how long to treat for relapse

[rochammer]

How long tx for relapse? I am 56 male geno 2 stage 3 vl 2.5 iu/ml did 24 weeks of Pegasys & riba clear during tx and 1 month post. Relapsed around 4 months post alt180 ast 118 on tx alt& ast were in the teens 8,14. Six-month pcr pos.12.5 iu/ ml I am now on week 24 of 48 undetected at week 4 & 24. I am on epo but in good shape and no other health problems. The sides are very bad. There is very little information on geno 2 relapeser and how long to treat for 48-72 & odds of achieving SVR. . Should I keep going after 48 weeks for as long as my body and mind can take it or stop?  All opinions are welcome Thank you

[mikesimon]

From http://clinicaloptions.com/

It has been hypothesized that HCV patients with genotype 1 who relapse following treatment with peginterferon and ribavirin may not have been treated long enough to achieve SVR. Preliminary results from a trial in which patients were randomized to receive either 48 or 72 weeks of therapy has demonstrated that relapse was reduced from 48% to 13% in patients treated for a longer period of time.[18] Retreatment with the same dose of peginterferon and ribavirin but for a longer period of time is therefore a reasonable option for patients with prior relapse. Such an approach should not be utilized in patients with nonresponse.

I would like to know which tests indicated that you were undetectable. I question the undetectable results from some of the less sensitive tests. I don't know whether the suggestion above for type 1s is applicable to your types but as a rule I would think that the longer you're undetectable the better your chances of SVR. I have suspected that virons persist in the liver sometimes even when the plasma is clear and that if treated long enough the cells which host the virons will die and the virus will be gone. This is only a theory but it seems reasonable. I relapsed after 53 weeks but cleared late by Heptimax <5 IU/ML. I then treated for 73 weeks (clear per Heptimax at wk. 12) believeing that that amount of time would insure that my liver cells would have the time to die a "natural" death and any persistant virons would be eliminated. Just a thought but whatever I'm clear. Mike

[who_is_this]

Years ago, my husband (3a) was treated for a full year with Infergen, was clear at 3months, relapsed at 6 months.  Then retreated with Peg alone (this was back in the early days of Peg, they were still experimenting with Riba so he didn't get any) for a full year, cleared and is clear to this day years later.

[Mister beagle bailey]

I'm a geno 2B and doing tx for the first time.  However, there was a couple of 2's that had relapsed posted on one of the April 7th threads.  You are half way done with your second treatment but if it was me I would have changed meds the second time around.  However, there are many who used the same meds again and did clear and are still clear.  It's like a catch 22 with this question.
I am doing 800 of the riba and 120 Peg-intron, undetectable at week 12 my first PCR and doing shot #16 this week of 24.  Are you a 2A or 2B?  Will say a prayer that all will work out for you and you'll stay undetectable.

Beagle

[mikesimon]

Here is the link to the article I quoted from:
http://clinicaloptions.com/hepatitis/treatment%20updates/doc%20eye%20for%20the%20hep%20guy/modules/shiffman.aspx

You have to register I seem to recall but it's free and I find some useful stuff there. I hope this helps you with your doctor if extending is what you want to do. There are other articles that may be of interest so check it out. I wish you the best Kalio. I know how you feel but you did clear your blood apparently and that's a whole lot better than not responding. You'll make it. Mike

There are video presentations of the articles but I try and find the modules where I can just read this stuff. So don't be surprised if a video tries to start on you. Mike

[NYgirl]

You see what I mean - re: last email?  Good for you! :)

[cuteus]

I have the same curiosity as Jm, what was the sensitivity of the PCRs used post tx?

[rochammer]

What a great group of folks! So many replies so fast –Thanks everyone. I guess forgot some information.
The PCR is Heptimax <5 IU/ML first round und at week 12 & 1 month post tx did Pegasys & riba 800. this time peg-intron & riba 800 clear so far week 4 and 24  Geno 2 a or b undetermined

At week 20 the first round 1 yr ago my doc said the latest information is to treat stage 3 for 48 weeks not just 24. (2 & 3) He did not think that I needed to go 48 because I responded so well to tx so it stopped  

Now I (we) are relpasers and should have done 48 weeks in the first place I guess more than 48 weeks maybe 60 or 72. My doc suggested 48 to 72 at the start of round 2 but is waiting- I guess to see what new information is out there at week 48 or so and if I am still able to continue mentally and physically

[who_is_this]

Heptimax wasn't around back when my husband first treated.  Heck, there weren't really clear guidelines on how long to treat  back then!  We just decided on one year to be sure, but that was with 3x/week Infergen.

Then he did the Peg alone.  Now he continues to be undetectable <5, years later.

[jmjm530]

I believe the protocol for geno 2's and 3's who relapse is to re-treat for 48 weeks. If I remember correctly, Goofy has a study on this, and the odds for SVR on re-treatment were very good. In fact, better than for first time treaters.

Because you started treatment very soon after relapse, I assume your doctor is considering this one long (albeit briefly interrupted) treatment of 48 weeks. Not sure if that flys in the face of any studies, etc. A second consult seems in order with someone with re-treatment experience.

-- Jim

[Mister beagle bailey]

Wow,  didn't know that as I'm a 2B.  Wonder why they can't find if your a A or B?
I asked my dr. for the heptimax test for my 12 week PCR but he said no as he has no faith in that test.  Instead he did the HCV RNA Quantitive real time PCR by Quest.  

Beagle

[cuteus]

OUCH! undetected at one month post tx by Heptimax, and still relapsed! Now that is what's so scary to some, but unfortunately someone has to make the unwanted statistics, you just pray it is not you!
I was tx naive in 2003 and decided to go for 72 due to still detected at wk 12, Roch, do whatever it takes so that this time is it. However long it takes. Maybe the riba can be increased? 800mg seems kind of low for this time, but it seems to be working just as well. That is good news to be clear at 4 wks into tx.
best luck

[jmjm530]

BB,

If convenient, ask your doctor specifically why he doesn't like Heptimax? Possibly because of some reported false positives? But in any event, you could also ask him to run Quest's qualitative that goes down I believe also to 5 or 10 IU/ml at the same time he runs their quantitative. BTW do you know the sensitivity of the quantitative? Some are 600 IU/ml others are 50 IU/ml. You definitely do not want the 600 IU/ml one.

Cuteus,

Being clear one month post treatment is associated with 90% chance of SVR. Rochammer appears to be in that 10%. Hopefully, he was re-tested immediately as some suggest Heptimax has some false positives. Dieterich on his web site states he never makes a major treatment decision based on a positive without re-testing. I also have a feeling some folks are taking the 4-week test too soon and start counting from their last peg shot. I think it should be from the last riba dose (or one week post peg since peg stays in your system a week). Wish I could find out how the folks counted who came up with the 90% figure, but I couldn't. And a few docs I contacted didn't have a clear answer either, each doint it their own way. Welcome again to the world of Hep C treatment. Take your number, wait on the line, and hope for the best.

-- Jim

[Mister beagle bailey]

That is great news to hear that he is still untectable 5 yrs. later.  What geno type did he have?
I have a friend that treated about 11 years ago and back then they didn't have geno types.  He treated for 18 months with the old meds that called for 3x a week shots and only had sxs with the first shot, then was fine durning the rest of his treatment.  He is still SVR today.  Who can really say why some clear and some don't.

Just so glad your hubby is one of the lucky one's.  It's good to hear happy ending.  

BTW--I'm on the peg-intron and 800 riba.  Hope I have the same response as he did.

Beagle

[Mister beagle bailey]

I will ask him about it this week.  He did say it showed to many false positive and that the heptimax was similar to a test that was out for years and that they no longer use.  As he explained it to me, they used this old test for years and then the lab notified all Drs. to retest their patients as soon as possible that was undetectable  or still treating because the test was showing it wasn't consistent from PCR to PCR.  He said his office had to track down all that ever treated with him to be retested and they were not happy about it.  It caused a lot of unhappy patients and some had to do treatment again. He said it was he*l to go through for him and the patients.  So now he's very careful what tests he uses and he researches them before using them.  There was something about the hepitmax he didnt like. He was very adamant about not giving me the heptimax which was the test I wanted.

But will ask him and I'll ask him the name of the old test.

Beagle

[Mister beagle bailey]

Jim,
Forgot to tell you, the test was Quantitive <50 IU/ML by Quest

Beagle

[jmjm530]

Thanks. I believe the test you use (Quantitive <50 IU/ML by Quest) is the first part of the Heptimax test. If the test turns out negative, then they re-test the sample using TMA technology which is more sensitive and goes down to 5 IU/ml.

[GoofyDad]

Sorry to hear about your relapse. The chance for relapse is certainly one of the scariest things about all this. I wish you only the best.

Also, very surprised to read that you were only at 12.5 iu at your relapse. My hepatologist told me to think of Interferon therapy as acting to 'train and condition' the immune system. Based on that, since you were holding the virus that low, maybe you are nearly trained and conditioned?

I'm not sure studies have validated the prevailing wisdom that relapsers need longer treatments on the second pass. It's possible (to my thinking) that the treatments are additive. Meaning a successful second treatment could theoretically be shorter than the first. I'm not sure I would want to test that theory though :-O

I also wonder if there isn't a certain randomness going on within our bodies under treatment. Sometimes there's a cold being passed in our family and I catch it, sometimes I beat it. I doubt it has as much to do with the virus as it does my immune response at the time of exposure.

Jim mentioned a study I had read. I think he's thinking about the infamous Mangia study. In that study, 10 of 11 who relapsed on a short 12 week tx retreated for 24 weeks. 9 of the 10 SVR'd on retreatment.

You say your Docs were impressed with your clearing at 12 weeks the first time around. What I've read indicates that nearly all geno 2/3's will have cleared by 12 weeks, so I'm not sure I see it as a good barometer of response. My docs feel a lack of a 4 week RVR is a warning sign.

24 weeks has been shown to be as effective as 48 in niave geno 2/3's. I know some docs are extending tx for niave geno 3's but I'm not sure what data they base that on. As a data point for you, I believe my docs would extend geno 3's based on not being clear at week 4.  

Did you and your docs ever consider upping the riba dose? Riba had been mentioned as helping to prevent relapse. I know kalio upped hers for the second leg (and I don't think it's been fun).

For anyone who's bothered to read this far - I got a <50 PCR report today - sample taken 4 weeks after last INF. TMA results still pending.

[Mister beagle bailey]

It's the second part of the test(the TMA) he doesn't have faith in.  I just wonder what the old test was that gave all the problem that lead him to not want to do the TMA part.

Beagle

[jmjm530]

If you have a chance ask if your doc is concerned about false positives in the heptimax tma or false negatives. I can live with a false positive because I'd re-test anyway -- probably with the same test and another. A false negative is another story because it can lead you believe you're cured when you're not. I've also heard of at least one doc who also doesn't use Heptimax but it was because of a false positive on the TMA. In his opinion of course :)

[jmjm530]

Regarding the study, I was addressing Kalio, not Rochammer. Kalio's doctors only want her to treat for another 24 weeks, which (added to the 24 she already treated) would be a total of 48 weeks.

My understanding is that the Manglia study showed excellent results with re-treatment (actually better than treatment naives) who retreated for 48 weeks. That would be 72 weeks total if my math is correct. That leaves Kalio 24 weeks short per the Manglia protocol.

Maybe you can catch her and share what you learned from the study in that respect. As you know I'm a geno 1 and don't get too involved with the lesser genotypes :)

-- Jim

[GoofyDad]

I'd have to check, but I don't recall anyone in the Mangia study treating for 48. IIRC, it's 12, 24, and 12 + 24.

One thing that's worth mentioning again. Where geno 1's use the 12 week as a barometer of response, for geno's 2/3 that doesn't seem to be a terribly good indicator, as nearly all will have cleared by then. Just my thoughts.

[jmjm530]

maybe it was that the 24-week retreatment had good results for those who relapsed at 24 weeks. I believe Calio treated 24 weeks the first time and relapsed. Do you happen to know the usual retreatment protocol in a case like that. You mentioned that you would re-treat right away in the event of a relapse.I assume from what you said that you'd do another 24 weeks or would you go 48?

[Mister beagle bailey]

I would think it's the false negatives and false positive as some of his patients had to retreat.  The way he made it sound that with the old test, things were so crazy they didn't know what was up or what was down.  Do you have any idea what old test he is talking about that he is comparing the heptimax to?

beagle

[LvdByGod]

i saw you sneek that good news in there at the end of your post!!!

CONGRATULATIONS GOOFY!!!  WOW, I AM SO EXCITED FOR YOU...THIS IS FANTASTIC NEWS... YOU ARE CERTAINLY ON THE RIGHT PATH FOR THE COVETED SVR!!!

i'M A 3a TOO as you may remember... and folks, MY LAST SHOT IS THIS EASTER!!!

I'VE GONE 1YR 6 MONTHS PAST THE FIRST CLEAR AFTER BREAKTHROUGH!!!

i'm praying for a miracle clearance esp after the breakthrough at 7 months into the original protocol... any prayers are very welcome here!!!

of course my breakthrough happened on a heptimax and the doc at that time would NOT repeat it...the bum!!! i didn't get another test until 3 monts later after switching docs...this one showed that i was clear again...so i opted for extending tx...infergen wasn't being used back then for relapsers that i knew of...

i pray the breakthrough was a false positive... that would be my biggest chance of getting an Svr now... since there is extreemly low chances if any, of clearing after a true breakthrough...

i hope everyone is well...i haven't been here as much because i am livered out!!!  kalio you are my hero for doing meds so soon after the relaps...my heart just breaks to here that happened... i pray i have your courage if that happens to me...which i half expect to happen...

i wonder what then the best most reliable test is than if the heptimax has had problems...what do you all think???
i also am very interested in finding out how long retreaters do if they have the 3a... i'm starting to think 3's are vertually as difficult to clear as the 1's...

[jmjm530]

Congratulations on the neg PCR! That should at least take the majority of weight off your shoulders. As others have told me, the virus usually breaks through vigorously, and the odds of being below 50 IU/ml are slim.

-- Jim

[jmjm530]

Lv says:i wonder what then the best most reliable test is than if the heptimax has had problems...what do you all think???
---------------------------------------------------------
First, we're not sure the Heptimax has problems, but assuming it does, I would imagine that the problems are in the TMA portion of the test, not the PCR portion. When you had your breakthrough that the doctor did not want to re-test -- was your viral load above 50 IU/ml? If it was, then that was the PCR portion of Heptimax which should be a reliable as any test. That said, I think it wrong that a doctor would not re-test ANY positive that a treatment decision would be based on.

As to other test options. If I were uncertain about a result, I'd probably get tests Qualitative that goes down to either 5 or 10 IU/ml. Unlike the Heptimax, you get either a positive or negative result -- no numbers. But for testing post treatment, or after you've been non-detectible, that's all you really need in most cases.

-- Jim

[jmjm530]

BTW, as you may or not remember, the main reason I was sweating the TMA portion of the Heptimax is because customer service suggested they were re-running the TMA. That got me very nervous because I figured they only re-run positives.

If I hadn't got that piece of information, I would have been pretty confident waiting for the results based on a negative PCR. Looking back, I think customer service just didn't read the charts correctly. The "r" they talked about was probably for "reflex", not "re-run". Reflex is a term Quest uses when you get a PCR negative. The serum then "reflexes" to the TMA where it is further tested.

-- Jim

[Mister beagle bailey]

Goofy---CONGRATULATIONS!!!! I am so glad your neg.  this is great news and we do need that here.  Thank God

Loved---Wow! your last will be Sunday.  Just know your PCR will be cleared.  It's going to feel good not to do meds.

Beagle

[cuteus]

I don't know if my hepatolgy practice have changed their stats for relapsing, but at EOT, I was told my chances of relapse was 23%, until wk 12 PCR, if that was negative, there was a 17% chance of relapse until 6mo PCR, after that it was 3%. Don't ask me how they came up with that, I can't find anything when I search, but maybe we can ask in The body for the current stats used by most drs.

[GoofyDad]

Thanks for the congrats everyone. I'll admit to being as nervous as a West Virgia sheep being led into a tent when the results were read to me. I was OK leading up to it, but when it got to the moment of truth.... Aaack!

So another small milestone checked off. Next is the TMA results, then I'm planning on waiting till the 12 week (as of now anyway).

Jim - Belt and suspenders? Sounds more like having those Levi's permanently riveted on to me.

LGB - You've come a long way. My crystal ball says you're home free. Congratulations.

Cuteus - I cited a study recently (TMA vs PCR) where a relatively large cohort showing negative by TMA (<5-10 iu) at EOT had a 14% chance of relapse (measured by PCR) in 6 mos. Geno 1 was 15% relapse, geno 2 slightly better.

Most importantly, 12.5% of those negative by PCR (<50-100 iu) at EOT showed positive by TMA (<5-10 iu) at EOT - and like 96% of those were positive by PCR at 6 mos. So to infer - chances of relapse if neg at EOT by 50-100 PCR ~ 27%. Neg by TMA ~ 14%.

Ask for the most sensitive test folks.

[dyce]

Glad to hear your good news. I know from reading your post the sx's were't easy. Thanks for posting the news , your gonna live a long and goofey life! Ha have ya tole mickey and donald yet?

Dyceman

[goldyn]

CONGRATULATIONS!!!!!!! YOU DESERVE A WHOLE BUNCH OF BIG SMILEY FACE EASTER EGGS FOR YOUR BASKET THIS YEAR........