DAA-PASS: A Prospective Evaluation of HCC Recurrence After Direct Acting Antiviral Therapy.

Challenge

Post-DAA HCC recurrence risk was flagged as a regulatory concern by the European Commission following early reports of unexpected early and aggressive recurrence, creating a mandatory post-authorization safety obligation for DAA manufacturers without an existing real-world study infrastructure capable of meeting the requirement.

Solution

The DAA-PASS prospective post-authorization safety study was embedded within the existing TARGET-HCC registry, using its established site network and data infrastructure to enroll HCV-infected patients with previously treated HCC and prospectively track recurrence in both the US and Europe.

Impact

Demonstrating that DAA therapy is not associated with increased HCC recurrence risk resolves the regulatory uncertainty that created the study mandate, while establishing Target RWE's ability to rapidly stand up prospective safety studies within existing registry infrastructure to meet regulatory obligations.