Tibotec announced results of a new study (VX950-C208), which showed that sustained virologic response (SVR) was achieved in more than 80 per cent of treatment-naïve patients with chronic genotype-1 hepatitis C virus (HCV) who took telaprevir, administered either every eight hours or every 12 hours, in combination with standard of care. Telaprevir, an investigational STAT-C (Specifically Targeted Antiviral Therapy for hepatitis C), is being co-developed by Tibotec in collaboration with Vertex Pharmaceuticals. The study was presented at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting).
In the phase-II study, which enrolled 161 treatment-naïve genotype-1 patients, rates of SVR (defined as undetectable HCV RNA at 24 weeks after completion of treatment) ranged from 81 to 85 percent in patients treated with the every eight hour telaprevir-based regimen, and 82 to 83 per cent in patients treated with the every twelve hour regimen. Adverse events (AEs) were similar to those observed in other trials with telaprevir and were mainly haematologic (anaemia) and cutaneous (rash and pruritus) in nature.
For the vast majority of patients, these high SVR rates were obtained with only 24 weeks of total treatment (half the duration of current standard of care). Total duration of treatment was decided using a criteria based on treatment response. Subjects who achieved undetectable HCV RNA at week four (rapid virologic response or RVR) and maintained this through week 20, were allowed to stop all treatment at week 24. Only 18 per cent of subjects were required to continue standard treatment up to week 48.
Approximately 180 million people worldwide are infected with HCV,1 the most common cause of liver transplant in Europe. People with HCV genotype-1 currently face treatment limitations, including a standard of care that cures just 40 to 50 per cent of patients. Without effective treatment, HCV can lead to serious and fatal diseases of the liver, including liver cancer4.
“The data presented today show that a significant number of treatment-naïve genotype 1 HCV patients achieved sustained virologic response with telaprevir, in combination with standard of care,” said professor Patrick Marcellin from Hôpital Beaujon in Clichy, France. “Telaprevir, which directly targets the virus by aiming to block its replication, could allow shortening treatment duration and increasing cure rates in people with HCV, [compared to standard of care] offering a new approach to treating HCV.”
“For too long, people with HCV have faced treatment limitations, necessitating a paradigm shift in HCV therapy,” said Roger Pomerantz, president of Tibotec Research and Development. “Tibotec is proud to apply its expertise in virology to discover, develop and make available new therapies that target HCV in a different way.”
There are currently two fully enrolled, pivotal phase-3 clinical trials examining telaprevir in genotype-1 HCV-infected adults – REALIZE in treatment-experienced patients and ADVANCE in treatment-naïve patients.
Tibotec BVBA is a global pharmaceutical and research development company.