospital while they took blood tests twice a day trying to figure  out what the heck was wrong, followed by 3 months out of school. All I remember them telling me was that there was something wrong with my blood.

Giving it to my girl or my wife just scares the hell out me. I don't want this anymore. So, here I am.

[cuteus]

I am sure that someone as well read as you already knows that hep c is not just a liver disease, that long term  chronic infection gives birth to many extrahepatic conditions, and that to just offer tx to those with a higher level of damage than stage one, is a disservice.
Plus at 49, not knowing if complications will arise that will halt the present trials, there is not much time to play with.
Once you have an emotional, financial and physical commitment to tx, stopping makes all that work a shameful waste.  
Following your train of thought, I should have waited for better tx since I was stage one.  Who is to say that the other symptoms I developed  prior to tx could have waited with me?  You know there is more to choosing tx than liver damage.
The age, medical insurance availability, extrahepatic conditions, all play a more important part in the decission making than liver damage, in my opinion.
Stating that someone should think twice about tx extension if they do not have stage 3 damage is discounting the committment and time  they already invested.  Almost like saying; 'your damage is not as bad as mine, so you can wait';  almost.
I have read this twice to different people (one with cryoglobulinemia)  and am personalizing the statement, since I too chose extension, if for no other reason than to ensure SVR, since there was no pressing medical reason to erradicate HCV.
I guess is just getting to me.

[jmjm530]

I apologize if I have offended you or anyone that was not my intent. To treat or not to treat is a very personal decision and I'm sorry if I did not make that point. I also offered two references with two very different points of view. Please read the references. Dr. Gish makes his points with much more intelligence and elegance than I am able.

All I'm saying is that there are two different points of view.

I applaud your decision to treat at stage 1, it was obviously the right decision for you.

In my case, I can categorically state that if I was a stage 1, after what I've been through the last 14 weeks, I would wait for newer therapies. But that's just me.

The main point I was trying to make was not whether to treat or not to treat, but how agressively do you treat if you're a stage 1 and are still virus positive at week #12. In this situation, a stage 1 might opt out of treatment while someone with a more advanced stage would find opting out more difficult.

Again, sorry if I offended anyone.

[willing]

wheatgrass: getting your Dr's OK for an extension and just continuing to submit the reimbursement forms sounds like a good strategy. Though you've benefited from almost a 4-log drop in VL, your odds of getting to SVR with the standard 48 week tx have dropped from the 50-60% range before you took your first shot to about half that now because there is still detectable virus. Unfortunately this drop is very well documented, both in the recent studies TN cited and in the original Schering and Roche clinical trial data. However,how much of that loss you can recoup by extending is less clear, nor is the optimal duration clear. The two largest extended-tx studies, cited in that CME article above, have used a flat 72-weeks and gotten some encouraging results. It they refuse to pay, I  think your most productive path would be to work with your Dr. to convince the ins. co. that terminating your tx at 48 weeks directly jeopardizes your chances of SVR and thus violates their coverage contract...

califia: thanks for the kind word. I guess you and your Dr. will never know which one of you is right, but congratulations on getting the extension you wanted, and on the final success!

[chellski]

i don't know about your insurance; i don't have any.  I am on a program thru Roche (makers of pegasys/copegus) call Pegassist.
all my meds are free - i don't think it would hurt to call them or have your dr. get in touch with them.  Definitely seek out all options to treat as long as poss.
good luck.

[Califia]

One of the most useful things we can do here is exchange information about the treatment philosophies of our respective physicans.   I, too, am fascinated by the wide diversity of opinion in the medical community.  Here's another personal anecdote.  I consult on the side w/  the aforementioned Dr. Gish, who was my hepatologist for many years before an unfortunate change in insurance due to my HCV status, ironically enough.   What I can tell you is that his practice is still recommending the Buti formula of treating for 36 weeks past viral clearance.   Gish's associate, Ed Wakil, advised me only a couple of months ago that treating for any longer than 52 weeks in my case was probably unnecessary.  (Did I take his excellent advice to heart?  Well, no.)   I mention this only because my situation was very similar to that of Wheatgrass, as we were perhaps only a couple hundred virions apart at week 12 and each of us had experienced substantial and early VL drops.   Frankly, I was surprised to hear Wakil's verdict, but there it is.  He did not consider me a slow responder and felt my odds for SVR were good.   Of course I am also on record as clearing at week 16.   If relapse were to occur, Wakil added, the next step would be infergen.  

Wheatgrass, I hope this info can contribute in some useful way to your decision-making process.   The bottom line is to remain optimistic and supremely confident about positive outcome while we're swallowing the poison, for however long we do it.   The very best of luck to you.

[jmjm530]

Wheatgrass,

I’m sure you decision to treat came after long and careful thought. But you probably are aware that many doctors might have advised someone with your apparent long history of the virus, and yet only stage 1 fibrosis, to enlist a watchful waiting approach, as opposed to treating now.

“Treat or not to treat” is one of the many controversies in this field, and the pro’s and con’s are covered at length in a couple of excellent articles, “Controversies in Hepatitis C Therapy. You can link to the complete articles here: http://www.medscape.com/viewprogram/2053

Robert Gish, a leading Heptologist, and in fact a very aggressive treater, takes the position of selectively treating for HCV. Douglas LaBreque, takes the opposite position that virtually all patients should be treated.

But even LaBreque states: “Obviously, there are some patients where you may consider deferring or not using therapy at all. Patients who have a long duration of disease with minimal evidence of damage on biopsy, particularly those with genotype 1, may wish to defer treatment until a more effective therapy for genotype 1 is available or one with fewer side effects. Older patients who have minimal disease, particularly those with major medical problems, are also good candidates for deferral of therapy."

In your case, and in spite of minimal (stage 1) damage, you have decided to treat. Certainly an understandable choice that has proven successful for many in your situation.

But the decision you really have to make now is how aggressively do you want to treat the virus based on the fact that you’re a slow responder at week #12?

If you were a stage 2 or especially a 3, or 4, then you really wouldn’t have too many choices. You would probably treat harder, longer, and perhaps with a different interferon until you cleared, regardless of the odds. And even if the odds weren’t good based on your 12-week PCR, the benefit in this case would keeping your fibrosis at bay.

But you’re a stage 1. And as a slow responder, you have to carefully weigh the odds of clearing, against the potential side effects, both during and perhaps permanently after treatment. You have to weigh all this against the fact that the chance of cirrhosis in someone who is stage 1 and has had the virus a long time, is very small. And against the fact that better and safer treatments like protease inhibitors will probably be generally
available in about five years.

I don’t want to sound negative, in fact my position is just the opposite. I think you’re an enviable position that I personally would love to be in. You can treat and try and get rid of the dragon, or you can justifiable pull back for now and wait.

Whatever you decide, the best of luck. Again, I don’t want to dissuade you from continuing treatment, just carefully weigh the benefits against the risks, and if treatment at some point becomes too rough on the body, remember, you're one of the lucky ones who doesn't have to stick it out at all costs.

[wheatgrass]

Thanks for all the helpful comments. I have read and printed out the articles referenced, plus some others I found. I will bring them in to the doctor visit around the 16 week mark. I talked to my doctor's nurse about doing tests every 4 weeks between 12 and 24 weeks and she sounded like the doctor would order those no problem. I'll have to talk to the doctor though about the extension part. I'll come armed with these recent studies. I'm pretty confident my doctor is the best in my area, but no one knows everything, especially when running a practice and keeping up with all this new info coming out. I have a feeling she'll support extension if I want that. I'm pretty sure she even mentioned it as a possible path in some cases back when I started this. At the least I think I will go push for at least 36 weeks after testing undetectable, unless I still have a measurable load at 24 weeks. I don't know if I could afford that much extension all out of pocket.

Finding out if insurance will cover extension will be, I think, problamatic. After a number of phone calls asking direct questions, I was unable to even get them to tell me before I started treatment if they would cover that! Although they didn't actually say this, they were in effect saying "Send in the forms after you fill your first prescription and you'll find out."

That's what I did, and a week later, I got a check from them for their half of the prescription. If I extend, I think I'll just keep sending them in and just not even mention the word "extension".

Again, thanks everyone.

[Califia]

First, congratulations on that impressive VL reduction.  Worry not, that definitely bodes well for eventual SVR.   As for these medical semantics, you've put your finger on the problem very clearly.  Definitions, and even testing criteria, seem to vary significantly from study to study.   What's a poor patient to do?  Until there is some kind of professional consensus we're going to keep going in circles about treatment strategy.  It's that tricky either/or EVR classification--the 2+ log drop OR undetected criteria.   And exactly which is it?

Hep Guy's response came in while I was in the paragraph break and it's absolutely excellent as always. There is nothing to add except that I still vote you invest in another PCR in 4 weeks' time, and hope that it won't cost you an arm and leg --  maybe just a left liver lobe.   (Rumor has it they regenerate.)

[TnHepGuy_]

The nomenclature certainly can be confusing - and seems to be used rather interchangeably. In general, though, what I see used is:

- Rapid Viral Responder (RVR) = >=2-log decrease by week #4 or undetectable.

- Early Viral Responder (EVR) = >=2-log decrease by week #12 or undetectable.


You've had a 4-log drop since beginning tx - making you most certainly an EVR - which is the terrific news. The not-so-terrific news is that you haven't cleared completely by week #12 - which puts you in the category of "slow-responder".

If you take a look at the table of data in <a href="http://www.hivandhepatitis.com/2005icr/ddw2005/docs/hcv_052305_b.html">Reddy</a>, you'll see that of the 133 patients who had a >=2-log drop by week #12 yet remained HCV positive, only 34 went on to achieve SVR after 48 weeks of tx (for an SVR rate of 26.3%).

And here is some info from the <a href="http://www.natap.org/2005/HCV/060605_01.htm">Ferencia</a> study: "<i>Among patients who had had a

[layla]

I had a 2 log drop at 12 weeks but was not clear though I was under 600. My hapatologist recommended 48 weeks from clearing which I agree with now. The only thing I would have done differently is get tested evey month. After the 12 week test I tested again at 24 weeks and did an additonal 48 form there. I had wanted to do 36 form clearing as some docs recommend at taht time but my doc recommended 48. After have been through tx it is MUCH preferable to me to have done and extra 12 weeks on extension than do it over. No question about that. It nay not seem it now or at the time but when you are done and get SVR life goes on and looking back it makes happy I did it the way I did. It can be done.... LL

[wheatgrass]

I went from a viral load of 6.73 million just before treatment, down to a load of 760 at week 12. Given the high starting load, and if I understand the 2log thing correctly, then during the first 12 weeks I've had a 2log drop and then almost another whole 2log drop (6,730,000 to 67,300 would be a 2log drop, and 67,300 to 673 would be another).

So, I'm an early responder, I think, but what is confusing is that some treatment duration studies I read use the >=2log drop in the definition of early responsers, but then they talk about the EVR group as though they were all undetectable at week 12 (which doesn't doesn't match the definition they give of what an EVR is).

So if I've dropped to 760 at week 12, but it isn't until week 24 that I show as undetectable, am I considered an early responder or a delayed responder? It seems confusing.

[Califia]

What concerns me is that you (WG) say you have "bad" insurance, and indeed their coverage does seem to be minimal.  What are the chances they would  extend coverage to 72 weeks?  It doesn't seem very likely.

This is such a tough call.   Until definitions of "early responder" become more stable and further data becomes available,  optimal treatment duration  will be difficult to determine.   Wheatgrass,  you did not mention whether or not you've had at least a 2-log drop by 12 weeks.   That would be another factor to take into account, as is the amount of fibrosis you might have.  The more advanced your fibrosis, the more time you might want to spend in treatment.

Willing, I've been on a small vacation from posting and obsessing about all things hepatitic.  (There have to be some perks at 51 weeks of tx.)   Just wanted to tell you how much I've appreciated your thoughtful, research-based comments.