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Researchers Report Results for 28-day Phase II Study of VX-950 in Combination with Pegylated Interferon and Ribavirin in Hepatitis C Patients
Researchers Report Results for 28-day Phase II Study of VX-950 in Combination with Pegylated Interferon and Ribavirin in Hepatitis C Patients.
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[{"type":"text","content":"\n\n\n\n\n - 12 of 12 (100%) patients HCV RNA undetectable with no evidence of viral\n breakthrough at end of 28 days VX-950 dosing -\n\n - 92% (11 of 12) continued to have undetectable HCV RNA through 12 weeks of\n follow-on therapy -\n\nLOS ANGELES, May 22 /CNW/ -- Data to be presented this\nweek at the Digestive Disease Week conference show that plasma HCV RNA was\nreduced to undetectable levels (less than 10 IU/mL) in all 12 of 12 (100%)\npatients with genotype 1 HCV infection treated with VX-950, an investigational\noral hepatitis C virus (HCV) protease inhibitor being developed by Vertex\nPharmaceuticals Incorporated (Nasdaq: VRTX), in combination with pegylated\ninterferon alfa-2a (Pegasys(R); peg-IFN) and ribavirin (RBV) for 28 days. No\nviral breakthrough was observed in any patient during 28 days of VX-950\ndosing. All patients completed dosing with no serious adverse events; those\nadverse events reported are considered typical of peg-IFN and RBV combination\ntherapy. All patients enrolled in the 28-day study subsequently received\nfollow-on treatment with peg-IFN and RBV. Researchers reported for the first\ntime today that 11 of these patients (92%) continue to have no detectable\nvirus in their blood at the end of 12 additional weeks of follow-on\npeg-IFN+RBV dosing. The 12th patient was found to have detectable HCV RNA\n(less than 30 IU/mL) in the week 12 post-VX-950 follow-up sample, with\ncontinuing evidence of detectable HCV RNA in subsequent samples. All 12\npatients are continuing to receive peg-IFN+RBV.\n\"With the combination of VX-950, pegylated interferon and ribavirin, we\nobserved unprecedented antiviral activity, with all 12 genotype 1 patients\nreaching viral levels below the limits of detection at the end of dosing at 28\ndays,\" said Eric Lawitz, M.D., of Alamo Medical Research in San Antonio, the\ninvestigator presenting the study results. \"In addition, no serious adverse\nevents were reported, and those adverse events that were reported are similar\nto those observed in previous studies of pegylated interferon and ribavirin.\nThese results are highly encouraging for the initiation of future VX-950\nstudies that seek to evaluate the potential for viral eradication with short\nduration therapy.\"\nIn addition, researchers reported the results of a viral sequencing\nanalysis from patients in the 28-d...