CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Tibotec today announced that patient screening has begun in the ADVANCE study, a pivotal Phase 3 clinical study with the hepatitis C virus (HCV) protease inhibitor telaprevir in combination therapy for treatment-naïve patients with chronic HCV infection. Telaprevir is the most advanced HCV protease inhibitor in clinical development targeting treatment of hepatitis C, a disease that afflicts more than 3 million people in the United States alone, and 170 million worldwide. The ADVANCE trial will enroll 1,050 treatment-naïve genotype 1 HCV patients and will evaluate two 24-week telaprevir-based regimens in comparison to a 48-week control arm. The primary endpoint of the study is sustained viral response (SVR), defined as undetectable HCV RNA (<10 IU/mL) 24 weeks after the completion of treatment. In this study, rapid viral response (RVR) criteria will be used to determine which telaprevir patients can stop all treatment at 24 weeks.
