HCV-TARGET- Hepatitis C Therapeutic Registry and Research Network

HCV-TARGET is a longitudinal, observational study that will create a carefully maintained
research registry of HCV patients treated with antiviral therapies designed to rapidly inform
strategies for better management of populations underrepresented in clinical trials, identify
and remediate educational gaps relative to treatment guidelines and adverse event management
in order to optimize rates of sustained virological response (SVR), and serve as the core
resource for important collaborative translational studies utilizing biospecimens and
clinical data from diverse patient populations.

HCV-TARGET is a cooperative academic consortium of principal investigators from Clinical and
Translational Award (CTSA)-funded academic institutions and community-based sites affiliated
with the academic sites in geographic proximity. The Clinical Coordinating Center (CCC)
resides at the University of Florida and the Data Coordinating Center (DCC) resides at the
University of North Carolina at Chapel Hill.

The HCV-TARGET registry will characterize the population of chronic hepatitis C (HCV)
patients who are being treated with antiviral therapies at academic and community sites.
Patient characteristics such as age, race, ethnicity, comorbidity, and disease and treatment
status will be examined.

HCV-TARGET will also:

1. Provide baseline and treatment response data that will be used to pre-identify
candidates for enrollment in future clinical trials. HCV-TARGET will also develop a
well-characterized cohort of protease inhibitor treatment failures to be considered for
future trials.

2. Establish and maintain data, a specimen bank and other resources for ancillary studies
of the pathogenesis, diagnosis, natural history and treatment of HCV infection.

This study will investigate various aspects of treatment response to regimens containing
direct-acting antiviral agents for the treatment of chronic hepatitis C, including the
following:

- Patients underrepresented in clinical trials of approved antiviral therapies(including
African-Americans, patients with cirrhosis, and patients that are considered null
responders to treatment.)

- Treatment persistence

- Virological breakthrough

- Impact of viral load measurement on treatment efficacy

- Adverse Event Management and Surveillance.

The secondary aims for this study will investigate the following:

- Sustained virological response (SVR) rates and safety in special populations.

- Surveillance of drug-drug interactions.

- Treatment and management adherence.

- Pretreatment Education in HCV patient population.

- Use of specialty pharmacy for hepatitis C therapy.

Inclusion Criteria:

- All adult patients (age 18 or older) being treated with antiviral HCV treatment
regimens that contain telaprevir or boceprevir.

Exclusion Criteria:

- Inability to provide written informed consent.

- Currently participating in another clinical trial of hepatitis C therapeutics. Studies
comparing HCV RNA assays are not considered exclusionary.