News Stories and Other Posts

[TnHepGuy_]

<a href="http://www.natap.org/2005/AASLD/aasld_4.htm">THE PERFORMANCE OF APRI FOR THE DIAGNOSIS OF SIGNIFICANT HEPATIC FIBROSIS IS IMPROVED BY A SIMPLE MODIFICATION</a>

<a href="http://www.natap.org/2005/AASLD/aasld_5.htm">LONG TERM RESULTS AFTER THERAPY WITH PEGYLATED INTERFERON ALPHA 2A (PEGASYS) IN HCV POSITIVE LIVER TRANSPLANT RECIPIENTS</a>

<a href="http://www.natap.org/2005/AASLD/aasld_6.htm">PREDICTING OUTCOME IN PATIENTS WITH HCV AFTER OLT: A 15-YEARS FOLLOW-UP</a>

<a href="http://www.natap.org/2005/AASLD/aasld_7.htm">RECURRENT HEPATITIS C IS A RISK FACTOR FOR POOR OUTCOME AFTER LIVER RETRANSPLANTATION</a>

<a href="http://www.natap.org/2005/AASLD/aasld_8.htm">MULTICENTER RANDOMIZED TRIAL OF HCV TREATMENT WITH PEGINTERFERON-ALFA 2A (Pegasys) AND RIBAVIRIN AFTER LIVER TRANSPLANTATION:ONE-YEAR REPORT</a>

<a href="http://www.natap.org/2005/AASLD/aasld_9.htm">ON TREATMENT VIROLOGICAL RESPONSE OF 70% IN 100 PATIENTS TREATED WITH COMBINATION ANTIVIRAL THERAPY FOR RECURRENT HCV FOLLOWING LIVER TRANSPLANTATION</a>

<a href="http://www.natap.org/2005/AASLD/aasld_10.htm">
IS LIVER BIOPSY JUSTIFIED IN HEPATITIS C GENOTYPE 2 AND 3?</a>

<a href="http://www.natap.org/2005/AASLD/aasld_11.htm">
FIBROSCAN, MONITORING LIVER STIFFNESS: A NEW TOOL TO MEASURE LIVER FIBROSIS DURING THERAPY</a>

<a href="http://www.natap.org/2005/AASLD/aasld_14.htm">2.2% Liver Cancer developed Among SVRs; Sexual Dysfunction among HCV+</a>

<a href="http://www.natap.org/2005/AASLD/aasld_15.htm">FIVE MILLION AMERICANS INFECTED WITH THE HEPATITIS C VIRUS: A CORRECTED ESTIMATE</a>

[TnHepGuy_]

Just wanted to say hello to you both, thank you for the kind words, and hope that all is well with you and your families.

Very good to see each of you here, too.


TnHepGuy

[jmjm530]

A lot of doctors are very excited about the new drugs. If all goes as planned, some of the SVR data you are looking for will be here first or second quarter of next year

-- Jim

[rearfang]

As always, great to hear from you. Thanks for helping to keep us all informed.
Lauren

[newb]

Hey there,
Thanks for the translation and kind words. Sounds like it's a mite early to get excited, but the doc mentioned trying to get me into a phase 2 or 3 trial for responding relapsers, so maybe in the next couple of years...

Post tx life is good! After a year of feeling like ****, it's great to feel healthy and strong again, and I'm making the most of it! The thought of going back on tx is scary, but this sounds much different from peg-riba.

Will be keeping my fingers crossed! Best to you all.

newb

[TnHepGuy_]

Good to see you again. I hope all is well with you these days.


As far as the info released related to VX-950, the study was a 2 week trial, in which the first priority was to determine the safety of three dosing regimes over that time frame. There were 34 patients, most of whom had already failed traditional tx. The trial was broken down into three arms: first - 10 patients receiving 450 mg every 8 hours, second - 8 received 750 mg every 8 hours, and third - 10 received 1,250 mg every 12 hours. There were 2 patients in each arm used as controls who received placebo.

The viral load reduction results at the end of the two weeks showed two patients (from the 750 mg arm) as being undetectible at <10 PCR, though they also used a less sensitive test of <30 under which 5 (1 in the 450 mg arm and 4 in the 750 mg arm) showed as undetectible. The best and most consistant results occured at the 750 mg. dosing level.

It's too early in the trial process on this drug for any SVR information. They will get to that in the Phase II and Phase III versions, if all goes as planned. The person who did the presentation of the data at the conference felt there is the possibility that VX-950 could be used as a mono therapy, with the potential for full viral eradication by week #12, based upon data extrapolation. Whether or not that is the case, future trials with the drug are expected to include both mono arms and combo arms.


On a side note, it seems that over the two week trial period the most common sx's seen over placebo are abdominal pain and nausea. But what really caught my eye was this: "<i>Flatulence: 33% placebo; 11% VX-950</i>". Perhaps they've also found an antidote for beans, eggs and beer!


TnHepGuy

[cuteus]

hey you! you sneaked in there quitely, didn't ya?  I see you are still in the waiting business?  Many drugs do look promising and something has to pan out! They still have to iron out the kinks, and there is no SVR data yet, they are not to that testing level yet. Plus now they have to find out why some people had a viral load increase during the 14 days of trial.  That could or not take longer than anticipated. And once they release the new meds to a larger scale population of humans with all the different conditions, subconditions, genetic make ups, disease propensities, etc, you are bound to see side effects that were not seen in the early phases.  It is still  a few yrs away.  
I hope you are doing well, have not heard from you in a while.

[FlGuy]

I'm in week 20 and have not seen any of the spider nevi go away - yet.  I'm fair skinned so they are very apparent.  I have one an inch/half below my eye that a dermo zapped (nitrogen) two years ago. It subsided but came back.  It was the first thing that gastro noticed and said when he saw me. I guess there could be worse things.  At least they are entertainment for my daughter, calls me 'her dad, Spot'. She presses them to see how many she can get to blanche at the same time.
There are so many signs and symptoms for HCV and there is no general public awareness.  How many people have to have advanced chronic HCV?  I guess that duty, to some extent, falls on us here.

[TnHepGuy_]

<a href="http://www.natap.org/2005/AASLD/aasld_32.htm">Combination therapy with SCH-503034 HCV Protease Inhibitor & PegIntron in Non-Responders: phase !b study results</a>

<a href="http://www.natap.org/2005/AASLD/aasld_33.htm">VX-950 Hep C Protease Inhibitor</a>

<a href="http://www.natap.org/2005/AASLD/aasld_34.htm">
SCH 503034 HCV Protease Inhibitor Monotherapy in HCV Genotype 1 IFN Nonresponders</a>

<a href="http://www.natap.org/2005/AASLD/aasld_35.htm">Albuferon + Ribavirin in PegIFN Nonresponders: phase 2 study</a>

<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16166794&query_hl=1">Anticarcinogenic impact of interferon on patients with chronic hepatitis C: a large-scale long-term study in a single center</a>

[TnHepGuy_]

Physical bx has no comparative line of weakness grading the middle stages of damage, whereas the current non-invasives have this flaw. Also, bx has the highest overall accuracy covering all stages. Until these deficiencies are overcome via improvement and comparitive testing, non-invasives should retain a back seat and remain an adjunct testing regime; and only a primary for those unable to receive a traditional bx. When it comes to the critical job of histological information gathering, there is nothing better today than a good, old-fashioned stab-in-the-side.

As far as "blanket bx'ing" pre-tx, why not??? Is it because of the minimal physical risks involved in traditional bx? I'll go out on a limb and guess that if non-invasives were currently as-or-more accurate than bx you would most likely suggest (and rightly so) that every Hep C patient receive one - whether tx'ing or not - to know where they stand today, and then have the opportunity to take that extremely important information for use in their decision-making.

Also, current protocol for a non-tx'ing patient is to receive a traditional bx every 3 years. That, in-and-of-itself, constitutes "blanket bx's", anyway.


For tx'ing patients, given how huge of a negative predictor that increased histology is in terms of SVR, proper decision-making must include knowing the state of health of one's liver to be able to provide the best chance to reach that goal and for any after-care follow-up. And as things stand today, the most accurate information to be received comes via traditional bx. My main bone of contention lies with doctors who for whatever reasons (laziness, lack of knowedge in treating Hep C patients, giving into patients fears, giving into insurance companies demands, etc.) decide that they are going start a class of patients (be they geno 2's, 3's, etc.) or individuals (for a variety of non-scientifically backed reasons such as, "your viral load is low", "your liver functions are normal", "you've only had this a short time", "you're non-symptomatic", etc.) on tx while leaving perhaps the biggest predictor of tx failure (histology) a complete unknown!

Picture a patient with a high level of damage who begins tx in the dark, only to fail after the traditional length of time. Where do they stand at that point? They still need to know the state of health of their liver, yet haven't had a bx to find out. They are now classified as a non-responder to traditional tx, yet their 'investment' of body, soul and time that failed at standard tx lengths, may have paid off at longer times. Or at standard times with a more aggresive dosing approach, etc. They may no longer be considered good candidated for the type of peg-interferon they used and 'failed'. Maintainace therapy could be an option, but they still don't know their damage level until they get that bx. On and on. So they go into the future with many unknowns and new 'labels' that can greatly narrow their options. Some or all of which could have been avoided by a simple proceedure to gain critical information ahead of time.



TnHepGuy

[jmjm530]

10Hep said prev:"My main bone of contention lies with doctors who for whatever reasons...  decide that they are going start a class of patients (be they geno 2's, 3's, etc.) or individuals (for a variety of non-scientifically backed reasons such as, "your viral load is low", "your liver functions are normal"... "
----------------

I think we're in agreement on your main point above. Still, needle biopsy is not without risk as my very agressive hepatologist recently pointed out to me.

So I can certainly see situations where a legitimate no biopsy decision is based on a geno 2 or 3 and let's say a Fibrosure test showing grade 0 or 1.

And, of course, it's not just us that differ -- not surprisingly the "biopsy or not to biopsy" topic was recently debated  by two hepatologists at the Projects In Knowledge web site. The overall topic I believe was aptly called "Controversies in Treatment" and not surprisingly the preceding article in that series was something like "To treat or not to Treat geno 1's with minimal fibrosis." :)

As to the future, hopefully it will be blood markers combined with Fibroscan. As mentioned earlier, six months ago I had planned on a follow-up needle biopsy after my own treatment ended. Now I'm leaning toward traveling to Boston and having a Fibroscan instead.

Thanks for the disccussion.

-- Jim

[vegas777]

I'm with you on this one buddy....No needles unless absolutely necessary for biopsy!

*still has liver pain dip*

[FlGuy]

Spider nevi.  Can't tell you how much sunscreen I used over the years til I 'found out'.  Was looking in the mirror last night (not a real easy thing to do these days) and wondered if the nevi ever goes away.  I've looked at many of the resources named here and could not find any info on the subject.  Not that it's at the top of what I want for Christmas list (that would be end of TX clear PCR)- just curious.

[newb]

Thanks for the links, esp the "VX-950 Hep C Protease Inhibitor" article.

I saw my liver doc in June (annual checkup) and he was excited about a new type of drug being tested. I've never seen him excited before- he'd previously stated that a new type of treatment probably wouldn't be around for a few more years. So, hearing him talking about getting me into a trial for this new protease inhibitor type tx sounded pretty good.

Can you help translate the information about these VX-950 trials? Do the numbers mean that although there was a significant log drop, they didn't reach 0 viral load and that the study only lasted a short time? Are you aware of any studies with this drug where the patients actually achieved SVR?

Thanks,
old newb

[painintheside]

Once again, I agree with the Rizzi? study about the 2s and 3s. I am a 3a and have had this approx. 16 years (am 33) and have cirrhosis. I think it seems that more 3's are progressing faster than previously thought. Correct me if I am wrong!

Just get a biopsy.....I've had worse things!And you probably have too!

Sincerely,
Dana

[jmjm530]

Didn't check where the 77% came from, but I've seen better correlations, especially at the important extremes (little or no damage to cirrhosis) with some panels -- better still when correlated with Fibroscan. Also keep in mind some recent studies that challenge the absolute accuracy of needle biopsy. Relative sample size/location, absolute sample size and pathologist bias/error can skew things up to two stages. Personally, I got a two different readings off a complete stage from two different pathologists looking at the identical slides.

Again, I'm not against needle biopsy in geno 2's and 3's, just not for blanket biopsies. The skilled and experienced technician has a lot more tools at his/her disposal than just a few years ago. Dr. Cecil, for example, I believe doesn't use needle biopsy anymore in many cases.

Six months ago, I was pretty sure I'd get another needle biopsy when treatment ended. My decision now is to get a Fibroscan with correlating blood tests. "Hands on" is OK with me -- just don't want that needle in unless absolutely necessary.

-- Jim

[cuteus]

hey jm, I think the fibrosis link above has that model to predict damage. Still, with a 77% accuracy, I worry about that almost 25% who did not get accurately dx.  Maybe with the addition of the FS  it will eventually make it as the gold standard.

There is just something about "hands on" sample testing that gives me more security.

[jmjm530]

I agree the Rizzi paper is a wake up call to those doctors who blindly follow a no-biopsy protocol for geno 2's and 3's.

However, I don't find Rizzi a mandate for blanket biopsies (not that this is being stated) -- especially for those who choose to treat regardless --  because Rizzi focused on only one blood marker, the AST.

Lately, several studies show  promising blood markers such as AST/ALT ratio, Platelets and INR as predictive of cirrhosis. If you search the Archives under "Cirrhosis Calculator" you will a simple one.  Then there are newer blood marker panels such as Fibrosure/Fibrotest, etc. that suggest even better correlations with needle biopsy. And lastly, while still in limited trial in this country, there is the Fibroscan device that correlates liver "softness" with biopsy stage. Add some or all of these to the diagnostic soup, and I imagine Rizzi's estimate of missed cirrhotics should fall considerably.

Needle biopsy is still considered the gold standard, but with blood marker panels and non-evasisve devices like Fibroscan mounting a formidable challenge, the decision to biopsy a geno 2 or 3 should still be on an individual basis. Neither biopsy none or all.

-- Jim

[friole]

Yeah, that (Rizzi study) is the only one I looked at so far.  It definitely gives pause for a bx if you are a 2 or 3.  I think I would copy that study and give to my doc if I were a 2 or 3 and he would not biopsy.

[TnHepGuy_]

The <a href="http://www.natap.org/2005/AASLD/aasld_10.htm">Rizzi</a> paper should be a wake up call to all doctors who think that blindly tx'ing geno 2's & 3's without first doing a bx is the 'simple and easy' way to go. Where this 'method' fails is in considering the factor of extent-of-liver-damage into pre-tx and post-tx decision-making. This information can be critical in determining length of tx, amount of tx, maintainance, post-tx follow-up, etc. It's unethical to tell a patient "don't worry, be happy" that "you don't need a bx because you 'hit the lottery'" by being a 2 or 3. A lack of bx takes very important and much needed information out of patients (and doctors) hands before, during and after tx.


TnHepGuy

[cuteus]

ok, this is a lot of reading, but so far, I liked reading the HCC article who found NO hcv in the liver of the cancerous and non cancerous tissue. No hiding virus in the liver is good news.
Back to work, now.

[TnHepGuy_]

<a href="http://www.natap.org/2005/AASLD/aasld_17.htm">VIROLOGICAL AND HISTOLOGICAL FEATURES OF HCV IN PATIENTS WITH NORMAL ALT: RESULTS OF A TEN YEAR PROPSECTIVE FOLLOW-UP STUDY</a>

<a href="http://www.natap.org/2005/AASLD/aasld_18.htm">African-American patients had fewer office visits and were less likely to return for a second office visit</a>

<a href="http://www.natap.org/2005/AASLD/aasld_19.htm">COFFEE DRINKING DECREASES THE RISK OF CHRONIC LIVER DISEASE IN THE UNITED STATES POPULATION</a>

<a href="http://www.natap.org/2005/AASLD/aasld_22.htm">Troglitazone significantly reduced tumor growth in vivo, and caused tumor regression in liver cells</a>

<a href="http://www.natap.org/2005/AASLD/aasld_Liver.htm">Liver Transplant Articles AASLD</a>

<a href="http://www.natap.org/2005/AASLD/aasld_Fibrosis.htm">
Study Evaluations of Non-Invasive Fibrosis Tests</a>

<a href="http://www.natap.org/2005/AASLD/aasld_30.htm">LIVER HISTOLOGY IN HEPATITIS C PATIENTS WITH NORMAL ALT LEVELS</a>

<a href="http://www.natap.org/2005/AASLD/aasld_29.htm">Hispanics Developed Cirrhosis More Quickly Due to the presence of Fatty Liver & Diabetes</a>

<a href="http://www.natap.org/2005/AASLD/aasld_28.htm">IMPACT OF CAFFEINE CONSUMPTION ON ALT AND HISTOLOGICAL ACTIVITY IN PATIENTS WITH CHRONIC ACTIVE HCV</a>

<a href="http://www.natap.org/2005/AASLD/aasld_27.htm">CANNABINOIDS BLOCK INTERFERON-MEDIATED SUPPRESSION OF HEPATITIS C VIRUS (HCV) REPLICATION</a>

<a href="http://www.natap.org/2005/AASLD/aasld_26.htm">CRYOGLOBULINEMIA IS ASSOCIATED WITH STEATOSIS AND FIBROSIS IN CHRONIC HCV</a>

<a href="http://www.natap.org/2005/AASLD/aasld_25.htm">INDEPENDENT VALIDATION AND COMPARISON WITH FIBROSCAN, FIBROTEST AND LIVER BIOPSY OF CLINICAL GLYCOMICS FOR THE NON INVASIVE ASSESSMENT OF LIVER FIBROSIS IN CHRONIC HCV</a>