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news.Vertex Pharmaceuticals has said 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.
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Vertex has added that 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.
According to the Vertex, 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.
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 US FDA for telaprevir in the second half of 2010 for both treatment-naive and treatment-failure patients.
Advance was a Phase 3, randomized, double-blind, placebo-controlled trial that enrolled approximately 1,095 people infected with genotype 1 chronic HCV, the most common form of the virus in the US and Europe, who had not previously been treated for their HCV infection.
Ira Jacobson, chief of the division of gastroenterology and hepatology, Weill Cornell Medical College, and an investigator for the Advance trial, said: “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.”
Robert Kauffman, senior vice president and chief medical officer for Vertex, said: “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.
“These results for telaprevir show that 75% 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.”