F1 to F3/F4 in one year: Is it possible?

[mike716]

Hi, everyone! This is actually related to another query I posted recently regarding the Fibroscan test. However, as I didn't get many read-outs on this specific question, I thought I'd post again.

Has anyone heard of people progressing from F1 to F3/F4 in one year, as I seem to have done?

It would help me in dealing with the MDs here if I had a better idea about this. If Willy50, GSDgirl, GoofyDad, and any of my other friends here who have a lot of experience are still around, maybe you can give me a read-out. I'd appreciate it. I just don't know where I'm at with this any more.

Hope I'm not boring everyone with dumb questions.

Thanks.

Mike

[mike716]

I'm so sorry to hear about all your problems, Frank. It makes my own seem like nothing. It sounds, at least, like you are in good hands.

M.

[mike716]

I agree. I wouldn't trust those figures too much. Butr the important thing is that, yes, apparently the PIs are an eventuality for everyone who hasn't SVRed, whether from SOC, Alinia, non-resonse, relapse, or whatever. They look like the big second chance.

M.

[mike716]

Thanks, Brent!

[franke566]

Hi Mike,  I took a while to get back to you until after my visit with my Hepatologist and this is what he told me.  Liver Biopsies in the U.S. have long been the Gold Standard used as the final determination of the over all health of ones Liver BUT it
is far from perfect and considered "Old School" even antiquated by Newer Medicine
and younger specialists.  In my case I had a Gall stone removed and the surgeon with my Hepatologist visually got to get a pretty good look at the condition of my liver from
the top side and it is totally cirrhotic in appearance.  That, combined with the Ecos, past biopsy, fibrosure-fibrospect and esophageal varices, bouts of mental encephalapathy, ascites etc. determined that I am in end stage and a biopsy could be destructive or at best only confirm what he already knows,  So being F3-F4 on the fibrosure doesn't mean a thing to him.  He told me that too often patients put too much emphasis on a Biopsy and or Fibrospecht or Fibrosure-I can't remember if he said both were the same.
I had a ventricular infarction that presented during a nuclear stress test last November
and I had a nuclear stress one year before that showed nothing.  I asked my cardiologist:  So I had a heart attack sometime between the last test and this one?  
The cardio said possibly-or this one could just be a shadow.  So he allowed me to have the gall stone removed. I survived but continuing chest pain prompted an angiogram and it turns out I do have an infarction w ischemia and the cardio said:  Had I known that I wouldn't have cleared you 4 surgery last year.  I agree since the pain they thought was caused by a small gall stone turns out to be my heart. LOL.
  

[IAmTheWalrus]

This from UNOS website:
------------------------------------------------------------------------------------(http://www.unos.org/SharedContentDocuments/MELD_PELD_Calculator_Documentation.pdf)
-----------------------------------------------------------------------------------
The MELD score is calculated using the following formula:

MELD Score = 0.957 x Loge(creatinine mg/dL) + 0.378 x Loge(bilirubin mg/dL) + 1.120 x Loge(INR) + 0.6431

Multiply the score by 10 and round to the nearest whole number. Laboratory values less than 1.0 are set to 1.0 for the purposes of the MELD score calculation.

The maximum serum creatinine considered within the MELD score equation is 4.0 mg/dl (e.g. if you enter 4.3 for serum creatinine the formula will calculate 0.957 x Loge(4.0) for the serum creatinine portion of the MELD formula).

[Rockerforlife]

YOU ASKED:

If you don't SVR with SOC, or relapse, are your chances reduced for Boceprevir+SOC?

Well im still UN 3months post and i cleared 2 weeks after taKING the BOC,so far so good,ill let you know by Jan 05-2010....

i dont think the virus has a snowballs chance in hell with this killer drug Boceprevir

[Bali05]

About the PIs. We all would like them to be here today.

I keep hearing about them to be available in 2011.

Who can say for sure when we will have access to these drugs ?

It is estimated,when this and that happens and so on ........

Do we effectively know with certainty that these drugs

combined with 24wk SOC promising 80%SVR  are

going to be available in 2011. Or is it possible due to some delay

it will be 2012 or 2013  ?

If we seriously consider waiting a year makes a difference to some.

Is it going to be the beginning of 2011 or end ? We are almost in 2010

so it could just be 1 year additional wait or 2 years if it is towards the end of 2011

or 3 years if we go into 2012.

Does anybody no for sure ?

I asked a chief hepatologist that is familiar with Alinia trials for geno 4:

Q:
    If I turn out to be a nonresponder or relapser on Alinia+SOC would Telepravir be a possibility for retreatment of geno 4 in the future
    when it becomes available?
    
A:   Yes - the sustained virologic response rate is in the 40% range for nonresponders and 60-70% range for relapsers.

Just wonder where he got that data from. This must be geno 1 data applied to
me (geno 4) since there is very limited to no data for geno 4 and PIs.

[mike716]

If you don't SVR with SOC, or relapse, are your chances reduced for Boceprevir+SOC?

[Rockerforlife]

I heard that relapsers who do SOC and try again with 72 weeks dont have much better chance of SVR ,this was also a big factor why i chose the PI.

[Rockerforlife]

I chose the boceprevir trial over the 72 week SOC even tho my insurance would pay for all my meds for the SOC and i knew i had a 80% chance of getting the boceprevir,When i was seeing and hearing about the power of the PI`s over the SOC,it was a no brainer for me,i took a gamble and so far im winning

[mike716]

Don't worry, nothing you can say would depress me, sweety.

I'm already taking around 3g of Lorazepan (Valium) a day, just to keep going and to be able to sleep. The wine is a sort of kicker. I can cut it out if I have to, but right now I need it.

It's not so much the hep that's getting me, it's the horrible treatment I'm receiving at my hospital. Everything seemed just fine until two weeks ago, when it was revealed that my hep MD had goofed, telling me my liver was fine and I shouldn't treat until the PIs are approved. Now, after the Fibroscan showed F3/F4, he's backpeddling and covering himself, and he won't let me  talk to anyone else (afraid I'll spill his beans). I don't know where to turn. Maybe I can sort things out at the hospital, but I'm afraid to treat with someone who makes mistakes and won't admit them.

On Friday I'm going to see a hep MD at anotherhospital. But it's three hours away, and I have no health plan there.

All this is making me rather distraught, ergo the Valium and the wine. But I'm still going to the gym and to tango class, so I guess I'm not too freaked. Not yet, anyway.

Don't worry about me. There are so many people worse off. And, what the heck, I've had a pretty good life, and I'm 65. If it's over soon, so be it. I always felt it would be better to go out on a good note than just peter off in pain at the end.

But we shall see. I'm still fighting.

Mike

[WriteItDown]

Mike, that sounds bad!  You're making me want to give you a hug!  Maybe you need anti-depressants, have you considered them?  I think especially if you're considering treatment, you might need to get those two ducks into your row.  I don't think you're supposed to drink at all on treatment.  It messes with the drugs. And also, since the interferon can cause bad depression, if you're already having that problem, you probably ought to try to straighten it out beforehand.

Hope I'm not depressing you further.... :)

[mike716]

10%, huh? That's still a pretty big difference. In the trials you don't have a choice about it, but if I were dosing myself I'd do the 48 weeks (that is, if I was handling the anemia and sides okay).

[mike716]

I probably should, but I get so depressed in the evening that without the wine I can't even eat. Not sure which is worse: the damage that a glass of wine could cause, or the night-time depressions.

According to my calculations, a four-ounce glass of wine contains 1.2 grams of alcohol (based on the wine being 10% alcohol and having approximately the same density as water). The stuff I've read about alcohol and HCV says that more than 50 grams can hurt you if you have HCV. Let's say that's an underestimation, and that even a quarter of that can hurt you. It's still 50/4 = 12.5 grams, which is the equivalent of around ten glasses of wine (if my calculations are correct). So how bad can one glass be?

Mike

[Rockerforlife]

My trial gave my all my PCR results but some trial dont.I the boceprevir phase 2 trials there was a10% SVR difference between the 24 wk and the 48

[mike716]

Hiya, Marcy. How's the weather in Indonesia, Denmark, the West Indies, or wherever the heck you are right now? Here in tangoland it's raining and cold. So much for the summer in the Southern Hemisphere!

Is that conclusive now about the Pis, that geno 1b only treats for 24 weeks? I saw that a recent trial had a big 24-week arm and that results were good in it, but I wonder if the 48-week results aren't still better? I haven't been following all the trials, so I don't really know. What do you think?

Anyone else know what the latest is on treatment time with the PIs (Boceprevir, Telaprevir, or any of the others)?

Mike

[WriteItDown]

I think you might want to start cutting out that glass of wine at dinner.... it can't be helping your liver.

[mike716]

Thanks, Brent!

[mike716]

Is that the case for all the Boceprevir trials, that is, a sort of company policy?

M.

[mike716]

Yes, there are people for whom Fibroscan is not accurate: cholestatics (fat & obese), too-small inter-rib space, etc. However, I am thin, don't drink more than a glas of wine with supper, and have lots of intercostal space. So there's nothing obvious to rule out the accuracy of the Fibroscan result. Which doesn't necessarily mean it's the last word, either. It only sees 1/500th of the liver.

You're right about the APRI test: it's probably no good for people on Tx. It's a tool for following fibrosis progression, not for following viremia (which is what Tx attacks).

Lastly, I just checked my blood tests, and there's only one where they did my NR. So I won't be able to do a time MELD study. But I'll do it for the one I do have. Thanks for the idea.

Mike

[mike716]

Do you know the MELD calculation formula? Or should I just use one of the website calculators?

M.

[Marcia2202]

I just wanted to add that Dr. D.'s video is now a few years old. Before the PI's showed such good results. I don't know, but I would assume that he would tell people to wait for the PI's, if their liver damage is not too progressed and unless they are geno 3.  It looks like they have not found a PI that works on geno 3 yet.

Personally, I would go for a PI trial, if I was a geno 1. For all I know, you would still have to treat for 48 weeks with the alinia. And I don't think it is as potent as the PI's. With the PI's you have the chance to only treat for half the time. The less time on the drugs, the better....

[IAmTheWalrus]

Just a point of reference on MELD: Most hospitals don't try to put patients on the transplant list until MELD is >10 or >15.  Most transplants occur at MELD between 20 and 30 due to donor shortages. My own experience on the waiting list is that most patients with MELD >20 are very sick. They start getting all kinds of symptoms like jaundice, ascites, variceal bleeds, encephalopathy, etc.

Good luck (tango-wise and salami-wise)

[merryBe]

hi again Mike, sorry for delayed answers, been busy lately..

the MELD  was developed to help ascertain the severeities within end stage LD and to prioritize and push the sickest patients to the top of transplant wait lists, but it's still a helpful item before you reach end stage, if for no other reason than that it lets you know whether you are getting towards the end or not.
Meld is a ratio of INR, creatinine and bilurubin, you can do the calc. yourself by typing in MELD calculator. Score ranges from 6-40.....if you are 6 or under you still have an OK time line as a rule. The doc who developed the formula proved it's pretty right on, meaning that his predictors were accurate...as the scores go up the time line to morbidity are calculated and are accurate. Ergo someone with say a Meld of 30 will get a transplant before someone with a score of 29, even if the 29 patient has been waiting longer.

One thing about the fibroscan, extra abdominal weight also throws them off...it's harder to get an accurate read on those who have it, and unfortunately many HCV people do have wide waistlines do to endocrine dysfunction as well as adipose redistribution the virus is known for.

Also, the test you mentioned APRI I am not familiar with, but I'm wondering how accurate would it be for patients while treating...not very since the platelets are normally throw way off by treatment. So only give this test creedence if you are not on treatment drugs.

mb