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Vertex Pharmaceuticals (MA) (VRTX) Announces Sustained Viral Response Rate (SVR4) Data From All-Oral Study Of VX-135 In Combination With Daclatasvir In Hepatitis C


1/9/2014 10:20:02 AM

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BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the first data from the initial cohorts of an open-label Phase 2a study of VX-135, Vertex’s nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor, in combination with daclatasvir, Bristol-Myers Squibb's NS5A replication complex inhibitor. In an intent-to-treat analysis, the sustained viral response rate four weeks after the completion of treatment (SVR4) was 83 percent (10 of 12) in treatment-naïve genotype 1 patients who received 200 mg of VX-135 in combination with daclatasvir. In this arm, one patient discontinued treatment after the first dose due to a serious adverse event of vomiting/nausea. The 11 other patients in this arm completed 12 weeks of treatment, and 91 percent (10 of 11) achieved SVR4. In the study, the majority of adverse events were mild.

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