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>

[Forseegood]

hey thanks for the memories! interesting reading, I found that glucose article particularly interesting....be well...

[TnHepGuy_]

Increased Risk of Hospital Mortality in Patients with Hep C

Hep C Therapy with Interferon Alfa-2a and Ribavirin Is Safe in Practice

Refractory Ascites Increases Mortality Post Liver Transplant

Predictive Models for Liver Transplant Outcomes

AVI BioPharma Announces Hepatitis C Virus License Agreement with Chiron

Hope of Liver Cancer Blood Test

Intercell's Hepatitis C Vaccine Meets Success Criteria for Further Development

Nabi Biopharmaceuticals Announces U.S. Fast Track Designation for Civacir to Prevent Hepatitis C Re-infection in Liver Transplants

Method for Estimating Deaths on Liver Transplant Waiting List

Noninvasive Fibrosis Prediction

High serum hepatitis C virus (HCV) RNA load predicts the presence of HCV RNA in saliva from individuals with chronic and acute HCV infection

Twenty-four hour kinetics of hepatitis C virus and antiviral effect of alpha-interferon

Effects of fatty liver and related factors on the efficacy of combination antiviral therapy in patients with chronic hepatitis C

Detecting minimal traces of DNA using DNA covalently attached to superparamagnetic nanoparticles and direct PCR-ELISA

Long-term follow-up of chronic hepatitis C patients with sustained virological response to various forms of interferon-based anti-viral therapy

Thalidomide in the treatment of chronic hepatitis C unresponsive to alfa-interferon and ribavirin

Relation between viral fitness and immune escape within the hepatitis C virus protease

Noninvasive diagnosis of cirrhosis in chronic hepatitis C based on standard laboratory tests

Estimated progression rates in three United Kingdom hepatitis C cohorts differed according to method of recruitment



I saw discussion down below on generic riba. It got me off into search-ville and here is what I found when doing a query for ribavirin in the FDA's "Orange Book" of "Approved Drug Products
with Therapeutic Equivalence Evaluations". In determining the meaning of the "TE (Therapeutic Equivalent) Code" listing of "AB" for most of the majority of the listings, I ran into this, where the author states "...(pharmaceutical companies) must prove that their version of the drug can attain the same absorption from the gastrointestinal tract to the bloodstream as the innovator

[friole]

I jumped right in looking for the generic riba info you so graciously dug up.  The first link in the paragraph (here) did not link for me.  The other two links were non-specific for the riba.  I wonder if the first link rated the generic riba since bioavailability is what we are always looking for -- is it AA or AB  or B-

Other articles look interesting too, but this is the one I am interested in at present
Thanks, Kathy

[TnHepGuy_]

I, too, just checked and for some unknown reason the link is not working.


The jist of the search results is that the majority of the generic riba approved is rated "AB" by the FDA, thereby meaning that:

"<i>A  Drug products that FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products, i.e., drug products for which:

(1) there are no known or suspected bioequivalence problems.  These are designated AA, AN, AO, AP, or AT, depending on the dosage form; or

<b>(2) actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence.  These are designated AB</b></i>".




TnHepGuy

[GoofyDad]

Thanks for the links. Still trying to figure out whether ribasphere is AA, AB, or other. Anyone figure that one yet?

The EPO article from the first list is pretty interesting. Not so much for the results of using EPO, but rather the dramatic improvement in SVR rates acheived by bumping up ribavirin dosage from 13.3mg/kg to 15.5mg/kg. Overall, SVR rates seemed low in this study, but the group with higher riba dosing fared much better (as in like double the SVR rates).

Looks like the stepped up dose works out to about an extra 200mg pill per day. Conveniently, just what I happen to take. Helps make all the huffing and puffing just a little more palatable!

[friole]

Tn,Thanks, I guess my take is still that AA (being the standard for the name brand) is more bioavailable than a AB (like most generics) even tho the standards are close (close only counts in horseshoes, as they say). I think then it becomes a matter of money.  If the difference is not great, go with the name, if money is an issue, go with the generic, as the difference is minor.

[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'.

[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  

[jaroman]

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

[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...

[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.

[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

[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

[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

[friole]

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

[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

[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.

[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

[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

[cuteus]

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

[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

[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

[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.