Business
Researchers Report Initial Results for 14-day Phase Ib Study of VX-950, and Pegylated Interferon, Showing Anti-HCV Activity in Combination in Hepatitis C Patients
Researchers Report Initial Results for 14-day Phase Ib Study of VX-950, and Pegylated Interferon, Showing Anti-HCV Activity in Combination in Hepatitis C Patients.
About this update from Vortex Energy Corp.
[{"type":"text","content":"\n\n\n\n\n -New data show that plasma HCV RNA levels were below limit of detection (10\n IU/mL) in 8 of 8 patients continued on peg-IFN+RBV for 12 weeks-\n\nVIENNA, Austria, April 29 /CNW/ -- Data presented at the\n41st Annual Meeting of the European Association for the Study of the Liver\n(EASL) in Vienna today show that when VX-950, an investigational oral\nhepatitis C virus (HCV) protease inhibitor being developed by Vertex\nPharmaceuticals Incorporated (Nasdaq: VRTX), was dosed with pegylated\ninterferon alfa-2a (Pegasys(R); peg-IFN), the combination was well-tolerated\nand achieved a dramatic reduction in plasma viral RNA levels in patients with\nchronic genotype 1 HCV infection through 14 days of dosing. At day 14, the\nmajority of patients (6 of 8) receiving the combination had HCV RNA levels\nbelow the limit of quantitation (30 IU/mL, as measured by the Roche TaqMan(R)\nassay), and 4 of 8 patients had HCV RNA levels below the limit of detection\n(10 IU/mL, Roche TaqMan(R)). All patients enrolled in the 14-day study\nsubsequently received follow-on treatment with peg-IFN and ribavirin (RBV).\nResearchers reported for the first time today that 8 of 8 patients who\nreceived VX-950 and peg-IFN in combination for 14 days have no detectable\nvirus in their blood at the end of 12 additional weeks of peg-IFN+RBV dosing.\nThese patients continue to receive peg-IFN+RBV therapy. All patients were\noffered follow-on peg-IFN+RBV treatment according to clinical practice at the\ninvestigator sites.\n\"In the 14-day study, VX-950 in combination with pegylated interferon\nproduced a very rapid viral response in each of these genotype 1 patients, and\nno serious adverse events were observed,\" said Henk W. Reesink, MD, Associate\nProfessor of Medicine at Academic Medical Center in Amsterdam, and a lead\ninvestigator for the study. \"The continued viral suppression during follow-on\ntherapy points to the robustness of the viral response to VX-950 and pegylated\ninterferon, and is encouraging for the design of future VX-950 studies that\nseek to evaluate the potential for short-course, curative therapy.\"\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 rand...