---
title: >-
  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.
description: >-
  Explore this publication on real-world evidence: A Prospective, Pragmatic
  Post-Authorisation Safety Study of Early Recurrence of Hepatocellular
  Carcinoma in…
date: '2023-01-01'
category: Publications
tags:
  - EASL Congress
  - Poster Presentation
  - R&D
  - Care
  - Hepatology
  - HCC
  - Health System Partner
canonical_url: >-
  https://www.pedestalhealth.com/resources/publications/easl-congress/a-prospective-pragmatic-post-authorisation-safety-study-of/
source: Pedestal Health
license: © 2026 Pedestal Health. All rights reserved.
slug: a-prospective-pragmatic-post-authorisation-safety-study-of
id: ehGhwSpvoxKZqrVkOwNjz
contentType: article
---

## 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.

### [Andrea R. Mospan](/people/andrea-mospan/)

![Andrea R. Mospan, PhD, RAC — Profile Photo](https://images.ctfassets.net/h4s3ip99qawo/4w6bkwPHPqrXKYs4tHZPkK/1d21763b54ecc3466764986693b7072f/andrea-mospan.jpg)

### [Heather L. Morris](/people/heather-morris/)

![Heather Morris, PhD — Profile Photo](https://images.ctfassets.net/h4s3ip99qawo/16PnQ817q7tv964vhcUD5f/ce6797c32df11f022ef12ecbb9ffea49/heather-morris.jpg)