12 WK Labs

[tahoeunicorn]

Ok I had Dr. fax copy of my 12 wk they are as follows:

Total Protein    8.9 g/dl        (HIGH)

ALBUMIN        3.5 g/dl

SGOT (AST)    26 U/L

SGPT (ALT)     12 U/L

GGT                126 U/L       (HIGH)

ALKALINE PHOSPHATASE   132 U/L    (HIGH)

TOTAL BILIRUBIN     0.7 mg/dl

DIRECT  BILIRUBIN   0.2 mg/dl

HCV RNA, PCR QUANT       (HIGH)         13528       IU/ML          <10

HCV VIRAL LOG                  (HIGH)         4.131      LOG IU/ML     <1.000

WBC            6.1

LY#              2.5

RBC             3.94

Hgb             12.3  

MCH            31.3    pg

MCHC          31.3    g/dl

RDW            15.8  %

Plt               205         x10^3/uL

      

[Tallahassee]

I concur with SFbaygirl's recommendation:

"Throw in some Alinia, some Oxymatrine a little double dosing..."

All the best & do not give up!

[sldb]

I agree with sfbaygirl. Being 1a stage 4 cirrhosis it took me longer to reach the 2 log drop and und. than most. My hep  extended tx now svr.  We are slower to respond but it doesnt me we wont respond, what do u have to loose by staying o tx. I would find another dr.  At this stage we dont have alot of time to waste.

[sfbaygirl]

3's are not that different anymore...wisdom says they aren't good to go 24 weeks anymore and also 800 Ribavarin is outdated, so why is she a non responder. We know that VL flucuate, not only that but some tests are not as good as other PCR's as far as accuracy.  As we have seen 1's go to 24 weeks for UND, why not 3's. Okay, I understand that she didn't have a 2 log drop, but who is to say? Given the fluctuation of VL's. I dunno, we sure seem to be in a lot of uncharted waters these days....I sure would give it a chance given her stage...why not try to make it to 24. Throw in some Alinia, some Oxymatrine a little double dosing.  Seems like thinking outta the box for people is the way we can get SVR these days...Now I have to say I wouldn't take it to the extreme before I let it go, but 24 weeks seems a fair time to extend with some tweaks to SOC...Just my opinion!

[jmjm530]

Thanks for the clarification. Yes, she is definitely a non-responder. The 72 week studies are therefore not relevant. Hopefully her doctors will come up with a plan. Hopefully there are some correctable issues such as fatty liver, body weight, dosing, etc -- that her current doctors and/or a consult will pick up.

-- Jim

[comeagain]

she s a geno 3 not a 1 thats a whole different tsk due to RVR newest thoughts is 2 week for RVR gen 2,3 if not UND week 12 your defenitly non responder

[jmjm530]

Less than a two-log drop at week 12 is definition of "non-responder" as used by most studies. That is not to say she can't try for UND before week 24, and given she's a stage 4 that's certainly a reasonable option, but she would need a med team to support her and perhaps try something to accelerate the viral decline. If you look at many of the 72-week extended studies, they only extend if EVR (two log drop at week 12) and not with non-response (less than 2 log drop at week 12). That said, many of those studies used fixed dose riba and didn't customize treatment. It's not an easy call and a really good medical team is where I'd turn to, not saying she doesn't have one because I don't know. Also don't know what her current medical team has in mind, perhaps they have a trial they want her in right away, but in any event hopefully she will get more answers when she meets with them tomorrow. Another opinion (or two) is always a good idea in situations like this.

-- Jim

[sfbaygirl]

Interesting...as I posted in your other thread.  I perhaps don't see how you are a non responder. Maybe Jim or Bill or someone can explain why this is. I understand you didn't have a 2 log drop at week 12, but why not go to 24 weeks, perhaps with 2 interferons, more riba throw some Alina in there....dunno. Just seems like there is a chance at success here with some alternative SOC tx and other drugs. 12 weeks isn't the end, as we know. She did drop by week 12, are you saying because it isn't a 2 log drop that she won't clear by week 24 with some extra tx's in place?  Could someone explain to me why? I guess I am not getting your take Jim and Bill.  I would like to hear more.

[tahoeunicorn]

Thanks To Everyone. I have been able to change my dr.appt to Monday so I don't have to wait until Friday to ask my questions. His PA knew that I was really upset Thursday when she called me. So I'm not giving up. I may have to wait on new Meds. Whatever it takes I'm gonna do. I will still be around.

JMJM  and Bill-- Thanks I think I understand more of what I am up against now. Much Appreciation.

Lynn

[wyntre9]

I know how disappointed you must be but if you are not responding and haven't had a 1 log drop, I agree with everyone who said a different approach may be needed.  And being on week 61, I have to say that if this particular TX isn't working then you should spare yourself and your body and wait for better meds.  Personally, I have found it gets harder as time goes on.

Keep us posted and hang in there,

wyntre

[jmjm530]

My guess is that she will be labled a non-responder regardless, since she didn't make two logs at week 12  --  but if you're thinking future trial criteria, probably best to check on a trial by trial basis. Really no easy answers because moving on from this point is uncharted and probably would require at least two years on tx for a decent shot, and that assumes that she gets UND pretty soon. So either that, or stop, regroup and try again -- Maybe sooner than later with Telaprevir if they will accept non responders and if data from current previous non-responder trials look good.

The problem as you know with uncharted waters is that you need captains, i.e. physicans, up to the task, not to mention being up to the task yourself. Of course, step one -- as Frijole suggests -- is to take a good hard look at correctable elements in the current failed regimen. Just so many variables.

[frijole]

THose results are a little gloomy.You may have to regroup and start again after you have had a little recovery time.  Did you take all your meds?  No skips? No reductions?  I would still get the second opinion.  Fishdoc had virus in the 10 thousands, started upping the riba, and cleared, but she did have a substantial drop.

Bill - thanks for the ALT AST lesson.  Good information.

Tahoe, don't know what to say.
frijole

[alagirl]

Also, if you're basing everything on one test and the result is somewhat... unexpected, never hurts to ask for a retest.  Of course, this is from the girl whose insurance company tests for anything anytime, no problem.  Some doctors worry about asking for tests.

[Bill1954]

Hi Jim-

Thanks for the thoughts, and yes, I follow your train of thought here. I guess my concern was to see Tahoe stay in the game long enough to show viral response, even if the odds may be stacked against her in terms of SVR for this round.

As a cirrhotic non-responder, the currently (comercially) available therapeutic options are limited; even a temporary response at this juncture might open up doors to future attempts at IFN treatment. What is your take on this line of thought, if you don’t mind? I know one thing, it’s hard to weigh decisions like this; my hat is off to clinicians that face this on a daily basis.

Always good to hear from you--

Bill

[jmjm530]

That puts her in a more difficult spot being stage 4, but unless I read the studies wrong, a two-log drop at week 12 seems required for reasonable odds even if tx is extended to week 72. That said, maybe we've had some here who defied those odds by very long extensions and/or bumping up meds but I'd call that uncharted waters. But if those waters are tested, I'd imagine she would have to do something to get UND ASAP.  Not easy decisions, and hopefully the doctors at this facility can guide her well. A good second opinion would also be helpful.

[Bill1954]

Hi Jim; good advice to Tahoeunicorn, by the way. I mentioned the enzyme ratio in context to a previous comment in another thread:
http://www.medhelp.org/posts/show/430936
~~~~~~~~~

“Feb 07, 2008 06:40PM
I have called Insurance company and they will cover 2nd opinion. I just have to find the Doctor. Think I'm gonna call UT drs tomorrow. to late to do anything today.
Thanks yall are just what I needed to pick myself back up.

Bill-- According to bx done 5/07 Stage 4 grade 3 cirrhosis.

Now I start Fighting again

Thanks”
~~~~~~~~~~~~~

Take care,

Bill

[jmjm530]

I wouldn't call this a viral breakthough -- or not call it one -- just more or less a flat curve from week 4, as the difference is only around a log. Main point is that it didn't go down and your are detectible at week 12.

More of a concern, and perhaps the reason they want you to stop treatment, is that you didn't have two-log drop by week 12 (EVR). Even the 72 week studies suggest you need a two-log drop in order to have a decent chance of SVR.  In fact, you had less than a one-log drop in 12 weeks -- so again, your doctors may be making the correct call because extending tx beyond 48 weeks may have no benefit. Of course you'll want to go over all this with your doctors.

As to your ALT/AST ration and cirrhosis -- not sure I'd jump to conclusions given your high platelet count, unless a biopsy or other clinical symtons are out of whack. Did you have a biopsy? What about your ultrasound? Size of spleen? You will want to sit down with your doctors and ascess the amount of liver damage as best you can.

Given what appears to be a null response, continuing to treat may not make sense if you have significant liver damage, and less sense if you don't have significant liver damage. Again, discuss with your doctors.

Sorry things don't look better, but newer PI's like Telaprevir are out there.

-- Jim

[Bill1954]

From a comment above:

“While your liver enzymes are low, the concern is the >2:1 ratio of AST/ALT. This is quite often the case with cirrhotics.”

While one would expect to see elevated liver enzymes with a cirrhotic patient, this is clearly not the case in all situations, as you demonstrate so well.

Generally, elevated ALT/AST serve as diagnostic markers for liver disease. In many cases, this is what alerts Primary Care Physicians to problems. Many of us here have high enzymes, but typically, the ALT is higher than AST. When that ratio changes, and AST becomes 2x higher than ALT, that CAN indicate cirrhosis, among other things.

Nothing unexpected with this reading, but it serves to underscore the fact that low enzyme values are not necessarily predictive of good liver health. Schering-Plough is currently trying to educate health care providers about this issue through the use of CME’s, and is trying to get them to consider patient risk history along with traditional methods of diagnosis for HCV evaluation.

Nothing to worry about though—

Take care,

Bill

[tahoeunicorn]

Thanks All I did call my GI's PA and she has rescheduled my Appt. to Monday. So I explained to her that I had a lot of Concerns and Questions. Gonna get my pad and Write them down otherwise I'll forget.

HarryBeads: Thanks for the calm down..

Thanks to EVERYONE,

Lynn

[HARRYBEADS]

   Don't panic and get bent out of shape . Talk to the Docs and or do you have access to a Nurse practicioner in charge of you that you can call and talk to. We have one that I email every concern to and she talks to the Docs and gets right back to me,same day. Most people here are on treatment and they're opinions are Fogged up. No offense to anyone but he needs to ask the Doctors his concerns, so they can address them.

Harry

[Deb_c430]

Geesh I know that feeling!  They need to increase something as Bill and Debby said.
They changed me up a bit mine went up also.  Waiting now for pcr, regardless my Gi will go three more months.  

I am 1a, tho.    like Deb say knock it out  1 2 3!

[nygirl7]

Wow that sucks it looks like you've had a viral breakthrough - and it WAS going away so well!  Sometimes those of us who start with lower viral loads have it much HARDER  - even though most doctors and papers say it's easier to get rid of with a low starting viral load.

You do still have 12 weeks to add some more riba on board and see if you could whack it out but you are already on Procrit and it's not going to help your Hemo level any for sure.

How soon can you get in to see another hep doc?  Is there any chance that you can get into a vertex trial?  You are starting so darn low - jez this sucks.

I'm not an expert on any of this stuff - but with your viral load going up that is not a good thing and changes everything.

LEt's see what some of the other guys say before reacting but it almost seems like you'd be better off stopping for a few months then coming back on stronger meds and knocking it out 1-2-3.

[tahoeunicorn]

Pre-TX VL 19,901  4 wk VL 1,366 HCV  IU/ML by bDNA.

Yes I do take Procrit have been for 8 weeks. week 2-- RBC took hit and Plt.

See I don't understand it seems like my VL went UP???? can that happen???
Damn I'm confused

Bill--While your liver enzymes are low, the concern is the >2:1 ratio of AST/ALT. This is quite often the case with cirrhotics.
I don't understand what you mean..

Now really HELP.. this CrazyUnicorn is going Crazier or loosing my mind maybe who knows..
Thanks guys
Lynn

[nygirl7]

Tahoe do you remember what your baseline VL was?  13,000+ isn't very high - no way without the number to figure out how many logs you dropped.

Still - you have 12 more weeks to change the current treatment protocol - adding more riba might make your hemo drop but...it might make the difference that you need.

I've never had an ALT number that low in my life - the lowest I ever saw was 19 and that was with SVR.

Whens that appointment with another hep doc?  What was your baseline VL?

[Bill1954]

It appears that you’re liver is still fully compensated, and retains its synthetic function. Platelets, t. bili, and albumin are all excellent, so I would imagine you are in early cirrhosis (child class A).

While your liver enzymes are low, the concern is the >2:1 ratio of AST/ALT. This is quite often the case with cirrhotics.

Your Hemoglobin is still quite reasonable at 12.3. Are you currently taking any Procrit/EPO? If not, this could be a crude measure that you serum ribavirin concentration is below therapeutic levels. What is your assigned ribavirin dosage currently?

All in all, you look good for a cirrhotic- based on this data. This is the time to hit it hard, in my opinion. You might become RNA undetectable in days given the correct combination of meds. The chances of relapse are greater for you than some- but I think this is the time to get aggressive, before you begin to decompensate.

Try to be aggressive with the clinic at UT, and let them know what your dealing with at the front desk; otherwise they might put you into standard rotation, and it’ll probably be weeks or months before you’re seen.

Good luck, and let us know how things are going—

Bill