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Evolution of Treatment-Emergent Variants in Telaprevir Phase 3 Clinical Trials
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Reported by Jules Levin
EASL 2011 Berlin Germany March 30-April 3
JC Sullivan, S De Meyer, DJ Bartels, I Dierynck, E Zhang, J Spanks, A Tigges, N Adda, EC Martin, IM Jacobson, KE Sherman, S Zeuzem, G Picchio, and TL Kieffer
from Jules: this presentation/data is based in part on a model predicting when & if mutations/resistance will disappear & not be very relevant or relevant at all. The general line here is that after 1.5 or more years resistance will not be relevant & you can retreat with the same protease because unlike in HIV the mutations do not integrate into the genome & aren't archived forever. The other minority view among resistance researchers I have worked with since 1996 do not accept this notion. At the very least their position is, and I agree, we don't know what will happen in patients several years from now after failing HCV protease inhibitor therapy, the worst potential scenario is if some patients will likely remain on failing regimens for prolonged periods of time while the recommendation will be to stop therapy very early if failure is observed and patients will be required to come in to check viral load after being on telaprevir for 4 and 12 weeks and with boceprevir likely 8 and 12 weeks. We will see.
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