The opportunity to redefine the treatment of major diseases is what drives everyone at Vertex. Our development portfolio represents the fruit of these efforts. Spend some time here and look around. Click on the pipeline chart to get information on our development programs and links to selected published articles. Go further and see how, just maybe, disease challenges may be overcome with innovation.

Telaprevir (VX-950)
(HCV Infection)

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.

The ADVANCE study - Phase 3 telaprevir Clinical Development: In October 2008, Vertex completed enrollment in ADVANCE, the first Phase 3 clinical trial of telaprevir. ADVANCE is an international 3-arm pivotal trial evaluating two 24-week telaprevir-based treatment regimens in approximately 1,050 treatment-naïve genotype 1 HCV patients.

The ILLUMINATE study - Phase 3 telaprevir Clinical Development: In January 2009, Vertex completed enrollment in the global 2-arm ILLUMINATE trial that will include evaluation of 24-week and 48-week telaprevir-based regimens in genotype 1 treatment-naïve HCV patients. The ILLUMINATE trial enrolled approximately 500 patients.

The REALIZE study - Phase 3 telaprevir Clinical Development: In February 2009, Vertex and its collaborator, Tibotec, completed enrollment of REALIZE, a pivotal Phase 3 clinical trial of telaprevir–based treatment regimens for patients with genotype 1 HCV infection who failed to achieve SVR with prior therapy with pegylated-interferon and ribavirin. The REALIZE trial enrolleded approximately 650 patients.

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. The trials known as PROVE 1 and PROVE 2 are now complete, and PROVE 3 is ongoing. 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.