Meet Gilead! Abt-493 / abt-530 large phase III clinical project

Source: Biovalley 2016-01-14 January 14, 2016: at present, in the field of hepatitis C treatment, American biotechnology giant Gilead is the absolute hegemon Relying on the star drug of hepatitis C, sovaldi and the new generation of all oral hepatitis C cocktail harvoni, the company, as always, controls more than 85% of the market share of hepatitis C in the United States Just last week, Geely's first pan genotype hepatitis C cocktail, sof / vel, which aims to treat all six genotypes of hepatitis C, won the FDA's priority review without any doubt, and will perfectly complement the company's current hepatitis C assets (sovaldi and harvoni) The industry can't help exclaiming that Gilead is going to wipe out all hepatitis C patients and the competitors! (related reading: Geely's first pan gene hepatitis C cocktail therapy, sof / vel, has obtained the FDA's priority review qualification.) the industry believes that at present, in the field of hepatitis C, in addition to albertone and Geely, other pharmaceutical companies seem to be able to wash and sleep In addition to facing Gilead head-on, Aberdeen is also rapidly advancing another strategy, striving to break through in niche markets (i.e niche markets ignored by competitors) in different types of hepatitis C subtype groups At the same time, the company is also rapidly promoting the clinical project of abt-493 / abt-530, a pan gene hepatitis C cocktail under research Recently, Aberdeen announced the launch of six global phase III clinical studies to evaluate the efficacy and safety of Pan genotype hepatitis C cocktail abt-493 / abt-530 in the treatment of all six genotypes of hepatitis C Abt-493 / abt-530 (300mg / 120mg) is a full oral, once a day, ribavirin free, pan gene hepatitis C cocktail Abt-493 is an NS3 / 4A protease inhibitor, abt-530 is an NS5A inhibitor The company's work in hepatitis C over the past few years has helped to bring about changes in clinical care for hepatitis C, and the company continues to advance these phase III studies in the hope of meeting the medical needs of a broader group of people living with hepatitis C According to a statement issued by the company, the duration study and the elaboration study are part of the company's phase III hepatitis C pipeline project These studies will recruit about 1600 hepatitis C patients from more than 250 research sites in 27 countries around the world The main efficacy end point of these six phase III studies is the continuous virological response (svr12) after 12 weeks of treatment Endurance study: four endurance studies will evaluate the efficacy and safety of Pan genotype hepatitis C cocktail abt-493 / abt-530 for 12 weeks in hepatitis C population without cirrhosis The endurance-1 study will be conducted in patients with genotype 1 hepatitis C (GT1 HCV) to compare SVR at 12 weeks and 8 weeks of abt-493 / abt-530 treatment The efficacy and safety of abt-493 / abt-530 against placebo will be evaluated in patients with genotype 2 hepatitis C (GT2 HCV) The efficacy and safety of Pan genotype abt-493 / abt-530 and sofosbuvir / daclatasvir were compared The endurance-4 study will be carried out in hepatitis C patients with genotype 4-6 (GT4, gt5, gt6 HCV) Elaboration study: the elaboration study will be carried out in the refractory hepatitis C population to evaluate the efficacy and safety of Pan genotype hepatitis C cocktail abt-493 / abt-530 The expediton-1 study will be carried out in patients with HCV genotype-1, - 2, - 4, - 5, - 6 with compensatory cirrhosis (child Pugh a) The expression-4 study will be carried out in patients with severe renal impairment and end-stage renal disease (ESRD) and genotype 1-6 hepatitis C with or without cirrhosis More information on these studies can be found at (nct02604017, nct02640482, nct02640157, nct02636595, nct02642432, nct02651194).