Vertex reports 75% patients with HCV achieve viral cure with 12-week telaprevir-based combination regimen

May 26 2010

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 75% of people chronically infected with genotype 1 hepatitis C virus (HCV) who had not previously been treated achieved a sustained viral response (SVR or viral cure) after receiving a 12-week telaprevir-based combination regimen, followed by treatment with pegylated-interferon and ribavirin alone, in the Phase 3 ADVANCE trial. 69% of people achieved SVR after receiving an 8-week telaprevir-based combination regimen, followed by treatment with pegylated-interferon and ribavirin alone. 44% of people in the control arm achieved SVR after 48 weeks of treatment with the currently approved regimen of pegylated-interferon and ribavirin.

“As fewer than half of people with genotype 1 hepatitis C achieve a viral cure with currently approved therapies, new and more effective medicines are urgently needed.”

The safety and tolerability profile of telaprevir in the ADVANCE trial was consistent with the profile reported in Phase 2 studies, with an improvement in treatment discontinuation rates due to adverse events. Adverse events leading to discontinuation of all study drugs occurred in 6.9%, 7.7% and 3.6% of patients in the 12-week telaprevir-based arm, the 8-week telaprevir-based arm and the control arm, respectively.

"These first Phase 3 results are important for people with hepatitis C, as they represent a potential new era of therapy where doctors may be able to use direct acting antiviral medicines to improve treatment and help patients potentially avoid life-threatening liver-related consequences associated with chronic hepatitis C," said Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College, and an Investigator for the ADVANCE trial. "The ADVANCE results confirm findings seen in earlier trials of telaprevir and highlight that telaprevir-based combination regimens may increase viral eradication rates and shorten treatment time for many patients."

"These groundbreaking data are the result of our more than decade-long commitment to improving care for people with hepatitis C and should provide new hope for patients with this disease," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. "As fewer than half of people with genotype 1 hepatitis C achieve a viral cure with currently approved therapies, new and more effective medicines are urgently needed.

"These results for telaprevir show that 75 percent of patients in the 12-week telaprevir arm achieved a viral cure, with the majority receiving only 24 weeks of therapy, marking what we believe may be a potentially dramatic improvement in the future treatment of hepatitis C," concluded Dr. Kauffman.

Telaprevir is an investigational, oral inhibitor of HCV protease, an enzyme essential for viral replication, and is being developed by Vertex Pharmaceuticals in collaboration with Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma. Vertex plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) for telaprevir in the second half of 2010 for both treatment-naïve and treatment-failure patients.

SOURCE Vertex Pharmaceuticals Incorporated