| |
New HCV Treatments coming
|
| |
| |
from Jules: At AASLD & HepDart in Nov/Dec 2015 the latest research in HCV was reported, all the important studies, well over 100 reports including studies not just on new & current HCV therapies but also on many other key concerns like treatment around liver transplant and in patients with advanced liver disease/decompensated liver disease, cost-effectiveness, restrictions as barriers to care, costs associated with curing ALL with HCV, and of note studies on treating earlier in disease during stages F0-F2 rather than deferring until patients have cirrhosis. Of note we saw improved SVR rates to around 90% for the most difficult genotype to treat Genotype 3 with cirrhosis with daclatasvir+sofosbuvir and with Sofosbuvir+Valpatasvir, or perhaps better; see retreatment therapies below.
Despite the unique medical breakthrough of the last 50 years heralding the great effectiveness of all the new HCV therapies on the market including Harvoni, Abbvie 3D and simeprevir & daclatasvir, newer highly anticipated treatments are 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 potent protease inhibitor and a potent NS5A inhibitor, FDA approval (PDUFA date) is Jan 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 the followup NS5A to lepipasvir which is the NS5A inhibitor that is included in the combination along with sofosbuvir called Harvoni, and the expected FDA approval date is June 28, 2016. As you can see below the SVR rates are better than with Harvoni. Of note Gilead's 3rd generation treatment is a pangenotypic 3-drug regimen - Sofosbuvir+Valpatasvir+ a next generation protease inhibitor GS-9857 - you can see the link to a study of 8 weeks of treatment on this regimen reported at AASLD. Abbvie's next generation also pangenotypic therapy is ABT-493+ABT-530, the start of the global 6-studies phase 3 in genotypes 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 generation NS5A inhibitor, here are the 8 & 12 weeks treatment SVR rates below...... Merck reported early results of their next generation also pangenotypic 3-drug regimen which includes the Merck nucleotide MK-3682 (same class of drug as sofosbuvir) + a next generation NS5A inhibitor MK-8408 + their protease inhibitor Grazoprevir . J&J is developing a 3-drug pangenotypic regimen; J&J bought out Alios nucleotides and Achillion nucleotide and next generation NS5A inhibitor, and announced in August 2015 they started a phase 1 study of simeprevir + ACH-3102 + AL-335 http://www.natap.org/2015/HCV/080315_02.htm.
|
|
| |
| |
|
|
|
