Not quite UND

[neptune235]

Hi,

I'd like to solicit some opinion/comment on my HepDoc's decision to stop treatment.

I'm a WM, 51, GT 1a, infected over 30 years, probable early cirrhosis (last bx was 3/3, about 3yr ago).  This is my third go-round at tx.

Starting with the Alinia trial, I did 8 weeks of Pegasys/Riba.  I left the trial (viral load not decreasing fast enough), and switched (with no break) to daily Infergen/Riba (15mcg / 1400 mg.)  I've kept this up for 31 weeks now.  I've been on Procrit 40,000 since week 12 of the Infergen, and have had two transfusions over the course.

My viral load started at 35,000,000 and has dropped steadily the entire time on treatment.  I've had monthly PCRs, every 2 weeks for the last two months.

So now my viral load is 153 IU/ml.  Two weeks ago, it was 550.  I've never had a viral load  number larger than the previous one.

My doc tells me that since I'm not UND at over 24 weeks, I should stop.

I recognize the odds of SVR at this point are very low, it seems like I should continue, for another month or so, to see if I can get to UND.  Presumably, I would then complete an additional 48 weeks.

Got to get to UND before SVR, and I'm so close...

[Snookmiester]

I was more a stage 2, borderline 3........My actual biopsy report is probably in the archives if interested. The Fibroscan was administered in Dr Schiff's office, and the results interpretted by him. That consultation is probably also in the archives under my old screen name.....SnookMan.
There has been many members see reversal of damage, some without obtaining SVR. Not sure if Dr Cecil's forum is still up and running, but he commented on it many times.

[smaug48]

Thanks for posting.  Great to hear that someone went from stage 3 bridging fibrosis to 0-1 fibrosis after SVR (assuming the Fibroscan was accurate).

smaug

[Snookmiester]

Glad to see alot of good info still going around these forums, but just wanted to throw down my $.02....If you've come this close, and the VL IS dropping, continue if you can. You're a slow responder, and HCV doesn't always play by the rules or by what is written and logged in a trial. If anything at all can be said about this disease is that it has a mind of it's own, and each and every individual is unique.
I for instance was infected at birth. At 25yrs old, had stage 3 bridging fibrosis and type 1a. My VL was only in the thousands, yes thousands. On one of my heptimax's, it was in the hundreds. Dr's belived that my body was fighting it, yet not strong enough to supress it on it's own. But then again, I had stage 3 fibrosis also remeber so I had been infected for many years. This goes against most studies and trials.
Today I'm SVR, and have stage 0-1 fibrosis as revealed by the Fibroscan.
My words of advice are to keep going. SVR is the goal, but slowing the virus down is just as much important. If you are tolerating the meds, and slowly dropping in the VL......you are still responding and might just need to go an extended length of time. I know quite a few that were in your shoes and made it to SVR. Some that went the daily infergen route for 80-90 weeks. 48 weeks is a best case senario, each and every case is different. Talk with your Dr, and if you don't like what he or she says, find another....I treated with Dr Schiff in Miami, because I wasn't satisfied unless I was going to the best. Good luck with whatever you do

[Marc1955]

I hear you. In any event, large sample or not, here's hoping you make it 3/3.

Marc

[smaug48]

Well, that's the thing, there aren't more data.  I decided I wanted to give this tx the best shot I can because I'd prefer to do it just once.  

My doctor expressed doubts because of the minuscule number in the study. Fortunately for me, she respects the opinion of her patients with regard to their treatment.

I can only hope that a study comes out in the next few months that says conclusively tapering is ineffectual, and that super late responders need only add 50 (or anything less than 60) weeks to when they became und.  Anything that would give me confidence in ending tx earlier than my current plan would be more than welcome!!!

smaug

[Marc1955]

I'm like you, I'm a super late responder. Unfortunately I can't place any faith in a finding involving a total of two patients who achieved clearance by extending treatment like this. If I brought this study to my doctor, I think he'd laugh at me and I wouldn't be able to argue. 2/2 is just not enough to base a treatment decision on. I wish there were more data.

[smaug48]

Like you, I feel like I'm on a different schedule than most people.  I didn't und until week 28.  I've decided to treat for 88 weeks based on the study that Walrus posted above.  It's the only study I've found that has any data on SVR for super-late responders.

You might find this thread interesting:

http://www.medhelp.org/posts/show/577942

smaug

[Deb_c430]

So now you should be begining count of infergen, it all restarts, for the GIs , same old yuck for us!

So how ya feeling? hang in there,  Why did you switch after 8 weeks?

[neptune235]

Hi,

Thanks for the comments.  Just to be clear, I've done the 31 (now 33 weeks) of infergen, AFTER the 8 weeks of Pegasys.

[Deb_c430]

Same here Joe,   Your time restarts when there is a dose change. Or a medicine change.

Deb

[joemc34606]

You said you hae been on peg and infergen for a total of 31 weeks, if you take away the eight weeks you were on the peg you have only been on infergen for 23 weeks. I failed twice on interferon and went straight from interferon to infergen I was cleared at 20 weeks and have been clear since. I take weekly shots of nuepogen and procrit. I should finish treatment in June. Cant wait. Im no doctor but I think if I were as close as you I would at least keep going a few more weeks to see if you get und. I see a hepatoligist in Florida and see says after being cleared I should stay on 48 weeks, so thats what were going for. Good luck Joe

[neptune235]

I met with my HepDoc last week, and we agreed that I would get one more viral load result and if not UND, then to go off treatment.

So...my results came back today -- UND!!!

WooHoo!  So...I am pressing on for at least another 48 weeks...

[Rockerforlife]

Lokks like you may have to get in on the PI trials that are on going right now...to be honest...the odds of SVR with not clearing at wk 24 are very low...i think ive read somewhere between 2-5% will SVR in this group...i have read this in a study in the past..sorry to hear  your news about still detectalble at wk 24....i would get in on a PI trial

[neptune235]

Marc, I agree about the small sample size, which Brent noted.

However, it does demonstrate that it is possible to achieve SVR despite being dectable at 24 weeks.

[Marc1955]

Brent: One comment, a study of nine patients has no statistical significance whatsoever. Although the study seems hopeful, it falls substantially short of anything you could base a treatment regimen on.

[neptune235]

Thanks very much for the link to the Arase study, it appears to be directly on point.

I'm inclined to agree with you -- it will be a hard road to do an additional 48-60 weeks after UND, in light of treating now already for about 40 weeks.

Still, I am encouraged (despite the overall low odds) by the fact that the viral load has decreased steadily, and never risen.

BTW, my VL was 1 log down at 6 weeks, and 2 log down at 16 weeks, which is why I left the Alinia study.  

I'm just not on the same schedule at "regular" people, it would seem. :)

[IAmTheWalrus]

Here's a link to the Arase Study:

http://www.jstage.jst.go.jp/article/internalmedicine/47/14/47_1301/_article

[IAmTheWalrus]

If you have/had time to wait, the standard advice of not continuing after 24 weeks if not UND. If you do not have other options (trial study, waiting for newer drugs), then quitting now may be a hard pill.

Though the standard advice is not to continue if not UND by 24 weeks, I think sometimes that is not always the right way to go. There is some data from a small study in Japan (Arase, et. al.) that deal with longer treatments for slow responders (not UND at 12 weeks) and super-slow responders (not UND at 24 weeks). It comes down with better SVR odds when slow and super-slow responders continue TX for 60 weeks after UND.

If you had a 2Log drop in VL at 12 weeks and your VL has continued to come down durring TX, then I might consider looking and the longer TX. Obviously, if you do not get UND pretty soon the outlook gets worse. As you said, you have to get to UND before any treatment has a chance.

Be warned, that the extended TX is likely to be much longer than the current 48 week and 72 week TX with the attendant difficulties with side effects. You have to seriously ask yourself and your doctor if you are up to this.

Also note, that in the study, there is a very large percent increase in SVR among the extended treatment patients. But you have to consider the small sample size (only 7 patients with slow response and only 2 patients with super-slow response). The study shows statistical significance, but it is hard to draw conclusions from such a small sample size. Maybe a detailed discussion of this study with your doctor would be a good idea? Maybe a post on the expert forum to Dr. D. and he could weigh in?

Best of luck to you,
Brent

[kitkat14]

I tend to agree with portann.  The meds have obviously taken their toll on your system, requiring a blood transfusion is not a standard side effect, as far as I know.  Hopefully you have had some regression in your grade of liver damage as a result of having taken the meds in the first place.

I think I'd stop and wait for the next round of new drugs, if at all possible.  I'm at week 32 so I know the determination to finish the treatment is strong, but I think you need to let this one go.

All the best.
k

[portann]

Just thought I'd bump your post to the top for comments.

If I were detectable at over 24 weeks, I would listen to my doctor, and wait for another day and newer tx. Your 3/3 based on a three year old biopsy is a big concern, though.

There may be some people here in your situation who have personalized a treatment plan with an extra-long extension but I don't know who they are. I hope they respond. The prevailing thinking is if you're undetectable by 24 but not 12, then treat for 72. There are still many doctors who are not even keen to continue if not clear by 12.

You're so close but not close enough, in my limited view, to justify continued exposure to the meds. Until such time that you hit the jackpot with a treatment that works effectively for you, it would be best to get an up-to-date biopsy and see if your 3/3 has regressed. That would be great breaking news for you.