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Treatment of Chronic Hepatitis C: The Revolution!
Heiner Wedemeyer
Hannover Medical School
Germany
from Jules: here is Dr Wedemeyer’s slide presentation where he does a long review including vaccines, immune-based new therapies including Alisporivir, DAAs, direct acting activirals, new oral drugs, and reviews many of the reported studies from phase 2 & 3.
The FDA hearings on Oct 24/25 reviewed Simeprevir+PR for 24 weeks and Sofosbuvir +pR for 12 weeks, and as expected the panels voted unanimously to approve both 19-0 & 15-0. This is just the prelude to next year when the first 2 IFN-free regimens will be considered for approval by the FDA in the early part of 2014 & of course approval is expected, they are Gilead’s Sofosbuvir+Ledipasvir & Abbvie’s ABT450+ABT267+ABT333 both with and/or without RBV, phase 3 studies are ongoing, fully enrolled, phase 2 studied reported 95-100% SVR rates with 12 weeks therapy. FDA approval is expected around end of November & beginning of Decmber 2013. Sofosbuvir+Simprevir has yielded 96% SVR rates in hard-to-treat null responders & patients with advanced disease. Sofosbuvir+Daclatasvir has yielded 100% SVR rates in naives & patients who previously failed telaprevir or boceprevir.
"All oral therapy will lead to a change in treatment paradigm"
"The number of treatable patients will dramatically increase! Interferon-Free"
"There is an association between SVR & all-cause mortality & liver-related mortality among patients with advanced hepatic fibrosis”
New HCV oral IFN-free drug regimens will provide with 12-24 weeks convenient therapy an SVR is associated with reduced risk of progression to advanced liver disease, liver cancer and mortality
Will prevent HCV transmission and be cost-effective…..therapies will be once or twice daily, much less side effects than current IFN-based therapy
Drug interactions will be an issue but we can deal with that
"Next step:
Cure rates >100%!!"
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发表于 2013-10-29 19:34
