Bioavailability of the HCV NS3/4A Protease Inhibitor Telaprevir–Effect of Different Types of Food

Aims: Telaprevir (TVR) showed significantly increased SVR rates in Phase 3 studies versus SOC. This study evaluated the impact of different types of food on the bioavailability of orally administered TVR. Methods: In this open-label, randomized, 5-way cross-over trial in 30 HCVnegative, healthy volunteers pharmacokinetic profiles were assessed after single dose administration of TVR 750mg with a regular breakfast (533 kcal, 21g fat), under fasted conditions, with high-fat breakfast (928 kcal, 56g fat), lowcalorie/ high protein breakfast (260 kcal, 9g fat), and low-calorie/low-fat breakfast (249 kcal, 3.6g fat).…