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News Stories/Generic Riba/Other Posts

(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>
30 Responses
86075 tn?1238118691
hey thanks for the memories! interesting reading, I found that glucose article particularly interesting....be well...
Avatar universal
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
Avatar universal
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
Avatar universal
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
92903 tn?1309908311
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!

Avatar universal
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.
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