The HCV Wave

The nearly 170 million people infected with the hepatitis C virus (HCV) represent a massive wave of morbidity and mortality that may soon crash down on societies worldwide.

HCV is a viral infection that can cause progressive liver damage and may ultimately lead to liver failure and death. Most of the estimated 3.2 million people in the U.S. infected with HCV became infected 20 to 35 years ago, however more than two million remain undiagnosed and untreated. Today, some 10,000 people per year die from liver-related complications in the U.S.

While HCV can be cured in some patients, the currently approved therapy results in eradication of the virus, also known as a sustained viral response (SVR), in only 40-50% of genotype 1 patients who begin the 48-week treatment regimen. For every patient cured today, another is not, and those treatment-failure patients have few options for re-treatment of their disease.

Novel Approaches to Advance HCV Patient Care

Telaprevir is Vertex´s leading, specifically targeted antiviral therapy for hepatitis C (STAT-C) in development for the treatment of HCV infection. Telaprevir inhibits the activity of the HCV protease, an essential enzyme in HCV replication.

Clinical data presented in 2008 support a potentially differentiated profile for telaprevir to improve outcomes for patients who have not received prior HCV therapy and also for patients who failed prior HCV therapy. In Phase 2 studies in genotype 1 treatment-naïve patients, telaprevir, when combined with pegylated interferon and ribavirin, showed the potential to cure up to 69% of patients with 24 weeks of telaprevir-based therapy - half the duration of currently approved treatment. Telaprevir has also shown unprecedented antiviral activity in patients who failed prior treatment, and the full results of a Phase 2 study in these patients will be presented at a medical conference in 2009.

Enrollment of more than 2,200 patients is complete in a broad Phase 3 registration program that Vertex believes will enable the filing of a New Drug Application for telaprevir in treatment-naïve and treatment-failure patients in the second half of 2010.

In addition to ongoing Phase 3 studies, Vertex is evaluating the potential role of telaprevir as part of different dosing regimens, including the evaluation of a twice-daily dosing regimen, and also plans to evaluate telaprevir in important HCV sub-populations, including patients co-infected with HIV and HCV. Vertex also expects to initiate future clinical trials of telaprevir in combination with a novel HCV polymerase inhibitor, which Vertex gained as part of its acquisition of ViroChem Pharma in early 2009. Vertex also continues to advance other novel HCV protease inhibitors, including VX-813 and VX-985.