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AASLD 2010 News / Allison Crowe
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New Investigational Drug
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Sanjiv’s Story Part III
NEWSLETTER December 2010
Sanjiv’s Story – Updated September 2010,
[ Editor: Part I of SanjivSyal’s story was published in the October 2008 edition of the hepc.bull http://hepcbc.ca/bulletin/2008/2008-10.pdf
Part II appeared in November 2010.]
What I have gained from life in 50years is much more than what I have lost inthe past five managing health challenges.Each major setback may have initially shaken me up, but in hindsight it has provided me with an opportunity to introspect,take positive action, and to do my best in situations within my control..
SHOULD IL-28B GENOTYPE STRATIFICATION BE USED IN NEW TRIALS?
Right now, clinical trials are stratifiedinto arms, sometimes according to genotype,sometimes according to viral load, sometimesaccording to status as a non-responder/null-responder/relapse, etc.
These researchersbelieve that the patients should also bedivided according to IL-28B genotype (C/Cvs. non-C/C) before they are randomized todifferent arms. (This is a human, not a viral genotype). In this modeling trial, they showed that there could be a 10 to 20% difference in response rates especially at week4, according to the patient’s IL-28B genotype.
The difference may be even higher in non-white patients. It has been discovered that C/C GT1 patients have improved early responses, as shown in 3 hypothetical trials, where the researchers re-stratified results obtained in other trials. This stratification is especially important in the early phase trials.
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