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EASL Brief Preview, liver conference next week in Barcelona:
interferon-free therapies
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from Jules: The annual European liver meeting EASL, European Association for the Study of the Liver, starts April 18 where there will be new data on numerous oral HCV drugs in various stages of development and on new interferon-free oral HCV drug therapies. There are several presentations on Gilead's GS-7977, the new potent nucleotide inhibitor. A press release already announced this week Abbott's 95% SVR rate with only 12 weeks therapy in genotype 1 treatment-naives in 2 small studies with 3 HCV drugs, their potent protease ABT450 + a NNRTI, either ABT333 or ABT072, plus ribavirin. Abbott reported a 47% SVR rate in treatment-experienced patients with the same regimen, so for these patients more potent therapy regimens will have to be put together. There was a leak in data reported online by analysts this week, because much of the data is embargoed until presented at the conference, on the end-of-treatment data after 12 weeks therapy with the 2-drug combination of BMS' potent NS5A inhibitor daclatasvir+GS7977, where online analysts reported 97% of genotype 1 treatment-naive patients had undetectable virus after 12 weeks of treatment. There are several additional important new HCV drugs for which updates are expected including Roche's protease danoprevir boosted with low dose ritonavir, Boerhinger Ingelheim's protease BI201335 & their NNRTI BI207127, TMC435 the potent protease from Janssen, alisporivir the potent cyclophillin inhibitor. In phase 3 development, the last stage before FDA approval are daclatasvir, BI201335, TMC435, Alisporivir & already started or about to start for GS7977, with others quickly planning to move ahead fast as well. There will also be an update on a the 3-drug oral regimen of BI201335+BI207127+ribavirn. And of course there will be more updates & reports at EASL on additional new HCV drugs in development. At this point in development there are 5 major classes of new oral HCV drugs that are poised to be used in various combinations that include protease inhibitors, NS5A inhibitors, nucleotides, NNRTIs, and cyclophillin inhibitor, and ribavirin is still being used in some combinations. To leave you with one last thought: these 2 data leaks above report 95% SVR rates in small interferon-free multi-drug oral drug combinations of only 2 or 3 drugs, so is this the new standard of care that all future regimens will have to match for treatment-naives?? Roche, BMS, Gilead, Vertex, Abbott & Merck (also Idenix & Achllion, 2 smaller biotechs) each have several new HCV oral drugs at various stages of development, so are developing their own multi-drug interferon-free oral regimen with or without ribavirin.
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