Telaprevir enters Ph III trial in chronic HCV

The USA's Vertex Pharmaceuticals and Irish drugmaker Tibotec have initiated patient screening in the ADVANCE study, a pivotal Phase III trial with the hepatitis C virus protease inhibitor telaprevir in combination therapy for treatment-naive patients with chronic infection.

Telaprevir is the most advanced HCV protease inhibitor in clinical development targeting treatment of the liver disease which afflicts more than thee million people in the USA alone, and 170 million worldwide. The ADVANCE trial will enroll 1,050 treatment-naive genotype 1 HCV patients and will evaluate two 24-week telaprevir-based regimens in comparison to a 48-week control arm. The primary endpoint of the study is sustained viral response, defined as undetectable HCV RNA (<10 IU/mL) 24 weeks after the completion of treatment. In this study, rapid viral response criteria will be used to determine which telaprevir patients can stop all treatment at 24 weeks. According to the firms, this is the first Phase III study to evaluate whether an investigational HCV drug may be able to both increase the rate of SVR and shorten the duration of therapy to 24 weeks in patients with genotype-1 HCV infection compared to current treatment of 48 weeks.