Pharmasset presents positive Phase I data for hepatitis C drug

In this study, R7128 demonstrated potent antiviral activity and was generally safe and well-tolerated, and all 40 patients completed the study. R7128 is being developed in collaboration with Roche.

There were no serious adverse events, no adverse events requiring dose modification, no dose-related gastrointestinal adverse events and no clinically significant changes in hematologic or other laboratory parameters. The preliminary data on adverse events (AEs) reported shows the highest incidence of AEs was in the placebo group with 34 events in seven of eight patients receiving placebo.

Michelle Berrey, Pharmasset’s vice president and clinical development and chief medical officer, said: “R7128 has provided positive proof-of-concept that a single, direct-acting antiviral can deliver sufficient potency to suppress HCV in an interferon non-responder population. Since robust synergy has been observed with other potent inhibitors when combined with the standard of care for HCV, we hope that these monotherapy results will translate well when R7128 is used with standard of care for longer duration in a treatment-naive population.”