HCV-TARGET- Hepatitis C Therapeutic Registry and Research Network

• Sustained virological response (SVR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  The primary outcome measure is the occurence (yes or no) of SVR, defined as undetectable HCV RNA in serum at least 3 months after stopping therapy. Point estimates and confidence intervals will be calculated to describe the frequency of SVR in various sub-populations enrolled in HCV-TARGET.
  
  

• Treatment persistence [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  Treatment persistence will be the duration of treatment measured from the first dose of medication until treatment is discontinued. Reasons for premature discontinuation of treatment will be recorded.
  
  
• Virological breakthrough [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  The occurrence of virological breakthrough defined as an increase of HCV RNA by at least 1-log over nadir or to >100 IU if previously undetectable.
  
  
• Management of adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  Specific interventions to manage selected adverse events, such as anemia and skin rash, will be tabulated and described
  
  

HCV-TARGET is a longitudinal, observational study that will create a carefully maintained research registry of patients treated with telaprevir or boceprevir 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 regimens containing boceprevir and telaprevir 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 telaprevir and boceprevir (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.