News Stories/Generic Riba/Other Posts

[TnHepGuy_]

(Well for the time being at least, my information addiction persists. And as long as I remain in the "chronic-junkie phase", I thought I'd continue to pass some things along.)

<a href="http://www.natap.org/2006/HCV/020106_01.htm">Reversal of hepatic fibrosis - Fact or fantasy?</a>

<a href="http://www.natap.org/2005/AASLD/aasld_61.htm">Study Finds EPO Improved SVR Only in High Dose RBV Group</a>

<a href="http://www.hivandhepatitis.com/hep_c/news/2006/020306_a.html">In Whom, When, How, and with What Therapy to Treat Acute Hepatitis C?</a>

<a href="http://www.hivandhepatitis.com/hep_c/news/2006/020306_b.html">Hepatitis C Recurs Rapidly after Liver Transplant</a>

<a href="http://www.hcvadvocate.org/news/newsRev/2006/NewsRev-136.html#6">Liver Cancer Risk Is High in Hep C-Related Cirrhosis</a>

<a href="http://www.hcvadvocate.org/news/newsRev/2006/NewsRev-136.html#12">No Increased Risk for HCV Transmission Through Breastfeeding, Studies Show</a>

<a href="http://www.hcvadvocate.org/news/newsRev/2006/NewsRev-136.html#16">Albumin Prevents Liver Complications in Cirrhosis</a>

<a href="http://www.hcvadvocate.org/news/newsRev/2006/NewsRev-136.html#17">'Very Rare' Hep B Relapses Reported in Patients on Certain Arthritis Drugs</a>

<a href="http://www.hcvadvocate.org/news/newsRev/2006/NewsRev-137.html#1">Oral Glucose Tolerance Test Predicts Cirrhosis Prognosis</a>

<a href="http://www.hcvadvocate.org/news/newsRev/2006/NewsRev-137.html#2">MIGENIX to Initiate MX-3253 HCV Viral Kinetics Study in Treatment Naive Patients</a>

[cquest]

I hate to admit it but I enjoy fighting with insurance companies...I think it's cause I worked for Metlife/UnitedHealth Care/Uniprise/whatever else they are calling themselves now for 10 years and it's satisfying now to give back all the grief I had to take...ha!

And yes that white count is off the chart...poor thing was so dehydrated the IV's were popping out...her veins were collapsed and they had to stick her in  a half dozen different places. I guess I'll find out today if they'll let her go or try to take her tonsils out since they are still swollen and all red...
Cin

[friole]

White count 23? That sounds so off the chart, I can't even fathum it. Jeesh - mine is 1.6.  I hope she gets to come home soon.

I just don't believe that story about the transplant surviver who can't get tx.  It is so well documented that hep C will just destroy the new liver if not treated.  Don'tcha get sick of fighting sometimes?

[cquest]

It IS always something isn't it? Thanks for thinking of her, I really believe good energy helps and it must have helped her...she is doing better today...still can't eat and she's starving but at least she is complaining so that's always a good sign! Her white count was over 23, I read the note from the lab that it was 'critical' and they informed the floor (and exactly what time they called the floor so you know somebody is covering their a$$). She's still inhouse...probably tomorrow she can go home unless they want to take her tonsils out or something cause that's what they say is part of the problem...

Speaking of transplants...once again while 'outing' myself about HCV, I met this woman who's son in law didn't even know he had HCV until he had cirrhosis...he was at death's door...too sick to even know where he was...delirious...he finally got a transplant...the bad news is his ins. co won't pay for the tx because they say 'you got a new liver, you don't need tx now'! Can you imagine? They are fighting it out w/ them but what a crock! Really sad if he ends up too sick to tx or whatever else could go wrong...
Cin

[mikesimon]

I have only made up a few axioms in my life but I have one that applies here. My sister was visiting me a couple of days after transplant and I was lying there with my scar exposed for all the world to see and I didn't feel real good. She and I were talking and in that offhand way we all talk she muttered "I got a headache that's killing me". She immediately felt horrible that she'd complain to me when here I was after transplant and she began trying to apologize for her inconsiderate comment. I said right then "There's no pain like your pain" and I meant it and knew that it was absolutely true. She is a therapist and works with kids and families and she tells me she uses that line all the time because it's true. Your pain is your pain and it hurts you w/o regard to how much my pain hurts me and you're entitled to complain and cry and feel sorry for yourself. If another's exerience inspires or encourages you then that's fine and good but it does in no way denigrate your situation or your pain - there's no pain like your pain. There, have I lectured enough yet? Sorry if I adopted that pedantic tone I so detest. Mike

[NYgirl]

Wow. I am glad you shared that. All of that which you went through...makes me feel like quite the bit a crybaby sometimes.

You see people boo hoo I don't want to treat and crying about itty bitty sides....when compared to you we have it EASY.

Maybe next time I want to whine I'll think more. Well I know everybody's problems are equally serious cause they are THEIRS but boy does it help me to remember - when you think you got it hard someone else has it WORSE!

I am so glad that you endured. You are really quite an insipiration for us all.


_PS Kalio - nope no results. Since I made a pact with myself to treat until 24 for optimum chance at UND before making decision.....I have FORCED myself not to call and ask for the PCR.  I will get it in 3 weeks.  Not easy but...what if this is the week I kill those few virus left? If I got discouraged....it might not happen. So I'll stick it out wondering..... :)

[mikesimon]

Thank you for your kind words. I must tell you and, believe me I am not that modest, as my friends would rapidly attest to, but I only did what anyone else in my position would do. I may have had more knowledge then some and that may have inclined me to go further than some but it was only because of my knowldge and had nothing at all to do with courage. Quite the contrary perhaps - that I was just a lot more scared than most and consequently couldn't help but try to get rid of the virus. The virus never leaves with transplant - it's there just waiting to get comfy in the new liver. Some types and strains are more virulent than others but w/o TX the virus ain't going anywhere. I didn't even know that when I was transplanted - I didn't know anything at all. Karen and I thought that was the cure and now I'd be okay. And then BAM! - soaring enzymes and a sickness I never knew with my own liver. I was treated for rejection 2 or 3 times and looking back I wonder if it was acute rejection or the hep c. I've told this story before but I'll tell it again. When I was sick I talked with the pathologist and my surgeon and they said that hep c reinfection in the liver and rejection were indistinguishable on biopsy. In 2000 the rule was if the inflamation was close in time to transplant they'd call it acute rejection and if it were further away in time they'd call it hep c. In 2004 after I was clear I toured the bio research facility at UPMC and a brilliant woman Phd/MD was telling me about dendritic cells splatters and how they could tell the difference between rejection and hep c and how they could be used to predict if a person was likely to reject and on and on. She didn't know my story so when I asked her if this was known in 2000 she replied that it was in the research department but that they didn't share the info with the clinical side to preserve the integrity of the research. I told her my story. Immediately she said that they probably still had my blood there and that she could run some tests right then and tell me whether it was rejection or hep c. I declined - I really didn't want to know. I was just happy to be rid of the virus and what was done was over but it did make an impression on me. How did I get so far afield? I have a habit of doing that lately. Mike

[NYgirl]

One of my best friends from the 80s (did I get this from him? LOL) and the first person I ever knew with hep had a transplant. I remember seeing him before with his stomach so swollen but legs like sticks .... I just was so heartbroken and stood by him.  Shortly after his transplant he started getting high again...I don't know if he ever stopped or he tricked the tests with day amounts or something........

I couldn't believe it.  Now he has cancer (liver). What an absolute shame.

I don't know if he regot hcv or never got rid of it or what but...is that a heartbreak?

I have such admiration for you and all you have been through you are SUCH a fighter.

[mikesimon]

Sorry - didn't see that you posted that study already.
About the hep c after transplant: Yes indeed, I can attest to recurrence on a grand scale. I just knew that I had no choice but to eradicate the virus and that is why I did so much TX. I just wouldn't stop taking it as long as the TX appeared to be working. Even my surgeon tried to dissuade from going the whole 73 weeks my lasr TX with warnings of possible residual anemia and other consequences not yet known. He couched his warnings in terms of "transplant patients" & long term TX but I got the impression that non transplants may also be at risk. Mike

[mikesimon]

<A HREF="http://www.eurekalert.org/pub_releases/2006-02/fsu-lfs020706.php/">STUDY</A>

Landmark FSU study of Hepatitis C virus solves mystery that has stymied quest for cure

[cuteus]

many positive thoughts sent her way, may she have a swift recovery in all aspects.

[NYgirl]

Hepatitis C recurs rapidly after liver transplant



Extrahepatic sites may account for some viral replication

When a diseased liver is removed from a patient with Hepatitis C (HCV), serum viral levels plummet. However, after receiving a healthy liver transplant, virus levels rebound and can surpass pre-transplant levels within a few days, according to a new study published in the February 2006 issue of Liver Transplantation


http://www.innovations-report.de/html/berichte/medizin_gesundheit/bericht-54797.html

[NYgirl]

Schering-Plough's HCV drug gets fast track  SCH 503034,
http://www.upi.com/HealthBusiness/view.php?StoryID=20060130-103016-7347r

Experimental HCV protease inhibitor to receive fast track approval SCH 503034
http://www.aidsmap.com/en/news/E1F717B9-62DE-4324-A3F8-A5FED96F5675.asp


Migenix to start HCV drug trial in Q2 X-3253
http://www.upi.com/HealthBusiness/view.php?StoryID=20060123-024658-1573r


Landmark FSU study of Hepatitis C virus solves mystery that has stymied quest for cure FEBRUARY &, 2006 article
http://www.eurekalert.org/pub_releases/2006-02/fsu-lfs020706.php

[FlGuy]

Beth. In case you are still tuned in..Take a look at TnHep's post on 2/6 and the article titled 'Liver Cancer Risk Is High in Hep C- Related Cirrhosis.  Scroll down to the article just below it to find 'Hollywood Studio to Produce Feature Based on Tainted Blood Scandal'.  You've mentioned this on a few times in the past.  Perhaps this one will see the light of day.  Sounds like the makings of a real whodunit.  Hope you are well.

[GoofyDad]

Thanks.

[cquest]

I am so glad you find these things! Thanks!

Anyways,I spent all of last night with my oldest daughter (the one w/ the HCV too) taking her to the hospital...she started getting sick Sat night, sore throat, she would be standing up talking to me with her eyes closed...odd...I was secretely worried about her being back on something again but she just said she wasn't feeling good...so then Sun it got worse and yesterday her boyfriend calls me cause she can't talk, her throat was so sore...soooo I go over there after work to bring her something and she was white as a ghost, listless, her throat was filled with little bumps. I call the doc, they squeeze her in, turns out she has Strep throat and she's dehydrated...he takes one look at her and direct admits her...She still had her eyes closed too...didn't have the energy to move...poor thing...at least she's at the same hospital where I work so I can check on her today...always something...
Cin

[NYgirl]

I'll say a prayer for her...right now.

I got to say this is one time I bet you are GLAD she is "sick" though.... :)  I pray she can stay clean.  I am going to pray for that too...God knows we don't want our kids to make the mistakes we did but it's impossible to get them to listen to us.

Your Friend Deb

[friole]

Bless your heart - it is always something.  I hope you don't get it too

[TnHepGuy_]

Ribasphere is produced by Three Rivers Pharmacy and their 200mg pill has an "AB" rating from the FDA. "AB" ratings are the most common from given to generics and it means that the FDA is satisfied that they are "theraputically equivalent" to the original:

(from the FDA):

"<i>Therapeutic Equivalents.  Drug products are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.

FDA classifies as therapeutically equivalent those products that meet the following general criteria:  (1) they are approved as safe and effective;  (2) they are pharmaceutical equivalents in that they (a) contain identical amounts of the same active drug ingredient in the same dosage form and route of administration, and (b) meet compendial or other applicable standards of strength, quality, purity, and identity; (3) they are bioequivalent in that (a) they do not present a known or potential bioequivalence problem, and they meet an acceptable in vitro standard, or (b) if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standard; (4) they are adequately labeled;  (5) they are manufactured in compliance with Current Good Manufacturing Practice regulations.  The concept of therapeutic equivalence, as used to develop the List, applies only to drug products containing the same active ingredient(s) and does not encompass a comparison of different therapeutic agents used for the same condition (e.g., ibuprofen vs. naproxen for the treatment of pain).  Any drug product in the List repackaged and/or distributed by other than the application holder is considered to be therapeutically equivalent to the application holder's drug product even if the application holder's drug product is single source or coded as non-equivalent (e.g., BN).  Also, distributors or repackagers of an application holder's drug product are considered to have the same code as the application holder.  Therapeutic equivalence determinations are not made for unapproved, off-label indications.

FDA considers drug products to be therapeutically equivalent if they meet the criteria outlined above, even though they may differ in certain other characteristics such as shape, scoring configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration date/time and minor aspects of labeling (e.g., the presence of specific pharmacokinetic information) and storage conditions.  When such differences are important in the care of a particular patient, it may be appropriate for the prescribing physician to require that a particular brand be dispensed as a medical necessity.  With this limitation, however, FDA believes that products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product.</i>"


TnHepGuy

[TnHepGuy_]

A couple of things that stand out in the Procrit study that may account for the lower SVR figures:


- African Americans made up approximately 39% of the overall participants. As a group they tend to have much lower SVR rates (though those on high-dose riba did well here). And 39% is more than triple of their actual representation as a percentage of U.S. population (around 11-12%).


- Group 1 had a 60% discontinuation rate

- Group 2 had a 73% discontinuation rate

- Group 3 had a 49% discontinuation rate

These tx discontinuation rates - especially for groups 1 and 2 - would seem to be rather high.



As "goofydad" has said, probably the most beneficial information to glean from this study is the importance of (higher) riba dosage, as well as early Procrit intervention to help maintain those higher does amounts.


TnHepGuy

[cuteus]

what a relief to see we are still in the news! Thanks tnguy!

hey chev, have you ever had tomatoes come out on their own after the winter? the last two springs I have found little shoots coming out on their own after the cold. I have transplanted them, and they got as big and yielded as much as the saplings we have bought from the farmer.  It is like a little miracle of life, those seeds surviving that much hardship.  The first yr my boyfriend laughed at me, for thinking I would get anything from those tiny, almost microscopical things. Boy, did nature show him! last yr, he did not laugh at me.

[Forseegood]

I live in an apt but they are going to be opening a community garden a few blocks from here, and I'm going to rent a plot, so maybe I'll be asking you guys for tips...want to grow some winter veggies...since it's been in the 80's here almost all winter it seems like, don't know how "winter" it's going to be...

[jaroman]

Thank you for sending us the interesting reads!
Hope you are doing great.

[TnHepGuy_]

(here's the table from the non-working link - though there's no telling if it will look anything like a columnar table once it's posted. Here goes....)


Proprietary Name Search Results from "OB_Rx" table for query on "ribavirin."


Appl


# TE Code  RLD  Act. Ingrdt. Dsg Form;Route Strength Proprietary
Name  Applicant


  
076192  AB  No  RIBAVIRIN    CAPSULE; ORAL    200MG  RIBAVIRIN  SANDOZ  

--------------------------------------------------------------------------------

076277  AB  No  RIBAVIRIN    CAPSULE; ORAL    200MG  RIBAVIRIN  TEVA  

--------------------------------------------------------------------------------

077224  AB  No  RIBAVIRIN    CAPSULE; ORAL    200MG  RIBAVIRIN  ZYDUS PHARMS USA  

--------------------------------------------------------------------------------

077053  AB  No  RIBAVIRIN    TABLET; ORAL    200MG  RIBAVIRIN  TEVA  

--------------------------------------------------------------------------------

077456  AB  No  RIBAVIRIN    TABLET; ORAL    200MG  RIBAVIRIN  THREE RIVERS PHARMS  

--------------------------------------------------------------------------------

077094  AB  No  RIBAVIRIN    TABLET; ORAL    200MG  RIBAVIRIN  ZYDUS PHARMS USA  

--------------------------------------------------------------------------------

077456   No  RIBAVIRIN    TABLET; ORAL    400MG  RIBAVIRIN  THREE RIVERS PHARMS  

--------------------------------------------------------------------------------

077456   Yes  RIBAVIRIN    TABLET; ORAL    600MG  RIBAVIRIN  THREE RIVERS PHARMS  

[GoofyDad]

Could be that over bio-availability could garner an AB too, I guess?

I need to take off here, but I did find <a href="http://www.fda.gov/cder/orange/adppreface.htm">this little nugget</a> which includes this section:

<b>1.8 Description of Special Situations</b>

Certain drugs present special situations that deserve a more complete explanation than can be provided by the two-letter codes used in the List. These drugs have particular problems with standards of identity, analytical methodology, or bioequivalence that are in the process of resolution. The following drugs are in this category:

<i>Ribavirin 200mg Oral Capsule. Indicated for use and comarketed with interferon alfa-2b, recombinant (Intron A), as Rebetron Combination Therapy.</i>

I did not search for the 'more complete explanation'.