Advice on 12 week PCR needed

[miss moneypenny]

Hi all,

need a bit of feedback on my numbers for my 12 week PCR.

Here are my numbers:

Baseline VL - 155,000 IU
4 weeks - 44,000 IU
12 weeks - 3,000 IU

My baseline viral load of 155,00IU was only done 7 weeks before starting treatment, and was not repeated with first shot bloods, and as my VL (at another hospital) was only 17,000 copies 14 weeks previous to this I am wondering if it could have altered quite drastically at start of treatment from the 155,000 7 weeks before treatment.

I know this does not quite make the 2 log, I think it is 98%, but my nurse is happy with this and feels that it is not a bad drop. I suppose I am kind of relying on the fact that the baseline could be way out, but wondered what your take on this was.

I was also a bit concerned because it was an early PCR, as I take my shot on a friday and usually have PCR on a thursday, yet we had to do the 12 week on a monday as nurse was going to the Liver conference in Vienna.

I do know that it will be what it will be, but I am sure that you are aware how daunting those weeks of waiting and worrying are, so any input would be very gratefully received.

Hope everyone is doing well and feeling good

xx

[amommy]

Good morning!  I don't have any words of wisdom about your numbers, but it is CLEAR that you are a responder.  When will they do another pcr test for you?  Is there any way to get one in a couple of weeks to see where you stand?  
I'm sure plenty of others will have more insightful things to say :) Hope you are hanging in there ok!

[NYgirl]

Well...you didn't hit your two log drop (which would have been 1550) so that part is not good news.  They want you to be either clear or hit a two log by week 12.

I had a 3 log drop by week 4 but did not hit CLEAR until week 24 (somewhere between week 12 and 24).  My doctor most likely would tell you to stay on treatment since you ARE responding and see what happens at 24.

Sometimes those of us who start with very low viral loads have a harder time hitting the numbers for some unknown reason. It makes NO sense since they always try to tell you having a low viral load is a good predictor - but I find that information to be fake fake fake from my experience watching who has hit and who has not.

I would bet like me...if you continue you will hit clear by 24.  It probably does lower our odds a little but you know...this whole THING is a great big cr*pshoot and NOBODY really KNOWS who is going to SVR or not - so I think it's worth sticking with it big time!

I hope that gives you some encouragement!

[bobbyullc]

your baseline was  5.19 log

your 4 week was at 4.6 log

your 12 week was at 3.48 log

that is only a 1.71 log drop at the magicle 12 weeks.              
you dr. must know something he has not revealed.

good luck you are close.
bobby

[NYgirl]

FYI

Most of us have NO idea what our viral load was right prior to starting tx.  It seems all of us had the PCR weeks/months beforehand.  It IS a major problem with this tx - if they WOULD give us a test like the day before it would make it so much easier to "really" tell.  

But it just doesn't seem to occur to docs to be important like it is to US.

Hang in there!

[FlGuy]

No, Goof something else....
Great: I read your comment below and still don't quite get what your doc said about that lump.  Did he acknowlege that there was a lump there at all? If so, any guesses as to what it is? Or did he say that the presence of a lump is nowhere except between your ears?

[bobbyullc]

your vl is very very low so you have an excelent shot (no pun intended).
bobby

[NYgirl]

Low viral load can be a curse not a good thing always.  Look at some of us with very low numbers to start we had a MUCH harder time getting clear and log drops and stuff.

I certainly wouldn't stop treatment until I saw 24 week numbers...no way they couldn't make me. You are responding just not in the way that would guarantee the best results.

[mikesimon]

I would be optimistic if I were you. The truth about viral load is that it does fluctuate more widely than most people realize because most people don't get labs frequently. If you are considering your viral load to be 155,000 IU/ML than NO, you didn't have a 2 log drop. BUT YOU DON"T KNOW YOUR STARTING VIRAL LOAD. The 155,000 was from 7 weeks prior to starting TX and it could have changed significantly by the time you started. I had a viral load of 6.85 Million IU/ML 6 weeks before starting TX and at treatment time it was 3.65 million IU/ML. Mine decreased but it could have just as easily increased. I have seen, and so have a lot of members here, marked fluctuation in VL and the possibility exists that at the time you started TX your VL was higher than 155,000 IU/ML and that perhaps you did have a 2 log drop. There is no question that you're responding and I would view that in the most positve light there is. I can not see any advantage in seeing it any other way. I wish you the very best. Mike

[Mister beagle bailey]

like NY girl and amommy said your responder.  You did take the PCR test 3 days after your shot and I think you should have taken it on the 6th day or the morning of your next shot.  That's what dr tell most recommend.

amommy-- Tonight is your last shot right?  How are you feeling , better?

NY deb--How are you doing ?  I answered your e-mail, where is can do Zack?  He has not been on.  I also answered you a cajun down below on a thread.

BEAGLE

[ohgreat]

-->"Careful when and where you rub, you don't want to give us heppers a bad reputation"

Im already worried enough about the possibility of red palms, dont need to worry about the hairy one either. :D  har har (sorry people, lame atttempt at comedy)

This Dr. is my specialist. He treats a ton of people with HVC.  I just have to wait for Biops.(end of month)

[NYgirl]

ohgreat

ALL of our livers in here have inflammation pretty much.  That is called the "Grade" it is part of the whole process.  Liver damage.  Inflammation is what eventually makes fibrosis. How much fibrosis you have is the "Stage".

For example I am Grade 2 - Stage 3.

When you get back the biopsy you will see exactly where you stand on how much liver damage has progressed.

That is what most people use to determine if they start to treat or not.  Someone who has a Grade of 1 might not want to treat .....  inflammation is NOT UNCOMMON IT IS VERY VERY VERY VERY PREVALENT WITH ALL OF US IN HERE

DO NOT WORRY SO MUCH ABOUT IT = WE'VE ALL GOT IT!

Stop worrying before you make yourself CRAZY.  if you had no inflammation you probably wouldn't have hep.

Try to BREATHE and RELAX!

[ohgreat]

I am I am . I swear Im not worrying that much anymore.  Following yalls advice and just trusting in the new HCV doc has helped tremendously!  I'm just reporting on the conclusion of my 'manic panic' I've been going through.

At one point last week I had my 2 cats on their backs in my living room floor and I was rubbing on their livers trying to feel something...like test animals.  You should have seen the "Oh God, what is he doing now?" looks on their faces.  :)

I gotta admit, im not the tough guy type, im a long hair sensitive artist.  I've been going through a TON lately and I have been so lonely.  Things are getting better now though and I can see what you where saying about how it does get better!!

Next monday I get to pick my girlfriend up at the treatment center, she finally gets out after 4 and 1/2 months.  Cant wait to have someone to hug on & be able to be there for someone again.

:)

[NYgirl]

I tried to fix the home computer last night it's FRIED I have to reformat it this weekend (which means = hard part - finding all the disks LOL).  It begins to boot and then turns off bing bang boom.

I know I backed up my personal pictures and stuff recently but I HATE that I lost all my emails and junk!

I haven't seen CANDO I will check my mail and see if he has written back to me from yesterday.  I tend to think that I talked to him THEN because I was answering emails that were days old from him but it FELT like it was from yesterday since that is when I read them you know>?

[ohgreat]

No, he said my liver is definately inflamed.  I am feeling my inflamed liver. (it is huge and I could be feeling the distinct lobes which feel like two distinct lumps)

He seems to be more concerned with science than rubbing around and speculating i guess so hes not going to give me answers until biopsy, blood tests.  what a quack. ;)

[FlGuy]

I know what you mean.  You gotta wonder about docs who are interested in icky science stuff. So, what are the next steps? Is he referring you on to a specialist? Is he ordering other tests? What's the plan? Careful when and where you rub, you don't want to give us heppers a bad reputation

[FlGuy]

The return of your girlfriend will be a big relief to the cats too.

[willing]

OK, I know this is might seem harsh/cold, but I believe that the very supportive and encouraging nature of this board sometimes obscures the difficult tradeoffs in tx decisions. Before deciding whether to continue tx you should try to assess your SVR odds. Two studies worth looking at are <a href="http://www.natap.org/2006/HCV/040406_03.htm">predicting response in hepatitis C virus therapy</a> which tn posted above and reviews available studies in this area and <a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16618403&query_hl=8&itool=pubmed_docsum">Berg, et al '06</a> which is journal publication of fairly recent clinical trial. Per the Berg data, Figure 3,  your SVR odds are well below 17% if you do 48 weeks; if you do choose to continue you should consider  a minimum of 72 weeks and even then your odds will be below 50%. Odds are just odds, and I hope cuteus, who successfully got to SVR notwithstanding a less than 2 log drop by 12 will get a chance to comment.

IMHO, the tendency of the advice here, which is to continue tx regardless of the odds, goes against the one finding unequivocally supported by all tx outcome studies : when it's going to work, you can tell early on. From the above review:
"<em>Importantly, there has not been a single situation yet reported where a slower viral decay was associated with an improved sustained virologic response to anti-HCV therapy.</em>"
I recently learned I relapsed after 48 weeks. In hindsight, if my Dr. had ordered different tests, I might have known at week 12 my odds were poor and avoided 36 weeks of grief.
The advice to 1s that is most consistent with trial data seems to be : don't make your "should I tx" decision before week 12, then, if your VL curve gives you decent odds (>70%) continue, else wait for something better. Of course if your fibrosis is at  3 or above, none of this applies.

[mikesimon]

Do you just assume that her starting VL was 155,000? I don't know how anyone would know what it was at the start. Mike

[NYgirl]

I don't believe that every study that TELLS us whether we will have SVR or not is the bible.  I believe that every BODY is different and that in REALITY none of the "hard core" rules can be guaranteed EITHER WAY.  It's ALL really nothing but a cr*pshoot when you really look at it. NOBODY REALLY KNOWS.

I chose to continue (I was not clear at week 12) and finally was clear somewhere in between 12 - 24.  I chose to continue because that way I have a CHANCE to beat this thing.  If I take a naysayer outlook at 'odds' then I have NO CHANCE AT ALL to beat it because I will have quit.


We have to remember things like at the very LEAST right now my liver enzymes are normal (from 200s to 20s) and my liver fibrosis hopefully will at the LEAST go down a grade.  To me...that alone is worth treating.

[miss moneypenny]

thanks to you all for your responses, it is really helpful and thought provoking.

I do realise that my 12 week results are not ideal, but - as Mike commented - it is hard to just give up when for all I know my viral load could have been a lot higher than 155,000. I am not suffering TOO badly as yet, so will continue on to 24 weeks. I would ideally like a PCR before then, but so far my nurse is not keen. My Hep consultant is a very well known and recognised Hep C expert here in the UK, so I guess if he is happy to continue, then I should try and keep hopeful.

It is such a relief to have you all to bounce these things off,

All the best to all of you

xx

[GoofyDad]

Willing said: "Most 1s go into tx on the basis of Dr's advice that they have better than a 50% chance og getting to SVR. By week 12 those odds have either climbed to 70-80% or dropped significantly."

Not sure I get this. I can surely see where the 50% could move in either direction based on new information (like the VL recution ratios), but couldn't some people remain smack dab where they started? In otherwords, theoretically anyway, is there not a drop ratio that would not be persuasive either way?

I would submit that if the current algorithms don't recognize this, it points out deficiencies in our ability to measure and interpret the data.

[willing]

Mike : yes, and a 155000->300000 jump is only a 0.28 log fluctuation, about what you reported from your own tests. However, even if you round that 1.7 drop to 2, a 3000 at 12 puts you in the long-shot category per Berg. Continuing to at least 72 seems advisable.

Jim: there seems to be a very natural incompatibility between statistics and willpower/attitude in the face of adversity. Though people care about tx outcome odds before starting, once on board quitting seems like giving up. Deciding at 12 may make the most sense, but as far as I can tell, hardly anyone does. Thanks for your follow up about the CD8+T cell based tests, I guess that's still a ways off (though it looks like the PBMC based tests are starting to become more common).

[miss moneypenny]

I'm afraid I am getting a bit confused by all the big numbers now!

I just don't get it, if my baseline had been 300,000 and my 12 week was 3,000 that would be a 2 log drop, so why would that have not been a positive sign?

I am quite sure there is an enormous amount that I do not know but I thought any 2 log drop was good, is this not so?

Thanks for the input anyway!

[willing]

missmoneypenny:My point is certainly not that you can't get to SVR with a 1.7 drop at 12 ( and cuteus, with 1.8, is positive proof that persistence can pay off). However, note that a lower baseline VL of 17000 further reduces the tx-induced drop to about 0.76. Asking your Dr. about longer duration seems a good strategy. All the best.

nygirl: yes odds are just odds and if you have good reason to treat regardless of SVR outcome the odds are irrelevant. However, if you don't have significant fibrosis you may want to revisit your decision at 12. Most 1s go into tx on the basis of Dr's advice that they have better than a 50% chance og getting to SVR. By week 12 those odds have either climbed to 70-80% or dropped significantly. These are not results based on a single study, they're the cumulative record of all who have completed tx before us.

Mike: VL certainly fluctuates, but the correlation of tx outcome with drop from baseline doesn't seem to depend critically on when this is measured. For example, per your example, the fluctuation from 6.85 million to 3.65 million may look huge but is only a change from 6.83 to 6.56 or 0.27 in log units. A VL fluctuation of about 0.5 log may correspond  to a few thousand or many millions depending on your  VL range. However, a change from 17,000 (4.23) to 155,00(5.19) does seem to be large.

[prettydamscared]

Hi everyone,  My husband is starting treatment tomorrow.  51 yrs. old, 2b.  His doctor didn't order his bx to be graded or staged.  I have requested and will pick up tomorrow a newly graded and staged biopsy directly from the pathologist.  I did as Frile suggested a few weeks back and studied it myself.  I will see for sure tomorrow but believe it to be Stage 1 or 2, Grade 2, not Stage 0 -1 as his doctor told us last summer.  I am in the process of shopping around for a hepatologist as I firmly believe his doctor to be an idiot, but, in the meantime I believe we are somewhat on our own with monitoring his treatment.  His current doctor did not properly warn him about sides, didn't caution about stopping drinking prior to treatment (my husband is an alcoholic and his doctor is aware of that), it takes days to get a call back from office and I could go on and on.  Let it suffice to say that until we have another hepatologist to treat him, I'm thankful to have this board to ask questions.  I just read posts above about bloodwork for baseline vl, etc.  Ron's baseline vl is from approx. 1 year ago and his doctor's office thinks that's appropriate.  Is that too long ago to use as a baseline? How soon after starting treatment should bloodwork be done again?  Hubby's doc says 1 month.  Shouldn't red and white blood counts be monitored sooner than a month, or is that ok?  Should I suggest to him that he put off starting treatment until we've found a good doctor, keeping in mind that I have read a ton of stuff on this board and others and consider myself to be somewhat well informed now about sides, nutrition, supplements, etc. so I do know what to expect.  Appointment with well respected hepatologist in our area is May 24th and I hate like h## to suggest to him that he put off treatment until then because he'll use that as an excuse to start drinking again and besides, he's all geared up and ready. Thanks in advance for any help.
Char

[mikesimon]

For the sake of argument let's assume her starting viral load was 300,000 IU/ML. A 2 log drop would be 3,000 IU/ML and she would have achieved her 2 log drop. This would be slightly less than twice her VL of 155,000. Mine almost decreased by 50% in 6 weeks and I believe it is just as possible for VL to increase as it is for it to decrease. I have seen some significant fluctuations in VL and since Miss Moneypenny is definitely responding to the TX and I think her starting VL is unknown I'd continue the TX and have another test as soon as her doctor allows. I ralize that there can be negative consequences to TX but there are certainly negative consequences to HCV. That's just my take on it. Mike

[jmjm530]

Willing says: The advice to 1s that is most consistent with trial data seems to be : don't make your "should I tx" decision before week 12, then, if your VL curve gives you decent odds (>70%) continue, else wait for something better. Of course if your fibrosis is at 3 or above, none of this applies.
------------------------------------------------------
Yes IMO to above -- and most of rest W's post -- with the caveat that beside 3's and above, others so motivated be clearly made aware of the odds and options.  Also, some docs look for a 90% drop a month. We don't have week 8 data, but week 4 did not show a 90% drop.  

That said, because she was so close at week 12, Mike's argument about viral fluctuation must be considered -- especially in a borderline stage 2. For example, my VL was 189,000 IU/ml three months prior to treating but 1.5 million the day before treatment.

Best scenario, of course, is non-detectible at week 12, or earlier. That's why testing before week 12 can come in handy, giving the doctor an opportunity to individual treatment by changing dose or even peg, if appropriate. Some may think it overkill, but my doc ordered weekly VL tests from week 1 until I became non-detectible at week 6.  

-- Jim

[willing]

miss: the 2-log drop is definitely a good result; without it the chances of SVR are prety dim and a relatively small fluctuation in the right direction in your pre-tx test could have given the desired result. However, even with the 2 log drop the odds of SVR with 48 weeks of tx aren't that great when significant VL remains at 12 (see the two articles above for details). However, averages are approximations, statistics are not fate, and attitude counts for a *lot*. Best wishes!

jim: I'll be seeing my Dr. Monday to see about a follow up bx. I think Bill in the post below has already found the best post-relapse treatment, but he's way ahead of me...

nygirl: IMHO one of the (few) times it really pays to see a specialist is when considering extended. Many Drs are simply not willing to work outside the "standard of treatment" and more than 48 is still considered experimental and probably will be for another couple of years. Specialists seem to have greater license to work outside the box (maybe they pay higher malpractice premiums?). It might be worth getting an opinion before you commit.

[NYgirl]

According to my doctor here in New York - most GI type doctors would not be allowed prescribe to 72 weeks and would need to go to a specialist (ie: a Dr. Jacobsen type) doctor and get on a study.  He must follow the protocols in place.

Also he feels that a 72 could be more damaging than starting over and treating again if relapse.  As I already have an autoimmune from the Int...and when you stop and THINK about what the Int is doing inside our bodies...what it is killing or not killing - it makes the argument seem very valid to me.

[jmjm530]

Willing: Though people care about tx outcome odds before starting, once on board quitting seems like giving up.
---------------------------------------------
Agreed. And sometimes those of us who are the hardest fighters -- who have the most willopower -- in an ironic way those folks work against themselves in some tx scenarios.

I always liken treatment to fighting a war where strategic retreat is often used by the best generals when the odds of victory drop beyond a certain point. The idea, of course, is to re-group for a better fight, another day. The same mindset also applies to how long we treat. I was really torn between stopping at week 54 versus going longer. I knew I could go longer but in the end decided based on risks/rewards it was time to end the battle.

As I mentioned, I'm really not up on all the technicalities of the t-cell based testing, but from the little I do understand, this holds a lot of promise. Problem now is that unless we guess real lucky, all of us either treat too long or too short. Once we have the right tools to know when we clear the virus on treatment, that guesswork will be over. Another exciting development in trial, which I'm just started to follow is the integration of what appear to be Hep C like vaccines into the treatment process itself.

Not to pry, but have you made any treatment decisions yourself going forward? No need to answer if you're still mulling things over or just want to take a vacation from the whole thing for a while.  

-- Jim

[willing]

you're right, the trouble is the lack of data always makes you approximate.  Probability is just a way  of measuring uncertainty.  Before you start tx the rough measurement is that it works for about 50-55% of 1s. By week 12, you have data about how the meds are working for you and can compare your test results with the outcome of others who have treated prieviously. Ideally "others" means as close to you as possible (same age, sex, starting VL, fibrosis etc.) However there isn't enough data to make such a fine-grained comparison. If you ignore all other factors and only look at week 12  VL, then the odds look roughly like 80% for VL <50 and 17% if greater. Obviously there's much more to the story (what if your at 51 but with a low starting VL, under 40, female and with no scarring?) but there's never enough data to answer that question.

[cuteus]

nyg; I don't know where your dr gets that information, but just reading that makes me wonder about him.  When I started with the dr of liverdisease.com, she would have extended tx, if necessary(per her book), and a trial was not needed. They know how to word things for the insurance to cover things. The other hepatologist that monitored my tx until the end, Dr Bernstein, also did not put me on a trial, we just continued on to 72wks. I am worried about the information he is feeding you and, frankly, if he was my dr, I would have shopped for another by now.

missmoney, I personally believe that log drops mean diddly squat when you are still detectable at wk 12, if the dr is not willing to extend tx, I would stop before the 48 wks. Like willin said, the odds are now even lower if you continue to 48wks only. Why go on? In my case, been detectable at wk 12, even with two log drop, I knew I did not want to just end at 48 wks and relapse, not when I was in my 50's already. I looked at the Teravic 4 study, in addittion to the Berg(above) and chose that my best shot was to do at least 72 wks. In the teravic they addressed the blessed risk v benefit issue:
"The overall success of extended treatment is, of course, contingent on the assumption that extending treatment duration will have a positive effect on the risk:benefit ratio (i.e. response rates will increase but the incidence of adverse events will not). The TeraVIC-4 study was designed to test this hypothesis."  http://www.natap.org/2004/EASL/easl_06.htm
YOU decide in the end. The risk issue was not seen as significant in the teravic. Another problem with the studies mentioned is that we don't know the level of liver damage in the subjects, which could be a beneficial  factor if cirrhosis is not present in a slow responder.
Read the limited studies out there, see how they apply to you and go with the GUT. I honestly think that if you are a slow responder and are not going to extend tx, that is best to stop before wk 24.
best to you

[jmjm530]

NY says:

According to my doctor here in New York - most GI type doctors would not be allowed prescribe to 72 weeks and would need to go to a specialist (ie: a Dr. Jacobsen type) doctor and get on a study. He must follow the protocols in place.

Also he feels that a 72 could be more damaging than starting over and treating again if relapse. As I already have an autoimmune from the Int...and when you stop and THINK about what the Int is doing inside our bodies...what it is killing or not killing - it makes the argument seem very valid to me.
-------------------------
First paragraph is not exactly right. While it's true that a specialist (hepatologist) would be more comfortable prescribing extended treatment as opposed to the cookie-cutter protocols, going into a trial is not necessary. I did 54 weeks and wasn't in a trial. Others did longer than 54 weeks and they also weren't in a trial.

Not knowing exactly what the treatment is doing to your body, you doctor may have a point regarding his thoughts in the second paragraph.  Seems to me it's about time you either stop worrying and go with what your says (assuming you have confidence in him) , or get that consult with Dr. J, you've talked about. I strongly suggest the latter based on the feedback you've given us for some time now. You've gone so far, why not the extra few yards? But always easy for someone else to say. All the best moving forward.

-- Jim

[NYgirl]

Since the only option that my doctor (who says he has worked with Dr. J before) is to go for 72...I am still on the fence.  I was easily going to do 60 weeks no problem. But he says that there really is no such thing it's 48 or 72 - and honestly I'm not sure if I want to go that long.

I have to get a consult or at least a call in to Dr. J to see if he WOULD do a 60 week plan. I'm at 33 now so that leaves 15 weeks only which isn't very much.

But just doing a few extra weeks seems pointless for me...48 or 52 or something isn't a big enough difference that I would think it worthwhile.  60 however is 12 EXTRA and I would do that.

It's still up in the air - everybody (doctors included) feel something different.  It might just come down to how I feel. 72 is a long time extra

[jmjm530]

NY says: But he says that there really is no such thing it's 48 or 72 - and honestly I'm not sure if I want to go that long.
-------------
Hey, I did 54 weeks. I believe others here have done 60. Nothing in stone.


NY says:

I have to get a consult or at least a call in to Dr. J to see if he WOULD do a 60 week plan...
------------
That's a little like putting the cart before the horse, or in your case, your (or your doctor's)diagnosis before the consultant's diagnosis. The purpose of seeing a consultant is to get an *outside* opinion, not to give him your opinion (although I think I've broken that rule more than a few times. LOL.)

Anyway, the fact that your doctor has worked with Dr. J is good, but that doesn't mean that Dr. J will agree with the parameters your doctor has outlined to you.

All the best in whatever you decide.

-- Jim

[cuteus]

sometimes I wonder if anything I write is clear! I had a hard time reading my own stuff above.

NYG, he is probably going by the numbers used in the studies, 48 v 72, there are none using 54 v 48 or 60 v 48. They are just numbers, drs can decide or help you decide on the best number for you.
Mine asked ME how long I wanted to do, 72 just popped in my head because he surprised me with the question, it was just a target number, I could have stopped anytime between 48 and 72.