Telaprevir (VX-950)
(HCV Infection)
Telaprevir (VX-950) is an investigational oral protease inhibitor (PI) for the treatment of hepatitis C virus (HCV) infection. HCV protease is a unique HCV enzyme that is essential for viral replication and for helping HCV evade host immune defenses.
Telaprevir Clinical Development Plan
Telaprevir (VX-950) is an investigational oral protease inhibitor (PI) for the treatment of hepatitis C virus (HCV) infection. HCV protease is a unique HCV enzyme that plays a key role in viral replication and may also help the virus evade host immune defenses.
Phase 3 telaprevir Clinical Development: In March 2008, Vertex began a 1,050-patient Phase 3 clinical trial of telaprevir evaluating 24-week telaprevir-based treatment regimens compared to current standard treatment in treatment-naive patients with genotype 1 HCV.
Phase 2 telaprevir Clinical Development- The PROVE studies: In 2006 and 2007, Vertex initiated three Phase 2b clinical trials of telaprevir, designed to evaluate sustained viral response rates in more than 1000 patients with genotype 1 HCV. These trials, known as PROVE 1, PROVE 2 and PROVE 3, are now fully enrolled. The design and status of the PROVE studies is summarized here:
About Hepatitis C Hepatitis C is a liver disease caused by infection with hepatitis C virus (HCV), which is found in the blood of people with the disease. HCV, a serious public health concern affecting 170 million people worldwide, is spread through direct contact with the blood of an infected person. Though many people with hepatitis C may not experience symptoms, others may have symptoms such as jaundice, abdominal pain, fatigue and fever. Patients infected with HCV are at risk of developing chronic infection, which may ultimately lead to cirrhosis and liver cancer. HCV-associated liver disease accounts for 8,000-10,000 deaths per year in the United States.
