---
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: '2023-04-10'
author: Michael W. Fried, MD, FAASLD, Andrea R. Mospan, Heather L. Morris
category: Publications
tags:
  - 'Yes'
  - R&D
  - Hepatology
  - Care
  - Health System Partner
  - Poster Presentation
  - HCC
  - EASL Congress
  - Cleveland Clinic
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source: Pedestal Health
license: © 2026 Pedestal Health. All rights reserved.
slug: a-prospective-pragmatic-post-authorisation-safety-study-of
id: ehGhwSpvoxKZqrVkOwNjz
contentType: article
---

# 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

**Cleveland Clinic**

*Michael W. Fried, MD, FAASLD, Andrea R. Mospan, Heather L. Morris*

## 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.

## Use Cases / Links

Regulatory-mandate post-authorization HCC safety study execution within existing registry, DAA therapy and HCC recurrence: real-world prospective safety evidence, Registry-embedded prospective study design for post-market safety surveillance in HCC