Viral Breakthrough at 64 weeks

I'm absolutely devastated.  Too numb to cry or to think.  My husband has been undetectable since week 13 (geno 1, stage 4), but we just got a copy of his 64 week PCR in the mail, and the virus is back.  Not a big jump:  18 copies, but detectable just the same.  Sort of feels like someone yanked the ground out from underneath me -- but that must be nothing compared to what my husband must be feeling.  

It's hard to think of what the game plan should be now.  Is the consensus these days for or against maintenance therapy (keeping VL low/und to preserve liver function)?  Should we be expecting a call from the docs that he should stop?  Trying to focus on moving forward and feeling a little lost.  Thanks for reading and any input.
~eureka

[orleans]

praying for ya'll, love jerry

[Bobby1952]

  Get another VL test before doing anything. There are lots of false positives in PCR's. Get another one to verify it.

Bobby

[jdwithhcv]

I'm so sorry to hear of this.  I agree with Bobby, a second test is important.  Make sure its not a false positive.

I'll be keeping a good thought for you both.

jd

[jepperone]

Your feelings are quite understandable and am sure your husband is at a low point as well, I am sorry to hear this after going 64 weeks und. As above I would go for another re-test and go from their. On the positive side 2011 is just around the corner.

jep

[Bill1954]

Aw cr@p.

I imagine whether or not to undergo maintenance treatment is going to be between your husband and the doctor, but I don’t believe there’s much, if any evidence that it’s effective. The results of the IDEAL study suggest otherwise; and if I remember correctly, these results were disclosed in 2007, and more recently here:

http://www.hivandhepatitis.com/hep_c/news/2010/010510_b.html

“As previously reported, after 3.5 years, patients who received maintenance therapy had lower liver enzyme (ALT and AST) and HCV RNA levels, but were not significantly less likely to progress to hepatocellular carcinoma, decompensated cirrhosis (e.g., ascites, variceal hemorrhage, hepatic encephalopathy), fibrosis score increase of 2 or more points, or death.

In the present study, the HALT-C team explored whether persistent HCV RNA suppression during the trial was associated with reduced clinical outcomes. This analysis included 764 patients treated during the lead-in (standard combination therapy) phase of HALT-C and randomized to the maintenance therapy or no further treatment (control) arms.”


I’d be very tempted to continue treatment until this result can be verified with another test; we’ve seen low-level viremia falsely reported before; it’s known as a ‘TMA blip’. That’s a good place to start, I’d think; and go from there.

So sorry to hear this news… I’ve been here watching his brave struggle with this. I hope they find test error, and this will wash under the bridge for him, Eureka. All my best to you both,

Bill

[RCM829]

My heart just sank!
Oh, how I hate this crazy disease. Yes, get another PCR as soon as possible.
I don't believe maintenance therapy holds the cache it once did but lets take one step at a time. Lets see what the re-test shows.
I think you know you are truly in my thoughts and prayers.
We are right here for you, O.K.?
Robert.

[justme53]

I agree with some of the other posters. Re-test and stay on tx until the results come back. In the meantime, sending prayers and positive thoughts to support you through this blip.

Hang in there! Pam

[epiphiny]

I also echo what others have had, please have a second test and stay on treatment until the result comes through.  False positives DO happen.

[child24angel]

I've been on this long journey with you and I have to believe
in what our friends above have said....stay the course for now
and get another test.  Mistakes can be made, a false positive.

My heart is with you

Hugs
Elaine

[newleaf09]

So terribly sorry and surprised to hear of a breakthrough so far along.  I agree that he should re-test to be sure there was no lab error.

The Halt-C study found no value to maintenance IFN.  As I recall, fibrosis still progressed in patients who did not clear the virus.    

[GreatBird]

I had a blip (<25 but detected) at week 24. I was on a clinical trial and they called me back to retest. The next test was UND and so have the rest through 48 weeks and 4 weeks post. I'm waiting on the results for the 12 week post and I've got everything crossed.

The clinical trial folks felt it was a false positive. I'm hoping your DHs was too. That's a very low reading.

[jacksonblue]

very sorry to here this dont what to say being negative for 51 weeks will definitley help his liver . i relapsed after 72 weeks and biopsy did show a improvement went on to treat with pi 24 weeks and svr best wishes

[IMstacie]

this news is devastating and I also hope is is a false reading.  I will be praying for both of you.

[Willy50]

suppressive therapy, maybe better news;
http://www.natap.org/2009/HCV/121409_01.htm

I'm really sorry to hear about the breakthrough.  All that I can say is that there are good things coming and that this does not mean the end.  Further, If he is a responder it is very likely that the PI's will work for him.  Yes, his staging is a concern, but the PI's may be out in about one year.

Finally, I have a friend who was in a similar situation as your hubby.  They had failed TX twice and were approaching decompensation.  They planned on starting suppressive therapy, but first they started a regimen of diet and exercise and started w/ a few supplements.  They started TX with full dosing and so far have attained an RVR.  

My point is that one never knows.  Never give up, never lose hope.

I know this is crushing news but hang in there, BOTH of you.

best,
Willy

[portann]

Hi Eureka,

I sure as heck wouldn't change course at all until the results of another viral load test are in.

Too numb to think? I can understand that too darned well. Try to remember how far you've come together, through the transfusion and other temporary setbacks. You're a dream caregiver in this gruelling treatment and you seem to always adapt to whatever comes your way.

I'm out of touch with HCV issues these days but aren't there several conversion factors for copies to IU/ml and therefore, your husband's currently reported load of eighteen copies could be converted into anything from about 3 (three) IU/ml to about 18 (eighteen) IU/ml?


International Units to copies/mL.
Assay Conversion Factor
Amplicor HCV Monitor v2.0
(manual procedure) ........................1 IU/mL = 0.9 copies/mL
Cobas Amplicor HCV Monitor v2.0
(semi-automated procedure)............1 IU/mL = 2.7 copies/mL
Versant HCV RNA 3.0
Quantitative Assay...........................1 IU/mL = 5.2 copies/mL
Cx HCV RNA
Quantitative Assay...........................1 IU/mL = 3.8 copies/mL
SuperQuant....................................1 IU/mL = 3.4 copies/mL
http://www.hcvadvocate.org/hepatitis/factsheets_pdf/viralload_%202009.pdf


I'm not sure I'm converting correctly - being way too sleepy - but at eighteen copies, no matter the conversion factor for your husband's test, a lab error is certainly possible.

That's where I'd focus next, getting re-tested and ruling out error. This wouldn't be the first time that false results have sent people into tailspins until they found out otherwise. I think NYG had a false positive of 60 IU/ml four weeks post-tx and that's higher than your husband's number.

Fingers and toes crossed....

If not, you can sort that out, too; relapsers who went on to succeed can help point the way.

Best of luck and warm-up hugs,

Susan

[evangelin]

First a big hug from you and you know I understand the emotions.
Next, I wonder if it could be a passing blip that will be gone when you retest.  I remember someone in the past on medhelp having something like that but my mind won't recall who it was.
If not, I know you will regroup and form a new plan. Our roles and approaches have been similar.
Joe just had his first labs drawn after a 15 month failed tx.  We are very late to do this because finances have been a problem.  His albumin score is higher than before starting tx.  So are his rbc,wbc,hgb and even platelets are a little better.  His enzymes are worse which might just mean his cirrhotic liver is producing the enzymes better than before.  I don't know that is the case, and all the improvements are small ones, but at least things don't look worse than before.
If the time comes and you want to look in to it, the 3.0 dose of LDN had a positive effect on getting Joe back on his feet after tx.  His recovery was , in many ways, faster than the shorter failed tx of the past.  I don't want to rock your boat with anything new to worry about right now but I just thought I would mention LDN as a positive possibility.  Our Dr. didn't know if it would help or not, but he considered it very safe to try.  It isn't expensive either.
Well, I do hope this turns out to be an insignificant blip but I pray God to give you both the strength you need either way.
Your Friend,
Ev

[nygirl7]

Yes get another test to confirm before he stops treatment!  I had a false positive at EOT = "60".  The doctor insisted it was a false pos but I kept thinking it was just failure, relapse. I did what he said and got retested and it was negative. Has been ever since.

susan400 was right.  '60'.  But it wasn't real at all so it turned out ok - just don't give up, go get him retested!  It's worth the chance right and to turn up pos that late in the game and while still on the meds doesn't seem too likely to me!

Deb

[charm27]

I would defnitely get another test done.
Im sorry you received this news............................Im praying for the both of you.

Sending prayers
Hopefully this will be a bad error.

Love
Charm

[meakea]

News like this makes my heart sink but I echo what everyone has said for getting another test.  I'm sorry you are having this awful stress at this time.  I will pray for an error.

[miked]

Very similar thing happened to me on my first round of tx with SOC drugs.  I was a geno 1b, started tx at like 3M copies, got the 2+log drop but then never really went UND (unlike your husband).  At week 32 my VL went fro 9,600 to like 17,000.  I stayed on tx until the retest came in and it was around 30,000...game over with a viral break-through.

My first tx was really rough on me and I was worn out, under weight, mentally distressed but determined to kill the virus.  I studied my options and almost enrolled in the Infurgen trial which I heard has much worse symptoms than standard INF.

I ended up meeting with Dr. Paul Kwo from Indiana Med Center.  Unlike your husband I had virtually no liver damage.  We discussed getting me into one of the PI trials.  I took a year break and enrolled in the Vertex Prove 3 trial.  As luck had it, I got in the arm with RBV (people like Susan400 got in but without RBV and failed).  I also got in the arm with 12 weeks of VX950 + SOC follwed by another 12 weeks of SOC.  I went UND somewhere between week 1 and week 2 and remain UND today.  Prove 3 ended for me in October 2007.  I'm cured.

Things understandably look pretty dark to you guys right now.  They say it's always darkest before dawn.

Study your options, especially with the new PIs.  It isn't over until you say it is.

I don't come here everyday anymore but do lurk often.  If you need to reach me for any reason please feel free to send me an inmail and I'll get right back to you.

miked

[copyman]

so sorry to hear the bad news. this is exactly why I hate this disease. i agree with a few of the others about re-testing & treating again when the new PI's come out.

I really think with that low of VL it could be a false positive. usually relapse VL's are much higher as this disease comes back with a vengence.

If it turns out to be a relapse hang in there because this diseases worst enemy, PI's are right around the corner. You will beat this, you deserve it.

[Trish77]

Devastating news. A low number like 18 doesn't make sense and I'm hoping it's an error.  I'm going to hang in there hoping this is a false positive. Beyond that, I'd look to alternative therapies and PI's if it must come to that. I'm very sorry that you're both going through this right now.   My heart goes out to both of you.  Hanging in there with you.

Trish

[copyman]

forgot to ask, what weeks did your husband have PCR's done throughout tx? what was the sensitivity of the tests?

[merryBe]

so sorry for you guys if this is true. So sorry to hear it.

But please keep upbeat for now. The doctor who invented the tests admitted there are many false positives.

We just had a young man last week get retested and he was negative.

the thing is, if your husband relapses a number that low is virtually unheard of.
If the virus comes back, it usully does so with a vengence, and VL climbs often well above what it was before treatment in record time. So 18 is just too low to take seriously.

that number is far more likely to mean themachine was not pristinely clean as it should be, or that one slide touched another which can easily happe and cross contaminate. It only takes a molecule of blood to show up many virons so these machines must be vigorously maintained.

I'm just suggesting it would be very odd to have a reading that low and the chances are you will discover on a retest that he is still UND and many already have.
So before you get too upset, hang in there and insist on another test, preferably with a different lab.

[willing]

very sorry about the setback, but as others have said it's no time to lose the significant investment made. False positives are certainly a possibility though the odds there are pretty slim. The data on occult/residual infection (and there's quite a bit of it) suggests that even in the presence of residual virus SVRs are cured - ie the immune/viral balance has changed in a way that keeps the virus at very low levels.  Either way, pushing on seems the right strategy - perhaps maintenance therapy until a PI can be added. There might be some option for release of the PIs on a special need basis once the phase III data is complete and regulatory review is in process.

[Isobella]

Sooo sorry to hear you are going through this.  Don't throw in the towel yet....as so many others said above....get that 2nd PCR to determine if it was a false positive.

Thoughts, prayers and hugs headed your way.

Isobella

[eureka254]

I am so very touched by the caring and outpouring of thoughts and wisdom from everyone.  You've all helped so much to keep me upright and my feet on the ground.
What a difference a day and a forum make.

orleans:  thank you for the prayers -- every little one counts!

Bobby1952:  great advice and good reminder -- test, read, repeat!

jdwithouthcv:  yes, absolutely time for a re-test -- a little limited by what lab the insurance dictates, but the plan is Heptimax, <5 range test.  The good thought is that vl or no vl, he's still hcc-free. :)

jepperone:  definitely knocked us to our knees for a moment, but my husband, being the Marine he is, is back on his feet, ready to battle as the need calls.  (The doctor of need just hasn't called yet).

Bill1954:  It seems yet another paradox: there's lots of discussion about 'giving the liver a rest' by suppressing VL, but the medical literature as you point out with HALT-C & IDEAL don't support that.  Guess it's the nature of a stage 4 to grasp a little at any and all possibilities, well supported or otherwise (though be it perhaps not wise...)   It's encouraging to know that there are TMA 'blips' -- being that my husband was getting nervous about the EOT, it's actually not much of an effort to just keep on keeping on.  (As it stands, I think my husband is inclined to just ignore this result for the time being...)  Easy to do since we haven't heard from the doc/nurse as yet to discuss the results.

RCM829:
It's a good thing my husband has long laid claim to and embraced insanity -- otherwise this disease and treatment WOULD certainly have made him crazy by now ;) !  We've recovered from the initial shock and are now back to one foot in front of the other (his in front of mine, mine in front of his...)  Really appreciate your support.

justme53:
Good to hear from you -- I hope you're hanging in there, too!  ( I now know what fighter pilots feel like when they see/hear 'blip' -- let's shoot it down with a missle!)

epiphany:  such irony, that positives make one feel so negative... but this thread hit me like your moniker -- ah, yes, likely a false positive... let's hope!

child24angel:  words of wisdom echoed by words of an angel will help keep us on course -- your encouragement is heartfelt.

newleaf09:  we were preparing ourselves for the post-tx anxiety waiting for PCR, but this was definitely unexpected -- if not unheard of -- but we were surprised.  This is definitely one instance where we actually DO hope for lab error.  

GreatBird: so wishing for SVR for you!  Hope springs eternal, but knowing my hope was someone else's reality is tremendous solace.  Thanks for sharing that.  

jacksonblue:  our hope is that even if he doesn't get SVR out the grueling 72 weeks that it will at least do some good -- and knowing that even 72wk relapsers can succeed with PIs keeps us focused that even relapse for a cirrhotic is NOT the end of the line.

YuK:  we felt yuk, read yuk, and do feel better. :)

Willy50:  thank you so much for the link; in addition to VL suppression, the prevention of recurrence/development of hcc is especially pertinent to my husband (post-left lobe resection for massive hcc).  Up to this point there's been very little literature or data relative to successful maintenance/treatment of hcc patients (largely attributed to low survival rates), but it gives us some hope that this extended treatment is a good option for him even without SVR.  (None of the my husband's doctors at the 'highly-esteemed university medical center' seem to have an established protocol, or even suggested recommendations for his singular situation, just lots of "we're not sure" and "not enough evidence" responses.)  Our first wish is certainly for SVR, but if not, the aim is to stay compensated, hcc-free and healthy until release of one of the PIs.  

portann:  thanks for the kind words... and real-time PCR analysis!  Definitely keeps things in perspective.  Funny thing is that in light of this new test result, my husband has now decided he's going to ask to go back to full dose riba (he's been reduced by 200mg/day because of hgb below 10 again) even if it means repeated transfusions -- I wonder how the hepa-team will respond to that...

Evangelin:  big hugs back to you and your hubby.  We're definitely traveling the same highway -- my husband has all kinds of questions now in his head (infergen?  supplements?  maintenance while waiting for PIs?)... but for now we'll take it slow, retest, and see what conclusions to draw from there.  With the exception of AlkPh, his liver enzymes have been near normal for months, so the PCR came as a shock, but this too shall pass.

nygirl7:  ...and you're proof that 'breakthrough' and 'SVR' can live side-by-side!  It did seem odd, 18 copies... definitely not enough copies to put a brake on week 65 just yet.  

charm27:  your prayers are appreciated and good cheer always welcome... thanks.

meakea:   your support does help sooth the stress -- god bless.

miked:  I know you're a long-time member, and very much appreciate your post -- it's heartening to know that even the most difficult cases can be cured, and I'm very glad to hear that your trials and tribulations met with success.  Thank you so for sharing your story and extending your friendship.

copyman:  my hope is that even with this result, there's still a possibility for him to be SVR like you... a copy of copy.  As far as PCR testing, his docs were pretty thorough (with a little knudging):
0wk   17million IU
4wk    9,170 IU
8 wk   71 IU
12wk  <50 detected (at which point we requested <5 sensitivity)
13wk  <5 undetected
24wk  <5 undetected
36wk  <5 undetected
48 wk <5 undetected
56 wk <5 undetected
64 wk 18 IU

Trish77:  thanks for the encouragement -- in the end, if he doesn't SVR this time around, it'll be a race to see if he can make it to the PIs before the TP staging makes it to him.

MerryBe:  With all that you have on your plate it's very kind of you to post your thoughts and good cheer.  

willing:  have noticed your absence and it's great to hear from you.  My husband certainly didn't go into this treatment expecting fairy tale endings, so though it's definitely a setback with a resounding thud, we are further reinforced with the reality that the possibilities, good or bad, are endless and it's a rite of passage with this treatment to expect the unexpected.  Great point about the 'special need basis' for pre-FDA approval use -- definitely filing it in the mental cabinet for possible future use.  Many thanks.

Isobella:  I haven't thrown out my red shoes yet!  If weather dictates they need to go into the closet awhile, so be it --  it will only be so that they stay fresh and clean for the next dance...

~eureka

[willing]

re TMA blips,  the following (free-access) may be relevant:

http://www.ncbi.nlm.nih.gov/pubmed/18816437

the closing line makes the main point:
"because patients with positive TMA results may achieve SVR, management decisions during therapy should not be based on a single positive TMA test result."

but the data is also pretty interesting. In this group, 11 of 180 SVRs still showed virus, as measured by TMA, in the "graduation", 6-month post blood sample that awarded their SVR as PCR-negative. On follow up, an average of 30-months later, the 9 of these 11 they could round up  were still und by PCR, but now also by TMA. Sometimes things just take a while.

[volvic]

It is highly recommended to be tested again...
18 copies at week 64 could mean a false positive.
I had just before christmas myself a poz result with 17 copies i believe and continued therapy and am since that result non dectable
best of luck and think about the fact if the virus were to come back itis normally in the thousands and not such a low number of copies

[eureka254]

willing:  thanks for the excellent link.  I'm also learning that PCR amplification results and interpretation is pretty clear-cut, but the TMA process, perhaps not so much...

volvic: very much appreciate your comments and input.  Gives us hope that SVR isn't out of the picture quite yet...

Just an update: so I finally got a hold of the nurse today, and she didn't have any good answers, but she did agree that a re-test is in order.  She presented 2 possibilities: that it could indeed be a lab error (fingers crossed); or, it could be the first sign of viral breakthrough.  When posed the question, she stated she haa not had anyone treat with her for longer than 72 weeks.  (At which point we talked a little about the old HALT-C/IDEAL data and the new perspective now, three years later.)  

In either case, the treatment continues: a repeat Heptimax is scheduled for tomorrow, and the nurse is setting up a visit with the head doc next week to discuss the results, the plan, and the next CT Scan. Thanks to everyone for your support.  On eggshells until then... ~eureka

[GreatBird]

Sending good thoughts your way.

[child24angel]

Sending good wishes and prayers your way

Hugs
Elaine

[mikesimon]

I wish you the very best.
Good luck!
Mike

[justme53]

Good luck with the PCR re-draw today and here's hoping for a false positive.

Hang in there!

Pam

[Myown]

Good luck!

[nygirl7]

i can't wait to hear your good news - negative negative negative negative!!!!!!!!!!!!  Gosh it's going to seem as long for us in here almost as for you!  Sending all of my best thoughts prayers and wishes to you!!!!!!!! ♣ I know that is a club but to me it's a lucky charm ;)

[Trish77]

Waiting to exhale....my thoughts are with you both.

[Proactive]

Let me add my well wishing and positive thoughts also Eureka. I'm in the camp of lab error/contamination, especially with you so far into tx. I can't remember anyone here having a breakthrough in the later weeks of tx.
So best of luck, Pro

[mikesimon]

For what it's worth - I'm in the lab error camp too.
Again, good luck.
Mike

[merryBe]

if his enzmes were normal, that would make lab erroe even more likely....when the virus returns the Alt's normally shoot way up...mine went up ten fold...

if his were still normal, then the PCR was almost assuredly in error...

still waiting to hear....hope hope hope.

[eureka254]

Finally got the call this afternoon:  HUBBY'S HEPTAMAX IS <5 UND AGAIN !!!
(I usually don't like to shout here, but couldn't help myself on this one!)
Wow, what a rollercoaster ride. And it's NOT game over!

I almost can't believe it... finally stopped pinching myself (and him) long enough to get my hands to the keyboard and let all you wonderful people know, and to say how grateful I am to all of you.

Thank you ALL so VERY much for keeping my hopes up, and the support, and the wisdom... just everything.  

Just a footnote:
Because he's still UND, doc visit is postponed for a couple of weeks until after his quarterly CT-scan.  I found it *interesting* that his nurse responded that she herself has never encountered a similar situation (i.e. TMA-'blips'), and if he had tested positive for VL, maintenance therapy would be out of the question -- but in light of UND, the question still remains to be discussed with the doc.

Big hugs to everyone :)  
~eureka

[can-do-man]

That is great news, really happy for you both.........

cando

[child24angel]

The is WONDERFUL !!!!!!!!!!!!!!!!!!!!!!!!!
TRULY WONDERFUL !!!!!!!!!!!!!!!!!!!!!!!

Hugs
Elaine

[Bill1954]

And the marathon continues… thankfully, I imagine. Here’s to hoping that blip was something funky with the test dynamics, and not your husband’s immune surveillance. And good luck with the doctor’s appointment too; I trust you’ll let us know the outcome of that in a couple of weeks. Best to both of you—

Bill

[toaofpooh]

This gives me Goosebumps! :-)

[Trish77]

Doing a Snoopy happy dance here!!!!  :)  This is AWESOME news, Eureka...and now I can exhale. :)  I'm so very pleased for both of you...to infinity and beyond!!!

*big hugs*

Trish

[smaug48]

WHEW!!  :-)

[willing]

very, very good  news!

(and you might want to give  Nurse a pointer to that study lest she terminate someone else's tx prematurely)

[kciav]

Great news!  What a relief for you.

[mikesimon]

Truly fantastic news!
Congratulations!!!
Mike

[positude]

Glad to hear the good news. Best wishes!

[RCM829]

I am so happy for you both!
The fact that a TMA blip can occur (if indeed that is what this was) is interesting - I was previously unaware of this occurrence. This  bodes well for all of us currently doing SOC extended treatment.
You deserve this - keep up the great work!
My very best to you.

[comeagain]

What a relief Eureka can´t imagen the stress you and your husbands has been going through, give him the best from me.

Jan.

[comeagain]

Sorry husband not husbands because your not an old time mormon are you.

But that was only the men who could have several wasn´t it ?

[lapis]

I have just read this whole thread, and sorry I couldn't chime in sooner.  I also had a false positive, four weeks after finishing tx, and I was devastated.  But the folks here on the forum reassured me, I got the retest done after the weekend, and that result was UND.  Boy, it was so scary!  I was already planning to re-treat ASAP, just rushing forward in my mind, when in the end it was a false positive!

I'm glad your husband's test was UND this time, I really understand how that feels, and glad to know you're on the other side of it.

Lapis

[GoofyDad]

HR mentioned more than once that TMA's could get contaminated (from even a tech who happened to be HVC Pos if I remember correctly). You can see his patience waning on the subject:

http://www.medhelp.org/posts/Hepatitis-C/hepatitisresearcher/show/368386

"Yes, extremely important in this context. Thats why i have pointed 3 times already at the false positivity problem of theTMA and described the incredible cumbersome means to avoid false positives using  the supersensitive PCR test  (below 2 iU) at Labcorp/NGI."

[justme53]

That is extremely good news!!! So happy for both of you.

Hang in there, Pam