Business
VX-950, Investigational Oral Hepatitis C Protease Inhibitor, Demonstrates Rapid and Dramatic Reduction in Viral Levels in Combination with Pegylated Interferon
VX-950, Investigational Oral Hepatitis C Protease Inhibitor, Demonstrates Rapid and Dramatic Reduction in Viral Levels in Combination with Pegylated Interferon.
About this update from Vortex Energy Corp.
[{"type":"text","content":"\n\n\n\n\n-- Median 5.5 log10 reduction in HCV RNA achieved in patients receiving VX-950\n and peg-IFN in 14-day clinical study --\n\nCAMBRIDGE, Mass., Jan. 9 /CNW/ -- New data announced\ntoday by Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) show that VX-950,\nan investigational oral hepatitis C virus (HCV) protease inhibitor, dosed in\ncombination with pegylated interferon alfa-2a (Pegasys(R); peg-IFN), achieved\na rapid and dramatic reduction in plasma viral RNA levels in patients with\nchronic genotype 1 HCV infection. In this Phase Ib study, the combination of\nVX-950 and peg-IFN produced an initial median reduction in plasma HCV RNA of\nmore than 3 log10 in the first two days, followed by continued decline to a\nmedian 5.5 log10 reduction in HCV RNA at day 14, which equates to a 300,000-\nfold reduction in viral levels. The majority of patients (6 of 8) receiving\nthe combination achieved HCV RNA levels below the limit of quantitation (30\nIU/mL, as measured by the Roche TaqMan(R) assay) at 14 days, with 4 of 8\npatients achieving HCV RNA levels below the limit of detection (10 IU/mL,\nRoche TaqMan(R)). The antiviral activity of the combination through 14 days\nwas significantly greater than the activity of VX-950 administered as a single\nagent, and much greater than peg-IFN alone. In addition, VX-950 appeared to\nbe well-tolerated when dosed alone and in combination with peg-IFN in the\nstudy. The full data set will be presented at a medical conference later this\nyear.\n\"These data show that VX-950, in combination with pegylated interferon,\nproduced a very rapid viral response in each of these genotype 1 patients, who\nare historically the most difficult to treat effectively,\" said Henk W.\nReesink, MD, Associate Professor of Medicine at Academic Medical Center in\nAmsterdam, and a lead investigator for the study. \"The profound decreases in\nviral load strongly support the evaluation of VX-950 in combination with\npegylated interferon as part of a three-month treatment paradigm to achieve\nsustained viral responses (SVR) in HCV patients.\"\n\nStudy Design and Results\nThe 14-day, randomized, blinded, placebo-controlled Phase Ib study\nenrolled 20 treatment-naive patients with genotype 1 HCV, the most prevalent\nand difficult to treat form of HCV infection. Patients were randomized to\nreceive a new tablet formu...