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New HCV Treatments coming:pangenotypic 2-3 drug regimens
from Jules: At AASLD & HepDart in Nov/Dec 2015 the latest research in HCVwas reported, all the importantstudies, well over 100 reports including studies not just on new & currentHCV therapies but also on many other key concerns like treatment around livertransplant and in patients with advanced liver disease/decompensated liverdisease, cost-effectiveness, restrictions as barriers to care, costs associatedwith curing ALL with HCV, and of note studies on treating earlier in diseaseduring stages F0-F2 rather than deferring until patients have cirrhosis. Ofnote we saw improved SVR rates to around 90% for the most difficult genotype totreat Genotype 3 with cirrhosis with daclatasvir+sofosbuvir and withSofosbuvir+Valpatasvir, or perhaps better; see retreatment therapies below.
Despitethe unique medical breakthrough of the last 50 years heralding the greateffectiveness of all the new HCV therapies on the market including Harvoni,Abbvie 3D and simeprevir & daclatasvir, newer highly anticipated treatmentsare expected to be approved in 2016 and in the next few years. The Merck regimen of Elbasavir+Garazoprevir is composed 2 what can be considered 2nd generation in their classes, a potentprotease inhibitor and a potent NS5A inhibitor, FDA approval (PDUFA date) isJan 28 2016 . The next generation Gilead regimen Sofosbuvir+Velpatasvir(GS-5816) is a pangenotypic regimen, meaning it works for all genotypes(1/2/3/4/5/6) contains a 2nd generation NS5A inhibitor (GS-5816) that is thefollowup NS5A to lepipasvir which is the NS5A inhibitor that is included in thecombination along with sofosbuvir called Harvoni, and the expected FDA approvaldate is June 28, 2016. As you can see below the SVR rates are better than withHarvoni. Of note Gilead's 3rd generation treatment is a pangenotypic 3-drugregimen - Sofosbuvir+Valpatasvir+ a next generation protease inhibitorGS-9857 - you can see the link to a study of 8 weeks of treatment on thisregimen reported at AASLD below. Abbvie's next generation also pangenotypictherapy is ABT-493+ABT-530, the start of the global 6-studies phase 3 ingenotypes 1-6 was just announced http://www.natap.org/2016/HCV/011116_04.htm.ABT-493 is a next generation protease inhibitor and ABT-530 a next generationNS5A inhibitor, here are the 8 & 12 weeks treatment SVR rates below......Merck reported early results of their next generation also pangenotypic 3-drugregimen which includes the Merck nucleotide MK-3682 (same class of drug assofosbuvir) + a next generation NS5A inhibitor MK-8408 + their proteaseinhibitor Grazoprevir see link to their study of 8 weeks treatment below.J&J is developing a 3-drug pangenotypic regimen; J&J bought out Aliosnucleotides and Achillion nucleotide and next generation NS5A inhibitor, andannounced in August 2015 they started a phase 1 study of simeprevir + ACH-3102+ AL-335 http://www.natap.org/2015/HCV/080315_02.htm.
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发表于 2016-1-25 11:48