Eliav Barr

We’ve been discussing simplifying protocol designs for decades. And yet, a phase III protocol today collects nearly 6 million data points on average; a figure that’s been climbing by roughly 11% annually. Despite genuine efforts across the industry to reduce protocol complexity, the trend line hasn’t budged. The reasons are partly scientific and operational. And they’re also deeply human. The forces we can’t ignore Some complexity in our protocols is unavoidable and even necessary.

Elbasvir (EBR; HCV NS5A inhibitor) and grazoprevir (GZR; HCV NS3/4A protease inhibitor) are approved as a fixed-dose combination to treat patients chronically infected with HCV genotypes 1 and 4. During the development program and supported by in vitro potency, the efficacy of EBR + GZR was assessed in HCV GT3-infected patients.