A Prospective, Pragmatic Post-Authorisation Safety Study of Early Recurrence of Hepatocellular Carcinoma in Hepatitis C Virus-Infected Patients after Direct-Acting Antiviral (DAA) Therapy: DAA-PASS.

Challenge

Following early reports of potentially increased HCC recurrence after DAA therapy, the European Commission mandated a prospective post-authorization safety study from DAA manufacturers, but no existing real-world infrastructure was positioned to execute this study across the required US and European sites.

Solution

The DAA-PASS prospective safety study was designed and embedded within TARGET-HCC, enrolling HCV-infected patients with complete radiologic response after HCC treatment and prospectively tracking recurrence after DAA initiation across US and Italian sites over a planned sample of 600 patients.

Impact

Demonstrating that DAA therapy is not associated with increased HCC recurrence—and standing up a prospective regulatory-mandate study within an existing registry infrastructure—both resolves the safety uncertainty and demonstrates Target RWE's capacity to execute post-authorization safety obligations for pharma and regulatory clients.