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Phase 2 telaprevir study published in New England Journal of Medicine
Data from the PROVE3 trial published today in the New England Journal of Medicine show that telaprevir-based regimens are significantly more effective than the current standard of care in helping patients with chronic genotype 1 hepatitis C virus (HCV) who failed previous therapy achieve a sustained virologic response (SVR). Study participants, who had failed prior treatment with pegylated interferon combined with ribavirin, were randomly assigned to one of four treatment regimens, three of which contained telaprevir, an investigational DAA (Direct Acting Antiviral) being co-developed by Tibotec and Vertex Pharmaceuticals.
Chronic infection with HCV can cause severe liver problems, including liver cancer and cirrhosis, and is the most common cause of liver transplant in Europe. The goal of HCV treatment is to achieve SVR, which means the virus remains undetectable in patients blood six months after they have finished treatment. Patients who achieve SVR are considered cured. The current standard of care for HCV, pegylated interferon combined with ribavirin, may cause side effects and cures only about half of patients with genotype starting therapy for the first time. For those that fail therapy, re-treatment with standard of care is effective in a very limited proportion of patients.
After initial treatment patients with HCV who fail to achieve SVR typically don’t succeed when they are re-treated. This study shows that telaprevir may provide a much-needed new therapeutic option for patients undergoing a second round of treatment, said Michael P. Manns, M.D., Professor and Chairman, Department of Gastroenterology, Hepatology and Endocrinology Medical School of Hannover, Germany and principal investigator for the PROVE 3 study. The study also gave us important insights into the types of patients who are likely to respond to re-treatment.
In the study, patients were randomized to receive one of four courses of treatment:
“We are pleased to publish such promising data for a patient population that currently has so few treatment options,” said Maria Beumont-Mauviel, Medical Director, Clinical Development, Tibotec. “We’re continuing to evaluate the safety, efficacy, and optimal dosing regimen for telaprevir in a pivotal clinical trial program.”
Data from the PROVE1 and PROVE2 studies, which examined telaprevir in treatment-naive genotype 1 HCV patients, were published in the 30 April 2009 issue of the New England Journal of Medicine.