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news.Vertex Pharmaceuticals has completed dosing with VX-950 in a phase II, 28-day clinical study in hepatitis C virus infected patients. In the study there were no treatment discontinuations and no serious adverse events reported.
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The 28-day, phase II clinical study enrolled 12 treatment-naive patients with genotype 1 HCV. Patients received VX-950 in a tablet formulation at a dose of 750 mg every eight hours for 28 days in combination with standard doses of pegylated interferon alfa-2a, and ribavirin.
At the end of 28 days, patients completed dosing with VX-950 and then continued treatment with peg-IFN and RBV. This 28-day, phase II study was not designed to evaluate sustained viral responses in patients receiving VX-950.
The company has also completed three-month animal toxicology studies that will support clinical studies of VX-950 of up to three months duration. Initiation of additional phase II clinical studies in the US in patients with HCV is planned following required FDA review of these latest non-clinical and clinical results, and FDA review of a proposed clinical study protocol.