test results

[diane04]

Hi everyone, I am new to this forum. I am a 41 year old female. I drank beer pretty much daily until diagnosis in 2005.(could have had this either since 1991 or 2000) At that time my viral load was only 210,000 and alt and ast just avove normal. I was worried about cirrhosis due to my party life. Just had my biopsy this morning, went great. I had blood work done, platelets at 246, alt 66, ast 60, hcv viral load 10 mil and everything else optimal. The mcv was high at 95.9. clotting time is 10 sec. My question is I am suppose to start study drugs around the 12th next month will the mcv hender that? I am doing the roche r7128. Oh yea all my fibrosures over the last 5 years have been at the lowest end of the chart what are the odds of the biopsy being different? I am concerned about the mcv because I was told mcv says anemia.

[GoofyDad]

I'm acqainted with the treatment of decomp cirrhotics. Dr Gish at CPMC was (still is?) at the forefront of this some years ago.

Try this link for a gaggle of exclusions for compensated cirrhotics.
http://clinicaltrials.gov/ct2/results?term=vx-950

I don't mean to snipe, but it's troubling that you would just now look to find whether compensated cirrhotics are excluded, rather than before posting with such authority.

[newleaf09]

Perhaps it's the phase of the study that determines if cirrhotics are included.  Cirrhotics and stage 3's may be less responsive to therapy.  They probably wouldn't want riskier patients to be in the study of a new experimental drug for fear of poor response and increased risk of unforseen side effects to a new drug.  Can't move forward and get more funding if you endanger some of the patients.

I haven't looked much at the phase 2 criteria but I think most only exclude decompensated cirrhosis, not sure, hard to find the phases on clinicaltrials.gov.

I am pretty positive that the majority of phase 3's include compensated cirrhotics.  Those are trials that try to guarantee they have all of the safety kinks and proper dosages worked out and they just need the numbers to present that the drug helps everyone (it's all about marketability).

There are even studies for treating decompensateds only but they require intense monitoring of patients and the budget to cover treatment of adverse events.  Pity we don't see more.  They do see some successes in those trials.

[GoofyDad]

I should probably look this up, but my recollection is that the VX-950 Phase 1 and Phase 2 excluded compensated cirrhotics. In fact, I believe we had some board members who were excluded for that reason - a gut wrencher for someone who's  running out oof runway.

I would certainly agree that some studies include cirrhotics, but I think it's misleading to suggest that it's never a disqualifier...it often is.    

[diane04]

thanks to all and as soon as I get bx results I will post. Can't wait to see the differences and/or simularitys between bx and fibrosure. have a great 4th!   diane

[HCA]

I am currently in the Vertex Telaprevir Phase 3-one of the most important studies.
The trial protocol states as an exclusion 'any indication of liver decompensation'.,so I think Newleaf''s statement is correct.
Remenber that cirrhotics are queing in droves to treat with the new drugs and the trials must reflect the conditions which will be encountered in clinical practice.
Moreover the Vertex results announced at EASL 2009 refer specifically to outcomes in cirrhotic patients.

[GoofyDad]

Compensated cirrhosis is fine in studies

That's a peculiar statement, made with a great air of authority. I presume you to mean in a minority of studies?

[newleaf09]

Compensated cirrhosis is fine in studies, gives them a broader range of data.  Decompensated cirrhosis (liver failure) is usually excluded, however.

[copyman]

if your fibrosure tests have been on the low end and with platelets as high as yours I would say it is almost impossible you have cirrhosis. cirrhosis will stop you from getting into most studies. you will be fine. good luck in the study.

[newleaf09]

MCV is nothing.  Entry into a study will not be allowed unless you can start within certain guidelines.  Don't worry about biopsy results, they will not exclude you for that, they just want an idea of where you are.  Do you have a number you can call to reassure yourself that you are within the required parameters?

Everybody who participates in a study worries they'll get shut out before the start or be dropped when they are in it.  If you don't want to call them, you'll probably get the biopsy results over the phone in a week and can ask them then if you've satisfied all the screening stuff and if they have anything that could exclude you.  They are truly looking for suitable participants and will only exclude someone who falls outside their parameters.

Sure wished I'd worried less about getting in and being dropped.  I never really had a thing to be concerned about.

[HCA]

MCV stands for mean cell volume and is the size of the red cells when they pop out of the bone marrow.It is not an issue re your treatment.
The biochemical marker for anemia is your haemoglobin count-if this is normal you don't have anemia.