This phase IIa study is a randomized, open-label, three-arm study of AL-335, a nucleotide-based HCV NS5B polymerase inhibitor, odalasvir, an HCV NS5A inhibitor and simeprevir, an HCV NS3/4A protease inhibitor.
Patients will be randomized to one of three treatment arms and receive once daily treatment for a duration of four, six or eight weeks.
The primary objective of the study is to establish the safety of the treatment regimen with secondary endpoints consisting of pharmacokinetics, the proportion of subjects achieving sustained viral response (SVR), and the effect on the viral resistance profile after treatment. The study is expected to enroll approximately 60 patients across the three treatment arms.
Approximately 150 million people are chronically infected with HCV globally.
When left untreated, HCV causes progressive liver disease in many of those who are chronically infected, and this can lead ultimately to cirrhosis, hepatocellular carcinoma and a requirement for liver transplantation.
However, combinations of direct acting antiviral agents, including treatment regimens containing a protease inhibitor such as simeprevir, have shown the potential to be curative and convenient regimens for patients infected with HCV.